8–13–09 Thursday Vol. 74 No. 155 Aug. 13, 2009

Pages 40719–41032

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Contents Federal Register Vol. 74, No. 155

Thursday, August 13, 2009

Advisory Council on Historic Preservation Comptroller of the Currency See Historic Preservation, Advisory Council NOTICES Proposed Interagency Guidance – Funding and Liquidity Agriculture Department Risk Management, 40867–40868 See Forest Service NOTICES Consumer Product Safety Commission Agency Information Collection Activities; Proposals, PROPOSED RULES Submissions, and Approvals, 40807–40809 Audit Requirements for Third Party Conformity Assessment Bodies, 40784–40794 Army Department See Engineers Corps Defense Department See Engineers Corps Centers for Disease Control and Prevention NOTICES Engineers Corps Health Promotion and Disease Prevention Research Centers, NOTICES Special Interest Project Competitive, etc.: Proposed Suspension and Modification of Nationwide Disease, Disability, and Injury Prevention and Control Permit (21), 40815–40816 Special Emphasis Panel, 40822 Rescission of February 4, 2004 Order and Subsequent Environmental Protection Agency Amendments Prohibiting Importation of Birds, etc., RULES 40824–40826 Approval and Promulgation of Air Quality Implementation Plans: Centers for Medicare & Medicaid Services Ohio; Consumer Products Rule, 40745–40747 PROPOSED RULES Pennsylvania, 40747–40750 Medicare Program: Pesticide Tolerances: Home Health Prospective Payment System Rate Update Spinetoram, 40753–40760 (Calendar Year 2010); Republication, 40948–41005 Revisions to the California State Implementation Plan: Great Basin Unified Air Pollution Control District, Kern Coast Guard County Air Pollution Control District, Mohave Desert RULES Air Quality Management District, 40750–40753 Safety Zones: PROPOSED RULES Hood Canal Bridge Cable Laying Operation, Hood Canal, Approval and Promulgation of Air Quality Implementation WA, 40734–40736 Plans: Special Local Regulation for Marine Events: Ohio; Consumer Product Rule, 40804–40805 Mattaponi River, Wakema, VA, 40731–40734 Pennsylvania, 40805–40806 PROPOSED RULES NOTICES Drawbridge Operations: Cross-Media Electronic Reporting Rule State Authorized East River, New York City, NY, 40802–40804 Program Revision/Modification Approvals: NOTICES State of Washington, 40816–40817 Certificates of Alternative Compliance: Regional Waivers of Section 1605 (Buy American Lift Boat CAITLIN, 40829–40830 requirement) of 2009 American Recovery and Lift Boat PAUL, 40830 Reinvestment Act: Oceanographic Research Vessel FAIRFIELD City of Ocean Shores (the City), WA, 40817–40818 CHALLENGER, 40828 Offshore Supply Vessel BJ BLUE DOLPHIN, 40828–40829 Executive Office of the President Offshore Supply Vessel CALLAIS NAVIGATOR, 40827 See Trade Representative, Office of United States Offshore Supply Vessel HOS SILVER ARROW, 40829 Offshore Supply Vessel HOS SWEET WATER, 40827– Federal Aviation Administration 40828 RULES Offshore Supply Vessel PAO DE ACUCAR, 40829 Standard Instrument Approach Procedures, and Takeoff Meetings: Minimums and Obstacle Departure Procedures: 2006 Maritime Labour Convention; Informational, 40834 Miscellaneous Amendments, 40719–40723 PROPOSED RULES Commerce Department Airworthiness Directives: See Industry and Security Bureau Airbus Model A318 Series Airplanes, 40776–40778 See International Trade Administration American Champion Aircraft Corp. Models 7ECA, See National Oceanic and Atmospheric Administration 7GCAA, 7GCBC, 7KCAB, 8KCAB, and 8GCBC Airplanes, 40781–40783 Commodity Futures Trading Commission Bombardier Model DHC 8 100 and DHC 8 200 Series PROPOSED RULES Airplanes, and Model DHC 8 301, –311, and –315 Account Class, 40794–40799 Airplanes, 40778–40781

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Federal Communications Commission Homeland Security Department PROPOSED RULES See Coast Guard Television Broadcasting Services: See U.S. Customs and Border Protection Flagstaff, AZ, 40806 Industry and Security Bureau Federal Deposit Insurance Corporation NOTICES NOTICES Meetings: Meetings; Sunshine Act, 40818 Materials Technical Advisory Committee, 40813 Proposed Interagency Guidance – Funding and Liquidity Risk Management, 40867–40868 Interior Department See Fish and Wildlife Service Federal Reserve System See Land Management Bureau NOTICES See Minerals Management Service Proposed Interagency Guidance – Funding and Liquidity See Surface Mining Reclamation and Enforcement Office Risk Management, 40867–40868 International Trade Administration Fish and Wildlife Service NOTICES PROPOSED RULES Antidumping: Migratory Bird Hunting: Pressure Sensitive Plastic Tape from Italy, 40811–40812 Proposed Frameworks for Late-Season Migratory Bird Countervailing Duties: Hunting Regulations, 41008–41031 Wire Decking from the People’s Republic of China, 40812 NOTICES Agency Information Collection Activities; Proposals, International Trade Commission Submissions, and Approvals, 40835–40837 NOTICES Environmental Impact Statements; Availability, etc.: Investigations: Koyukuk/Nowitna National Wildlife Refuges, Galena, AK, Certain Active Comfort Footwear, 40843–40844 40837–40838 Pressure Sensitive Plastic Tape From Italy, 40845 Semiconductor Chips With Minimized Chip Package Size Food and Drug Administration and Products Containing Same (IV), 40844–40845 RULES Shifts in U.S. Merchandise Trade 2008, 40845–40846 Charging for Investigational Drugs Under an Investigational Meetings; Sunshine Act, 40846 New Drug Application, 40872–40900 Expanded Access to Investigational Drugs for Treatment Justice Department Use, 40900–40945 NOTICES New Animal Drugs for Use in Animal Feeds: Lodging of Consent Decree Under the Clean Air Act and Oxytetracycline; Neomycin, 40723–40726 Resource Conservation and Recover Act, 40846 Membership of the Senior Executive Service Standing Forest Service Performance Review Boards, 40846–40854 RULES Downpayment and Periodic Payments: Land Management Bureau Sale and Disposal of National Forest System Timber, NOTICES 40736–40744 Meetings: NOTICES Idaho Falls District Resource Advisory Council, 40838– Environmental Impact Statements; Availability, etc.: 40839 Okanogan–Wenatchee National Forest, WA, 40809–40811 Western Montana Resource Advisory Council, 40838 Meetings: Public Lands; Proposed Supplementary Rules for Camping: Eastern Arizona Counties Resource Advisory Committee, Montana, North Dakota, and South Dakota, 40839–40841 40811 Realty Actions: Proposed Amendment to Noncompetitive Land Use Government Accountability Office Lease; Montana, 40842–40843 NOTICES Recreation and Public Purposes Act Classification of Privacy Act; Systems of Personnel Records, 40818–40820 Public Lands in Sweetwater County, WY, 40841– 40842 Health and Human Services Department See Centers for Disease Control and Prevention Minerals Management Service See Centers for Medicare & Medicaid Services RULES See Food and Drug Administration Geological and Geophysical Explorations of the Outer See Health Resources and Services Administration Continental Shelf-Changing Proprietary Term of Certain See National Institutes of Health Geophysical Information, 40726–40731 Health Resources and Services Administration National Credit Union Administration NOTICES NOTICES Agency Information Collection Activities; Proposals, Proposed Interagency Guidance – Funding and Liquidity Submissions, and Approvals, 40820–40822 Risk Management, 40867–40868 Historic Preservation, Advisory Council National Highway Traffic Safety Administration NOTICES RULES Meetings: Federal Motor Vehicle Safety Standards: Advisory Council on Historic Preservation, 40826 Controls, Telltales and Indicators, 40760–40764

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National Institutes of Health See National Highway Traffic Safety Administration NOTICES Meetings: Treasury Department Center for Scientific Review, 40823–40824 See Comptroller of the Currency National Institute on Alcohol Abuse and Alcoholism, See Thrift Supervision Office 40823 U.S. Customs and Border Protection National Oceanic and Atmospheric Administration NOTICES NOTICES Agency Information Collection Activities; Proposals, Deadline Extension for Applications: Submissions, and Approvals, 40826–40827 Seat on the Monterey Bay National Marine Sanctuary Commercial Gauger and Laboratory: Advisory Council, 40812–40813 Accreditation and Approval of Inspectorate America Meetings: Corp., 40831–40832 Marine Protected Areas Federal Advisory Committee, Accreditation and Approval of Intertek USA, Inc, 40831 40814 Accreditation and Approval of Oiltest, Inc., 40830–40831 New England Fishery Management Council, 40813–40814 Accreditation and Approval of Saybolt LP, 40832 National Estuarine Research Reserve System, 40814–40815 Accreditation and Approval of SGS North America, Inc., Taking and Importing of Marine Mammals, 40815 40831 Nuclear Regulatory Commission Commercial Gauger: PROPOSED RULES Approval of Intertek USA, Inc., 40833 Performance-Based Emergency Core Cooling System Approval of Marine Technical Surveyors, Inc., 40832– Acceptance Criteria, 40765–40776 40833 NOTICES Approval of Petrospect, Inc, 40833 Draft Regulatory Guide: Issuance, Availability, 40854–40855 Veterans Affairs Department License Application Request: NOTICES U.S. Army Installation Command for Schofield Barracks, Agency Information Collection Activities; Proposals, Oahu, HI, 40855–40857 Submissions, and Approvals, 40868 Meetings: Office of United States Trade Representative Geriatrics and Gerentology Advisory Committee, 40868– See Trade Representative, Office of United States 40869 Veterans’ Rural Health Advisory Committee, 40869 Securities and Exchange Commission NOTICES Order of Suspension of Trading: Separate Parts In This Issue V-Twin Holdings, Inc., et al., 40857 Self-Regulatory Organizations; Proposed Rule Changes: Part II Chicago Board Options Exchange, Inc., 40859–40861 NASDAQ OMX PHLX, Inc., 40857–40859, 40862–40864 Health and Human Services Department, Food and Drug NYSE Amex LLC, 40861–40862 Administration, 40872–40945 Surface Mining Reclamation and Enforcement Office Part III PROPOSED RULES Health and Human Services Department, Centers for Montana Regulatory Program, 40799–40802 Medicare & Medicaid Services, 40948–41005 NOTICES Agency Information Collection Activities; Proposals, Part IV Submissions, and Approvals, 40834–40835 Interior Department, Fish and Wildlife Service, 41008– 41031 Thrift Supervision Office NOTICES Proposed Interagency Guidance – Funding and Liquidity Reader Aids Risk Management, 40867–40868 Consult the Reader Aids section at the end of this page for Trade Representative, Office of United States phone numbers, online resources, finding aids, reminders, NOTICES and notice of recently enacted public laws. Implementation of the U.S.–EC Beef Hormones To subscribe to the Federal Register Table of Contents Memorandum of Understanding, 40864–40867 LISTSERV electronic mailing list, go to http:// listserv.access.gpo.gov and select Online mailing list Transportation Department archives, FEDREGTOC-, Join or leave the list (or change See Federal Aviation Administration 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.

10 CFR Proposed Rules: 50...... 40765 14 CFR 97 (2 documents) ...... 40719, 40721 Proposed Rules: 39 (3 documents) ...... 40776, 40778, 40781 16 CFR Proposed Rules: 1112...... 40784 17 CFR Proposed Rules: 190...... 40794 21 CFR 312 (2 documents) ...... 40872, 40900 316...... 40900 558...... 40723 30 CFR 251...... 40726 Proposed Rules: 926...... 40799 33 CFR 100...... 40731 165...... 40734 Proposed Rules: 117...... 40802 36 CFR 223...... 40736 40 CFR 52 (3 documents) ...... 40745, 40747, 40750 180...... 40753 Proposed Rules: 52 (2 documents) ...... 40804, 40805 42 CFR Proposed Rules: 409...... 40948 424...... 40948 484...... 40948 489...... 40948 47 CFR Proposed Rules: 73...... 40806 49 CFR 571...... 40760 50 CFR Proposed Rules: 20...... 41008

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Rules and Regulations Federal Register Vol. 74, No. 155

Thursday, August 13, 2009

This section of the FEDERAL REGISTER Independence Avenue, SW., impractical. Furthermore, airmen do not contains regulatory documents having general Washington, DC 20591; use the regulatory text of the SIAPs, applicability and legal effect, most of which 2. The FAA Regional Office of the Takeoff Minimums or ODPs, but instead are keyed to and codified in the Code of region in which the affected airport is refer to their depiction on charts printed Federal Regulations, which is published under located; by publishers of aeronautical materials. 50 titles pursuant to 44 U.S.C. 1510. 3. The National Flight Procedures The advantages of incorporation by The Code of Federal Regulations is sold by Office, 6500 South MacArthur Blvd., reference are realized and publication of the Superintendent of Documents. Prices of Oklahoma City, OK 73169 or the complete description of each SIAP, new books are listed in the first FEDERAL 4. The National Archives and Records Takeoff Minimums and ODP listed on REGISTER issue of each week. Administration (NARA). For FAA forms is unnecessary. This information on the availability of this amendment provides the affected CFR material at NARA, call 202–741–6030, sections and specifies the types of SIAPs DEPARTMENT OF TRANSPORTATION or go to: http://www.archives.gov/ and the effective dates of the, associated federal_register/ Takeoff Minimums and ODPs. This Federal Aviation Administration code_of_federal_regulations/ amendment also identifies the airport ibr_locations.html. and its location, the procedure, and the 14 CFR Part 97 Availability—All SIAPs and Takeoff amendment number. [Docket No. 30678; Amdt. No. 3332] Minimums and ODPs are available online free of charge. Visit http:// The Rule Standard Instrument Approach www.nfdc.faa.gov to register. This amendment to 14 CFR part 97 is Procedures, and Takeoff Minimums Additionally, individual SIAP and effective upon publication of each and Obstacle Departure Procedures; Takeoff Minimums and ODP copies may separate SIAP, Takeoff Minimums and Miscellaneous Amendments be obtained from: ODP as contained in the transmittal. 1. FAA Public Inquiry Center (APA– Some SIAP and Takeoff Minimums and AGENCY: Federal Aviation 200), FAA Headquarters Building, 800 textual ODP amendments may have Administration (FAA), DOT. Independence Avenue, SW., been issued previously by the FAA in a ACTION: Final rule. Washington, DC 20591; or Flight Data Center (FDC) Notice to 2. The FAA Regional Office of the Airmen (NOTAM) as an emergency SUMMARY: This establishes, amends, action of immediate flight safety relating suspends, or revokes Standard region in which the affected airport is directly to published aeronautical Instrument Approach Procedures located. charts. The circumstances which (SIAPs) and associated Takeoff FOR FURTHER INFORMATION CONTACT: created the need for some SIAP and Minimums and Obstacle Departure Harry . Hodges, Flight Procedure Takeoff Minimums and ODP Procedures for operations at certain Standards Branch (AFS–420), Flight amendments may require making them airports. These regulatory actions are Technologies and Programs Divisions, effective in less than 30 days. For the needed because of the adoption of new Flight Standards Service, Federal remaining SIAPS and Takeoff or revised criteria, or because of changes Aviation Administration, Mike Minimums and ODPS, an effective date occurring in the National Airspace Monroney Aeronautical Center, 6500 at least 30 days after publication is System, such as the commissioning of South MacArthur Blvd., Oklahoma City, provided. new navigational facilities, adding new OK 73169 (Mail Address: P.O. Box Further, the SIAPs and Takeoff obstacles, or changing air traffic 25082, Oklahoma City, OK 73125) Minimums and ODPS contained in this requirements. These changes are Telephone: (405) 954–4164. amendment are based on the criteria designed to provide safe and efficient SUPPLEMENTARY INFORMATION: This rule contained in the U.S. Standard for use of the navigable airspace and to amends Title 14 of the Code of Federal Terminal Instrument Procedures promote safe flight operations under Regulations, Part 97 (14 CFR part 97), by (TERPS). In developing these SIAPS and instrument flight rules at the affected establishing, amending, suspending, or Takeoff Minimums and ODPs, the airports. revoking SIAPS, Takeoff Minimums TERPS criteria were applied to the DATES: This rule is effective August 13, and/or ODPS. The complete regulators conditions existing or anticipated at the 2009. The compliance date for each description of each SIAP and its affected airports. Because of the close SIAP, associated Takeoff Minimums, associated Takeoff Minimums or ODP and immediate relationship between and ODP is specified in the amendatory for an identified airport is listed on FAA these SIAPs, Takeoff Minimums and provisions. form documents which are incorporated ODPs, and safety in air commerce, I find The incorporation by reference of by reference in this amendment under 5 that notice and public procedures before certain publications listed in the U.S.C. 552(a), 1 CFR part 51, and 14 adopting these SIAPS, Takeoff regulations is approved by the Director CFR part 97.20. The applicable FAA Minimums and ODPs are impracticable of the Federal Register as of August 13, Forms are FAA Forms 8260–3, 8260–4, and contrary to the public interest and, 2009. 8260–5, 8260–15A, and 8260–15B when where applicable, that good cause exists ADDRESSES: Availability of matters required by an entry on 8260–15A. for making some SIAPs effective in less incorporated by reference in the The large number of SIAPs, Takeoff than 30 days. amendment is as follows: Minimums and ODPs, in addition to For Examination— their complex nature and the need for Conclusion 1. FAA Rules Docket, FAA a special format make publication in the The FAA has determined that this Headquarters Building, 800 Federal Register expensive and regulation only involves an established

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body of technical regulations for which Eureka, CA, Murray Field, RNAV (GPS)–, Lanai City, HI, Lanai, RNAV (GPS) RWY 3, frequent and routine amendments are Orig Orig necessary to keep them operationally Eureka, CA, Murray Field, Takeoff Lanai City, HI, Lanai, Takeoff Minimums and current. It, therefore—(1) is not a Minimums and Obstacle DP, Amdt 4 Obstacle DP, Amdt 5 Eureka, CA, Murray Field, VOR–A, Amdt 7 Lanai City, HI, Lanai, VOR OR TACAN RWY ‘‘significant regulatory action’’ under Lakeport, CA, Lampson Field, NDB OR GPS– 3, Amdt 7 Executive Order 12866; (2) is not a A, Orig-A, CANCELLED Coeur ’ Alene, ID, Coeur D’Alene-Pappy ‘‘significant rule ’’ under DOT Lakeport, CA, Lampson Field, RNAV (GPS)- Boyington Field, NDB RWY 5, Amdt 2B Regulatory Policies and Procedures (44 A, Orig Twin Falls, ID, Joslin Field-Magic Valley FR 11034; February 26, 1979) ; and (3) Marysville, CA, Yuba County, GPS RWY 14, Rgnl, NDB RWY 25, Amdt 6A does not warrant preparation of a Orig-A, CANCELLED Westminster, MD, Clearview Airpark, Takeoff regulatory evaluation as the anticipated Marysville, CA, Yuba County, GPS RWY 32, Minimums and Obstacle DP, Orig Orig-A, CANCELLED impact is so minimal. For the same Lansing, MI, Capital City, ILS OR LOC RWY Marysville, CA, Yuba County, RNAV (GPS) 28L, Amdt 26 reason, the FAA certifies that this RWY 14, Orig Lansing, MI, Capital City, NDB OR GPS RWY amendment will not have a significant Marysville, CA, Yuba County, RNAV (GPS) 28L, Amdt 24A, CANCELLED economic impact on a substantial RWY 32, Orig Lansing, MI, Capital City, RADAR–1, Amdt number of small entities under the Napa, CA, Napa County, RNAV (GPS) RWY 15 criteria of the Regulatory Flexibility Act. 36L, Amdt 1 Lansing, MI, Capital City, RNAV (GPS) RWY Napa, CA, Napa County, RNAV (GPS) RWY 10R, Orig List of Subjects in 14 CFR Part 97 36L, Orig Lansing, MI, Capital City, RNAV (GPS) RWY Air Traffic Control, Airports, Redding, CA, Redding Muni, ILS OR LOC/ 24, Orig DME RWY 34, Amdt 11 Lansing, MI, Capital City, RNAV (GPS) RWY Incorporation by reference, and Redding, CA, Redding Muni, LOC/DME BC Navigation (Air). 28L, Orig RWY 16, Amdt 7 Lansing, MI, Capital City, VOR RWY 24, Issued in Washington, DC, on July 24, Redding, CA, Redding Muni, RNAV (GPS) Amdt 9 2009. RWY 34, Amdt 1 Pellston, MI, Pellston Rgnl Arpt Of Emmet John M. Allen, Salinas, CA, Salinas Muni, GPS RWY 13, County, ILS OR LOC RWY 32, Amdt 11 Orig, CANCELLED Director, Flight Standards Service. Pellston, MI, Pellston Rgnl Arpt Of Emmet Salinas, CA, Salinas Muni, GPS RWY 31, County, RNAV (GPS) RWY 5, Orig Orig, CANCELLED Adoption of the Amendment Pellston, MI, Pellston Rgnl Arpt Of Emmet Salinas, CA, Salinas Muni, RNAV (GPS) County, RNAV (GPS) RWY 23, Orig ■ Accordingly, pursuant to the authority RWY 13, Orig Pellston, MI, Pellston Rgnl Arpt Of Emmet Salinas, CA, Salinas Muni, RNAV (GPS) Y delegated to me, Title 14, Code of County, RNAV (GPS) RWY 32, Orig RWY 31, Orig Federal Regulations, Part 97 (14 CFR Pellston, MI, Pellston Rgnl Arpt Of Emmet Salinas, CA, Salinas Muni, RNAV (GPS) Z part 97) is amended by establishing, County, VOR RWY 23, Amdt 16 amending, suspending, or revoking RWY 31, Orig Santa Ana, CA, John Wayne-Orange County, Pellston, MI, Pellston Rgnl Arpt Of Emmet Standard Instrument Approach Takeoff Minimums and Obstacle DP, Amdt County, VOR/DME RWY 5, Amdt 12 Procedures and/or Takeoff Minimums 5 Fergus Falls, MN, Fergus Falls Muni-Einar and/or Obstacle Departure Procedures Visalia, CA, Visalia Muni, GPS RWY 12, Mickelson Field, ILS OR LOC RWY 31, effective at 0902 UTC on the dates Orig-B, CANCELLED Amdt 2 specified, as follows: Visalia, CA, Visalia Muni, GPS RWY 30, Fergus Falls, MN, Fergus Falls Muni-Einar Orig-A, CANCELLED Mickelson Field, NDB RWY 31, Amdt 2 PART 97—STANDARD INSTRUMENT Visalia, CA, Visalia Muni, ILS OR LOC/DME Fergus Falls, MN, Fergus Falls Muni-Einar Mickelson Field, RNAV (GPS) RWY 31, APPROACH PROCEDURES RWY 30, Amdt 6 Visalia, CA, Visalia Muni, RNAV (GPS) RWY Orig ■ 1. The authority citation for part 97 12, Orig Fergus Falls, MN, Fergus Falls Muni-Einar continues to read as follows: Visalia, CA, Visalia Muni, RNAV (GPS) RWY Mickelson Field, RNAV (GPS) RWY 35, 30, Orig Orig Authority: 49 U.S.C. 106(), 40103, 40106, Visalia, CA, Visalia Muni, Takeoff Minimums Fergus Falls, MN, Fergus Falls Muni-Einar 40113, 40114, 40120, 44502, 44514, 44701, and Obstacle DP, Amdt 3 Mickelson Field, Takeoff Minimums and 44719, 44721–44722. Lamar, CO, Lamar Muni, RNAV (GPS) RWY Obstacle DP, Orig ■ 2. Part 97 is amended to read as 18, Amdt 1 Fergus Falls, MN, Fergus Falls Muni-Einar Mickelson Field, VOR RWY 13, Amdt 1 follows: Daytona Beach, FL, Daytona Beach Intl, Takeoff Minimums and Obstacle DP, Amdt Fergus Falls, MN, Fergus Falls Muni-Einar Effective 27 AUG 2009 4 Mickelson Field, VOR RWY 35, Amdt 10 Manokotak, AK, Manokotak, RNAV (GPS) Stuart, FL, Witham Field, Takeoff Minimums Ahoskie, NC, Tri-County, NDB RWY 1, Amdt RWY 3, Orig and Obstacle DP, Amdt 2 2, CANCELLED Manokotak, AK, Manokotak, RNAV (GPS) Albany, GA, Southwest Georgia Rgnl, ILS OR Raleigh/Durham, NC, Raleigh-Durham Intl, RWY 21, Orig LOC RWY 4, Amdt 11 ILS OR LOC RWY 5L, Amdt 5 Manokotak, AK, Manokotak, RNAV (GPS)–A, Albany, GA, Southwest Georgia Rgnl, LOC Raleigh/Durham, NC, Raleigh-Durham Intl, CANCELLED BC RWY 22, Amdt 8 ILS OR LOC RWY 5R, Amdt 27 Manokotak, AK, Manokotak, Takeoff Albany, GA, Southwest Georgia Rgnl, NDB Raleigh/Durham, NC, Raleigh-Durham Intl, Minimums and Obstacle DP, Amdt 1 RWY 4, Amdt 13 ILS OR LOC RWY 23L, Amdt 8 Yakutat, AK, Yakutat, ILS OR LOC/DME Albany, GA, Southwest Georgia Rgnl, RNAV Raleigh/Durham, NC, Raleigh-Durham Intl, RWY 11, Amdt 1 (GPS) RWY 4, Amdt 1 ILS OR LOC RWY 23R, ILS RWY 23R (CAT Yakutat, AK, Yakutat, RNAV (GPS) RWY 2, Albany, GA, Southwest Georgia Rgnl, RNAV II), Amdt 1 (GPS) RWY 16, Amdt 1 ILS RWY 23R (CAT III), Amdt 11 Yakutat, AK, Yakutat, RNAV (GPS) RWY 11, Albany, GA, Southwest Georgia Rgnl, RNAV Raleigh/Durham, NC, Raleigh-Durham Intl, Amdt 2 (GPS) RWY 22, Amdt 1 RNAV (GPS) Y RWY 5L, Amdt 1 Scottsdale, AZ, Scottsdale, RNAV (RNP) Y Albany, GA, Southwest Georgia Rgnl, RNAV Raleigh/Durham, NC, Raleigh-Durham Intl, RWY 3, Orig-A (GPS) RWY 34, Amdt 1 RNAV (GPS) Y RWY 5R, Amdt 1 Eureka, CA, Murray Field, GPS RWY 11, Albany, GA, Southwest Georgia Rgnl, VOR Raleigh/Durham, NC, Raleigh-Durham Intl, Orig-B, CANCELLED OR TACAN RWY 16, Amdt 27 RNAV (GPS) Y RWY 23L, Amdt 1 Eureka, CA, Murray Field, RNAV (GPS) RWY Donalsonville, GA, Donalsonville, Takeoff Raleigh/Durham, NC, Raleigh-Durham Intl, 12, Orig Minimums and Obstacle DP, Orig RNAV (GPS) Y RWY 23R, Amdt 1

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Raleigh/Durham, NC, Raleigh-Durham Intl, Nashville, TN, Nashville Intl, ILS OR LOC DEPARTMENT OF TRANSPORTATION RNAV (RNP) Z RWY 5L, Orig RWY 2R, ILS RWY 2R (CAT II), ILS RWY Raleigh/Durham, NC, Raleigh-Durham Intl, 2R (CAT III), Amdt 7 Federal Aviation Administration RNAV (RNP) Z RWY 5R, Orig Nashville, TN, Nashville Intl, ILS OR LOC Raleigh/Durham, NC, Raleigh-Durham Intl, RWY 20L, Amdt 5 14 CFR Part 97 RNAV (RNP) Z RWY 23L, Orig Nashville, TN, Nashville Intl, ILS OR LOC Raleigh/Durham, NC, Raleigh-Durham Intl, RWY 20R, Amdt 10 [Docket No. 30679; Amdt. No. 3333] RNAV (RNP) Z RWY 23R, Orig Nashville, TN, Nashville Intl, ILS OR LOC Las Vegas, NV, McCarran Intl, VOR RWY RWY 31, Amdt 9 Standard Instrument Approach 25L/, Amdt 3 Nashville, TN, Nashville Intl, RNAV (GPS) Procedures, and Takeoff Minimums Dayton, OH, James M Cox Dayton Intl, ILS RWY 13, Amdt 1 and Obstacle Departure Procedures; OR LOC RWY 6L, ILS RWY 6L (CAT II), Nashville, TN, Nashville Intl, RNAV (GPS) Y Miscellaneous Amendments ILS RWY 6L (CAT III), Amdt 9 RWY 2C, Amdt 1 Dayton, OH, James M Cox Dayton Intl, ILS Nashville, TN, Nashville Intl, RNAV (GPS) Y AGENCY: Federal Aviation OR LOC RWY 18, Amdt 10 RWY 2L, Amdt 1 Administration (FAA), DOT. Dayton, OH, James M Cox Dayton Intl, ILS Nashville, TN, Nashville Intl, RNAV (GPS) Y ACTION: Final rule. OR LOC RWY 24L, Amdt 9 RWY 2R, Amdt 1 Dayton, OH, James M Cox Dayton Intl, ILS Nashville, TN, Nashville Intl, RNAV (GPS) Y SUMMARY: This rule establishes, amends, OR LOC RWY 24R, Amdt 8 RWY 20L, Amdt 1 suspends, or revokes Standard Dayton, OH, James M Cox Dayton Intl, NDB Nashville, TN, Nashville Intl, RNAV (GPS) Y Instrument Approach Procedures RWY 6R, Amdt 9 RWY 20R, Amdt 2 Dayton, OH, James M Cox Dayton Intl, RNAV (SIAPs) and associated Takeoff Nashville, TN, Nashville Intl, RNAV (GPS) Y Minimums and Obstacle Departure (GPS) RWY 6L, Amdt 1 RWY 31, Amdt 1 Dayton, OH, James M Cox Dayton Intl, RNAV Nashville, TN, Nashville Intl, RNAV (RNP) Z Procedures for operations at certain (GPS) RWY 6R, Amdt 1 RWY 2C, Orig airports. These regulatory actions are Dayton, OH, James M Cox Dayton Intl, RNAV Nashville, TN, Nashville Intl, RNAV (RNP) Z needed because of the adoption of new (GPS) RWY 18, Amdt 1 RWY 2L, Orig or revised criteria, or because of changes Dayton, OH, James M Cox Dayton Intl, RNAV Nashville, TN, Nashville Intl, RNAV (RNP) Z occurring in the National Airspace (GPS) RWY 24L, Amdt 1 RWY 2R, Orig System, such as the commissioning of Dayton, OH, James M Cox Dayton Intl, RNAV Nashville, TN, Nashville Intl, RNAV (RNP) Z new navigational facilities, adding new (GPS) RWY 24R, Amdt 1 RWY 20L, Orig Dayton, OH, James M Cox Dayton Intl, RNAV obstacles, or changing air traffic Nashville, TN, Nashville Intl, RNAV (RNP) Z requirements. These changes are (GPS) RWY 36, Amdt 1 RWY 20R, Orig Redmond, OR, Roberts Field, GPS RWY 10, Nashville, TN, Nashville Intl, RNAV (RNP) Z designed to provide safe and efficient Orig-A, CANCELLED RWY 31, Orig use of the navigable airspace and to Redmond, OR, Roberts Field, RNAV (GPS) Jasper, TX, Jasper County-Bell Field, GPS promote safe flight operations under RWY 4, Orig RWY 18, Amdt 1, CANCELLED instrument flight rules at the affected Redmond, OR, Roberts Field, RNAV (GPS) Jasper, TX, Jasper County-Bell Field, GPS airports. RWY 10, Orig RWY 36, Orig, CANCELLED DATES: This rule is effective August 13, Redmond, OR, Roberts Field, RNAV (GPS) Jasper, TX, Jasper County-Bell Field, NDB RWY 22, Orig RWY 18, Amdt 10 2009. The compliance date for each Redmond, OR, Roberts Field, RNAV (GPS) Y Jasper, TX, Jasper County-Bell Field, RNAV SIAP, associated Takeoff Minimums, RWY 28, Amdt 1 (GPS) RWY 18, Orig and ODP is specified in the amendatory Redmond, OR, Roberts Field, RNAV (GPS) Z Jasper, TX, Jasper County-Bell Field, RNAV provisions. RWY 28, Orig (GPS) RWY 36, Orig The incorporation by reference of Johnstown, PA, John Murtha Johnstown- Jasper, TX, Jasper County-Bell Field, Takeoff certain publications listed in the Cambria County, ILS OR LOC RWY 33, Minimums and Obstacle DP, Orig regulations is approved by the Director Amdt 6 Abingdon, VA, Virginia Highlands, LOC Johnstown, PA, John Murtha Johnstown- of the Federal Register as of August 13, RWY 24, Amdt 3 2009. Cambria County, RNAV (GPS) RWY 5, Abingdon, VA, Virginia Highlands, RNAV Amdt 1 (GPS) RWY 6, Orig ADDRESSES: Availability of matter Johnstown, PA, John Murtha Johnstown- Abingdon, VA, Virginia Highlands, RNAV incorporated by reference in the Cambria County, RNAV (GPS) RWY 15, (GPS) RWY 24, Orig amendment is as follows: Amdt 1 Abingdon, VA, Virginia Highlands, VOR/ For Examination— Johnstown, PA, John Murtha Johnstown- DME–B, Amdt 6 1. FAA Rules Docket, FAA Cambria County, RNAV (GPS) RWY 23, Hot Springs, VA, Ingalls Fld, GPS RWY 7, Headquarters Building, 800 Amdt 1 Orig-A, CANCELLED Independence Avenue, SW., Johnstown, PA, John Murtha Johnstown- Hot Springs, VA, Ingalls Fld, ILS OR LOC Washington, DC 20591; Cambria County, RNAV (GPS) RWY 33, RWY 25, Amdt 4 Amdt 1 2. The FAA Regional Office of the Hot Springs, VA, Ingalls Fld, RNAV (GPS) region in which the affected airport is Johnstown, PA, John Murtha Johnstown- RWY 7, Orig Cambria County, VOR RWY 23, Amdt 8 located; South Boston, VA, William M. Tuck, GPS 3. The National Flight Procedures Johnstown, PA, John Murtha Johnstown- RWY 1, Orig, CANCELLED Cambria County, VOR/DME RWY 23, South Boston, VA, William M. Tuck, RNAV Office, 6500 South MacArthur Blvd., Amdt 2 (GPS) RWY 1, Orig Oklahoma City, OK 73169 or Reading PA, Reading Rgnl/Carl A. Spaatz South Boston, VA, William M. Tuck, RNAV 4. The National Archives and Records Fld, NDB RWY 36, Amdt 25 (GPS) RWY 19, Orig Administration (NARA). For San Juan, PR, Luis Munoz Marin Intl, Takeoff South Boston, VA, William M. Tuck, VOR– information on the availability of this Minimums and Obstacle DP, Amdt 7 A, Amdt 8 material at NARA, call 202–741–6030, Aberdeen, SD, Aberdeen Rgnl, Takeoff Beckley, WV, Raleigh County Memorial, VOR or go to: http://www.archives.gov/ Minimums and Obstacle DP, Orig RWY 19, Amdt 4 _ Nashville, TN, Nashville Intl, ILS OR LOC federal register/ Parkersburg, WV, Mid-Ohio Valley Rgnl, ILS code_of_federal_regulations/ RWY 2C, Amdt 1 OR LOC RWY 3, Amdt 13 Nashville, TN, Nashville Intl, ILS OR LOC ibr_locations.html. RWY 2L, ILS RWY 2L (CAT II), ILS RWY [FR Doc. E9–18660 Filed 8–12–09; 8:45 am] Availability—All SIAPs are available 2L (CAT III), Amdt 9 BILLING CODE 4910–13–P online free of charge. Visit nfdc.faa.gov

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to register. Additionally, individual This amendment also identifies the Policies and Procedures (44 FR 11034; SIAP and Takeoff Minimums and ODP airport and its location, the procedure February 26, 1979); and (3) does not copies may be obtained from: and the amendment number. warrant preparation of a regulatory 1. FAA Public Inquiry Center (APA– evaluation as the anticipated impact is The Rule 200), FAA Headquarters Building, 800 so minimal. For the same reason, the Independence Avenue, SW., This amendment to 14 CFR part 97 is FAA certifies that this amendment will Washington, DC 20591; or effective upon publication of each not have a significant economic impact 2. The FAA Regional Office of the separate SIAP as amended in the on a substantial number of small entities region in which the affected airport is transmittal. For safety and timeliness of under the criteria of the Regulatory located. change considerations, this amendment Flexibility Act. incorporates only specific changes FOR FURTHER INFORMATION CONTACT: List of Subjects in 14 CFR Part 97 Harry J. Hodges, Flight Procedure contained for each SIAP as modified by Standards Branch (AFS–420) Flight FDC/P–NOTAMs. Air Traffic Control, Airports, Technologies and Programs Division, The SIAPs, as modified by FDC P– Incorporation by reference, and Flight Standards Service, Federal NOTAM, and contained in this Navigation (Air). Aviation Administration, Mike amendment are based on the criteria Issued in Washington, DC, on July 24, Monroney Aeronautical Center, 6500 contained in the U.S. Standard for 2009. South MacArthur Blvd., Oklahoma City, Terminal Instrument Procedures John M. Allen, (TERPS). In developing these changes to OK 73169 (Mail Address: P.O. Box Director, Flight Standards Service. 25082, Oklahoma City, OK 73125) SIAPs, the TERPS criteria were applied telephone: (405) 954–4164. only to specific conditions existing at Adoption of the Amendment SUPPLEMENTARY INFORMATION: This rule the affected airports. All SIAP ■ Accordingly, pursuant to the authority amends Title 14, Code of Federal amendments in this rule have been delegated to me, Title 14, Code of Regulations, Part 97 (14 CFR part 97) by previously issued by the FAA in a FDC Federal regulations, Part 97, 14 CFR part amending the referenced SIAPs. The NOTAM as an emergency action of 97, is amended by amending Standard complete regulatory description of each immediate flight safety relating directly Instrument Approach Procedures, SIAP is listed on the appropriate FAA to published aeronautical charts. The effective at 0901 UTC on the dates Form 8260, as modified by the National circumstances which created the need specified, as follows: Flight Data Center (FDC)/Permanent for all these SIAP amendments requires making them effective in less than 30 Notice to Airmen (P–NOTAM), and is PART 97—STANDARD INSTRUMENT days. incorporated by reference in the APPROACH PROCEDURES amendment under 5 U.S.C. 552(a), 1 Because of the close and immediate CFR part 51, and § 97.20 of Title 14 of relationship between these SIAPs and ■ 1. The authority citation for part 97 the Code of Federal Regulations. safety in air commerce, I find that notice continues to read as follows: The large number of SIAPs, their and public procedure before adopting Authority: 49 U.S.C. 106(g), 40103, 40106, complex nature, and the need for a these SIAPs are impracticable and 40113, 40114, 40120, 44502, 44514, 44701, special format make their verbatim contrary to the public interest and, 44719, 44721–44722. publication in the Federal Register where applicable, that good cause exists expensive and impractical. Further, for making these SIAPs effective in less ■ 2. Part 97 is amended to read as airmen do not use the regulatory text of than 30 days. follows: the SIAPs, but refer to their graphic Conclusion By amending: § 97.23 VOR, VOR/ depiction on charts printed by DME, VOR or TACAN, and VOR/DME publishers of aeronautical materials. The FAA has determined that this or TACAN; § 97.25 LOC, LOC/DME, Thus, the advantages of incorporation regulation only involves an established LDA, LDA/DME, SDF, SDF/DME; by reference are realized and body of technical regulations for which § 97.27 NDB, NDB/DME; § 97.29 ILS, publication of the complete description frequent and routine amendments are ILS/DME, MLS, MLS/DME, MLS/RNAV; of each SIAP contained in FAA form necessary to keep them operationally § 97.31 RADAR SIAPs; § 97.33 RNAV documents is unnecessary. This current. It, therefore—(1) is not a SIAPs; and § 97.35 COPTER SIAPs, amendment provides the affected CFR ‘‘significant regulatory action’’ under Identified as follows: sections and specifies the types of SIAP Executive Order 12866; (2) is not a and the corresponding effective dates. ‘‘significant rule’’ under DOT regulatory * * * Effective Upon Publication

FDC date State City Airport FDC No. Subject

07/09/09 ...... OR AURORA ...... AURORA STATE ...... 9/7851 RNAV (GPS) RWY 35, ORIG–B. 07/09/09 ...... OR AURORA ...... AURORA STATE ...... 9/7852 RNAV (GPS) RWY 17, ORIG–A. 07/09/09 ...... NV TONOPAH ...... TONOPAH ...... 9/7854 GPS RWY 15, ORIG–A. 07/09/09 ...... NV TONOPAH ...... TONOPAH ...... 9/7855 VOR OR GPS–A, AMDT 3A. 07/09/09 ...... AK PLATINUM ...... PLATINUM ...... 9/7856 RNAV (GPS) RWY 13, ORIG. 07/09/09 ...... AK TOGIAK VILLAGE ...... TOGIAK ...... 9/7857 RNAV (GPS) RWY 21, ORIG. 07/09/09 ...... WY GREYBULL ...... SOUTH BIG HORN COUNTY ...... 9/7923 TAKEOFF MINIMUMS AND OB- STACLE DP, ORIG. 07/22/09 ...... NY ISLIP ...... LONG ISLAND MACARTHUR ...... 9/8067 RNAV (GPS) RWY 6, ORIG. 07/22/09 ...... NE OSHKOSH ...... GARDEN COUNTY ...... 9/8108 NDB RWY 12, AMDT 1A. 07/22/09 ...... NE CHAPPELL ...... BILLY G RAY FIELD ...... 9/8109 NDB OR GPS RWY 30, AMDT 2. 07/10/09 ...... CO EAGLE ...... EAGLE COUNTY REGIONAL ...... 9/8133 LDA/DME RWY 25, ORIG–B. 07/11/09 ...... MT STEVENSVILLE ...... STEVENSVILLE ...... 9/8254 RNAV (GPS) A, ORIG. 07/11/09 ...... CA HANFORD ...... HANFORD MUNI ...... 9/8255 VOR–A, AMDT 9. 07/11/09 ...... CA HANFORD ...... HANFORD MUNI ...... 9/8257 RNAV (GPS) RWY 32, ORIG–A.

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FDC date State City Airport FDC No. Subject

07/11/09 ...... MT HELENA ...... HELENA REGIONAL ...... 9/8260 RNAV (RNP) Z RWY 9, ORIG. 07/11/09 ...... AL HAMILTON ...... MARION COUNTY–RANKIN FITE ...... 9/8352 RNAV (GPS) RWY 18, ORIG. 07/13/09 ...... CA IMPERIAL ...... IMPERIAL COUNTY ...... 9/8666 TAKEOFF MINIMUMS AND OB- STACLE DP, AMDT 2. 07/14/09 ...... WY NEWCASTLE ...... MONDELL FIELD ...... 9/8931 TAKEOFF MINIMUMS AND OB- STACLE DP, AMDT 3. 07/14/09 ...... OK ALTUS ...... ALTUS/QUARTZ MOUNTAIN RGNL .. 9/8941 VOR A, AMDT 4C. 07/15/09 ...... NV RENO ...... RENO/TAHOE INTL ...... 9/9101 ILS RWY 16R, AMDT 10D. 07/17/09 ...... NY ISLIP ...... LONG ISLAND MACARTHUR ...... 9/9568 RNAV (GPS) RWY 6, ORIG. 07/17/09 ...... CA OROVILLE ...... OROVILLE MUNI ...... 9/9700 GPS RWY 1, ORIG. 07/17/09 ...... CA OROVILLE ...... OROVILLE MUNI ...... 9/9701 VOR OR GPS–A, AMDT 6. 07/21/09 ...... OR REDMOND ...... ROBERTS FIELD ...... 9/0045 ILS OR LOC RWY 22, AMDT 2A. 07/21/09 ...... OR REDMOND ...... ROBERTS FIELD ...... 9/0046 VOR/DME RWY 22, AMDT 3. 07/21/09 ...... OR REDMOND ...... ROBERTS FIELD ...... 9/0047 VOR A, AMDT 5. 07/21/09 ...... CA OROVILLE ...... OROVILLE MUNI ...... 9/0053 TAKEOFF MINIMUMS AND OB- STACLE DP, AMDT 2. 07/21/09 ...... WV MORGANTOWN ...... MORGANTOWN MUNI–WALTER L. 9/0093 ILS OR LOC RWY 18, AMDT 13. BILL HART FLD. 07/22/09 ...... OR PORTLAND ...... PORTLAND INTL ...... 9/0161 ILS ROR LOC RWY 28L, AMDT 1A. 07/22/09 ...... FL MELBOURNE ...... MELBOURNE INTL ...... 9/0262 RNAV (GPS) RWY 27L, ORIG– A. 07/22/09 ...... WY DOUGLAS ...... CONVERSE COUNTY ...... 9/0323 RNAV (GPS) RWY 29, ORIG. 07/22/09 ...... WY DOUGLAS ...... CONVERSE COUNTY ...... 9/0324 VOR RWY 29, AMDT 1

[FR Doc. E9–18661 Filed 8–12–09; 8:45 am] FOR FURTHER INFORMATION CONTACT: and Type C medicated feeds containing BILLING CODE 4910–13–P Harlan Howard, Center for Veterinary oxytetracycline and neomycin sulfate, Medicine (HFV–126), Food and Drug in a 1:1 ratio, for several production and Administration, 7500 Standish Pl., therapeutic indications in chickens, DEPARTMENT OF HEALTH AND Rockville, MD 20855, 240–276–8111, turkeys, swine, cattle, and sheep. The HUMAN SERVICES e-mail: [email protected]. supplemental NADA is approved as of SUPPLEMENTARY INFORMATION: In the July 2, 2009, and the regulations are Food and Drug Administration Federal Register of August 8, 2003 (68 amended in 21 CFR 558.455 to reflect FR 47332), as corrected October 7, 2003 the approval. Pennfield has since 21 CFR Part 558 (68 FR 57911), as part of the Drug withdrawn its hearing request for NDA Efficacy Study Implementation (DESI) 138–939. [Docket No. FDA–2009––0665] program, CVM announced the effective Approval of this supplemental NADA did not require review of any new safety New Animal Drugs for Use in Animal conditions of use for several drug or effectiveness data. Therefore, a Feeds; Oxytetracycline; Neomycin products and use combinations that were listed in § 558.15 (21 CFR 558.15). freedom of information summary was AGENCY: Food and Drug Administration, CVM proposed to withdraw the NADAs not prepared. HHS. for those products or use combinations The DESI evaluation was concerned ACTION: Final rule. lacking substantial evidence of only with the effectiveness of the drug effectiveness following a 90-day products and use combinations. Nothing SUMMARY: The Food and Drug opportunity to supplement the NADAs in this document constitutes a bar to Administration (FDA) is amending the with labeling conforming to the relevant further proceedings with respect to animal drug regulations to reflect findings of effectiveness. questions of safety of the subject drugs approval of a supplemental new animal In response to that notice, Pennfield in treated animals or of the drugs or drug application (NADA) filed by Oil Co., (Pennfield) 14040 Industrial their metabolites in food products Pennfield Oil Co. The supplemental Rd., Omaha, NE 68144, filed a hearing derived from treated animals. NADA provides for the use of fixed- request for its approved NADA 138–939 Products that comply with FDA’s combination Type A medicated articles NEO–OXY 50/50, NEO–OXY 100/100, findings of effectiveness are eligible for containing oxytetracycline and and NEO–OXY 100/100 MR copying, as described in the Generic neomycin sulfate to formulate two-way, (oxytetracycline and neomycin sulfate). Animal Drug and Patent Term fixed-combination drug Type B and These products are two-way, fixed- Restoration Act Policy Letter Eight, Type C medicated feeds for chickens, combination Type A medicated articles August 21, 1991 (56 FR 41561). turkeys, swine, cattle, and sheep. This used to make two-way combination Accordingly, sponsors may now obtain approval reflects FDA’s effectiveness drug Type C medicated feeds. Pennfield approval of abbreviated NADAs for this conclusions which relied on the subsequently filed a supplement to fixed combination Type A medicated National Academy of Sciences/National NADA 138–939 to revise the labeling of article. Research Council (NAS/NRC) Drug these products to comply with these The agency has determined under 21 Efficacy Study Group’s evaluation of the findings of effectiveness. The CFR 25.33 that this action is of a type effectiveness of these drugs when used supplemental NADA provided for use of that does not individually or in animal feed as single ingredients. these fixed-combination Type A cumulatively have a significant effect on DATES: This rule is effective August 13, medicated articles to formulate two- the human environment. Therefore, 2009. way, fixed-combination drug Type B neither an environmental assessment

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nor an environmental impact statement the Center for Veterinary Medicine, 21 The redesignation, additions, and is required. CFR part 558 is amended as follows: revisions read as follows: This rule does not meet the definition PART 558—NEW ANIMAL DRUGS FOR § 558.455 Oxytetracycline and neomycin. of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because USE IN ANIMAL FEEDS * * * * * it is a rule of ‘‘particular applicability.’’ (b) Sponsors. See Nos. 048164 and Therefore, it is not subject to the ■ 1. The authority citation for 21 CFR 066104 in § 510.600(c) of this chapter. congressional review requirements in 5 part 558 continues to read as follows: U.S.C. 801–808. * * * * * Authority: 21 U.S.C. 360b, 371. (d) Special considerations. Cattle List of Subjects in 21 CFR Part 558 ■ 2. Amend § 558.455 as follows: feeds shall bear the following warning ■ a. Revise paragraph (b); statement: ‘‘Use of more than one Animal drugs, Animal feeds. ■ b. Redesignate paragraph (d) as product containing neomycin or failure ■ Therefore, under the Federal Food, paragraph (e); to follow withdrawal times may result Drug, and Cosmetic Act and under ■ c. Add new paragraph (d); and in illegal drug residues.’’ authority delegated to the Commissioner ■ d. Revise newly redesignated (e) Indications for use—(1) Chickens. of Food and Drugs and redelegated to paragraph (e). It is used in feed as follows:

Oxytetracycline and neomycin sulfate amount in grams per ton of feed Indications for use Limitations Sponsors

(i) 10 to 50 Chickens: For increased rate of Feed continuously; do not feed to 048164 weight gain and improved feed effi- chickens producing eggs for 066104 ciency. human consumption; in low cal- cium feeds withdraw 3 days before slaughter.

(ii) 100 to 200 Chickens: For control of infectious Feed continuously for 7 to 14 d; do 048164 synovitis caused by Mycoplasma not feed to chickens producing 066104 synoviae; control of fowl cholera eggs for human consumption; in caused by Pasteurella multocida low calcium feed, withdraw 3 d be- susceptible to oxytetracycline. fore slaughter.

(iii) 400 Chickens: For control of chronic res- Feed continuously for 7 to 14 d; do 048164 piratory disease (CRD) and air sac not feed to chickens producing 066104 infection caused by M. eggs for human consumption; in gallisepticum and Escherichia coli low calcium feeds, withdraw 3 d susceptible to oxytetracycline. before slaughter.

(iv) 500 Chickens: For reduction of mortality Feed continuously for 5 d; do not 048164 due to air sacculitis (air-sac- infec- feed to chickens producing eggs 066104 tion) caused by E. coli susceptible for human consumption; withdraw to oxytetracycline. 24 hours before slaughter; in low calcium feeds withdraw 3 d before slaughter.

(2) Turkeys. It is used in feed as follows:

Oxytetracycline and neomycin sulfate amount Indications for use Limitations Sponsors

(i) 10 to 50 grams per ton (g/ton) of Growing turkeys: For increased rate Feed continuously; do not feed to 048164 feed of weight gain and improved feed turkeys producing eggs for human 066104 efficiency. consumption.

(ii) 100 g/ton of feed Turkeys: For control of hexamitiasis Feed continuously for 7 to 14 d; do 048164 caused by Hexamita meleagridis not feed to turkeys producing eggs 066104 susceptible to oxytetracycline. for human consumption.

(iii) 200 g/ton of feed Turkeys: For control of infectious Feed continuously for 7 to 14 d; with- 048164 synovitis caused by M. synoviae draw 5 d before slaughter; do not 066104 susceptible to oxytetracycline. feed to turkeys producing eggs for human consumption.

(iv) To provide 25 milligrams per Turkeys: For control of complicating Feed continuously for 7 to 14 d; with- 048164 pound (mg/lb) of body weight daily. bacterial organisms associated draw 5 d before slaughter; do not 066104 with bluecomb (transmissible en- feed to turkeys producing eggs for teritis; coronaviral enteritis) sus- human consumption. ceptible to oxytetracycline.

(3) Swine. It is used in feed as follows:

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Oxytetracycline and neomycin sulfate amount Indications for use Limitations Sponsors

(i) 10 to 50 g/ton of feed Swine: For increased rate of weight Feed continuously. 048164 gain and improved feed efficiency. 066104

(ii) To provide 10 mg/lb of body 1. Swine: For treatment of bacterial Feed continuously for 7 to 14 d; with- 048164 weight daily. enteritis caused by E. coli and Sal- draw 5 d before slaughter. 066104 monella choleraesuis and treat- ment of bacterial pneumonia caused by P. multocida susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by E. coli suscep- tible to neomycin. 2. Breeding swine: For control and Feed continuously for not more than 048164 treatment of leptospirosis (reducing 14 d; withdraw 5 d before slaugh- 066104 the incidence of abortion and ter. shedding of leptospirae) caused by Leptospira pomona susceptible to oxytetracycline.

(4) Cattle and sheep. It is used in feed as follows:

Oxytetracycline and neomycin sulfate amount Indications for use Limitations Sponsors

(i) 10 to 20 g/ton of feed Sheep: For increased rate of weight Feed continuously. 048164 gain and improved feed efficiency. 066104

(ii) To provide 0.05 to 0.1 mg/lb of Calves (up to 250 lb): For increased Feed continuously; in milk replacers 048164 body weight daily. rate of weight gain and improved or starter feed. 066104 feed efficiency.

(iii) To provide 10 mg/lb of body 1. Calves and beef and nonlactating Feed continuously for 7 to 14 d; in 048164 weight daily. dairy cattle: For treatment of bac- feed or milk replacers. If symptoms 066104 terial enteritis caused by E. coli persist after using for 2 or 3 days, and bacterial pneumonia (shipping consult a veterinarian. Treatment fever complex) caused by P. should continue 24 to 48 hours be- multocida susceptible to oxytetra- yond remission of disease symp- cycline; treatment and control of toms. A withdrawal period has not colibacillosis (bacterial enteritis) been established for use in caused by E. coli susceptible to preruminating calves. Do not use neomycin. in calves to be processed for veal. A milk discard time has not been established for use in lactating dairy cattle. Do not use in female dairy cattle 20 months of age or older. Withdraw 5 d before slaugh- ter. 2. Calves (up to 250 lb): For treat- Feed continuously for 7 to 14 d; in 048164 ment of bacterial enteritis caused milk replacers or starter feed. If 066104 by E. coli susceptible to oxytetra- symptoms persist after using for 2 cycline; treatment and control of or 3 days, consult a veterinarian. colibacillosis (bacterial enteritis) Treatment should continue 24 to caused by E. coli susceptible to 48 hours beyond remission of dis- neomycin. ease symptoms. A withdrawal pe- riod has not been established for use in preruminating calves. Do not use in calves to be processed for veal. A milk discard time has not been established for use in lac- tating dairy cattle. Do not use in fe- male dairy cattle 20 months of age or older. Withdraw 5 d before slaughter.

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Oxytetracycline and neomycin sulfate amount Indications for use Limitations Sponsors

3. Sheep: For treatment of bacterial Feed continuously for 7 to 14 d. If 048164 enteritis caused by E. coli and bac- symptoms persist after using for 2 066104 terial pneumonia caused by P. or 3 days, consult a veterinarian. multocida susceptible to oxytetra- Treatment should continue 24 to cycline; treatment and control of 48 hours beyond remission of dis- colibacillosis (bacterial enteritis) ease symptoms. Withdraw 5 d be- caused by E. coli susceptible to fore slaughter. neomycin.

(iv) To provide 25 mg/head/day Calves (250 to 400 lb): For increased Feed continuously. 048164 rate of weight gain and improved 066104 feed efficiency.

(v) To provide 75 mg/head/day Growing cattle (over 400 lb): For in- Feed continuously. 048164 creased rate of weight gain; im- 066104 proved feed efficiency, and reduc- tion of liver condemnation due to liver abscesses.

(vi) To provide 0.5 to 2.0 g/head/ day Cattle: For prevention and treatment Feed 3 to 5 d before and after arrival 048164 of the early stages of shipping in feedlots. A withdrawal period 066104 fever complex. has not been established for use in preruminating calves. Do not use in calves to be processed for veal. A milk discard time has not been established for use in lactating dairy cattle. Do not use in female dairy cattle 20 months of age or older.

Dated: August 7, 2009. ways use geophysical information that information that MMS retains and, William . Flynn, may not otherwise be reprocessed without an extension, is subject to Acting Director, Center for Veterinary without the term extension. The release by MMS 25 years after issuing Medicine. extension does not apply to geological the permit. The extension provides [FR Doc. E9–19414 Filed 8–12–09; 8:45 am] data or information. incentives to permittees and third BILLING CODE 4160–01–S DATES: Effective Date: This rule becomes parties to reprocess, market, or in other effective on September 14, 2009. ways use geophysical information that FOR FURTHER INFORMATION CONTACT: may not otherwise be reprocessed DEPARTMENT OF THE INTERIOR David Zinzer, Geophysicist, Offshore without the term extension. Energy and Minerals Management, Analysis of Comments and Minerals Management Service Resource Evaluation Division, at (703) Recommendations 787–1628. 30 CFR Part 251 SUPPLEMENTARY INFORMATION: This final The MMS has decided to proceed with the final rule after carefully [Docket ID: MMS–2008–OMM–0006] rule implements changes put forward by our proposed rulemaking published considering all written comments on the RIN 1010–AD41 June 18, 2007 (72 FR 33417). The proposed rulemaking. comment period ended August 17, 2007. Comment: One commenter continued Geological and Geophysical (G&G) to comment about issues and changes Explorations of the Outer Continental The MMS received four sets of written comments. One set of comments and put forward by our proposed Shelf—Changing Proprietary Term of rulemaking, published July 17, 2002 (67 Certain Geophysical Information recommendations was from an industry association; two sets were from third FR 46942), and the subsequent related AGENCY: Minerals Management Service party users of geophysical data and final rulemaking, published March 30, (MMS), Interior. information collected on the Outer 2006 (71 FR 16033). ACTION: Final rule. Continental Shelf (OCS); and one set Response: Changes put forth by the was from the public. June 18, 2007, proposed rulemaking are SUMMARY: This final rule extends the directly addressed in this final proprietary term of certain reprocessed Summary of Proposed Rulemaking rulemaking. However, MMS has geophysical information submitted to The MMS proposed to extend, upon clarified, where necessary, certain MMS under a permit. The rule gives up successful application to MMS, the points or matters that pertain to all of 30 to 5 years of additional protection to proprietary term of geophysical CFR part 251. reprocessed vintage geophysical information that a permittee or third Comment: Three comments cited the information that MMS retains and, party reprocessed 20 or more years after substantial costs that can be incurred in without an extension, is subject to MMS issued the germane permit under reprocessing existing geophysical release by MMS 25 years after issuing which the originating data were information. One estimated costs of the permit. The extension provides collected. The rule proposed to give up reprocessing exclusive 2–D data of $5– incentives to permittees and third to 5 years of additional protection to 10 million for a project of 5,000 sq. km parties to reprocess, market, or in other reprocessed vintage geophysical (1,930 sq./mi.). The second comment

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noted several geophysical service of reprocessing during the proprietary commenter also questioned why most companies have and continue to invest period. Also for clarification, MMS eligible vintage geophysical information vast amounts of capital in the reminds permit applicants that we issue would come from the Alaska OCS. acquisition, processing, and separate geological and geophysical Response: These are revenue reprocessing of nonexclusive permits, or one of each, for a survey. estimates only, expected to be in the geophysical data; and that the annual The MMS does not issue a combined ballpark but with a wide range. The aggregate of investments by companies geological and geophysical permit, i.e., MMS believes that the best market for in the Gulf of Mexico (GOM) and other there is no ‘‘G&G’’ permit per se. this type of vintage, reprocessed OCS areas is in the hundreds-of- Comment: One comment noted that geophysical information is in the Alaska millions of dollars. A third comment the proposed rule requires filing for an OCS where little or no modern 3–D stated the time involved (typically about extension of the proprietary term (after information exists and where OCS lease 1 year) in reprocessing and the a 1-year grace period) within 30 days of sales are currently scheduled. While substantial costs that can be incurred in completion of reprocessing. The reprocessed vintage 2–D and 3–D reprocessing existing geophysical commenter believes this required time geophysical information in the GOM information warrant a minimum of 10 is too short and recommends the that MMS retains is eligible for 5-year years proprietary term extension. required time to file for an extension extensions of the 25-year proprietary Response: The MMS recognizes the should be extended to 90 days. term, there is less demand as modern significant investment that the Response: The MMS agrees that 30 2–D and 3–D information is available in geophysical service industry and oil and days may be an insufficient amount of most of the same areas. gas industry make in acquiring, time to file for an extension, and will Comment: One comment asked for licensing, processing, and reprocessing allow permittees and third parties up to clarification of a ‘‘germane permit.’’ geophysical data and information; and 90 days to file (see § 251.14(b)(2)). The Another commenter used the term that the competitive and economic sooner an application is filed, the ‘‘underlying permit’’ in their comments. value of these data and information sooner MMS may approve the Response: Both refer to the MMS continues during the proprietary period. extension. permit under which the original raw However, only data and information Comment: Another comment data were collected by the permittee. that are selected and retained by MMS requested that MMS not require a Comment: One commenter will be released to the public. Data and seismic company to apply for an recommended MMS add to the rule information not retained by MMS are extension. If MMS still requires definitions for processed geophysical not subject to release by MMS; submission of an application, then MMS information and date of completion of therefore, the extension does not apply should allow the seismic company to reprocessing. Another commenter to data and information not retained by submit the application as early as the recommended adding the definition of MMS. The MMS maintains that the 15th anniversary of the originating reprocessing. original proprietary term and the 5-year permit. The commenter also stated that Response: The definitions for extension in the proposed rule provide MMS’ proposed rulemaking creates a processed geophysical information and an adequate incentive for investing in new administrative and management reprocessing are already in the 30 CFR reprocessing and the opportunity to burden on MMS of tracking these 251 regulations (see § 251.1). It appears recoup that investment. extensions and the geophysical data and that commenters were not clear on what Comment: One comment noted that information to which they apply. definitions apply to this rulemaking. all processed or reprocessed geophysical Response: The MMS does not require The definition for processed information is of value to a licensee a permittee to apply for an extension of geophysical information is contained in (third party). Instances of licensees the proprietary term; absent an the definition titled processed applying their own processing extension, the reprocessed information geophysical or geological information. techniques should be considered the would retain its 25-year term. However, The definition for reprocessing is also exception rather than the norm; an approved application is required for contained in that same definition— Exploration and Production (E&P) a permittee to get an extension of the reprocessing is the additional companies license raw data (from term. Adding 5 years to the proprietary processing other than ordinary permittees). It appears that MMS is term for information reprocessed processing used in the general course of failing to consider or fully appreciate between 15 and 20 years after the permit evaluation. The MMS interprets date of that an operator must secure a license to date will not extend the term beyond completion to be the date that the geophysical information in order to the original 25-year term. Extending the reprocessed information first becomes apply those additional processing term for information that is reprocessed available in a useable format for inhouse techniques. MMS states that these 20 or more years after the permit date interpretation by MMS or the permittee, sophisticated processing techniques are allows a sufficient amount of time for or first becomes available to third only performed by E&P companies, an permittees and third parties to market, parties via sale, trade, license assertion and premise the commenter sell, trade, license, or otherwise use the agreement, or other means. We revised categorically rejects. The commenter reprocessed information, and allows the definition of processed geophysical also noted that reprocessing of MMS to keep the number of or geological information to include this geophysical information can and does applications for an extension at a wording for date of completion. To occur numerous times over a number of manageable level. further clarify that this revised years. Comment: One comment questioned regulation applies strictly to reprocessed Response: The MMS recognizes that MMS’ estimates of $3 million to $25 geophysical information, we have added geophysical companies make significant million in revenue over the first 5 years definitions for geophysical information investment in developing reprocessed after the rule becomes effective, and geological information to the rule. geophysical information, apply generated by licensing or selling Also, to recognize its growing use as a advanced algorithms and other geophysical information reprocessed 20 major geophysical technique in the sophisticated techniques in reprocessing or more years after MMS issued the OCS, electromagnetic is added to the list geophysical information for license or germane permit and for which MMS of key geophysical techniques in the sale, and acknowledges the recurrence extended the proprietary term. The definition of geophysical exploration.

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Comment: One commenter believes of time to ensure that a seismic market products as their own. The there is justification for greater than a company will achieve a return on their ending result would be a total violation 5-year term extension, stating that Brazil investment of the reprocessed of a seismic company’s intellectual has a 10-year reset when data are geophysical information and creates an property rights. It would also raise a reprocessed before they are made incentive for the seismic companies to question as to whether MMS has any public. pursue and implement technological rights to that processed geophysical Response: The confidentiality advances in processing that will data, and whether MMS has breached (proprietary) period for geophysical certainly occur. In turn, this will its obligation to hold the raw seismic data/information collected offshore minimize the need for acquiring more data in confidence for 50 years. Brazil by data acquisition companies costly, new geophysical data that will be Response: The MMS does not acquire (similar to permittees in the U.S.) is 10 constrained by obstructions offshore processed or reprocessed geophysical years, plus an additional 10 years if the and marine environmental concerns. information that can be reverse- information is reprocessed during the Response: The MMS maintains that engineered back to its raw data format. initial 10-year confidentiality period. In the original proprietary term and the Most geophysical information retained Brazil and other countries, ‘‘data’’ and 5-year extension in the proposed rule by MMS has undergone stacking and ‘‘information’’ are treated the same with provide an adequate incentive for migration, following previous regards to a proprietary term. For the investing in reprocessing and the processing steps such as U.S. OCS, geophysical data has a 50- opportunity to recoup that investment. demultiplexing, gain adjustments, year proprietary term while processed Comment: The commenter also deconvolution, amplitude and velocity geophysical information has a 25-year suggests MMS state that the extension of analyses, normal move-out corrections, term. the confidentiality period may be and filtering. Other geophysical Comment: The commenter strongly applied to other processed or information, which has not undergone supports the proposed rule and urges reprocessed information derived from migration, would still require MMS to adopt the proposed changes data collected under the same identification of field geometry (source quickly. The proposed rule is necessary originating permit. and receiver locations) and other to amend changes to the final rule in Response: The extension of the parameters and filters used to collect 2006, which modifies the start dates of proprietary term will be determined data before attempting reverse proprietary terms for geophysical data separately for each approved engineering. As such, the geophysical and information and any derivatives of application, including reprocessed information that MMS retains enjoys a these data. The commenter also information derived from data collected 25-year term, not a 50-year term since it supports provisions in the proposed under the same originating permit. is not, nor can it become, raw data. rule that would allow multiple Comment: Another commenter stated Comment: The same commenter extensions up to a maximum of 50 that the 25-year proprietary term was suggested that MMS incorporate in the years. too long and objected to any extension rule, a comprehensive list of the criteria Response: The MMS believes that the of time. The commenter proposed a the Regional Director would use to proposed extension of up to 5 years of 10-year [basic] term with a 5-year determine whether to approve or deny the proprietary term of geophysical extension for reprocessing geophysical a seismic company’s application for an information that a permittee or third data. If geophysical information is extension of the confidentiality period. party reprocessed 20 or more years after allowed to become public sooner, the Without stated criteria, a seismic MMS issued the germane permit under effect would be to encourage company would have added which the originating data were exploration, allow the scientific uncertainty/risk to account for in its collected, is fair and appropriate. community to access important analysis and determination of whether Comment: Another commenter information that could be valuable to to make an investment in reprocessing similarly believes that the concept of an research, and to give students training to geophysical information in the later extension to the proprietary period for be geophysicists a much more robust years of an originating permit. geophysical information is a much data set with which to hone their The commenter also stated that needed addition to the regulations as processing and interpretative skills. requiring an application process to they currently exist after the changes Response: The MMS finds that an obtain an extension of the enacted in 2006. The commenter extension of the proprietary term, by up confidentiality period wrongly ‘‘implies contends that the proposed extension is to 5 years, is appropriate. The MMS that the seismic company may somehow too short and should be extended to 10 encourages geophysical service be able to obfuscate the regulatory years. The proposed 5-year extension companies and E&P companies to make requirements of the original permit, would significantly limit the value of vintage and other geophysical submit geophysical information that is projects conducted by geophysical information available, as soon as not in fact recently reprocessed contractors and processing firms, and as possible, to the science community, geophysical information, or submit a result, degrade the value of preexisting students, and to government agencies geophysical information that is not information and lessen interest in for research. reprocessed geophysical information.’’ applying new reprocessing techniques Comment: One commenter contends Response: In according confidentiality to older information sets. A third that most, if not all, processed or to reprocessed geophysical information, commenter believes that proposing an reprocessed geophysical information MMS does not need and will not apply additional 5 years, while certainly submitted to MMS includes data added any criteria other than those specified in appreciated, does not adequately as a convenience to the user that allows 30 CFR part 251, and in particular, the address concerns that the commenter the user to work the data on seismic definitions of geophysical information articulated to the MMS Director in the workstations. The additional data can be and processed geophysical information April 21, 2006 letter and in a June 2006 used by a third party to reverse-engineer as they appear in this rulemaking. An workshop with MMS. The commenter the processing, allowing them to applicant who completes the MMS recommends an extension by MMS of effectively obtain the raw underlying application for the 5-year extension of no less than 7 years. The commenter data, at which point they can apply the proprietary term will furnish MMS states that this is a reasonable amount their own processing techniques and all the information MMS will need to

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approve the protection. The application The range of estimated values Small Business Administration will be will request such information as name depends on the number of lease sales in investigated for appropriate action. and address, the area in which the areas where eligible vintage geophysical Small Business Regulatory Enforcement information was collected, permit information exists, mostly in the Alaska Fairness Act number, date, description of the OCS, the amount and quality of processing performed, date of reprocessed geophysical information, The final rule is not a major rule completion of reprocessing, and and economic factors. The MMS under 5 U.S.C. 804(2) of the Small certification that the geophysical assumes 15 extensions will be approved Business Regulatory Enforcement information meets the definition of over the 5-year period after this final Fairness Act. This final rule: processed geophysical information. The rule is effective. a. Will not have an annual effect on MMS believes that the information (2) This final rule will not create a the economy of $100 million or more. required on the application is relevant serious inconsistency or otherwise b. Will not cause a major increase in to its approval of a seismic company’s interfere with an action taken or costs or prices for consumers, application for an extension. planned by another agency. individual industries, Federal, State, or (3) This final rule will not alter the local government agencies, or Additional Clarification Added To the budgetary effects of entitlements, grants, geographic regions. Final Rule user fees, or loan programs or the rights c. Will not have significant adverse We have added a new paragraph to or obligations of their recipients. effects on competition, employment, (4) This final rule will not raise novel § 251.14(b) to make it clear that investment, productivity, innovation, or legal or policy issues arising out of legal geophysical information that is granted the ability of U.S.-based enterprises to mandates, the President’s priorities, or compete with foreign-based enterprises. the extension is subject to same the priorities set forth in E.O. 12866. submission, inspection, and selection Unfunded Mandates Reform Act criteria under 30 CFR 251.12 and Regulatory Flexibility Act This final rule will not impose an reimbursement criteria identified under The Department of the Interior unfunded mandate on State, local, or 30 CFR 251.13. This paragraph clarifies certifies that this final rule will not have tribal governments or the private sector the intent that the reprocessed a significant economic effect on a of more than $100 million per year. The geophysical information is treated in the substantial number of small entities final rule will not have an effect on same manner as other geophysical data under the Regulatory Flexibility Act State, local, or tribal governments or the and information collected under a (5 U.S.C. 601 et seq.). private sector. A statement containing permit and processed by permittees or This final rule will extend the the information required by the third parties. We also clarified proprietary term for vintage reprocessed Unfunded Mandates Reform Act (2 paragraph (3) of § 251.14(b) by explicitly geophysical information. The only U.S.C. 1501 et seq.) is not required. stating under what conditions one may entities affected by this final rule change apply for an extension for a new are about 10 geophysical companies, if Takings Implication Assessment (E.O. reprocessing of permitted data. still in existence, whose reprocessed 12630) Procedural Matters geophysical information being held by Under the criteria in E.O. 12630, this MMS may be released later than under final rule does not have significant Regulatory Planning and Review current regulations. The Small Business takings implications. The final rule is (Executive Order (E.O.) 12866) Administration classifies geophysical not a governmental action capable of surveying and mapping service This final rule is not a significant rule interference with constitutionally companies under the North American as determined by the Office of protected property rights. A Takings Industry Classification System Code Management and Budget (OMB) and is Implication Assessment is not required. 541360. The criteria for determining a not subject to review under E.O. 12866. small entity for this classification code Federalism (E.O. 13132) (1) This final rule will not have an is annual receipts of less than $4.5 Under the criteria in E.O. 13132, this effect of $100 million or more on the million. All of the 10 geophysical final rule does not have federalism economy. It will not adversely affect in companies potentially affected by this implications. This final rule will not a material way the economy, final rule have annual receipts greater substantially and directly affect the productivity, competition, jobs, the than $4.5 million; therefore, this final relationship between the Federal and environment, public health or safety, or rule will not have a significant State governments. To the extent that State, local, or tribal governments or economic effect on a substantial number State and local governments have a role communities. of small entities. in OCS activities, this final rule will not The MMS estimates that over the first Your comments are important. The affect that role. A Federalism 5 years after the rule becomes effective, Small Business and Agriculture Assessment is not required. revenue generated by licensing or Regulatory Enforcement Ombudsman selling geophysical information and 10 Regional Fairness Boards were Civil Justice Reform (E.O. 12988) reprocessed 20 or more years after MMS established to receive comments from This rule complies with the issued the germane permit, and for small businesses about Federal agency requirements of E.O. 12988. which MMS extended the proprietary enforcement actions. The Ombudsman Specifically, this rule: term, will be in a range from $3 million will annually evaluate the enforcement (a) Meets the criteria of section 3(a) to $25 million over the period. More activities and rate each agency’s requiring that all regulations be revenue will be generated in the first responsiveness to small business. If you reviewed to eliminate errors and year during which there is a 1-year grace wish to comment on the actions of ambiguity and be written to minimize period to apply for extensions of MMS, call 1–888–734–3247. You may litigation; and proprietary terms of all eligible comment to the Small Business (b) Meets the criteria of section 3(b)(2) reprocessed information. In subsequent Administration without fear of requiring that all regulations be written years, applications must be filed within retaliation. Allegations of in clear language and contain clear legal 90 days of completion of processing. discrimination/retaliation filed with the standards.

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Consultation With Indian Tribes (E.O. 2012; total 3 burden hours). Once the regulations at 30 CFR part 251. The 13175) rulemaking becomes effective, we will information collection does not include Under the criteria in E.O. 13175, we consolidate the burden into the primary questions of a sensitive nature. have evaluated this final rule and collection, 30 CFR 251, 1010–0048. The final regulation will allow determined that it has no substantial The title of the collection of permittees and third parties to apply for information is ‘‘30 CFR part 251, effects on federally recognized Indian an up to 5-year extension of the 25-year Request for Geophysical Extension.’’ tribes. There are no Indian or tribal proprietary term within 90 days after Respondents include approximately 10 lands in the OCS. the date of completion of the Federal OCS permittees. Responses to Paperwork Reduction Act (PRA) this collection are required to obtain or reprocessing. This benefit adds 3 new This rule contains a new information retain a benefit. The frequency of burden hours to the information collection requirement; therefore, a reporting is on occasion. The MMS will collection requirements already submission to OMB under the PRA is protect proprietary information approved for 30 CFR part 251. The required. The OMB has approved the according to the Freedom of Information rulemaking imposes no new non-hour new requirement under OMB Control Act (5 U.S.C. 552) and its implementing burden costs. Refer to the chart for the Number 1010–0179 (expiration 08/31/ regulations (43 CFR part 2), and under new requirement and burden.

Average number of annual Annual burden 30 CFR 251 Reporting and recordkeeping requirement Hour burden responses hours

251.14(b)(3) ...... Request extension of time period for permitted ac- Burden included in 30 CFR Part 251 (1010– 0 tivities. 0048)

251.14(b)(1), (2), (3) ...... NEW: Apply for extension of the proprietary term for 1 3 Extensions...... 3 geophysical information within 90 days after re- processing completion date; any subsequent ex- tension requests.

Total ...... 3 responses ...... 3

Based on a comment received during nature. The MMS completed a PART 251—GEOLOGICAL AND the proposed rule stage, MMS extended Categorical Exclusion Review for this GEOPHYSICAL (G&G) EXPLORATIONS the time allowed for respondents to action and concluded that the OF THE OUTER CONTINENTAL SHELF request an extension of the proprietary rulemaking does not include an term from 30 days to 90 days after extraordinary circumstance, therefore, ■ 1. The authority citation for part 251 completion of reprocessing. This change preparation of an environmental continues to read as follows: did not affect the paperwork burden analysis or environmental impact Authority: 31 U.S.C. 9701, 43 U.S.C. 1334. between the proposed and final rule. statement will not be required. ■ A Federal agency may not conduct or Data Quality Act 2. Amend § 251.1 as set forth below: sponsor, and a person is not required to ■ A. Add definitions for Geological respond to, a collection of information In developing this rule, we did not information, Geophysical data, and unless it displays a currently valid OMB conduct or use a study, experiment, or Geophysical information in alphabetical control number. The public may survey requiring peer review under the order; Data Quality Act (Pub. L. 106–554, app. comment, at any time, on the accuracy ■ B. Revise the definitions for of the information collection burden of C § 515, 114 Stat. 2763, 2763A–153– 154). Geophysical exploration and Processed our regulations and may submit geological or geophysical information; comments to the Department of the Effects on the Energy Supply (E.O. and Interior; Minerals Management Service; 13211) ■ C. Delete the definition for Attention: Regulations and Standards This rule is not a significant energy Information. Branch; MS–4024; 381 Elden Street; action under the definition in E.O. Herndon, Virginia 20170–4817. § 251.1 Definitions. 13211. A Statement of Energy Effects is National Environmental Policy Act of not required. * * * * * 1969 Geological information means List of Subjects in 30 CFR Part 251 geological or geochemical data that have This rule does not constitute a major Continental shelf, Freedom of been analyzed, processed, or Federal action significantly affecting the information, Oil and gas exploration, interpreted. quality of the human environment. The Public lands—mineral resources, * * * * * MMS has analyzed this rule under the Reporting and recordkeeping Geophysical data means criteria of the National Environmental requirements, Research. Policy Act (42 U.S.C. 4321 et seq.) and measurements that have not been determined that it falls within the Dated: July 2, 2009. processed or interpreted. categorical exclusion for ‘‘regulations Ned Farquhar, Geophysical exploration means * * * that are of an administrative, Acting Assistant Secretary—Land and exploration that utilizes geophysical financial, legal, technical, or procedural Minerals Management. techniques (e.g., gravity, magnetic, nature and whose environmental effects ■ For the reasons stated in the preamble, electromagnetic, or seismic) to produce are too broad, speculative, or conjectural the Minerals Management Service data and information on oil, gas, and to lend themselves to meaningful (MMS) amends 30 CFR part 251 as sulphur resources in support of possible analysis’’ in that it is a rule of a legal follows: exploration and development activities.

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The term does not include processing used in the general course of ■ C. Redesignate paragraphs (b)(2) and geophysical scientific research. evaluation. Reprocessing operations (b)(3) as (b)(7) and (b)(8), respectively; * * * * * may include varying identified and Geophysical information means parameters for the detailed study of a ■ D. Add new paragraphs (b)(2), (b)(3), geophysical data that have been specific problem area. Reprocessing may (b)(4), (b)(5), and (b)(6) to read as processed or interpreted. occur several years after the original follows: processing date. Reprocessing is * * * * * determined to be completed on the date § 251.14 Protecting and disclosing data Processed geological or geophysical and information submitted to MMS under a that the reprocessed information is first permit. information means data collected under available in a useable format for in- a permit and later processed or house interpretation by MMS or the * * * * * reprocessed. Processing involves permittee, or becomes first available to (b) Timetable for release of G&G data changing the form of data so as to third parties via sale, trade, license and information related to oil, gas, and facilitate interpretation. Processing agreement, or other means. sulphur that MMS acquires. Except for operations may include, but are not high-resolution data and information limited to, applying corrections for * * * * * released under 30 CFR 250.197(b)(2), known perturbing causes, rearranging or MMS will release or disclose acquired ■ 3. Amend § 251.14 as set forth below: filtering data, and combining or data and information in accordance transforming data elements. ■ A. Revise the introductory text in with paragraphs (b)(1) through (b)(7) of Reprocessing is the additional paragraph (b); this section. processing other than ordinary ■ B. Revise the table in paragraph (b)(1); (1) * * *

If you or a third party submit and MMS retains * * * The Regional Director will release them to the public * * *

(i) Geological data and information, ...... 10 years after MMS issued the permit. (ii) Geophysical data, ...... 50 years after MMS issued the permit. (iii) Geophysical information processed or reprocessed less than 20 25 years after MMS issued the permit. years after MMS issued the germane permit, (iv) Geophysical information processed or reprocessed 20 or more 25 years after MMS issued the permit; or, if you or a third party applied years after MMS issued the germane permit, for an extension of the proprietary term, 5 years after MMS approved the application for an extension. In any case MMS will release the in- formation no later than 50 years after MMS issued the permit.

(2) Permittees and third parties may maximum term is reached, the MMS DEPARTMENT OF HOMELAND apply to MMS for an extension of the Regional Director will release the SECURITY 25-year proprietary term for geophysical information to the public. Coast Guard information reprocessed 20 or more (4) Geophysical information years after MMS issued the germane processed or reprocessed 20 or more permit. You must submit the 33 CFR Part 100 years after MMS issued the germane application to MMS within 90 days after permit and granted the extension will be [Docket No. USCG–2009–0460] completion of the reprocessing, except during the initial 1-year grace period as subject to submission, inspection, and RIN 1625–AA08 provided in paragraph (b)(5) below. selection criteria under 30 CFR 251.12 Special Local Regulation for Marine Filing locations are listed in § 251.5(d). and reimbursement criteria identified Events; Mattaponi River, Wakema, VA Your application must include: under 30 CFR 251.13. (i) Name and address of the permittee (5) There will be a 1-year grace AGENCY: Coast Guard, DHS. or third party; period, starting September 14, 2009, to ACTION: Temporary final rule. (ii) Product name; allow permittees and third parties (iii) Identification of the geophysical sufficient time to meet the above SUMMARY: The Coast Guard is information area; requirements and to apply for all establishing special local regulations (iv) Identification of originating eligible extensions. During this time, during the Mattaponi Madness Drag permit number and date; Boat Races, a series of power boat races (v) Description of reprocessing MMS will not release geophysical information which was reprocessed 20 to be held on the waters of the performed; Mattaponi River, near Wakema, (vi) Identification of the date of or more years after the date that MMS issued the germane permit. Virginia. These special local regulations completion of reprocessing the are necessary to provide for the safety of geophysical information; (6) After September 14, 2010 MMS life on navigable waters during the (vii) Certification that the product will resume releasing eligible events. This action is intended to meets the definition of processed reprocessed information. If an restrict vessel traffic during the power geophysical information and that all application for extension is not filed, boat races in a segment of the Mattaponi other information in the application is not filed on time, or not approved by River that flows along the border of King accurate; and MMS, the original 25-year proprietary (viii) Signature and date. William County and King and Queen term applies to the release date of the (3) With each new reprocessing of County near Wakema, Virginia. permitted data, you may apply for an reprocessed geophysical information. DATES: This rule is effective from extension of up to 5 years. However, the * * * * * August 15 through August 16, 2009. maximum proprietary term for [FR Doc. E9–19198 Filed 8–12–09; 8:45 am] ADDRESSES: Comments and material geophysical information is 50 years after BILLING CODE 4310–MR–P received from the public, as well as MMS issued the permit. Once the documents mentioned in this preamble

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as being available in the docket, are part inclement weather, the event will be Small Entities of docket USCG–2009–0460 and are rescheduled for August 16, 2009. The Under the Regulatory Flexibility Act available online by going to http:// races will be held on the Mattaponi (5 U.S.C. 601–612), we have considered www.regulations.gov, selecting the River immediately adjacent to the whether this rule would have a Advanced Docket Search option on the Rainbow Acres Campground, King and significant economic impact on a right side of the screen, inserting USCG– Queen County, Virginia. The power boat substantial number of small entities. 2009–0460 in the Docket ID box, races will consist of approximately 40 The term ‘‘small entities’’ comprises pressing Enter, and then clicking on the vessels conducting high speed straight small businesses, not-for-profit item in the Docket ID column. This line runs along the river and parallel organizations that are independently material is also available for inspection with the shoreline. A fleet of spectator owned and operated and are not or copying at the Docket Management vessels is expected to gather near the dominant in their fields, and Facility (M–30), U.S. Department of event site to view the competition. To governmental jurisdictions with Transportation, West Building Ground provide for the safety of participants, populations of less than 50,000. Floor, Room W12–140, 1200 New Jersey spectators and other transiting vessels, The Coast Guard certifies under 5 Avenue, SE., Washington, DC 20590, the Coast Guard will temporarily restrict U.S.C. 605(b) that this rule will not have between 9 a.m. and 5 p.m., Monday vessel traffic in the event area during a significant economic impact on a through Friday, except Federal holidays. the power boat races. substantial number of small entities. FOR FURTHER INFORMATION CONTACT: If Discussion of Comments and Changes The rule will affect the following you have questions on this temporary entities, some of which may be small rule, call or e-mail Dennis Sens, Project The Coast Guard did not receive entities: Owners or operators of vessels Manager, Fifth Coast Guard District comments in response to the NPRM. intending to transit the affected section Prevention Division, Portsmouth, VA, Accordingly, the Coast Guard is of the Mattaponi River from 9 a.m. to 7 telephone (757) 398–6204, e-mail establishing temporary special local p.m. on August 15, 2009 and August 16, [email protected]. If you have regulations on specified waters of the 2009. This rule would not have a questions on viewing the docket, call Mattaponi River, near Wakema, significant economic impact on a Renee V. Wright, Program Manager, Virginia. substantial number of small entities for Docket Operations, telephone 202–366– Regulatory Analyses the following reasons. Although the 9826. regulated area will apply to a 3⁄4 mile SUPPLEMENTARY INFORMATION: We developed this rule after segment of the Mattaponi River, traffic considering numerous statutes and may be allowed to pass through the Regulatory Information executive orders related to rulemaking. regulated area with the permission of On June 25, 2009, we published a Below we summarize our analyses the Coast Guard Patrol Commander. In notice of proposed rulemaking (NPRM) based on 13 of these statutes or the case where the Patrol Commander entitled Special Local Regulation for executive orders. authorizes passage through the Marine Events; Mattaponi River, Regulatory Planning and Review regulated area during the event, vessels Wakema, VA in the Federal Register (74 shall proceed at the minimum speed FR 30256). We received no comments This rule is not a significant necessary to maintain a safe course that on the proposed rule. No public meeting regulatory action under section 3() of minimizes wake near the race course. was requested, and none was held. Executive Order 12866, Regulatory The Patrol Commander will allow non- Under 5 U.S.C. 553(d)(3), the Coast Planning and Review, and does not participating vessels to transit the area Guard finds that good cause exists for require an assessment of potential costs between races. Before the enforcement making this rule effective less than 30 and benefits under section 6(a)(3) of that period, we will issue maritime days after publication in the Federal Order. The Office of Management and advisories so mariners can adjust their Register. The potential dangers posed Budget has not reviewed it under that plans accordingly. by high speed power boat races in a Order. Assistance for Small Entities restricted waterway and in close We expect the economic impact of proximity to other vessel traffic make this rule to be so minimal that a full Under section 213(a) of the Small special local regulations necessary. Regulatory Evaluation is unnecessary. Business Regulatory Enforcement Delaying the effective date would be Although this regulation will prevent Fairness Act of 1996 (Pub. L. 104–121), contrary to the public interest, since traffic from transiting a portion of the in the NPRM we offered to assist small immediate action is needed to ensure Mattaponi River during the events, the entities in understanding the rule so the safety of the event participants, effect of this regulation will not be that they could better evaluate its effects support vessels, spectator craft and significant due to the limited duration on them and participate in the other vessels transiting the event area. that the regulated area will be in effect rulemaking process. However, the Coast Guard will provide and the extensive advance notification Small businesses may send comments advance notifications to users of the that will be made to the maritime on the actions of Federal employees affected waterways via marine community via marine information who enforce, or otherwise determine information broadcasts, local notice to broadcast, local radio stations and area compliance with, Federal regulations to mariners, commercial radio stations and newspapers so mariners can adjust their the Small Business and Agriculture area newspapers. plans accordingly. Additionally, the Regulatory Enforcement Ombudsman regulated area has been narrowly and the Regional Small Business Background and Purpose tailored to impose the least impact on Regulatory Fairness Boards. The The Mattaponi Volunteer Rescue general navigation yet provide the level Ombudsman evaluates these actions Squad will be sponsoring a series of of safety deemed necessary. Vessel annually and rates each agency’s power boat racing events entitled the traffic will be able to transit the responsiveness to small business. If you ‘‘Mattaponi Madness Drag Boat Event.’’ regulated area between heats, when the wish to comment on actions by The power boat races will be held on Coast Guard Patrol Commander deems it employees of the Coast Guard, call August 15, 2009 and, in the case of is safe to do so. 1–888–REG–FAIR (1–888–734–3247).

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The Coast Guard will not retaliate direct effect on one or more Indian categorical exclusion determination will against small entities that question or Tribes, on the relationship between the be available in the docket where complain about this rule or any policy Federal Government and Indian Tribes, indicated under ADDRESSES. or action of the Coast Guard. or on the distribution of power and List of Subjects in 33 CFR Part 100 responsibilities between the Federal Collection of Information Government and Indian Tribes. Marine safety, Navigation (water), This rule calls for no new collection Reporting and recordkeeping Energy Effects of information under the Paperwork requirements, Waterways. Reduction Act of 1995 (44 U.S.C. 3501– We have analyzed this rule under ■ For the reasons discussed in the 3520). Executive Order 13211, Actions preamble, the Coast Guard amends 33 Concerning Regulations That CFR part 100 as follows: Federalism Significantly Affect Energy Supply, A rule has implications for federalism Distribution, or Use. We have PART 100—SAFETY OF LIFE ON under Executive Order 13132, determined that it is not a ‘‘significant NAVIGABLE WATERS Federalism, if it has a substantial direct energy action’’ under that order because effect on State or local governments and it is not a ‘‘significant regulatory action’’ ■ 1. The authority citation for part 100 would either preempt State law or under Executive Order 12866 and is not continues to read as follows: impose a substantial direct cost of likely to have a significant adverse effect Authority: 33 U.S.C. 1233. compliance on them. We have analyzed on the supply, distribution, or use of this rule under that Order and have energy. The Administrator of the Office ■ 2. Add temporary § 100.35–T05–0460 determined that it does not have of Information and Regulatory Affairs to read as follows: implications for federalism. has not designated it as a significant § 100.35–T05–0460, Mattaponi River, energy action. Therefore, it does not Wakema, Virginia. Unfunded Mandates Reform Act require a Statement of Energy Effects (a) Regulated area. The following is a The Unfunded Mandates Reform Act under Executive Order 13211. regulated area: All waters of the of 1995 (2 U.S.C. 1531–1538) requires Technical Standards Mattaponi River, from surface to bottom Federal agencies to assess the effects of and shore to shore, immediately their discretionary regulatory actions. In The National Technology Transfer adjacent to Rainbow Acres particular, the Act addresses actions and Advancement Act (NTTAA) (15 Campground, in King and Queen that may result in the expenditure by a U.S.C. 272 note) directs agencies to use County, Virginia. This area is a section State, local, or Tribal government, in the voluntary consensus standards in their of the Mattaponi River approximately aggregate, or by the private sector of regulatory activities unless the agency 3⁄4-mile long, bounded to the east by a $100,000,000 or more in any one year. provides Congress, through the Office of line that runs parallel along longitude Though this rule will not result in such Management and Budget, with an 076°52′43″ W near the mouth of an expenditure, we do discuss the explanation of why using these Mitchell Hill Creek, and bounded to the effects of this rule elsewhere in this standards would be inconsistent with west by a line that runs parallel along preamble. applicable law or otherwise impractical. ° ′ ″ Voluntary consensus standards are longitude 076 53 41 W just north of Taking of Private Property technical standards (e.g., specifications Wakema, Virginia. All coordinates This rule will not effect a taking of of materials, performance, design, or reference Datum NAD 1983. private property or otherwise have operation; test methods; sampling (b) Definitions: (1) Coast Guard Patrol taking implications under Executive procedures; and related management Commander means a commissioned, Order 12630, Governmental Actions and systems practices) that are developed or warrant, or petty officer of the Coast Interference with Constitutionally adopted by voluntary consensus Guard who has been designated by the Protected Property Rights. standards bodies. Commander, Coast Guard Sector This rule does not use technical Hampton Roads. Civil Justice Reform standards. Therefore, we did not (2) Official Patrol means any vessel This rule meets applicable standards consider the use of voluntary consensus assigned or approved by Commander, in sections 3(a) and 3(b)(2) of Executive standards. Coast Guard Sector Hampton Roads Order 12988, Civil Justice Reform, to with a commissioned, warrant, or petty Environment minimize litigation, eliminate officer on board and displaying a Coast ambiguity, and reduce burden. We have analyzed this rule under Guard ensign. Department of Homeland Security (c) Special local regulations. (1) Protection of Children Management Directive 023–01 and Except for persons or vessels authorized We have analyzed this rule under Commandant Instruction M16475.lD, by the Coast Guard Patrol Commander, Executive Order 13045, Protection of which guide the Coast Guard in no person or vessel may enter or remain Children from Environmental Health complying with the National in the regulated area. Risks and Safety Risks. This rule is not Environmental Policy Act of 1969 (2) The operator of any vessel in the an economically significant rule and (NEPA) (42 U.S.C. 4321–4370f), and regulated area must: (i) Stop the vessel does not create an environmental risk to have concluded this action is one of a immediately when directed to do so by health or risk to safety that may category of actions which do not any Official Patrol. disproportionately affect children. individually or cumulatively have a (ii) Proceed as directed by any Official significant effect on the human Patrol. Indian Tribal Governments environment. This rule is categorically (d) Enforcement period. This section This rule does not have Tribal excluded, under figure 2–1, paragraph will be enforced from 9 a.m. to 7 p.m. implications under Executive Order (34)(), of the Instruction because it on August 15, 2009. In the case of 13175, Consultation and Coordination establishes special local regulations inclement weather, this section will be with Indian Tribal Governments, under 33 CFR Part 100. An enforced from 9 a.m. to 7 p.m. on because it does not have a substantial environmental analysis checklist and a August 16, 2009.

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Dated: July 29, 2009. Regulatory Information any construction barge participating in Wayne E. Justice, The Coast Guard is issuing this the project while the barge is in Rear Admiral, U.S. Coast Guard, Commander, temporary final rule without prior operation; and, (2) all waters between Fifth Coast Guard District. notice and opportunity to comment any barge participating in the project [FR Doc. E9–19431 Filed 8–12–09; 8:45 am] pursuant to authority under section 4(a) and the Hood Canal Bridge itself. The BILLING CODE 4910–15–P of the Administrative Procedure Act safety zone will be in effect from 6 a.m. (APA) (5 U.S.C. 553(b)). This provision on June 15, 2009, until 6 a.m. on authorizes an agency to issue a rule September 30, 2009, unless cancelled or DEPARTMENT OF HOMELAND without prior notice and opportunity to ended sooner by the Captain of the Port SECURITY comment when the agency for good or her Designated Representative. The Captain of the Port, Puget Sound cause finds that those procedures are Coast Guard may enlist the aid and cooperation of ‘‘impracticable, unnecessary, or contrary Federal, State, or local Law Enforcement to the public interest.’’ Under 5 U.S.C. 33 CFR Part 165 Officers to enforce the rules contained 553(b)(B), the Coast Guard finds that in this section pursuant to 33 CFR 6.04– good cause exists for not publishing a [Docket No. USCG–2009–0496] 11. notice of proposed rulemaking (NPRM) with respect to this rule because RIN 1625–AA00 Regulatory Analyses publishing a NPRM would be contrary We developed this rule after Safety Zone; Hood Canal Bridge Cable to the public interest because immediate considering numerous statutes and Laying Operation, Hood Canal, WA action is necessary to ensure the safety executive orders related to rulemaking. of the construction personnel and the Below we summarize our analyses AGENCY: Coast Guard, DHS. maritime public from the dangers based on 13 of these statutes or ACTION: Temporary final rule. associated with the Hood Canal Bridge executive orders. Construction Project. SUMMARY: The Coast Guard is For the same reasons, the Coast Guard Regulatory Planning and Review establishing a temporary safety zone in also finds under 5 U.S.C. 553(d)(3) that This rule is not a significant the vicinity of the Hood Canal Bridge good cause exists for making this rule regulatory action under section 3(f) of due to the ongoing Hood Canal Bridge effective less than 30 days after Executive Order 12866, Regulatory Construction Project. The safety zone is publication in the Federal Register. Planning and Review, and does not necessary to help protect construction Background and Purpose require an assessment of potential costs personnel and the maritime public from and benefits under section 6(a)(3) of that the numerous dangers associated with The Hood Canal Bridge Construction Order. The Office of Management and the Hood Canal Bridge Construction Project is a complex construction Budget has not reviewed it under that Project. All persons and vessel are operation involving multiple Order. prohibited from entering the zone construction barges and the installation The economic impact of this unless authorized by the Captain of the of underwater cables. Due to the temporary rule is expected to be Port, Puget Sound or her Designated numerous dangers associated with such minimal. This expectation is based on Representative. operations, the Coast Guard is the fact that the safety zone established DATES: This rule is effective from 6 a.m. establishing a temporary safety zone for by this regulation will encompass small on June 15, 2009, until 6 a.m. on the project to help protect construction areas and be of such a short duration September 30, 2009. personnel and the maritime public from that the zone should not significantly the numerous dangers associated with ADDRESSES: Documents indicated in this impact commercial or recreational it. preamble as being available in the traffic. docket are part of docket USCG–2009– Discussion of Rule Small Entities 0496 and are available online by going The temporary safety zone established to http://www.regulations.gov, inserting Under the Regulatory Flexibility Act by this rule is necessary to help protect (5 U.S.C. 601–612), we have considered USCG–2009–0496 in the ‘‘Keyword’’ construction personnel in the Hood box, and then clicking ‘‘Search.’’ They whether this rule would have a Canal Bridge Construction Project and significant economic impact on a are also available for inspection or the maritime public from the numerous copying at the Docket Management substantial number of small entities. dangers associated with the project and The term ‘‘small entities’’ comprises Facility (M–30), U.S. Department of will do so by prohibiting any person or Transportation, West Building Ground small businesses, not-for-profit vessel from entering the zones unless organizations that are independently Floor, Room W12–140, 1200 New Jersey authorized by the Captain of the Port, Avenue, SE., Washington, DC 20590, owned and operated and are not Puget Sound or her Designated dominant in their fields, and between 9 a.m. and 5 p.m., Monday Representative. Persons wishing to through Friday, except Federal holidays. governmental jurisdictions with request authorization to operate within populations of less than 50,000. FOR FURTHER INFORMATION CONTACT: If or transit through the safety zone must The Coast Guard certifies under 5 you have questions on this temporary contact the USCG Sector Seattle Joint U.S.C. 605(b) that this rule will not have rule, call or e-mail ENS Ashley Wanzer, Harbor Operations Center at 206–217– a significant economic impact on a Waterways Management, Sector Seattle, 6001. Additional information regarding substantial number of small entities. Coast Guard; telephone 206–217–6175, the construction work may be obtained This rule will affect the following e-mail [email protected]. If from Kiewit-General Construction entities, some of which may be small you have questions on viewing the Company at 360–620–3423 or the on- entities: The owners or operators of docket, call Renee V. Wright, Program scene official patrol or M/V REDWOOD vessels intending to transit the affected Manager, Docket Operations, telephone CITY on VHF–FM channel 13, 14, or 16. waterway during the effective period. 202–366–9826. The safety zone encompass: (1) All The safety zone will not have a SUPPLEMENTARY INFORMATION: waters within a 100 yard radius around significant economic impact on a

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substantial number of small entities for State, local, or Tribal government, in the voluntary consensus standards in their the following reasons: This rule will be aggregate, or by the private sector of regulatory activities unless the agency in effect for a limited duration and $100,000,000 or more in any one year. provides Congress, through the Office of within a limited area. The area within Though this rule will not result in such Management and Budget, with an the zone and the surrounding waterway an expenditure, we do discuss the explanation of why using these is not considered a critical waterway to effects of this rule elsewhere in this standards would be inconsistent with the boating public. The Captain of the preamble. applicable law or otherwise impractical. Port Puget Sound may waive any of the Taking of Private Property Voluntary consensus standards are requirements of this rule for any vessel technical standards (e.g., specifications or class of vessels upon finding that This rule will not effect a taking of of materials, performance, design, or application of the rule is unnecessary or private property or otherwise have operation; test methods; sampling impractical for the purposes of port taking implications under Executive procedures; and related management security, safety, or environmental safety. Order 12630, Governmental Actions and systems practices) that are developed or The Coast Guard will give notice to the Interference with Constitutionally adopted by voluntary consensus public via a Broadcast Notice to Protected Property Rights. standards bodies. Mariners that the regulation is in effect. Civil Justice Reform This rule does not use technical Assistance for Small Entities This rule meets applicable standards standards. Therefore, we did not Under section 213(a) of the Small in sections 3(a) and 3(b)(2) of Executive consider the use of voluntary consensus Business Regulatory Enforcement Order 12988, Civil Justice Reform, to standards. Fairness Act of 1996 (Pub. L. 104–121), minimize litigation, eliminate Environment we offer to assist small entities in ambiguity, and reduce burden. understanding the rule so that they can Protection of Children We have analyzed this rule under better evaluate its effects on them and Department of Homeland Security participate in the rulemaking process. We have analyzed this rule under Management Directive 023–01 and Small businesses may send comments Executive Order 13045, Protection of Commandant Instruction M16475.lD, on the actions of Federal employees Children from Environmental Health which guide the Coast Guard in who enforce, or otherwise determine Risks and Safety Risks. This rule is not complying with the National compliance with, Federal regulations to an economically significant rule and Environmental Policy Act of 1969 the Small Business and Agriculture does not create an environmental risk to (NEPA) (42 U.S.C. 4321–4370f), and Regulatory Enforcement Ombudsman health or risk to safety that may have concluded this action is one of a and the Regional Small Business disproportionately affect children. category of actions which do not Regulatory Fairness Boards. The Indian Tribal Governments individually or cumulatively have a Ombudsman evaluates these actions significant effect on the human annually and rates each agency’s This rule does not have Tribal environment. This rule is categorically implications under Executive Order responsiveness to small business. If you excluded, under figure 2–1, paragraph 13175, Consultation and Coordination wish to comment on actions by (34)(g), of the Instruction, because it with Indian Tribal Governments, employees of the Coast Guard, call 1– involves the establishment of a because it does not have a substantial 888–REG–FAIR (1–888–734–3247). The temporary safety zone. Coast Guard will not retaliate against direct effect on one or more Indian An environmental analysis checklist small entities that question or complain Tribes, on the relationship between the and a categorical exclusion about this rule or any policy or action Federal Government and Indian Tribes, determination are available in the of the Coast Guard. or on the distribution of power and responsibilities between the Federal docket where indicated under Collection of Information Government and Indian Tribes. ADDRESSES. This rule calls for no new collection Energy Effects List of Subjects in 33 CFR Part 165 of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– We have analyzed this rule under Harbors, Marine safety, Navigation 3520). Executive Order 13211, Actions (water), Reporting and recordkeeping Concerning Regulations That Federalism requirements, Security measures, Significantly Affect Energy Supply, Waterways. A rule has implications for federalism Distribution, or Use. We have under Executive Order 13132, determined that it is not a ‘‘significant ■ For the reasons discussed in the Federalism, if it has a substantial direct energy action’’ under that order because preamble, the Coast Guard amends 33 effect on State or local governments and it is not a ‘‘significant regulatory action’’ CFR Part 165 as follows: would either preempt State law or under Executive Order 12866 and is not impose a substantial direct cost of likely to have a significant adverse effect PART 165—REGULATED NAVIGATION compliance on them. We have analyzed on the supply, distribution, or use of AREAS AND LIMITED ACCESS AREAS this rule under that Order and have energy. The Administrator of the Office ■ determined that it does not have of Information and Regulatory Affairs 1. The authority citation for Part 165 implications for federalism. has not designated it as a significant continues to read as follows: energy action. Therefore, it does not Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Unfunded Mandates Reform Act require a Statement of Energy Effects Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; The Unfunded Mandates Reform Act under Executive Order 13211. 33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; of 1995 (2 U.S.C. 1531–1538) requires Pub. L. 107–295, 116 Stat. 2064; Department Technical Standards Federal agencies to assess the effects of of Homeland Security Delegation No. 0170.1. their discretionary regulatory actions. In The National Technology Transfer particular, the Act addresses actions and Advancement Act (NTTAA) (15 ■ 2. Add temporary § 165.T13–092 to that may result in the expenditure by a U.S.C. 272 note) directs agencies to use read as follows:

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§ 165.T13–092 Safety Zone; Hood Canal adopted in 1991. The changes remove been cut, removed, and paid for. (36 Bridge Cable Laying Operation, Hood obsolete references and procedures; CFR 223.49(d).) Canal, WA make downpayments and periodic This final rule revises 36 CFR 223.49 (a) Location. The following area is a payments optional for stewardship by: (1) Removing obsolete definitions, safety zones: (1) All waters of the Hood contracts; allow downpayment and references and procedures; (2) making Canal, from surface to bottom, within a periodic payment amounts to be downpayments optional for stewardship 100 yard radius around any recalculated when contracts receive rate contracts; (3) adding procedures to construction barge participating in the redeterminations; revise procedures for recalculate downpayments when Hood Canal Bridge Construction Project releasing downpayments; and allow contracts receive rate redeterminations; while the barge is in operation; and downpayments to be temporarily (4) revising procedures for releasing (2) All waters of the Hood Canal, from reduced for certain delays, downpayments; and (5) adding surface to bottom, between any barge interruptions, or extensions. This final procedures to temporarily reduce participating in the Hood Canal Bridge rule protects the Government’s financial downpayments when the Forest Service Construction Project and the Hood security, reduces speculative bidding, authorizes or orders certain contract Canal Bridge itself. and encourages purchasers to harvest delays, interruptions, or extensions. (b) Enforcement period. This rule will timber in a timely manner. In addition, Section 223.49(b) is revised to make be enforced from 6 a.m. on June 15, the rule provides financial relief to downpayments optional for stewardship 2009, until 6 a.m. September 30, 2009, timber purchasers when forest product contracts. Stewardship contracts are unless cancelled or ended sooner. prices drastically decline or purchasers awarded on a best value basis, which (c) Regulations. receive additional contract time and are virtually eliminates the potential for (1) In accordance with the general not expected to operate. speculative bidding because factors other than price determine best value. regulations in 33 CFR Part 165, Subpart DATES: This final rule is effective Further, section 323 of the Department C, no vessel may enter, transit, moor, or September 14, 2009. anchor within this safety zone unless of the Interior and Related Agencies FOR FURTHER INFORMATION CONTACT: Appropriations Act of 2003 (as authorized by the Captain of the Port or Lathrop Smith, Forest Management her Designated Representative. contained in division F of Public Law staff, at (202) 205–0858, or Richard 108–7; 16 U.S.C. 2104 Note) authorizes (2) ‘‘Designated Representative’’ Fitzgerald, Forest Management staff, at means any Coast Guard commissioned, the Forest Service to apply the value of (202) 205–1753. Individuals who use timber or other forest products removed warrant, or petty officer who has been telecommunication devices for the deaf designated by the Captain of the Port to under a stewardship project as an offset (TDD) may call the Federal Information against the cost of service work. Doing act on her behalf. Relay Service (FIRS) at 1–800–877–8339 (3) To request authorization to operate so provides financial security to the between 8 a.m. and 8 p.m., Eastern Government and incentivizes within the safety zone, contact the Standard Time, Monday through Friday. USCG Sector Seattle Joint Harbor contractors to harvest timber and SUPPLEMENTARY INFORMATION: Operations Center at 206–217–6001. perform service work in a timely Additional information regarding the Background manner. Stewardship contracts require construction work may be obtained from contractors to make cash deposits equal The downpayment regulation (36 CFR in value to timber they plan to cut Kiewit-General Construction Company 223.49) and periodic payments at 360–620–3423, or the on-scene before performing service work. To get regulation (36 CFR 223.50) were these cash deposits back, contractors official patrol, or M/V REDWOOD CITY adopted on July 31, 1991, (56 FR 36099) on VHF–FM channel 13, 14, or 16. must perform the service work. to protect the Government’s financial Alternatively, if a contractor performs Dated: June 14, 2009. security, reduce speculative bidding, the service work first, the Government S.E. Englebert, encourage purchasers to harvest timber uses the value of timber the contractor Captain, U.S. Coast Guard, Captain of the in a timely manner and to comply with harvests to offset the service work’s cost. Port, Puget Sound. section 2d of the Federal Timber For these reasons, most stewardship [FR Doc. E9–19434 Filed 8–12–09; 8:45 am] Contract Payment Modification Act contracts do not need a downpayment. BILLING CODE 4910–15–P (Pub. L. 98–478, 98 Stat 2213; 16 U.S.C. However, there can be exceptions. For 618) (Buy-out Act).1 example, if the value of the timber The downpayment regulation requires greatly exceeds the cost of services DEPARTMENT OF AGRICULTURE purchasers to make a cash deposit in the under a contract, a downpayment may timber sale account at the time of sale be needed to provide financial security. Forest Service award equal to 10 percent of the sale’s Therefore, this final rule allows total advertised value plus 20 percent of contracting officers to require 36 CFR Part 223 the bid premium. This cash is held by downpayments on stewardship the Forest Service and cannot be used contracts when needed to ensure the RIN 0596–AC80 by the purchaser until (i) on scaled Government’s financial security. Sale and Disposal of National Forest sales, stumpage representing 25 percent This rule also revises § 223.49(c) to System Timber; Downpayment and of the total bid value has been charged allow downpayments to be recalculated Periodic Payments and paid for, or (ii) on tree measurement when contracts receive rate sales, stumpage representing 25 percent redeterminations. The initial AGENCY: Forest Service, USDA. of the total bid value is shown on the downpayment amount deemed ACTION: Final rule. timber sale statement of account to have necessary to protect the Government’s financial security and encourage SUMMARY: This final rule revises the 1 Section 2(d) provides that ‘‘[e]ffective January 1, purchasers to timely harvest timber in is Forest Service’s downpayment and 1985, in any contract for the sale of timber from the based on a percentage of a contract’s National Forests, the Secretary of Agriculture shall periodic payment regulations to reflect require a cash down-payment at the time the value at time of award. However, timber changes in contracting procedures and contract is executed and periodic payments to be sale contracts contain procedures to authorities since these regulations were made over the remaining period of the contract.’’ redetermine stumpage rates for (1)

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environmental modification; (2) purchasers that are billed, or are about Paragraph (g) is amended to allow catastrophic damage; (3) Forest Service to be billed, the periodic payment is an contracts subject to paragraph (e)’s ordered suspension or delay; and (4) economic incentive to resume or higher downpayment requirement to emergency rate redeterminations. accelerate harvesting. have their downpayments recalculated Redetermined rates can change a This final rule revises 36 CFR 223.50 when stumpage rates are redetermined. contract’s total value. While many by: (1) Amending paragraph (b) to This change was made for the same contracts already provide that required clarify that periodic payments are not reasons as the changes to paragraph (c). deposits can be redetermined when required for stewardship contracts and In addition, paragraphs (g)(1) and (2) are contract rates are redetermined, the (2) amending paragraph (f) to add removed to eliminate obsolete practice has not been to adjust procedures to recalculate periodic references to ineffective purchaser downpayments. This final rule clarifies payment(s) amounts after contractual credit and converting units of measure that downpayments should be rate redeterminations and to remove other than board feet to board feet. The recaclulated when rates are obsolete procedures. These changes removal of those paragraphs was made redetermined. Allowing downpayment were made for the same reasons as the for the same reasons as the deletions redeterminations maintains the corresponding changes made to section made in paragraph (a)(2). government’s financial security because 223.49. Paragraph (j) is amended to specify the same percentage of downpayment to that the Chief of the Forest Service may Amendments to the Downpayment total contract value deemed necessary preclude temporary downpayment Requirements under § 223.49 is retained under this reductions under paragraph ()(2) and final rule. Section 223.49 is amended as follows: (3) to deter speculation. In addition, this rule revises In paragraph (a)(2), the definition of Paragraph (k) is added to allow § 223.49(d) to allow downpayments to ineffective purchaser credit is removed temporary downpayment reductions be released when they equal or exceed and paragraphs (3)–(5) are renumbered when a contractor is not cutting or the value of a sale’s remaining timber. (2)-(4). Section 329 of the Department of removing timber because its scheduled Section 223.49(d)(1) was added for the Interior and Related Agencies operations were delayed, interrupted, or scaled sales and § 223.49(d)(2) was Appropriations Act, 1999 (as contained extended for 30 consecutive days or added for tree measurement sales. This in section 101(e) of division A of Public more for any of the following reasons: change was made to prevent situations Law 105–277; 16 U.S.C. 535a) directed, (1) Forest Service requested or ordered where prices on sales subject to among other things, that the ‘‘purchaser delay or interruption of operations for stumpage rate adjustments decline so credit’’ procedure be eliminated no later reasons other than breach; (2) a contract much that the downpayment exceeds than April 1, 1999. The use of purchaser term addition pursuant to contractor the value of remaining timber without credit was discontinued in timber sales shifting operations to a sale designated triggering the downpayment’s release. advertised after March 31, 1999, by by the Forest Service as in urgent need The Forest Service never intended to making changes in timber sale contract of harvesting; or (3) a contract term hold downpayments greater than the provisions (File code 2450 letter to extension authorized upon a value of remaining timber. Regional Foresters dated February 19, Finally, this rule adds § 223.49(k), determination of substantial overriding which allows downpayments to be 1999). As of March 30, 2008, only public interest, including a market- temporarily reduced when the Forest $6,000 worth of purchaser credit was related contract term addition, or urgent Service authorizes or orders certain being used to cover downpayment removal contract term extension under contract delays, interruptions, or requirements. Because no additional 36 CFR 223.53. extensions. The Forest Service has purchaser credit is being earned, Paragraph (l) is added to allow determined that it is not necessary to references to ineffective purchaser downpayments to be reduced to the require full cash downpayments when credit in the downpayment regulation greater of $1,000 or two percent of the the scenarios identified in § 223.49(k) are obsolete and unnecessary. amount stated in the contract during occur. In paragraph (b), the option of using qualifying periods of delay, Periodic payments are ‘‘amounts effective purchaser credit is eliminated interruption, or extension under specified in a contract that a purchaser for the same reasons cited above. A paragraph (k), unless the purchaser is must pay by the periodic payment sentence has also been added making cutting or removing timber. Purchasers determination date(s) unless reduced by downpayments optional for stewardship cannot cut or remove a contract’s timber amounts paid as stumpage for volume contracts unless needed to ensure the until the downpayment stated in the removed.’’ (36 CFR 223.50(a)(4).) The Government’s financial security. contract is restored. In paragraph (c), obsolete references initial periodic payment is equal to 35 Amendments to the Periodic Payment to converting units of measure other percent of the total contract value or 50 Requirements percent of the bid premium, whichever than board feet to board feet have been is greater. Where an additional periodic removed. The downpayment amount is Section 223.50 is amended as follows: payment is required by the contract, 75 calculated as a percentage of sale value Paragraph (b)(3) is added to clarify percent of the total contract value at without regard to unit of measure. that not all stewardship contracts time of award must be paid by the Paragraph (c) is further amended to require periodic payments. Paragraph (f) second periodic payment determination include procedures to recalculate is amended to remove obsolete contract date. The periodic payment(s) amount is downpayments when contract rates are modification procedures and add reduced when payment would result in redetermined. procedures to recalculate periodic the purchaser’s credit balance for timber Paragraph (d) is amended to allow payment(s) amounts following a charges exceeding the current contract downpayments to be released when the contract rate redetermination value (36 CFR 223.50(c)). Many estimated value of remaining timber is authorized. The obsolete procedures purchasers never receive a periodic less than the downpayment. Paragraph being removed required pre-1991 payment bill because their stumpage (d)(1) is added for scaled sales and contract purchasers to make a written payments for volume removed stay paragraph (d)(2) is added for tree request by 1991 to receive market- ahead of periodic payment amounts. For measurement sales. related contract term additions.

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Agency Response to Major Public and (2) the Federal Register notice redetermining contract rates Therefore, Comments proposes significant changes in the a sale’s eligibility for MRCTA does not On October 29, 2008, the Forest amount and requirements for mean it will receive a rate or periodic Service published a notice of proposed downpayments and periodic payments payment redetermination. On March 31, rule and request for comment on yet the basic facts and conditions that 2009, the Forest Service had revisions to 36 CFR 223.49 and 223.50 have caused the agency to pursue these approximately 615 sales eligible for in the Federal Register (73 FR 64288). rule changes are undisclosed. Unless downpayment and periodic payment otherwise noted, no changes were made redeterminations under this rule. Of During the comment period, which in response to the following comments. those 615 sales, only 199 still had ended December 29, 2008, the Forest Comment 5: The Forest Service states downpayments on deposit, for a total Service received 4 comments responsive a desire to lower the risk of timber value of $6.8 million. Without looking to the rule’s merits and 2 non- contract default. This would not be at the statement of account for each one responsive comments. The four proposed unless default was a of those contracts, it is not possible to responsive comments were from the significant problem. What is the rate assess each contract’s periodic payment Federal Timber Purchasers Committee, and percentage of default in the last five status. Westek Forest, Ltd., New Hampshire or ten years and over the past 12 Comment 7: How many sales would Timber Owners Association, and the months? What is the projected rate of be eligible for redetermination under the Wilderness Society. Following are the default based on current market three clauses (environmental Forest Service’s responses to those conditions? modification, catastrophic damage and comments. Response 5: The Forest Service does emergency rate determination)? What Comment 1: We believe the proposed not track defaults so it can not calculate percentage of sales does this represent? changes to the downpayment regulation a percentage of defaults over a five or How often do these cases occur? are well designed and will help timber ten year period. Although snapshots of Response 7: The commenter is asking purchasers with cash management in the timber sale accounting system can the Forest Service to quantify where and these difficult markets. be taken to determine the number of when unpredictable events such as Response 1: This is a statement for contracts coded as defaulted on specific natural disasters may occur in the which no response is necessary. dates, the system can not tally the future. Any attempt to do so would be Comment 2: We urge you to act number of defaults over a period of purely speculative. However, we do expeditiously to give timber purchasers time. know that on March 31, 2009, there as much relief as possible in order to On March 31, 2009, the Forest Service were 1,972 open sales and 615 or 31 keep them viable and preserve options had 1,972 open contracts on forms FS– percent were potentially eligible for for the management of the National 2400–6 and FS–2400–6T. Twenty-three emergency rate redeterminations. Of Forests. of those contracts or 1.2 percent were those 615 sales, only 199 still had Response 2: This is a statement for coded in the timber sale accounting downpayments on deposit in the which no response is necessary. system as defaulted. On March 31, 2008, amount of $6.8 million. Comment 3: I agree with the proposed there were 1,961 open contracts on Comment 8: The Forest Service rule change. This change will give those same forms; 24 or 1.2 percent retains authority to set larger contractors better flexibility to complete were coded as defaulted. Sales on other downpayment amounts and proposes to stewardship contracts. contract forms were not included in limit redeterminations in geographic Response 3: This is a statement for these calculations because the Forest areas where speculation has or could which no response is necessary. Service is not aware of any other types occur. Where has the agency set larger Comment 4: Nationwide, the forest of open contracts subject to this final downpayments in the past? How does products industry is undergoing rule. the agency recognize when speculation extreme stress due to reduced demand A projected default rate based on is occurring? for forest products, lower prices, and current market conditions would only Response 8: The Forest Service uses increased costs of production. It does be an unsubstantiated estimate subject appraisal performance reports, Forest the American people no good to force to dispute. However, it is reasonable to Service Manual (FSM) 2422, and Bid wood producers into bankruptcy or to predict that when purchasers are forced Monitoring Reports, FSM 2432.52, to deal with timber sale contracts that to cease operating due to adverse market identify speculative bidding. The cannot be operated profitably under conditions, uncompleted contracts are agency has not increased current market conditions. If these sale at an increased risk of default. An downpayments pursuant to the contracts are cancelled and the timber objective of the final rule is to lower authority in 36 CFR 223.49(c). reoffered, it would not sell or would default risk by adjusting downpayments Comment 9: The agency states: only bring greatly reduced prices. This to reflect drastic declines in contract ‘‘Further, the Forest Service has process would be expensive and yield values and temporarily reducing determined that the benefits of no positive results. We have reviewed downpayments when appropriate. temporarily reducing downpayments the proposed rules and agree that they These changes are expected to help under 223.49(k) outweigh the potential would have an overall positive effect on purchaser cash flow, which may help increased risks to the government’s the Forest Service timber sale program them continue operating and/or financial security.’’ Federal Register, and are in the best interest of the people purchasing contracts. Volume 73, No. 210, page 64,290. Please of the United States. Comment 6: The Forest Service provide a copy of the analysis that led Response 4: These are statements for recently described over 1,000 agency to this determination. which no response is necessary. timber sales as eligible for market- Response 9: The Forest Service has The remaining comments were from a related contract term additions closely monitored the drastic decline in single respondent prefaced by the (MRCTA). All would then be eligible for forest product markets since late 2004. statements that (1) significant downpayment and periodic payment As the market decline deepened, reports information necessary to fully redeterminations. in the national press, trade bulletins, understand the proposed rule and Response 6: The MRCTA procedures (such as Random Lengths, TDC prepare informed comments is missing do not include a mechanism for Stumpage Price Report, WWPA

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Barometer and others), as well as if a purchaser isn’t operating; (i) Market-Related Contract Term discussions with individual purchasers industry requests; and (j) in the event a Additions an unprecedented 15 and representatives from industry contract defaults while the consecutive quarters. The previous associations, provided information downpayment has been temporarily greatest decline of the softwood lumber about falling prices and a growing reduced, the government can still apply index was in the early 1980s when it number of mill closures. Despite the the performance bond to damages. lost about 36 percent of its value and current decline’s severity, the default Since the analysis of market would have triggered 12 consecutive rate on open sales has been less than conditions that led to the proposed rule, quarters of Market-Related Contract 1.25 percent over the last two years. The the Forest Service has learned that Term Additions if the procedure had Forest Service believes this relatively housing starts in April 2009 hit a record been in place at that time. The softwood low default rate, in the face of extreme low down almost 80 percent from the lumber index hit its lowest point yet in market turmoil, is the result of several peak in January 2006; greatly exceeding March 2009, and showed a slight successful proactive measures it has the 46 percent decline during the 1981 increase in April 2009, but it is too early taken to avoid the widespread defaults downturn and the 60 percent decline in to tell if the April increase marks the seen in the 1980s. These measures the 1986–1991 period.2 U.S. Census beginning of a recovery. include (1) market-related contract term Bureau data shows privately-owned The data and predictions indicate that additions; (2) additional contract time housing starts in April were at a while the decline in demand for lumber authorized under the November 2006, seasonally adjusted annual rate of may be at or near bottoming out, the November 2007, and September 2008 458,000 which is 12.8 percent below the recovery will be long and gradual. findings of substantial overriding public revised March estimate of 525,000 and Meanwhile the agency has been interest; (3) emergency rate is 54.2 percent below the revised April routinely receiving reports of sawmills redeterminations; and (5) contract 2008 rate of 1,001,000.3 Adding to this curtaining operations or permanently cancellations, rate redeterminations, dismal picture, a Western Wood closing. The Forest Service and extensions authorized by the 2008 Products Association (WWPA) March accomplishes many of its vegetation Farm Bill. Despite the apparent success 24, 2009, news release predicted that management objectives through timber of these measures, forest product makets the poor economy and a weak housing sale contracts, which enables the Forest have continued to worsen, leading the market are expected to reduce demand Service to achieve its objectives while Forest Service to conclude that this rule for lumber in the U.S to the lowest level generating revenues. A large pool of 4 is needed to further reduce the risk of in modern history. The article notes timber sale purchasers allows the Forest defaults. After careful consideration, the that since reaching an all-time high of Service to accomplish these objectives Forest Service determined that the 64.3 billion board feet in 2005, U.S. in a more cost-effective manner by benefits of further reducing potential demand for lumber has dropped by increasing competition for National defaults and their associated costs more than 55 percent representing the Forest System timber sales, which can outweigh any potential increased risks steepest decline in the history of the result in higher contract prices. Absent to the government’s financial security industry. While home construction a viable industry infrastructure capable created by this rule. which accounts for about 45 percent of of purchasing and processing Forest the lumber used each year is predicted Service timber, the Forest Service would This determination was made based to increase slightly in 2010 to a little have to pay service contractors to on extensive oral discussions among the over a half million, WWPA does not perform certain vegetative management Washington Office’s Forest Management expect housing starts to exceed 1 objectives currently achieved by selling staff. The Forest Management staff million units until 2012. timber. This would substantially reduce considered the following factors: (a) Another measure of the drastic the Agency’s ability to accomplish Deteriorating market conditions; (b) decline in lumber prices is the Bureau important management objectives such procedures to temporarily reduce of Labor Statistics index for softwood as reducing hazardous fuels in wildland downpayments when the Forest Service lumber. The Forest Service monitors urban interface areas where much of the orders a delay or interruption for this index to determine when drastic work must be perfomed by mechanical environmental reasons are already part declines in forest products prices means and can often be done with of all post-April 2004 contracts; (c) sufficient to trigger granting Market- timber sales. existing administrative authority to Related Contract Term Additions Temporarily reducing downpayments change the rule to achieve its intended pursuant to 36 CFR 223.52 occur. The is unlikely to prevent or reduce defaults effect; (d) concern that these changes are softwood lumber index began declining by itself. However, in conjunction with needed to prevent the loss of industry in the 3rd calendar quarter of 2004 and other relief measures, it is expected to infrastructure; (e) concern that costs to beginning with the 3rd quarter of 2005 provide short-term relief that will help the government of treating vegetation began triggering Market-Related reduce the number of defaults and loss under service contracts exceeds the Contract Term Additions. Through the of industry infrastructure that might costs of doing so under timber sale first quarter of calendar year 2009 the occur in its absence. Specifically it will contracts; (f) general knowledge that softwood index, after adjustments to a free up cash purchasers need for a most defaults occur after the constant dollar basis, has lost about 49 variety of reasons including (1) downpayment has been released; (g) percent of its value and has triggered harvesting sales that are operable in this general knowledge that cash flow is economic climate, (2) storing increasing critical to sustained operations for 2 USA Today, May 20, 2009, Record-low housing inventories of lumber until demand timber purchasers, and tying up money starts in April cast pall over market, by Julie picks up, (3) making payments on in downpayments on sales the Forest Schmidt. 3 NEW RESIDENTIAL CONSTRUCTION IN equipment, and (4) maintaining bonds Service is not expecting purchasers to APRIL 2009, U.S. Census Bureau News, Joint on existing sales. operate until market conditions improve Release, U.S. Department of Housing and Urban On March 31, 2009, the Forest Service obligates cash that may be needed Development, May 19, 2009; http:// had 1,972 open contracts on forms FS– elsewhere; (h) general knowledge that www.census.gov/const/newresconst. 2400–6 and FS–2400–6T. Twenty-three 4 Western Wood Products Association, news purchasers’ fixed costs, including release, Robert Bernhardt, Jr. Information Services of those contracts or 1.2 percent were payments on equipment, continue even Director, March 24, 2009. coded in the timber sale accounting

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system as defaulted. Only five of the removal include, but are not limited to Contract provision B/BT3.34 does not default sales still had downpayments on situations where: permit emergency rate redeterminations deposit, which totaled $101,300; less 1. Dead or dying timber is subject to for contracts receiving contract term than 1 percent of the $26.1 million total rapid deterioration; extensions pursuant to 36 CFR 223.53 value of downpayments on deposit. One 2. Failure to harvest the timber The contract permits, however, year earlier, on March 31, 2008, there promptly could threaten public safety. emergency rate redeterminations to were 1,961 open contracts of which 24 For example, removing hazardous trees facilitate the rapid harvest of National or 1.2 percent were coded as defaulted; along public roads. Forest System timber and the urgent 5 of the defaults still had 3. Failure to harvest the timber removal harvesting. This is done downpayments on deposit in the promptly could create an insect disease pursuant to provision B/BT8.21. amount of $100,600. epidemic on National Forest system However, the Forest Service may modify Considering the above-referenced lands or other lands or resources. timber sale contracts in accordance with factors, the Forest Service determined The Forest Service is currenty drafting 36 CFR 223.112. In response to the an amendment to chapter 50 of the sale that the benefits of temporarily reducing severity of the current market preparation handbook, FSH 2409.18, downpayments under 223.49(k) conditions, and in the interest of that will provide land managers with outweigh the potential increased risks to preventing further erosion of the timber more specific guidance to determine the government’s financial security. industry infrastructure, the Forest when a sale contains timber in urgent Comment 10: This and previous Service is currently modifying rates on need of removal. Federal Register notices on market- contracts extended pursuant to 36 CFR Comment 12: The proposed rule 223.53 to allow emergency rate related contract term additions and language at 36 CFR 223.49(c)(4) and substantial overriding public interest redetermination procedures when 223.49(g)(4) lists ‘‘an emergency rate requested by purchasers. Contracting (SOPI) determinations describe the redetermination’’ as a reason for government’s reasons for wanting to Officers should not modify contracts contract downpayment redetermination. that are in breach and shall seek maintain numerous economically viable But we can find no definition of the timber sale purchasers. These include Washington Office advice prior to term ‘‘emergency rate redetermination.’’ modifying contracts that are determined having a pool of contractors in Response 12: Emergency rate situations where the Forest Service to be at high risk for default. For much redetermination is a procedure the same reason this rule allows determines that timber is in need of addressed in standard timber sale urgent removal. But the definition of temporary reductions in downpayments contract provisions (B/BT3.34) and when a timber purchaser receives ‘‘urgent removal’’ at 36 CFR 223.53 standard integrated resource timber applies only to private and other non- additional time to harvest timber in contract clauses (D/DT.3.4) for adjusting urgent need of removal on non-NFS National Forest System (NFS) lands. rates when the Bureau of Labor The context for the term here and in the lands pursuant to 36 CFR 223.53. Statistics Producer Price Index stated in This rule does not modify emergency market-related contract term addition/ the contract declines by 25% or more rate redetermination procedures. substantial overriding public interest after the contract award date. Comment 14: We believe the Forest (SOPI) Federal Register notices imply Comment 13: If the Forest Service is Service should make concurrent that the term refers to NFS lands. Please referring to ‘‘urgent removal’’ (as changes in its National Environmental provide the regulatory cite that allows defined at 36 CFR 223.53) in its use of Policy Act (NEPA) procedures in order the Forest Service to shift contract the emergency rate redetermination to reduce the need for downpayment operations to a NFS sale in urgent need clause, then it should clearly state so and periodic payment redeterminations of harvesting as described on page and disclose to the public that and ensure that important resource 64,290 of the Federal Register notice. downpayment and periodic payment management goals are being met. Response 10: The authority is in 36 reductions would be granted to allow Response 14: Changes to NEPA CFR 223.112, Modification of contracts. timber companies to pursue harvest on procedures recommended by the Implementation procedures are private and non-National Forest System commenter are not responsive to the documented in Forest Service (NFS) lands. merits of the rule. Handbook 2409.18, section 55.21. In Response 13: Prior to authorizing Comment 15: Stating that the addition, please see the response to urgent removal contract extensions proposed rule only changes the amount comment 11. pursuant to 36 CFR 223.53, a Regional of the downpayment is the wrong lens Comment 11: It is unclear how exactly Forester must make a determination that through which to view environmental the agency defines ‘‘urgent’’ projects in there is a substantial overriding public impacts. While downpayments may each context, the conditions under interest in extending National Forest have been required for many years, the which it is applied or how the Forest System timber sale contracts for proposed reductions to just 2% of the Service maintains consistency in the undamaged (green) timber not requiring downpayment or $1000.00 whichever is application of this term throughout the expeditious removal in order to greater while still holding the contract national forest system (NFS). This lack facilitate the rapid harvest of is significant and unprecedented. This of clarity would then affect who is catastrophically damaged timber would expose the Federal government potentially eligible for downpayment requiring expeditious removal on to significant financial risk. The agency and periodic payment redeterminations. private and other non-National Forest states their belief that this will not result The term and its application here System lands. Similarly Forest Service in an increase in speculative bidding should be defined. policy is to grant contract term and that the benefits will outweigh the Response 11: The determination of adjustments on certain timber sale potential increased risks to the whether timber in a specific sale or contracts for undamaged (green) timber government’s financial security. No project is in urgent need of removal is not requiring expeditious removal in evidence for these assertions is a decision the Forest Service makes on order to facilitate the rapid harvest of presented. a case-by-case basis after considering other National Forest System timber in Response 15: This comment pertains the relative conditions on the ground. urgent need of harvesting (FSH 2409.18, to the rule’s procedures to temporarily Indicators of a sale in urgent need of § 55.21). reduce downpayments when contracts

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are delayed, interrupted or extended for Comment 17: Because commercial industry. However, the rule’s effect may reasons listed in § 223.49(k). Contrary to sales are now most often regarded as a be significant for individual purchasers the commenter’s assertion that this is tool to meet management objectives and on the brink of closure; with significant and unprecedented, timber not the objective or purpose and need unemployment rates continuing to sale contract forms FS–2400–6 and FS– itself, the effect of possible contract increase at alarming rates, preventing or 2400–6T dated April 2004 and later extensions (and subsequent reducing job losses is a national issue. already allow temporary downpayment downpayment and periodic payment One respondent commenting on this reductions when the Forest Service redeterminations) must be analyzed rule wrote that the forest products orders certain delays or interruptions. under NEPA in determining the ability industry sector of New Hampshire’s This rule expands this existing process of commercial sales (for each alternative economy is vibrant and is the third to include situations where the that uses this tool) to meet the purpose largest sector of manufacturing in the downpayment’s economic inducement and need. We do not think this would Granite State, employing over 9,500 to operate is not warranted. entail undue burden on the agency people directly with an annual payroll The agency believes these temporary given current and suggested procedures. over $320 million. The respondent also reductions will not increase speculative Response 17: Please see the response stated that high quality timber from the bidding because nothing in the final to comment 16. White Mountain National Forest rule removes the downpayment Comment 18: Commenter presented a provides an important raw material requirement at time of award. Once series of comments questioning agency source. deposited, the downpayment can not be NEPA procedures for forest management Further, a June 2008 report by the temporarily reduced unless one of the projects and proposing changes to those University of Minnesota-Deluth three conditions specified in the rule procedures. Labovitz School’s Bureau of Business Response 18: These comments are occurs. Therefore, speculative bidders and Economic Research addressed the beyond the final rule’s scope and are must speculate that the market will rise economic impact of declines in forestry- nonresponsive to its merits. above overbids and that at least one of related industries in Minnesota, Comment 19: National Forest System Wisconsin and Michigan. (https:// the conditions allowing temporary (NFS) lands supply a very small downpayment reductions will occur. lsbe.d.umn.edu/departments/bber/ percentage of the U.S. timber supply bber_projects.php). The report Even if that happened, the (< 4% according to recent estimates). A documented that, in 2006, forestry downpayment still has to be seemingly small percentage of Forest related industries in the study area reestablised before the sale can be Service timber sale contracts (eligible employed over 58,000 workers and operated. Considering these safeguards, for downpayment and/or periodic estimated that for every worker laid off the Forest Service concluded the rule payment redetermination) multiplied by another 2.2 jobs were lost in the was unlikely to increase speculative a small percentage of the timber supply economy. The collapsing timber bidding. means a very small percentage of the industry in this three State region Nevertheless, the Forest Service will U.S. timber supply would be affected by provided the impetus in the 2008 Farm continue to monitor bidding patterns this proposed rule. As described above, Bill, Section 8401 of the Food, and the agency will deny temporary the Forest Service should disclose the Conservation, and Energy Act of 2008, downpayment reductions where total number of timber sale contracts Public Law 110–246,122 Stat. 1651, speculative bidding is occurring. In eligible for downpayment and periodic granting additional contract time and response to this comment, the final rule payment redeterminations in order to price relief to qualifying contracts. has been revised to clarify that requests assess the full impact of the proposed While the National Forest System’s for temporary downpayment reductions rule and its financial (and other) effects. contribution to the national timber may be denied in market areas where The notion that failure to enact this supply may not be significant, it is an the Chief determines speculative change will affect the U.S. timber important component and in some areas bidding is occurring. industry is not credible—the amount or it is the primary source. Comment 16: For the reasons cited in value of timber involved simply is not Comment 20: The terms of the our response, we believe the Forest large enough to be important. proposed rule would allow companies Service has failed to follow proper Response 19: On March 31, 2009, the to bid on and hold National Forest procedures in proposing this rule Forest Service had 1,972 sales on System timber sales for future harvest without analysis under the National contract forms FS–2400–6 and FS– while receiving most of their Environmental Policy Act (NEPA). We 2400–6T. The remaining value of those downpayment back for a number of believe that changes in the Forest sales was $249.1 million. Of those sales, loosely defined reasons. Service Handbook (FSH), Forest Service 615 or 31 percent were potentially Response 20: As noted previously, Manual (FSM) and agency NEPA eligible for emergency rate this final rule requires purchasers to analysis of economic effects as we redeterminations. Only 199 of those 615 make downpayments at time of award detailed would fulfill agency still had downpayments on deposit, in and only allows temporary reductions requirements for this proposed rule the amount of $6.8 million. Although when the conditions specified in section under NEPA. We urge the agency to the data base could not be queried to 223.49(k) are met. Once those consider them in completing the show how many sales eligible for conditions cease to exist, purchasers required regulatory certification of emergency rate redeterminations are must restore their downpayments. environmental impact for the proposed also eligible for periodic payment Comment 21: The proposed rule rule. redeterminations, it would be less than change has been justified in part on the Response 16: The changes in the FSH, 615. basis of community stability and FSM and agency NEPA analysis of The commenter is correct that the economic health. This is dubious at economic effects provided by the number of Forest Service contracts best. It is questionable whether this rule commenter are not responsive to the eligible for downpayment and periodic will make a difference even in local or merits of the rule. Furthermore, this payment redeterminations is small and regional markets. It has been clear for final rule is categorically excluded failure to enact the rule is unlikely to years that supplying timber to local under 36 CFR 220.6. significantly affect the U.S. timber mills is an ineffective (at best) strategy

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for supporting sustainable local there were 1,961 open contracts of the proposed rule on other costs economic development. (Rasker, R., which 24 or 1.2 percent were coded as associated with timber harvest and Gorte, J. F., and Alkire, C. 1996. Logging defaulted. The 24 defaulted sales had suggested that there is research National Forests to Create Jobs: An performance bonds totaling about $4.4 providing compelling evidence for Unworkable Covenant, Washington, DC: million; only 5 still had downpayments maintaining lands in their protected The Wilderness Society.) The Forest on deposit in the amount of $100,600. state and/or for treating vegetation with Service should analyze the socio- Had this final rule been in effect when methods other than timber sales. economic costs associated with an those contracts defaulted, the potential Response 24: These comments are historic emphasis on resource loss to the government of reduced beyond the scope of this rule and were extraction, which has resulted in downpayments could have equaled the deemed nonresponsive to the rule’s repetitious cycles of socio-economic reduced downpayment amounts. merits. distress for rural communities. The However, that estimate is a worst-case extractive industries, including the scenario based on the assumption that Conclusion timber industry, represent an ever every defaulting contractor had (1) a This final rule revises the Forest smaller portion of the total jobs and temporarily reduced downpayment, (2) Service’s downpayment and periodic income in rural counties. The relative insufficient bonding to cover default payment regulations to reflect changes importance of these industries damages, and (3) an inability to pay in contracting procedures and compared to expanding industries in the applicable damages, including those authorities since these regulations were professional and service sectors and ordered by a Federal court. Such an adopted in 1991. The rule will protect those which depend on non-labor outcome is unlikely. the Government’s financial security, income must be acknowledged. Although the Government may reduce speculative bidding, and Response 21: The Forest Service potentially lose some financial security encourage purchasers to harvest timber agrees that communities with a broad under this rule, the Forest Service in a timely manner. In addition, the rule economic base tend to be more stable believes this risk is outweighed by the provides financial relief to timber than those dependent on a single benefits associated with averting purchasers when forest product prices business. But a socio-economic analysis potential defaults. Given the above data, drastically decline or purchasers receive isn’t needed to demonstrate that the loss the factors addressed in response 9, and additional contract time and are not of jobs has adverse economic effects, default costs to the Forest Service, expected to operate. especially in small rural communities. industry, and timber-dependent With rising unemployment rates, any communities, the agency believes the Regulatory Certifications loss of jobs, regardless of business sector potential risks associated with this rule Regulatory Impact or community size, has a negative effect are justified. on communities where lost jobs are Comment 23: Citing the ability of This final rule has been reviewed located. Arguing that the Forest Service potential contractors to bid on yet more under USDA procedures and Executive program is insignificant when looking at Federal (and private) sales would only Order 12866 on Regulatory Planning the industry or the country as a whole seem to increase Federal exposure to and Review. The Office of Management and downplaying the importance of jobs risk. Continued market downturn would and Budget (OMB) has determined that in extractive industries ignores the result in continued downpayment and this is not a significant regulatory action significance of those jobs to affected periodic payment redetermination. and is not subject to OMB review. This individuals and communities. To the Examining the need for timber sales in rule will not have an annual effect of extent that this rule reduces defaults, it the first place and other possible $100 million or more on the economy is also expected to help reduce job methods to accomplish the purpose and nor adversely affect productivity, losses. need for vegetation management competition, jobs, the environment, Comment 22: What is not fully projects would seem a more prudent public health or safety, nor State or local discussed or disclosed is the extent of and less fiscally risky approach. Governments. This rule will not possible financial risk and exposure Response 23: Contracting officers are interfere with an action taken or accruing to the Federal government, and required under 36 CFR 223.101 to make planned by another agency nor raise to taxpayers, from these proposed an affirmative determination of a new legal or policy issues. This rule changes, especially during extensive purchaser’s responsibility prior to consists of technical administrative market downturn as is the case today. awarding a contract. When conducting a changes to regulations affecting the Response 22: Any estimate or responsibility determination, administration of commercial timber prediction of future defaults or specific consideration is given to the purchaser’s sales on National Forest lands. Finally, damage amounts associated with them financial ability to complete the contract this action will not alter the budgetary would be highly speculative and subject while taking into account all of the impact of entitlements, grants, user fees, to challenge. The October 29, 2008, purchaser’s commercial and or loan programs or the rights and Federal Register notice (73 FR 64288) governmental business commitments. obligations of recipients of such discussed the financial risks of the This process limts the government’s programs. Accordingly, this final rule is proposed changes in relative terms. In risk. not subject to OMB review under addition, data pulled from the timber When proposing vegetation Executive Order 12866. sale accounting system on March 31, management projects, the Forest Service Regulatory Flexibility Act 2009, showed 1,972 open contracts, of considers alternatives to timber sale which 23 were coded as defaulted. The contracts for accomplishing the This final rule has been considered in defaulted contracts had a remaining necessary work, including stewardship light of the Regulatory Flexibility Act (5 value of $18.3 million and performance contracts, procurement contracts, U.S.C. 601 et seq.), and it is hereby bonds totaling about $2.5 million. Only agreements, and using its own certified that this rule will not have a five of the defaults still had employees. significant economic impact on a downpayments on deposit when they Comment 24: The commenter substantial number of small entities. defaulted, in the amount of $101,300. presented a series of comments This rule makes only technical By comparison, on March 31, 2008, pertaining to questions of the effect of administrative changes to existing

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regulations affecting the administration Justice Reform. If this rule were both. In determining whether or not of certain commercial timber sales on adopted, (1) all State and local laws and affiliation exists, the Forest Service shall National Forest System land. The final regulations that are in conflict with this consider all appropriate factors, rule imposes minimal additional rule or which would impede its full including, but not limited to, common requirements on all timber purchasers implementation would be preempted; ownership, common management, and while providing economic relief from (2) no retroactive effect may be given to contractual relationships. current market conditions. The this rule; and (3) it would not require (b) Timber sale contracts shall include information required is easily within the administrative proceedings before provisions that require purchasers to capability of small entities to produce. parties may file suit in court challenging make a downpayment in cash at the its provisions. time a timber sale contract is executed, Unfunded Mandates Reform except that a downpayment is not Pursuant to Title II of the Unfunded Controlling Paperwork Burdens on the required for stewardship contracts Mandates Reform Act of 1995, which Public unless the contracting officer the President signed into law on March This final rule does not contain any determines that a downpayment is 22, 1995, the Department has assessed record-keeping or reporting needed to ensure the government’s the effects of this rule on State, local, requirements or other information financial security. and Tribal Governments and the private collection requirement as defined in 5 (c) The minimum downpayment shall sector. This final rule does not compel CFR Part 1320, Controlling Paperwork be equivalent to 10 percent of the total the expenditure of $100 million or more Burdens on the Public. Accordingly, the advertised value of each sale, plus 20 by any State, local, or Tribal review provisions of the Paperwork percent of the bid premium, except in Government or anyone in the private Reduction Act of 1995 (44 U.S.C. 3501 those geographic areas where the Chief sector. Therefore, a statement under et seq.) and its implementing of the Forest Service determines that it section 202 of the Act is not required. regulations at 5 CFR part 1320 do not is necessary to increase the amount of apply. the downpayment in order to deter Environmental Impact speculation. The amount of the The agency’s preliminary assessment List of Subjects in 36 CFR Part 223 downpayment shall be redetermined is that this rule falls within 36 CFR Administrative practice and when contract rates for timber are 220.6, which excludes from procedures, Exports, Forests and forest redetermined under the terms of the documentation in an environmental products, Government contracts, contract for environmental assessment or impact statement ‘‘rules, National Forests, Reporting and modification; catastrophic damage; regulations, or policies to establish recordkeeping requirements. market change; or an emergency rate Service-wide administrative procedures, ■ For the reasons set forth in the redetermination. For the purpose of program processes, or instructions’’ that preamble, Part 223 of Title 36 of the recalculating the minimum do not significantly affect the quality of Code of Federal Regulations is amended downpayment, total advertised value the human environment. This final rule as follows: shall be replaced with total establishes uniform criteria to redetermined value. temporarily reduce or change timber PART 223—SALE AND DISPOSAL OF (d) A purchaser cannot apply the sale downpayments and periodic NATIONAL FOREST SYSTEM TIMBER amount deposited as a downpayment to payments. This rule does not change the cover other obligations due on that sale ■ longstanding requirement that timber 1. The Authority citation for Part 223 until: sale contracts include downpayments continues to read as follows: (1) On scaled sales, stumpage value and periodic payments. Implementation Authority: 90 Stat. 2958, 16 U.S.C. 472a; 98 representing 25 percent of the total bid of this rule will be controlled at the Stat. 2213; 16 U.S.C. 618, 104 Stat. 714–726, value of the sale has been charged and local level by the Timber Sale 16 U.S.C. 620–620j, unless otherwise noted. paid for, or the estimated value of unscaled timber is equal to or less than Contracting Officer. This final rule falls Subpart B—Timber Sale Contracts under 36 CFR 220.6(d)(2), which the amount of the downpayment; or (2) On tree measurement sales, excludes from documentation in an ■ 2. Revise § 223.49 to read as follows: environmental assessment or impact stumpage value representing 25 percent statement ‘‘rules, regulations, or policies § 223.49 Downpayments. of the total bid value of the sale is to establish Service-wide administrative (a) For the purposes of this section, shown on the timber sale statement of procedures, program processes, or the terms listed in this paragraph shall account to have been cut, removed, and instructions’’ that do not significantly have the following meaning: paid for, or the estimated value of affect the quality of the human (1) Total bid value is the sum of the timber remaining to be cut, removed environment. products obtained by multiplying the and paid for as shown on the timber sale rate the purchaser bid for each species statement of account is equal to or less No Takings Implications by the estimated volume listed in the than the amount of the downpayment. This final rule has been analyzed in contract. On lump sum sales, the downpayment accordance with the principles and (2) Bid premium is the amount in amount may be applied to payment for criteria contained in Executive Order excess of the advertised value that a release of the single payment unit. 12630. It has been determined that the purchaser bids for timber offered. (e) A purchaser or any affiliate of that rule does not pose the risk of a taking (3) Lump sum timber sales are purchaser awarded a Forest Service of private property. There are no private premeasured sales where the entire timber sale contract must meet the property rights to be affected because value of the sale is paid in one payment additional downpayment requirements the rule applies to commercial timber at time of release for cutting. of paragraph (g) of this section under the sale on National Forest lands. (4) Affiliate. Concerns or individuals following circumstances: are affiliates if directly or indirectly, (1) The purchaser or its affiliate after Civil Justice Reform Act either one controls or has the power to September 29, 1988, has failed to This final rule has been reviewed control the other, or a third party perform in accordance with the terms of under Executive Order 12988, Civil controls or has the power to control a Forest Service or Bureau of Land

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Management timber sale contract and is (i) For the purpose of releasing funds collection and written notice from the notified by a Contracting Officer that a deposited as downpayment by a contracting officer that the basis for contract has expired uncompleted or is purchaser subject to paragraph (f) of this temporarily reducing the downpayment terminated for cause; and section, the Forest Service shall no longer exists. Purchaser shall not cut (2) The estimated value of the compute the estimated value of timber or remove timber on a contract where unscaled timber on scaled sales, or the as follows: the downpayment has been temporarily estimated value of the timber (1) On scaled sales, the estimated reduced until the downpayment amount outstanding on tree measurement sales, value of the unscaled timber is the sum stated in the contract is fully restored. included in those terminated or expired of the products obtained by multiplying ■ 3. Amend § 223.50 by revising contracts exceeds $100,000; and the current contract rate for each species paragraphs (b) introductory text and (f) (3) Unpaid damages claimed by the by the difference between the advertised and adding paragraph (b)(3) to read as Government remain outstanding prior to volume and the volume that has been follows: award of the new sale at issue and scaled of that species. corrective action has not been taken to (2) On tree measurement sales, the § 223.50 Periodic payments. avoid future deficient performance. estimated value of the timber * * * * * (f) A subsequent final determination outstanding (i.e., not shown on the (b) Except for lump sum sales, each by the Contracting Officer or by a court timber sale statement of account as cut timber sale contract of more than one of competent jurisdiction that a contract and removed) is the sum of the products full normal operating season shall was improperly classified under the obtained by multiplying the current provide for periodic payments. The criteria in paragraph (e) of this section contract rate for each species by the number of periodic payments required will result in the refund or credit of any difference between the advertised will be dependent upon the number of unobligated portion of the amount of volume and the volume that has been normal operating seasons within the downpayment exceeding that required shown on the timber sale statement to contract, but shall not exceed two such by paragraphs (c) and (d) of this section have been cut and removed of the payments during the course of the and the limitations of paragraph (h) of species. The current contract rate for contract. Periodic payments must be this section on application of each species is that specified in the made by the periodic payment downpayment shall no longer apply. Forest Service timber sale contract. determination date, except that the (j) In order to deter speculation, the (g) Notwithstanding the provisions of amount of the periodic payment shall be Chief of the Forest Service may increase paragraphs (c) and (d) of this section, a reduced to the extent that timber has the period for retention of the purchaser meeting the criteria of been removed and paid for by the downpayment and/or preclude paragraph (e) of this section must make periodic payment determination date. temporary reduction of the a minimum downpayment equal to 20 Should the payment fall due on a date downpayment under paragraphs (k)(2) percent of the total advertised value of other than normal billing dates, the and (k)(3) of this section for future that sale, plus 40 percent of the total bid contract shall provide that the payment contracts subject to such criteria as the premium. This higher downpayment date will be extended to coincide with Chief may adopt after giving the public requirement applies throughout the the next timber sale statement of notice and opportunity to comment. account billing date. National Forest System, except in those (k) The Forest Service may areas where the Chief of the Forest temporarily reduce the downpayment * * * * * Service determines, before when a purchaser’s scheduled (3) Notwithstanding this paragraph advertisement of the sale, that another operations are delayed, interrupted, or (b), periodic payments are not required downpayment rate is necessary to extended for 30 or more consecutive for stewardship contracts unless the achieve the management objectives of days for any of the following reasons: contracting officer determines that the National Forest System. The amount (1) Forest Service requests or orders periodic payments are needed to ensure of the downpayment shall be purchaser to delay or interrupt the Government’s financial security. redetermined in accordance with this operations for reasons other than * * * * * paragraph when contract rates for breach; (f) The amount of any periodic timber are redetermined under the terms (2) A contract term addition pursuant payment(s) not yet reached shall be of the contract for environmental to purchaser shifting operations to a sale revised when rates are redetermined modification; catastrophic damage; designated by the Forest Service as in under the contract. The revised periodic market change; or an emergency rate urgent need of harvesting; or payment amounts shall be based on a redetermination. For the purpose of (3) An extension of the contract term recalculated total contract value using redetermining the downpayment, total authorized upon a determination of the same procedures described in (c) advertised value shall be replaced with substantial overriding public interest, and (d) of this section. The recalculated total redetermined value. including a market-related contract term total contract value is the current (h) A purchaser subject to the addition, or an urgent removal contract contract value following the rate additional downpayment requirements term extension under 36 CFR 223.53. redetermination plus: of paragraph (g) of this section cannot (l) When purchaser is not cutting or (1) The total value of timber scaled apply the amount deposited as a removing timber under contract during prior to establishing redetermined rates downpayment to other uses until: a qualifying period of delay, in a scaled sale; or (1) On scaled sales, the estimated interruption, or extension listed in (2) The total value of timber shown on value of the unscaled timber is equal to paragraph (k) of this section, the the timber sale statement of account as or less than the amount of the downpayment may be reduced to $1000 having been cut, removed and paid for. downpayment; or or 2 percent of the downpayment (2) On tree measurement sales, the amount stated in the contract, Dated: August 7, 2009. estimated value remaining to be cut and whichever is greater. The purchaser Ann Bartuska, removed as shown on the timber sale must restore the downpayment to the Acting Deputy Undersecretary, NRE. statement of account is equal to or less full amount stated in the contract within [FR Doc. E9–19372 Filed 8–12–09; 8:45 am] than the amount of the downpayment. 15 days from receipt of the bill for BILLING CODE 3410–11–P

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ENVIRONMENTAL PROTECTION business are Monday through Friday, Branch (AR–18J), U.S. Environmental AGENCY 8:30 a.m. to 4:30 p.m., excluding Protection Agency, Region 5, 77 West Federal holidays. Jackson Boulevard, Chicago, Illinois 40 CFR Part 52 Instructions: Direct your comments to 60604, (312) 886–0258, Docket ID No. EPA–R05–OAR–2007– [email protected]. [EPA–R05–OAR–2007–1129; FRL–8941–9] 1129. EPA’s policy is that all comments SUPPLEMENTARY INFORMATION: Approval and Promulgation of Air received will be included in the public docket without change and may be Throughout this document whenever Quality Implementation Plans; Ohio; ‘‘we,’’ ‘‘us,’’ or ‘‘our’’ is used, we mean Consumer Products Rule made available online at www.regulations.gov, including any EPA. This supplementary information AGENCY: Environmental Protection personal information provided, unless section is arranged as follows: Agency (EPA). the comment includes information I. When did the State submit the requested ACTION: Direct final rule. claimed to be Confidential Business rule revisions to EPA, and did the State Information (CBI) or other information satisfy the administrative requirements SUMMARY: EPA is approving a request whose disclosure is restricted by statute. of 40 CFR Part 51, Appendix V? submitted by the Ohio Environmental Do not submit information that you II. What are the revisions that the State is requesting for incorporation into the SIP? Protection Agency (Ohio EPA) on consider to be CBI or otherwise October 5, 2007, to revise the Ohio State A. Definitions and Applicability for protected through www.regulations.gov Volatile Organic Compounds Emissions Implementation Plan (SIP) under the or e-mail. The www.regulations.gov Web From Consumer Products Clean Air Act. The State has submitted site is an ‘‘anonymous access’’ system, B. Standards and Exemptions for Volatile new volatile organic compounds (VOCs) which means EPA will not know your Organic Compounds Emissions From control rules for approval under Chapter identity or contact information unless Consumer Products 3745–112 of the Ohio Administrative you provide it in the body of your C. Administrative and Reporting Code (OAC). The rules include OAC comment. If you send an e-mail Requirements, Variances, and Testing 3745–112–01 to OAC 3745–112–08 and comment directly to EPA without going Methods for Volatile Organic Compounds Emissions From Consumer are intended to assist the State in through www.regulations.gov your e- achieving and/or maintaining the Products mail address will be automatically III. What will approval of these rules national 8-hour ground level ozone captured and included as part of the accomplish? standard through the regulation of VOCs comment that is placed in the public IV. What action is EPA taking? in consumer products. Ohio followed, docket and made available on the V. Statutory and Executive Order Reviews with some modifications, the Ozone Internet. If you submit an electronic I. When did the State submit the Transport Commission’s ‘‘Model Rule comment, EPA recommends that you requested rule revisions to EPA, and for Consumer Products,’’ (Model Rule) include your name and other contact did the State satisfy the administrative in developing the State’s submittal. information in the body of your requirements of 40 CFR Part 51, DATES: comment and with any disk or CD–ROM This direct final rule will be Appendix V? effective October 13, 2009, unless EPA you submit. If EPA cannot read your receives adverse comments by comment due to technical difficulties Ohio EPA submitted the requested September 14, 2009. If adverse and cannot contact you for clarification, revisions to EPA on October 7, 2007, comments are received, EPA will EPA may not be able to consider your and demonstrated through its submittal publish a timely withdrawal of the comment. Electronic files should avoid that the State satisfied all the direct final rule in the Federal Register the use of special characters, any form requirements of 40 CFR Part 51, informing the public that the rule will of encryption, and be free of any defects Appendix V, ‘‘Criteria for Determining not take effect. or viruses. the Completeness of Plan Submissions.’’ ADDRESSES: Submit your comments, Docket: All documents in the docket The administrative requirements are identified by Docket ID No. EPA–R05– are listed in the www.regulations.gov outlined in Section 2.1 of this appendix. OAR–2007–1129, by one of the index. Although listed in the index, Most notably, a public hearing was held following methods: some information is not publicly on June 12, 2007, and the rules became 1. www.regulations.gov: Follow the available, e.g., CBI or other information effective State-wide on September 12, on-line instructions for submitting whose disclosure is restricted by statute. 2007. Certain other material, such as comments. II. What are the revisions that the State 2. E-mail: [email protected]. copyrighted material, will be publicly available only in hard copy. Publicly is requesting for incorporation into the 3. Fax: (312) 692–2551. SIP? 4. Mail: John M. Mooney, Chief, available docket materials are available Criteria Pollutant Section, Air Programs either electronically in The State has requested that EPA Branch (AR–18J), U.S. Environmental www.regulations.gov or in hard copy at approve new rules under Chapter 3745– Protection Agency, 77 West Jackson the Environmental Protection Agency, 112 of the OAC. These rules include Boulevard, Chicago, Illinois 60604. Region 5, Air and Radiation Division, 77 3745–112–01 (Definitions); 3745–112– 5. Hand Delivery: John M. Mooney, West Jackson Boulevard, Chicago, 02 (Applicability); 3745–112–03 Chief, Criteria Pollutant Section, Air Illinois 60604. This facility is open from (Standards); 3745–112–04 (Exemptions); Programs Branch (AR–18J), U.S. 8:30 a.m. to 4:30 p.m., Monday through 3745–112–05 (Administrative Environmental Protection Agency, 77 Friday, excluding Federal holidays. We Requirements); 3745–112–06 (Reporting West Jackson Boulevard, Chicago, recommend that you telephone Andy Requirements); 3745–112–07 Illinois 60604. Such deliveries are only Chang, Environmental Engineer, at (312) (Variances); and 3745–112–08 (Test accepted during the Regional Office 886–0258 before visiting the Region 5 Methods). All submitted rules are normal hours of operation, and special office. intended to assist the State in achieving arrangements should be made for FOR FURTHER INFORMATION CONTACT: and/or maintaining the national 8-hour deliveries of boxed information. The Andy Chang, Environmental Engineer, ground level ozone standard through the Regional Office official hours of Criteria Pollutant Section, Air Programs regulation of volatile organic

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compounds in consumer products. The III. What will approval of these rules based on the proposed action. The EPA revisions are described in detail below. accomplish? will not institute a second comment period, therefore, any parties interested A. Definitions and Applicability for Approval of these rules submitted by Ohio EPA will help attain and maintain in commenting on this action should do Volatile Organic Compounds Emissions so at this time. If we do not receive any From Consumer Products the national eight-hour standard for ground-level ozone, and reduce eight- comments, this action will be effective Ohio EPA submitted definitions and hour ozone levels. Ozone is a human October 13, 2009. applicability rules, which adopt almost respiratory system irritant, and is V. Statutory and Executive Order verbatim, the rules found in the Model harmful to the environment as well. Reviews Rule. There are very minor Both ozone and volatile organic Under the Clean Air Act, the modifications, which are related to compounds are components of smog, Administrator is required to approve a which poses a significant threat to implementation and compliance dates SIP submission that complies with the animal, plant, and human life. By that are updated from the Model Rule. provisions of the Act and applicable maintaining the national standard for With exceptions only applicable to the Federal regulations. 42 U.S.C. 7410(k); ground-level ozone and decreasing the Federal Insecticide, Fungicide, and 40 CFR 52.02(a). Thus, in reviewing SIP levels of ozone, the benefits to human Rodenticide Act (FIFRA) regulated submissions, EPA’s role is to approve and environmental health in the State of products, the implementation date is state choices, provided that they meet Ohio and surrounding areas is expected January 1, 2009. Unless provided in the criteria of the Clean Air Act. to be permanent. subsequent rule 3745–112–04 Accordingly, this action merely (Exemptions), the applicability rule IV. What action is EPA taking? approves state law as meeting Federal applies to any person who sells, requirements and does not impose supplies, offers for sale, or manufactures We are approving revisions to the Ohio SIP; the State has submitted new additional requirements beyond those consumer products on or after January imposed by state law. For that reason, 1, 2009, for use in the State of Ohio. rules under Chapter 3745–112 of the OAC. These rules encompass OAC rule this action: Specifying implementation and • Is not a ‘‘significant regulatory 3745–112–01 to OAC rule 3745–112–08, compliance dates do not make the rules action’’ subject to review by the Office and are intended to assist the state of less stringent; therefore, EPA concludes of Management and Budget under Ohio in achieving and/or maintaining that the State’s definitions and Executive Order 12866 (58 FR 51735, the national 8-hour ground level ozone applicability rules for VOC emissions October 4, 1993); from consumer products are approvable. standard through the regulation of VOCs • Does not impose an information in consumer products. Ohio drafted collection burden under the provisions B. Standards and Exemptions for their rules based almost entirely on the of the Paperwork Reduction Act (44 Volatile Organic Compounds Emissions Model Rule with one exception, U.S.C. 3501 et seq.); From Consumer Products severability, which was already • Is certified as not having a addressed in OAC rule 3745–15–09. Ohio EPA adopted the Model Rule’s significant economic impact on a We are approving these rules because substantial number of small entities standards for VOC emissions in their they will help reduce emissions of entirety with very minor modifications; under the Regulatory Flexibility Act (5 volatile organic compounds and will U.S.C. 601 et seq.); Ohio EPA has specified that any therefore help reduce ground-level • consumer product manufactured prior Does not contain any unfunded ozone concentrations in the State of mandate or significantly or uniquely to January 1, 2009, may be sold, Ohio and surrounding areas. Ohio EPA’s supplied, or offered for sale after affect small governments, as described rules closely follow the Model Rule, in the Unfunded Mandates Reform Act January 1, 2009 (sell-through of which EPA has determined to be products). The State’s exemptions rules of 1995 (Pub. L. 104–4); approvable in other SIPs. The State’s • Does not have Federalism were based entirely on the Model Rule, submittal meets the requirements of and include those for ‘‘Innovative implications as specified in Executive Section 183 of the Clean Air Act, as well Order 13132 (64 FR 43255, August 10, Products.’’ Specifying a date pertaining as requirements of 40 CFR Part 51, to sell-through of products does not 1999); Appendix V. • Is not an economically significant weaken the rules; therefore, EPA We are publishing this action without regulatory action based on health or concludes that the State’s standards and prior proposal because we view this as safety risks subject to Executive Order exemptions rules for VOC emissions a noncontroversial amendment and 13045 (62 FR 19885, April 23, 1997); from consumer products are approvable. anticipate no adverse comments. • Is not a significant regulatory action C. Administrative and Reporting However, in the Proposed Rules section subject to Executive Order 13211 (66 FR Requirements, Variances, and Testing of this Federal Register publication, we 28355, May 22, 2001); Methods for Volatile Organic are publishing a separate document that • Is not subject to requirements of Compounds Emissions From Consumer will serve as the proposal to approve the Section 12(d) of the National Products State plan if relevant adverse written Technology Transfer and Advancement comments are filed. This rule will be Act of 1995 (15 U.S.C. 272 note) because The rules covering these sections effective October 13, 2009 without application of those requirements would were drafted in their entirety based on further notice unless we receive relevant be inconsistent with the Clean Air Act; guidance from the Model Rule. All adverse written comments by September and requirements and methodologies mirror 14, 2009. If we receive such comments, • Does not provide EPA with the exactly those found in the Model Rule; we will withdraw this action before the discretionary authority to address, as therefore, EPA concludes that the State’s effective date by publishing a appropriate, disproportionate human administrative and reporting subsequent document that will health or environmental effects, using requirements, variances, and testing withdraw the final action. All public practicable and legally permissible methods for VOC emissions from comments received will then be methods, under Executive Order 12898 consumer products are approvable. addressed in a subsequent final rule (59 FR 7629, February 16, 1994).

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In addition, this rule does not have Dated: July 28, 2009. 8-hour ozone maintenance plan for the tribal implications as specified by Walter W. Kovalick Jr, York-Adams Counties 8-Hour Ozone Executive Order 13175 (65 FR 67249, Acting Regional Administrator, Region 5. Maintenance Area (the Area). This November 9, 2000), because the SIP is ■ 40 CFR part 52 is amended as follows: revision amends the maintenance plan’s not approved to apply in Indian country 2009 and 2018 motor vehicle emissions located in the state, and EPA notes that PART 52—[AMENDED] budgets (MVEBs) by unequally dividing it will not impose substantial direct the existing approved MVEBs which ■ costs on tribal governments or preempt 1. The authority citation for part 52 covers the entire maintenance area into continues to read as follows: tribal law. two sub-regional MVEBs, one set of Authority: 42 U.S.C. 7401 et seq. MVEBs for each county comprising the The Congressional Review Act, 5 area. The revised plan continues to U.S.C. 801 et seq., as added by the Small Subpart KK—Ohio demonstrate maintenance of the 8-hour Business Regulatory Enforcement national ambient air quality standard ■ Fairness Act of 1996, generally provides 2. Section 52.1870 is amended by (NAAQS) for ozone. EPA is approving that before a rule may take effect, the adding paragraph (c)(147) to read as this SIP revision to the Pennsylvania agency promulgating the rule must follows: maintenance plan for York-Adams in submit a rule report, which includes a § 52.1870 Identification of plan. accordance with the requirements of the copy of the rule, to each House of the Clean Air Act (CAA). Congress and to the Comptroller General * * * * * DATES: This rule is effective on October of the United States. EPA will submit a (c) * * * (147) On October 5, 2007, Ohio 13, 2009 without further notice, unless report containing this action and other EPA receives adverse written comment required information to the U.S. Senate, submitted revisions to Ohio Administrative Code Chapter 3745–112, by September 14, 2009. If EPA receives the U.S. House of Representatives, and such comments, it will publish a timely the Comptroller General of the United Rules 3745–112–01 through 3745–112– 08. The revisions regulate the volatile withdrawal of the direct final rule in the States prior to publication of the rule in Federal Register and inform the public the Federal Register. A major rule organic compounds content of consumer products. that the rule will not take effect. cannot take effect until 60 days after it (i) Incorporation by reference. ADDRESSES: Submit your comments, is published in the Federal Register. (A) Ohio Administrative Code Rule identified by Docket ID Number EPA– This action is not a ‘‘major rule’’ as 3745–112–01 ‘‘Definitions.’’, Rule 3745– R03–OAR–2008–0591 by one of the defined by 5 U.S.C. 804(2). 112–02 ‘‘Applicability.’’, Rule 3745– following methods: Under section 307(b)(1) of the Clean 112–03 ‘‘Standards.’’, Rule 3745–112–04 A. http://www.regulations.gov. Follow Air Act, petitions for judicial review of ‘‘Exemptions.’’, Rule 3745–112–05 the on-line instructions for submitting this action must be filed in the United ‘‘Administrative requirements.’’, Rule comments. States Court of Appeals for the 3745–112–06 ‘‘Reporting B. E-mail: [email protected]. appropriate circuit by October 13, 2009. requirements.’’, Rule 3745–112–07 C. Mail: EPA–R03–OAR–2008–0591, Filing a petition for reconsideration by ‘‘Variances.’’, and Rule 3745–112–08 Carol Febbo, Chief, Energy, Radiation the Administrator of this final rule does ‘‘Test methods.’’, adopted September 5, and Indoor Environment Branch, not affect the finality of this action for 2007, effective on September 15, 2007. Mailcode 3AP23, U.S. Environmental the purposes of judicial review nor does (B) September 5, 2007, ‘‘Director’s Protection Agency, Region III, 1650 it extend the time within which a Final Findings and Orders’’, signed by Arch Street, Philadelphia, Pennsylvania petition for judicial review may be filed, Chris Korleski, Director, Ohio 19103. and shall not postpone the effectiveness Environmental Protection Agency. D. Hand Delivery: At the previously- listed EPA Region III address. Such of such rule or action. Parties with [FR Doc. E9–19305 Filed 8–12–09; 8:45 am] deliveries are only accepted during the objections to this direct final rule are BILLING CODE 6560–50–P encouraged to file a comment in Docket’s normal hours of operation, and response to the parallel notice of special arrangements should be made proposed rulemaking for this action ENVIRONMENTAL PROTECTION for deliveries of boxed information. published in the Proposed Rules section AGENCY Instructions: Direct your comments to of today’s Federal Register, rather than Docket ID No. EPA–R03–OAR–2008– file an immediate petition for judicial 40 CFR Part 52 0591. EPA’s policy is that all comments review of this direct final rule, so that received will be included in the public [EPA–R03–OAR–2008–0591; FRL–8941–4] docket without change, and may be EPA can withdraw this direct final rule made available online at http:// and address the comment in the Approval and Promulgation of Air www.regulations.gov, including any proposed rulemaking. This action may Quality Implementation Plans; personal information provided, unless not be challenged later in proceedings to Pennsylvania; Revised Motor Vehicle the comment includes information enforce its requirements. (See section Emission Budgets for the York-Adams claimed to be Confidential Business Counties 8-Hour Ozone Maintenance 307(b)(2).) Information (CBI) or other information Area List of Subjects in 40 CFR Part 52 whose disclosure is restricted by statute. AGENCY: Environmental Protection Do not submit information that you Environmental protection, Air Agency (EPA). consider to be CBI or otherwise pollution control, Carbon monoxide, ACTION: Direct final rule. protected through http:// Incorporation by reference, www.regulations.gov or e-mail. The Intergovernmental relations, Lead, SUMMARY: EPA is taking direct final http://www.regulations.gov Web site is Nitrogen dioxide, Ozone, Particulate action to approve a State an anonymous access system, which matter, Reporting and recordkeeping Implementation Plan (SIP) revision means EPA will not know your identity requirements, Sulfur oxides, Volatile submitted by the Commonwealth of or contact information unless you organic compounds. Pennsylvania. The revision amends the provide it in the body of your comment.

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If you send an e-mail comment directly during normal business hours at the Air road MVEBs for Volatile Organic to EPA without going through http:// Protection Division, U.S. Environmental Compounds (VOCs) and Nitrous Oxides www.regulations.gov, your e-mail Protection Agency, Region III, 1650 (NOX), which are ozone precursors, address will be automatically captured Arch Street, Philadelphia, Pennsylvania which are then used for transportation and included as part of the comment 19103. Copies of the State submittal are planning and conformity purposes. that is placed in the public docket and available at the Pennsylvania There are two separate metropolitan made available on the Internet. If you Department of Environmental planning organizations (MPOs), in this submit an electronic comment, EPA Protection, Bureau of Air Quality, P.O. maintenance area, one in each county, recommends that you include your Box 8468, 400 Market Street, Harrisburg, with individual responsibility for doing name and other contact information in Pennsylvania. transportation conformity for their the body of your comment and with any FOR FURTHER INFORMATION CONTACT: respective county. Pennsylvania has disk or CD–ROM you submit. If EPA Martin Kotsch, (215) 814–3335, or by unequally divided the existing MVEBs cannot read your comment due to e-mail at [email protected]. and created sub-regional MVEBs for technical difficulties and cannot contact each county to better accommodate the SUPPLEMENTARY INFORMATION: you for clarification, EPA may not be transportation planning and conformity Throughout this document whenever able to consider your comment. processes within the Area. ‘‘we’’, ‘‘us’’, or ‘‘our’’ is used, we mean Electronic files should avoid the use of EPA. II. Summary of Pennsylvania’s SIP special characters, any form of Revision and EPA’s Review 2009 and encryption, and be free of any defects or Table of Contents 2018 Motor Vehicle Emission Budgets viruses. I. Background Docket: All documents in the II. Summary of Pennsylvania’s SIP Revision On May 23, 2008, the State of electronic docket are listed in the and EPA’s Review Pennsylvania submitted to EPA a formal http://www.regulations.gov index. III. Final Action revision to its State Implementation Although listed in the index, some IV. Statutory and Executive Order Reviews Plan (SIP). The SIP revision proposes information is not publicly available, MVEBs that reflect the unequal division i.e., CBI or other information whose I. Background of the existing MVEBs for the disclosure is restricted by statute. On January 14, 2008 (73 FR 2163) maintenance area. The divided MVEBs Certain other material, such as EPA redesignated the York-Adams continue to ensure maintenance of the copyrighted material, is not placed on Counties area of Pennsylvania to NAAQS for ozone for the York-Adams the Internet and will be publicly attainment for the 8-hour ozone area. The following table lists the available only in hard copy form. NAAQS. For the York-Adams Counties previously approved MVEBs and the Publicly available docket materials are area, the redesignation included proposed reallocation of the MVEBs into available either electronically in http:// approval of an 8-hour ozone sub-regional budgets for the York- www.regulations.gov or in hard copy maintenance plan, which identifies on- Adams Counties area.

YORK-ADAMS AREA REALLOCATION OF THE MVEBS INTO SUB-REGIONAL BUDGETS CURRENT MVEBSINTHEAPPROVED MAINTENANCE PLAN—BOTH COUNTIES [Tons/day]

2004 2009 2018 Base year Projection Projection

VOC ...... 16.1 15.9 9.0 NOX ...... 26.4 22.8 10.0

PROPOSED MVEBSINTHEREVISED MAINTENANCE PLAN FOR BOTH COUNTIES [Tons/day] 1

2009 2018 Budget Budget

Adams County

VOC ...... 3.84 2.34 NOX ...... 4.87 2.54

York County

VOC ...... 12.09 6.72 NOX ...... 17.96 7.50 1 Due to rounding, the new reallocated budgets, if combined, are insignificantly higher then the previously approved mobile budgets for the en- tire area. This slight difference will still ensure maintenance of the 8-hour ozone attainment as the combined MVEBs are still lower then the at- tainment year budgets.

EPA is proposing to approve the 2009 new MVEBs for transportation III. Final Action and 2018 MVEBs for VOCs and NOX conformity planning. emissions listed above in Table 1 as the EPA is approving Pennsylvania’s May 23, 2008 SIP revision submittal which amends the 8-hour ozone maintenance

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plans for the York-Adams area. This • Is certified as not having a This action is not a ‘‘major rule’’ as revision unequally divides the significant economic impact on a defined by 5 U.S.C. 804(2). previously approved 2009 and 2018 substantial number of small entities C. Petitions for Judicial Review MVEBs to create sub-regional MVEBs under the Regulatory Flexibility Act for the two counties comprising the (5 U.S.C. 601 et seq.); Under section 307(b)(1) of the Clean area. EPA is approving this SIP revision • Does not contain any unfunded Air Act, petitions for judicial review of to the maintenance plan for the Area mandate or significantly or uniquely this action must be filed in the United because the May 23, 2008 submittal affect small governments, as described States Court of Appeals for the continues to demonstrate maintenance in the Unfunded Mandates Reform Act appropriate circuit by October 13, 2009. of the 8-hour ozone NAAQS with the of 1995 (Pub. L. 104–4); Filing a petition for reconsideration by aggregated sub-regional MVEBs. EPA is • Does not have Federalism the Administrator of this final rule does publishing this rule without prior implications as specified in Executive not affect the finality of this action for proposal because the Agency views this Order 13132 (64 FR 43255, August 10, the purposes of judicial review nor does as a noncontroversial amendment and 1999); it extend the time within which a anticipates no adverse comment, since • Is not an economically significant petition for judicial review may be filed, no significant adverse comments were regulatory action based on health or and shall not postpone the effectiveness received on the SIP revision at the State safety risks subject to Executive Order of such rule or action. Parties with level. However, in the Proposed Rules 13045 (62 FR 19885, April 23, 1997); objections to this direct final rule are • section of today’s Federal Register, EPA Is not a significant regulatory action encouraged to file a comment in is publishing a separate document that subject to Executive Order 13211 (66 FR response to the parallel notice of 28355, May 22, 2001); will serve as the proposal to approve the • proposed rulemaking for this action SIP revision if adverse comments are Is not subject to requirements of published in the proposed rules section filed. This rule will be effective on section 12(d) of the National of today’s Federal Register, rather than October 13, 2009 without further notice Technology Transfer and Advancement file an immediate petition for judicial unless EPA receives adverse comment Act of 1995 (15 U.S.C. 272 note) because review of this direct final rule, so that by September 14, 2009. application of those requirements would EPA can withdraw this direct final rule If EPA receives adverse comment, be inconsistent with the Clean Air Act; and address the comment in the EPA will publish a timely withdrawal in and proposed rulemaking. • Does not provide EPA with the the Federal Register informing the This action to approve the York- discretionary authority to address, as public that the rule will not take effect. Adams Counties revised maintenance appropriate, disproportionate human EPA will address all public comments plan may not be challenged later in health or environmental effects, using in a subsequent final rule based on the proceedings to enforce its requirements. practicable and legally permissible proposed rule. EPA will not institute a (See, section 307(b)(2)). second comment period on this action. methods, under Executive Order 12898 Any parties interested in commenting (59 FR 7629, February 16, 1994). List of Subjects in 40 CFR Part 52 In addition, this rule does not have must do so at this time. Environmental protection, Air Tribal implications as specified by pollution control, Incorporation by IV. Statutory and Executive Order Executive Order 13175 (65 FR 67249, reference, Intergovernmental relations, Reviews November 9, 2000), because the SIP is Nitrogen dioxide, Ozone, Reporting and not approved to apply in Indian country A. General Requirements recordkeeping requirements, Volatile located in the State, and EPA notes that organic compounds. Under the Clean Air Act, the it will not impose substantial direct Administrator is required to approve a costs on Tribal governments or preempt Dated: July 28, 2009. SIP submission that complies with the Tribal law. William C. Early, provisions of the Act and applicable B. Submission to Congress and the Acting Regional Administrator, Region III. Federal regulations 42 U.S.C. 7410(k); ■ 40 CFR 52.02(a). Thus, in reviewing SIP Comptroller General 40 CFR part 52 is amended as follows: submissions, EPA’s role is to approve The Congressional Review Act, 5 PART 52—[AMENDED] State choices, provided that they meet U.S.C. 801 et seq., as added by the Small the criteria of the Clean Air Act. Business Regulatory Enforcement ■ 1. The authority citation for part 52 Accordingly, this action merely Fairness Act of 1996, generally provides continues to read as follows: approves State law as meeting Federal that before a rule may take effect, the Authority: 42 U.S.C. 7401 et seq. requirements and does not impose agency promulgating the rule must additional requirements beyond those submit a rule report, which includes a Subpart XX—Pennsylvania imposed by State law. For that reason, copy of the rule, to each House of the this action: Congress and to the Comptroller General ■ 2. In § 52.2020, the table in paragraph • Is not a ‘‘significant regulatory of the United States. EPA will submit a (e)(1) is amended by revising the entry action’’ subject to review by the Office report containing this action and other for the 8-Hour Ozone Maintenance Plan of Management and Budget under required information to the U.S. Senate, for the York-Adams, PA Area to read as Executive Order 12866 (58 FR 51735, the U.S. House of Representatives, and follows: October 4, 1993); the Comptroller General of the United • Does not impose an information States prior to publication of the rule in § 52.2020 Identification of plan. collection burden under the provisions the Federal Register. A major rule * * * * * of the Paperwork Reduction Act cannot take effect until 60 days after it (e) * * * (44 U.S.C. 3501 et seq.); is published in the Federal Register. (1) * * *

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EPA-APPROVED NON-REGULATORY OR QUASI-REGULATORY MATERIAL

Name of non-regulatory SIP State submittal revision Applicable geographic area date EPA approval date Additional explanation

******* 8-Hour Ozone Maintenance York-Adams Counties Area ... 6/14/07 1/14/08, 73 FR 2163. Plan for the York-Adams, PA Area. 5/23/08 8/13/09 [Insert page number where the document be- gins].

*******

* * * * * Pollution Control District (KCAPCD) publicly available only at the hard copy [FR Doc. E9–18864 Filed 8–12–09; 8:45 am] SIP; and, a limited approval and limited location (e.g., copyrighted material), and BILLING CODE 6560–50–P disapproval of revisions to the Mohave some may not be publicly available in Desert Air Quality Management District either location (e.g., CBI). To inspect the (MDAQMD) SIP. These revisions hard copy materials, please schedule an ENVIRONMENTAL PROTECTION concern particulate matter (PM) appointment during normal business AGENCY emissions from fugitive dust sources. hours with the contact listed in the FOR This action was proposed in the Federal FURTHER INFORMATION CONTACT section. 40 CFR Part 52 Register on November 18, 2008. Under FOR FURTHER INFORMATION CONTACT: Jerry [EPA–R09–OAR–2008–0566; FRL–8939–2] authority of the Clean Air Act as Wamsley, EPA Region IX, (415) 947– amended in 1990 (CAA or the Act), this 4111, [email protected]. Revisions to the California State action directs California to correct rule SUPPLEMENTARY INFORMATION: Implementation Plan, Great Basin deficiencies in GBUAPCD Rule 401; Throughout this document, ‘‘we,’’ ‘‘us’’ Unified Air Pollution Control District, and, this action simultaneously and ‘‘our’’ refer to EPA. Kern County Air Pollution Control approves KCAPCD Rule 402 and District, Mohave Desert Air Quality MDAQMD Rule 403.1 and directs Table of Contents Management District California to correct the deficiencies I. Proposed Action within these rules. II. Public Comments and EPA Responses AGENCY: Environmental Protection III. EPA Action DATES: Agency (EPA). Effective Date: This rule is IV. Statutory and Executive Order Reviews effective on September 14, 2009. ACTION: Final rule. ADDRESSES: EPA has established docket I. Proposed Action SUMMARY: EPA is finalizing the number EPA–R09–OAR–2008–0566 for On November 18, 2008 (73 FR 68369), following actions: A disapproval of this action. The index to the docket is EPA proposed to disapprove GBUAPCD revisions to the Great Basin Unified Air available electronically at http:// Rule 401. In this same action, EPA Pollution Control District (GBUAPCD) www.regulations.gov and in hard copy proposed a limited approval and limited portion of the California State at EPA Region IX, 75 Hawthorne Street, disapproval of KCAPCD Rule 402 and Implementation Plan (SIP); a limited San Francisco, California. While all MDAQMD Rule 403.1. Table 1 lists the approval and limited disapproval of documents in the docket are listed in rules that California submitted for revisions to the Kern County Air the index, some information may be incorporation within the SIP.

TABLE 1—SUBMITTED RULES

Local agency Rule # Rule title Adopted Submitted

GBUAPCD ...... 401 Fugitive Dust...... 12/04/06 05/08/07 KCAPCD ...... 402 Fugitive Dust...... 11/03/04 01/13/05 MDAQMD ...... 403.1 Fugitive Dust Control ...... 11/25/96 03/03/97

We proposed to disapprove remove the ‘‘reasonable precautions’’ adopted to reduce Owens dry lakebed GBUAPCD Rule 401 because some language. dust emissions, and specify an provisions do not satisfy the 3. GBUAPCD should either provide a enforceable implementation schedule. requirements of section 110 and part D precise wind speed exemption from the We proposed a limited approval of of the Act. These provisions are rule’s emission standards, or delete the KCAPCD Rule 402 and MDAPCD Rule discussed below. language concerning ‘‘normal wind 403.1 because we determined that these 1. The rule lacks a 20% opacity limit. conditions’’. rules improve the SIP and are largely GBUAPCD should either incorporate or 4. GBUAPCD should remove consistent with the relevant CAA reference such a 20% opacity limit. director’s discretionary language in requirements. We simultaneously 2. The rule lacks a clear description Section D.1. proposed a limited disapproval because of required control measures for meeting 5. As specified by the PM–10 plan, some rule provisions conflict with the rule’s opacity and property line PM GBUAPCD should define required emission limits. GBUAPCD should also BACM provisions beyond those already section 110 and part D of the Act.

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Regarding KCAPCD Rule 402, the prevent full approval of the SIP limited disapproval of KCAPCD Rule provisions listed below conflict with revision. 402 and MDAQMD Rule 403.1; these section 110 and part D of the Act and 1. The following terms should be rules will be incorporated within the prevent full approval of the SIP defined: Brackish water, paved roads SIP, including those provisions revision. used for industrial activity, Dust Control identified as deficient. 1. The definitions for ‘‘open storage Plan, industrial fugitive dust sources, In finalizing a disapproval of piles’’ and ‘‘prevailing wind direction’’ industrial fugitive dust sources, and GBUAPCD Rule 401, our action will not contain instances of APCO discretion exterior transfer lines. incorporate submitted GBUAPCD Rule that should be delimited by specific 2. Sections C.2.(a)(i), C.2.(b)(i), 401 into the SIP, instead, it will retain criteria for adjudicating the issues C.2(d)(i), C.4(d)(i) state that weekly 1977 adopted rule within the SIP. We within these definitions. brackish water treatments or biweekly will not impose sanctions, pursuant to 2. The rule provides an overly broad sweeping and collection are presumed section 179 of the Act, because Rule 401 exemption for agricultural operations. to be sufficient for meeting the required is not a required CAA submittal. Note 3. The rule provides an overly broad Road Surface Silt Loading standard. that the submitted rule has been exemption for actions required by However, compliance with the rule’s silt adopted by the GBUAPCD, and EPA’s Federal or State endangered species loading standard needs to be confirmed final disapproval does not prevent the legislation, or the Surface Mining and by observations using the appropriate local agency from enforcing it. Reclamation Act. test method. With KCAPCD Rule 402, we will not 4. The rule provides an overly broad 3. At Section C.4.(b), there is a impose sanctions under section 179 of exemption for public parks and requirement to permanently eliminate the Act, because Rule 402 is not a recreation areas such as county, State, 2,750 square feet of bulk material required submittal under the CAA and and national parks, recreation areas, storage piles that were exposed during is not an essential Reasonably Available forests, and monuments. 1990; however, it is unclear how this Control Measure (RACM) under the 5. The rule provides exemptions for provision can be enforced effectively Indian Wells Maintenance Plan. The contractors provided reasonably given the lack of specificity within the submitted rule has been adopted by the available control measures were rule concerning these storage piles. KCAPCD, and EPA’s final limited implemented prior to a contract 4. Section C.5 does not provide a date disapproval does not prevent the local termination date and a final grading certain by which the BLM and the agency from enforcing it. inspection. However, no records are District jointly prepare a dust control Regarding Rule 403.1, we will not required to demonstrate implementation plan that reduces BLM PM–10 impose sanctions under section 179 of of reasonably available control emissions by at least 20 percent relative the Act, because Rule 403.1 is not an measures. to 1990 levels. essential RACM given the ongoing clean 6. Monitoring provisions are set aside 5. The exemption for agricultural data observed in the Trona subregion for large operations for a calendar operations at Section D(1)(a) should be since 1992. The submitted rule has been quarter. This exemption from removed. adopted by the MDAQMD, and EPA’s monitoring is not justified or explained. 6. In Section F.1(c), the rule should final limited disapproval does not 7. The rule states that no visible state explicitly what the freeboard prevent the local agency from enforcing emissions are allowed beyond the requirements are instead of it. property line of an active operation; incorporating the California Vehicle however, the rule does not specify an Code by reference. Also, these IV. Statutory and Executive Order opacity limit and the test methods for requirements should be incorporated Reviews determining compliance for unpaved within the appropriate paragraph in A. Executive Order 12866, Regulatory roads which are exempted from the Section C. Planning and Review property line limit. Our proposed action contains more 8. The suggested reasonably available information on the basis for this The Office of Management and Budget control measures for fugitive dust listed rulemaking and on our evaluation of (OMB) has exempted this regulatory in Table 1 are not specific and lack these rules. action from Executive Order 12866, standards for determining compliance entitled ‘‘Regulatory Planning and and allied test methods. II. Public Comments and EPA Review.’’ 9. Large operations may set aside Responses B. Paperwork Reduction Act applying control measures if the APCO EPA’s proposed action provided a 30- concurs that ‘‘special technical, e.g. day public comment period. During this This action does not impose an non-economic circumstances’’ prevent period, we received no comments on information collection burden under the control measure implementation. This our proposed actions on these rules. provisions of the Paperwork Reduction exemption is vague and allows for This comment period closed December Act, 44 U.S.C. 3501 et seq. Burden is inappropriate Director’s Discretion. 18, 2008. defined at 5 CFR 1320.3(b). KCAPCD should define the III. EPA Action C. Regulatory Flexibility Act circumstances that may prevent control measure implementation and the No comments were submitted The Regulatory Flexibility Act (RFA) criteria the APCO will use to decide sufficient to change our assessment of generally requires an agency to conduct these issues. these rules as described in our proposed a regulatory flexibility analysis of any 10. The rule should specify that all action. Therefore, as authorized in rule subject to notice and comment records demonstrating compliance sections 110(k)(3) and 301(a) of the Act, rulemaking requirements unless the should be maintained for two years and EPA is finalizing a disapproval of agency certifies that the rule will not made available to the Control Officer GBUAPCD Rule 401; this action will not have a significant economic impact on upon request. incorporate GBUAPCD Rule 401 into the a substantial number of small entities. Regarding Rule MDAQMD Rule 403.1, SIP. Also, as authorized in sections Small entities include small businesses, the provisions listed below conflict with 110(k)(3) and 301(a) of the Act, we are small not-for-profit enterprises, and section 110 and part D of the Act and finalizing a limited approval and a small governmental jurisdictions.

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This rule will not have a significant in the development of regulatory G. Executive Order 13045, Protection of impact on a substantial number of small policies that have federalism Children From Environmental Health entities because SIP approvals under implications.’’ ‘‘Policies that have Risks and Safety Risks section 110 and subchapter I, part D of federalism implications’’ is defined in EPA interprets Executive Order 13045 the Clean Air Act do not create any new the Executive Order to include (62 FR 19885, April 23, 1997) as requirements but simply approve regulations that have ‘‘substantial direct applying only to those regulatory requirements that the State is already effects on the States, on the relationship actions that concern health or safety imposing. Therefore, because the between the national government and risks, such that the analysis required Federal SIP approval does not create the States, or on the distribution of under section 5–501 of the Executive any new requirements, I certify that this power and responsibilities among the Order has the potential to influence the action will not have a significant various levels of government.’’ Under regulation. This rule is not subject to economic impact on a substantial Executive Order 13132, EPA may not Executive Order 13045, because it number of small entities. issue a regulation that has federalism Moreover, due to the nature of the approves a state rule implementing a implications, that imposes substantial Federal standard. Federal-State relationship under the direct compliance costs, and that is not Clean Air Act, preparation of flexibility required by statute, unless the Federal H. Executive Order 13211, Actions That analysis would constitute Federal government provides the funds Significantly Affect Energy Supply, inquiry into the economic necessary to pay the direct compliance Distribution, or Use reasonableness of State action. The costs incurred by State and local This rule is not subject to Executive Clean Air Act forbids EPA to base its governments, or EPA consults with actions concerning SIPs on such Order 13211, ‘‘Actions Concerning State and local officials early in the grounds. Union Electric Co., v. U.S. Regulations That Significantly Affect process of developing the proposed EPA, 427 U.S. 246, 255–66 (1976); 42 Energy Supply, Distribution, or Use’’ (66 regulation. EPA also may not issue a U.S.C. 7410(a)(2). FR 28355, May 22, 2001) because it is regulation that has federalism not a significant regulatory action under D. Unfunded Mandates Reform Act implications and that preempts State Executive Order 12866. Under sections 202 of the Unfunded law unless the Agency consults with State and local officials early in the I. National Technology Transfer and Mandates Reform Act of 1995 Advancement Act (‘‘Unfunded Mandates Act’’), signed process of developing the proposed into law on March 22, 1995, EPA must regulation. Section 12 of the National Technology prepare a budgetary impact statement to This rule will not have substantial Transfer and Advancement Act accompany any proposed or final rule direct effects on the States, on the (NTTAA) of 1995 requires Federal that includes a Federal mandate that relationship between the national agencies to evaluate existing technical may result in estimated costs to State, government and the States, or on the standards when developing a new local, or tribal governments in the distribution of power and regulation. To comply with NTTAA, aggregate; or to the private sector, of responsibilities among the various EPA must consider and use ‘‘voluntary $100 million or more. Under section levels of government, as specified in consensus standards’’ (VCS) if available 205, EPA must select the most cost- Executive Order 13132, because it and applicable when developing effective and least burdensome merely approves a state rule programs and policies unless doing so alternative that achieves the objectives implementing a federal standard, and would be inconsistent with applicable of the rule and is consistent with does not alter the relationship or the law or otherwise impractical. statutory requirements. Section 203 distribution of power and The EPA believes that VCS are requires EPA to establish a plan for responsibilities established in the Clean inapplicable to this action. Today’s action does not require the public to informing and advising any small Air Act. Thus, the requirements of perform activities conducive to the use governments that may be significantly section 6 of the Executive Order do not of VCS. or uniquely impacted by the rule. apply to this rule. EPA has determined that the approval J. Congressional Review Act action promulgated does not include a F. Executive Order 13175, Coordination Federal mandate that may result in With Indian Tribal Governments The Congressional Review Act, 5 estimated costs of $100 million or more U.S.C. 801 et seq., as added by the Small to either State, local, or tribal Executive Order 13175, entitled Business Regulatory Enforcement governments in the aggregate, or to the ‘‘Consultation and Coordination with Fairness Act of 1996, generally provides private sector. This Federal action Indian Tribal Governments’’ (65 FR that before a rule may take effect, the approves pre-existing requirements 67249, November 9, 2000), requires EPA agency promulgating the rule must under State or local law, and imposes to develop an accountable process to submit a rule report, which includes a no new requirements. Accordingly, no ensure ‘‘meaningful and timely input by copy of the rule, to each House of the additional costs to State, local, or tribal tribal officials in the development of Congress and to the Comptroller General governments, or to the private sector, regulatory policies that have tribal of the United States. EPA will submit a result from this action. implications.’’ This final rule does not report containing this rule and other have tribal implications, as specified in required information to the U.S. Senate, E. Executive Order 13132, Federalism Executive Order 13175. It will not have the U.S. House of Representatives, and Federalism (64 FR 43255, August 10, substantial direct effects on tribal the Comptroller General of the United 1999) revokes and replaces Executive governments, on the relationship States prior to publication of the rule in Orders 12612 (Federalism) and 12875 between the Federal government and the Federal Register. A major rule (Enhancing the Intergovernmental Indian tribes, or on the distribution of cannot take effect until 60 days after it Partnership). Executive Order 13132 power and responsibilities between the is published in the Federal Register. requires EPA to develop an accountable Federal government and Indian tribes. This action is not a ‘‘major rule’’ as process to ensure ‘‘meaningful and Thus, Executive Order 13175 does not defined by 5 U.S.C. 804(2). This rule timely input by State and local officials apply to this rule. will be effective September 14, 2009.

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K. Petitions for Judicial Review (E) Kern County Air Pollution Control Regulatory Public Docket in Rm. S– Under section 307(b)(1) of the Clean District 4400, One Potomac Yard (South Bldg.), Air Act, petitions for judicial review of (1) Rule 402, ‘‘Fugitive Dust’’, adopted 2777 S. Crystal Dr., Arlington, VA. The this action must be filed in the United on November 29, 1993 and amended on Docket Facility is open from 8:30 a.m. States Court of Appeals for the November 3, 2004. to 4 p.m., Monday through Friday, appropriate circuit by October 13, 2009. * * * * * excluding legal holidays. The Docket Filing a petition for reconsideration by (350) * * * Facility telephone number is (703) 305– the Administrator of this final rule does (i) * * * 5805. not affect the finality of this rule for the (A) * * * FOR FURTHER INFORMATION CONTACT: purposes of judicial review nor does it (2) Rule 401, ‘‘Fugitive Dust’’, adopted Samantha Hulkower, Registration extend the time within which a petition on September 5, 1974 and amended on Division (7505P), Office of Pesticide for judicial review may be filed, and December 04, 2006. Programs, Environmental Protection shall not postpone the effectiveness of * * * * * Agency, 1200 Pennsylvania Ave., NW., such rule or action. Parties with [FR Doc. E9–19338 Filed 8–12–09; 8:45 am] Washington, DC 20460–0001; telephone objections to this direct final rule are BILLING CODE 6560–50–P number: (703) 603–0683; e-mail address: encouraged to file a comment in [email protected]. response to the parallel notice of SUPPLEMENTARY INFORMATION: proposed rulemaking for this action ENVIRONMENTAL PROTECTION published in the proposed rules section AGENCY I. General Information of today’s Federal Register, rather than A. Does this Action Apply to Me? file an immediate petition for judicial 40 CFR Part 180 You may be potentially affected by review of this direct final rule, so that [EPA–HQ–OPP–2008–0805; FRL–8426–9] EPA can withdraw this direct final rule this action if you are an agricultural and address the comment in the Spinetoram; Pesticide Tolerances producer, food manufacturer, or proposed rulemaking. This action may pesticide manufacturer. Potentially AGENCY: not be challenged later in proceedings to Environmental Protection affected entities may include, but are enforce its requirements. (See section Agency (EPA). not limited to those engaged in the 307(b)(2).) ACTION: Final rule. following activities: • Crop production (NAICS code 111). List of Subjects in 40 CFR Part 52 SUMMARY: This regulation amends the • Animal production (NAICS code Environmental protection, Air tolerances for the combined residues of 112). pollution control, Incorporation by spinetoram in or on almond, hulls; nut, • Food manufacturing (NAICS code reference, Intergovernmental relations, tree, group 14; and pistachio and 311). Particulate matter, Reporting and establishes tolerances for date; • Pesticide manufacturing (NAICS recordkeeping requirements. pomegranate; pineapple; pineapple, code 32532). processed residue; spice, subgroup 19B, This listing is not intended to be Dated: May 12, 2009. except black pepper; and hop, dried Laura Yoshii, exhaustive, but rather to provide a guide cones. The Interregional Research for readers regarding entities likely to be Acting Regional Administrator, Region IX. Project Number 4 (IR-4) requested these affected by this action. Other types of ■ Part 52, Chapter I, Title 40 of the Code tolerances under the Federal Food, entities not listed in this unit could also of Federal Regulations is amended as Drug, and Cosmetic Act (FFDCA). be affected. The North American follows: DATES: This regulation is effective Industrial Classification System August 13, 2009. Objections and (NAICS) codes have been provided to PART 52—[AMENDED] requests for hearings must be received assist you and others in determining ■ 1. The authority citation for Part 52 on or before October 13, 2009, and must whether this action might apply to continues to read as follows: be filed in accordance with the certain entities. If you have any instructions provided in 40 CFR part questions regarding the applicability of Authority: 42 U.S.C. 7401 et seq. 178 (see also Unit I.C. of the this action to a particular entity, consult SUPPLEMENTARY INFORMATION). Subpart F—California the person listed under FOR FURTHER ADDRESSES: EPA has established a INFORMATION CONTACT. ■ 2. Section 52.220 is amended by docket for this action under docket B. How Can I Access Electronic Copies adding paragraphs (c) (244)(i)(C)(2), identification (ID) number EPA–HQ– of this Document? (335)(i)(E), and (350)(i)(A)(2) to read as OPP–2008–0805. All documents in the follows: docket are listed in the docket index In addition to accessing electronically available at http://www.regulations.gov. available documents at http:// § 52.220 Identification of plan. Although listed in the index, some www.regulations.gov, you may access * * * * * information is not publicly available, this Federal Register document (c) * * * e.g., Confidential Business Information electronically through the EPA Internet (244) * * * (CBI) or other information whose under the ‘‘Federal Register’’ listings at (i) * * * disclosure is restricted by statute. http://www.epa.gov/fedrgstr. You may (C) * * * Certain other material, such as also access a frequently updated (2) Rule 403.1, ‘‘Fugitive Dust Control copyrighted material, is not placed on electronic version of EPA’s tolerance for the Searles Valley Planning Area’’, the Internet and will be publicly regulations at 40 CFR part 180 through adopted on June 22, 1994 and amended available only in hard copy form. the Government Printing Office’s e-CFR on November 25, 1996. Publicly available docket materials are cite at http://www.gpoaccess.gov/ecfr. * * * * * available in the electronic docket at To access the OPPTS Harmonized (335) * * * http://www.regulations.gov, or, if only Guidelines referenced in this document, (i) * * * available in hard copy, at the OPP go directly to the guidelines at http://

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www.epa.gov/opptsfrs/home/ residues of the insecticide spinetoram, III. Aggregate Risk Assessment and guidelin.htm. expressed as a combination of: Determination of Safety XDE-175-J: 1-H-as-indaceno[3,2-d] C. Can I File an Objection or Hearing Section 408(b)(2)(A)(i) of FFDCA oxacyclododecin-7,15-dione,2 2-[(6- Request? allows EPA to establish a tolerance (the deoxy-3-O-ethyl-2,4-di-O-methyl-a-L- legal limit for a pesticide chemical Under section 408(g) of FFDCA, 21 mannopyranosyl)oxy]-13-[[(2R,5S,6R)-5- residue in or on a food) only if EPA U.S.C. 346a, any person may file an (dimethylamino)tetrahydro-6-methyl-2H determines that the tolerance is ‘‘safe.’’ objection to any aspect of this regulation -pyran-2-yl]oxy]-9-ethyl- Section 408(b)(2)(A)(ii) of FFDCA and may also request a hearing on those 2,3,3a,4,5,5a,5b,6,9, defines ‘‘safe’’ to mean that ‘‘there is a objections. You must file your objection 10,11,12,13,14,16a,16b-hexadecahydro reasonable certainty that no harm will or request a hearing on this regulation 14-methyl-,(2R,3aR,5aR,5bS,9S,13S,14R, result from aggregate exposure to the in accordance with the instructions 16aS,16bR); pesticide chemical residue, including provided in 40 CFR part 178. To ensure XDE-175-L: 1H-as-indaceno[3,2- all anticipated dietary exposures and all proper receipt by EPA, you must d]oxacyclododecin-7,15-dione, 2-[(6- other exposures for which there is identify docket ID number EPA–HQ– deoxy-3-O-ethyl-2,4-di-O-methyl-a-L- reliable information.’’ This includes OPP–2008–0805 in the subject line on mannopyranosyl)oxy]-13-[[(2R,5S,6R)-5- exposure through drinking water and in the first page of your submission. All (dimethylamino)tetrahydro-6-methyl- residential settings, but does not include requests must be in writing, and must be 2H-pyran-2-yl]oxy]-9-ethyl- occupational exposure. Section mailed or delivered to the Hearing Clerk 2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b- 408(b)(2)(C) of FFDCA requires EPA to as required by 40 CFR part 178 on or tetradecahydro-4,14-dimethyl-, give special consideration to exposure before October 13, 2009. (2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS); of infants and children to the pesticide In addition to filing an objection or ND-J:(2R,3aR,5aR,5bS,9S,13S, chemical residue in establishing a hearing request with the Hearing Clerk 14R,16aS,16bR)-9-ethyl-14-methyl-13- tolerance and to ‘‘ensure that there is a as described in 40 CFR part 178, please [[(2S,5S,6R)-6-methyl-5- reasonable certainty that no harm will submit a copy of the filing that does not (methylamino)tetrahydro-2H-pyran-2- result to infants and children from contain any CBI for inclusion in the yl]oxy]-7,15-dioxo- aggregate exposure to the pesticide public docket that is described in 2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13, chemical residue....’’ ADDRESSES. Information not marked 14,15,16a,16b-octadecahydro-1H-as- Consistent with section 408(b)(2)(D) confidential pursuant to 40 CFR part 2 indaceno[3,2-d]oxacyclododecin-2-yl 6- of FFDCA, and the factors specified in may be disclosed publicly by EPA deoxy-3-O-ethyl-2,4-di-O-methyl-alpha- section 408(b)(2)(D) of FFDCA, EPA has without prior notice. Submit this copy, L-mannopyranoside; and reviewed the available scientific data identified by docket ID number EPA– NF-J: (2R,3S,6S)-6-([(2R,3aR,5aR, and other relevant information in HQ–OPP–2008–0805, by one of the 5bS,9S,13S,14R,16aS,16bR)-2-[(6-deoxy- support of this action. EPA has following methods: 3-O-ethyl-2,4-di-O-methyl-alpha-L- sufficient data to assess the hazards of • Federal eRulemaking Portal: http:// mannopyranosyl)o oxy]-9-ethyl-14- and to make a determination on www.regulations.gov. Follow the on-line methyl-7,15-dioxo- aggregate exposure for the petitioned-for instructions for submitting comments. 2,3,3a,4,5,5a,5b,6,7,9,10, tolerances for combined residues of • Mail: Office of Pesticide Programs 11,12,13,14,15,16a,16b-octadecahydro- spinetoram on almond, hulls at 19 ppm; (OPP) Regulatory Public Docket (7502P), 1H-as-indaceno[3,2-d]oxacyclododecin- nut, tree, group 14 at 0.10 ppm; Environmental Protection Agency, 1200 13-yl]oxy)-2-methyltetrahydro-2H-pyran pistachio at 0.10 ppm; date at 0.10 ppm; Pennsylvania Ave., NW., Washington, -3-yl(methyl)formamide pomegranate at 0.30 ppm; pineapple at DC 20460–0001. in or on the raw agricultural 0.04 ppm; pineapple, processed residue • Delivery: OPP Regulatory Public commodities pineapple at 0.02 parts per at 0.15 ppm; spice, subgroup 19B, Docket (7502P), Environmental million (ppm); pomegranate at 0.3 ppm; except black pepper at 1.7 ppm; and Protection Agency, Rm. S–4400, One date at 0.1 ppm; spice, subgroup 19B, hop, dried cones at 22 ppm. EPA’s Potomac Yard (South Bldg.), 2777 S. except black pepper at 1.7 ppm; hop, assessment of exposures and risks Crystal Dr., Arlington, VA. Deliveries dried cones at 22 ppm; and pineapple, associated with establishing tolerances are only accepted during the Docket process residue at 0.08 ppm. follows. Facility’s normal hours of operation Additionally, the petition proposed to (8:30 a.m. to 4 p.m., Monday through increase the levels of existing tolerances A. Toxicological Profile Friday, excluding legal holidays). for nut, tree, group 14 and pistachio EPA has evaluated the available Special arrangements should be made from 0.04 to 0.08 ppm and almond, toxicity data and considered its validity, for deliveries of boxed information. The hulls from 2.0 ppm to 9.0 ppm. That completeness, and reliability as well as Docket Facility telephone number is notice referenced a summary of the the relationship of the results of the (703) 305–5805. petition prepared on behalf of IR-4 by studies to human risk. EPA has also Dow AgroSciences, LLC, the registrant, considered available information II. Petition for Tolerance which is available to the public in the concerning the variability of the In the Federal Register of December 3, docket, http://www.regulations.gov. sensitivities of major identifiable 2008 (73 FR 73648) (FRL–8391–3), EPA There were no comments received in subgroups of consumers, including issued a notice pursuant to section response to the notice of filing. infants and children. 408(d)(3) of FFDCA, 21 U.S.C. Based upon review of the data Spinetoram has low acute toxicity via 346a(d)(3), announcing the filing of a supporting the petition, EPA has revised the oral, dermal and inhalation routes of pesticide petition (PP 8E7450) by IR-4, tolerances to higher levels than exposure. It is a dermal sensitizer but Rutgers, The State University of New proposed for almond, hulls; nut, tree, not an eye or dermal irritant. In Jersey, 500 College Road East, Suite 201 group 14; pistachio; pineapple; and subchronic toxicity studies conducted W., Princeton, 08540. The petition pineapple, process residue. The reason in rats, mice and dogs, spinetoram requested that 40 CFR 180.635 be for these changes are explained in Unit produces multi-organ toxicity. amended by establishing tolerances for IV.D. Treatment had no adverse effects on

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survival but decreases in body weight, www.regulations.gov in document toxicological profiles for each are body weight gain and/or food Human Health Risk Assessment for similar (generalized systemic toxicity) consumption were observed in all three Application of spinosad to date and with similar doses and endpoints species. Treatment-related findings pomegranate and spinetoram to chosen for human-health risk included the presence of a mild anemia, pineapple, date, pomegranate, hopes, assessment. alterations in clinical chemistry and spices (crop subgroup 19B, except Spinosad and spinetoram should be parameters, increased liver weights, black pepper) on page 4 and attachment considered toxicologically identical in presence of histiocytic aggregates of 3 pages 49–54 in docket ID number the same manner that metabolites are macrophages in various organs and EPA–HQ–OPP–2008–0805. generally considered toxicologically identical to the parent. Although, as tissues, and degeneration with B. Toxicological Endpoints regeneration of the kidney tubules. Dogs stated above, the doses and endpoints appear to be the most sensitive species. For hazards that have a threshold for spinosad and spinetoram are similar, In the subchronic study with dogs, below which there is no appreciable they are not identical due to variations lower thymus weights, atrophy of the risk, a toxicological point of departure in dosing levels used in the spinetoram (POD) is identified as the basis for thymic cortex, arteritis and/or and spinosad toxicological studies. EPA derivation of reference values for risk perivascular inflammation in numerous compared the spinosad and spinetoram assessment. The POD may be defined as organs with necrosis of the bone marrow doses and endpoints for each exposure the highest dose at which no adverse leading to regenerative anemia was scenario and selected the lower of the effects are observed (the NOAEL) in the seen. In the chronic study with dogs, two doses for use in human risk toxicology study identified as assessment. there were no treatment-related effects appropriate for use in risk assessment. A summary of the toxicological on survival, body weight, hematology, However, if a NOAEL cannot be endpoints for spinetoram/spinosad used clinical chemistry or gross pathology. determined, the lowest dose at which for human risk assessment can be found Treatment-related changes were limited adverse effects of concern are identified at http://www.regulations.gov in the to arteritis and necrosis of the arterial (the LOAEL) or a Benchmark Dose document Human Health Risk walls of the epididymides in males and (BMD) approach is sometimes used for Assessment for Application of spinosad thymus, thyroid, larynx, and urinary risk assessment. Uncertainty/safety to date and pomegranate and bladder in females. It is postulated that factors (UFs) are used in conjunction spinetoram to pineapple, date, chronic treatment exacerbated the with the POD to take into account pomegranate, hopes, and spices (crop spontaneous arteritis in genetically uncertainties inherent in the subgroup 19B, except black pepper) on predisposed Beagle dogs (it is called the extrapolation from laboratory animal page 8 in docket ID number EPA–HQ– ‘‘Beagle Pain Syndrome’’). In data to humans and in the variations in OPP–2008–0805. developmental toxicity studies, there is sensitivity among members of the no evidence of increased susceptibility human population as well as other C. Exposure Assessment following in utero exposures in rats and unknowns. Safety is assessed for acute 1. Dietary exposure from food and rabbits. In the 2-generation reproduction and chronic dietary risks by comparing feed uses. In evaluating dietary study, no adverse effects were observed aggregate food and water exposure to exposure to spinetoram/spinosad, EPA on the offspring at dose levels that the pesticide to the acute population considered exposure under the produced parental toxicity. EPA has adjusted dose (aPAD) and chronic petitioned-for tolerances as well as all concluded that spinetoram is population adjusted dose (cPAD). The existing spinetoram/spinosad tolerances toxicologically identical to another aPAD and cPAD are calculated by in 40 CFR 180.635. EPA assessed dietary pesticide, spinosad. Based on the dividing the POD by all applicable UFs. exposures from spinetoram/spinosad in structural similarity of spinetoram and Aggregate short-, intermediate-, and food as follows: spinosad and the similarity of the chronic-term risks are evaluated by i. Acute exposure. Quantitative acute toxicological database for the currently comparing food, water, and residential dietary exposure and risk assessments available studies, spinetoram is exposure to the POD to ensure that the are performed for a food-use pesticide, classified as ‘‘not likely to be margin of exposure (MOE) called for by if a toxicological study has indicated the carcinogenic to humans’’ based on lack the product of all applicable UFs is not possibility of an effect of concern of evidence for carcinogenicity of exceeded. This latter value is referred to occurring as a result of a 1–day or single spinosad in mice and rats. No indication as the level of concern (LOC). exposure. of neurotoxicity was observed in the For non-threshold risks, the Agency No such effects were identified in the acute neurotoxicity screening battery in assumes that any amount of exposure toxicological studies for spinetoram/ rats, or in the subchronic and chronic will lead to some degree of risk. Thus, spinosad; therefore, a quantitative acute toxicity studies conducted on the Agency estimates risk in terms of the dietary exposure assessment is spinetoram. All the mutagenicity probability of an occurrence of the unnecessary. studies conducted on spinetoram were adverse effect greater than that expected ii. Chronic exposure. Spinosad is negative. The no-observed-adverse- in a lifetime. For more information on registered for application to all of the effect-level (NOAEL) derived from the the general principles EPA uses in risk same crops as spinetoram, with similar chronic dog study is well characterized, characterization and a complete pre-harvest and retreatment intervals, and together with the traditional description of the risk assessment and application rates greater than or uncertainty/safety factors will provide process, see http://www.epa.gov/ equal to spinetoram. Further, both adequate protection for effects observed pesticides/factsheets/riskassess.htm. products control the same pest species. in laboratory animals. Specific The Agency has concluded that For this reason, EPA has concluded it information on the studies received and spinosad should be considered would overstate exposure to assume that the nature of the adverse effects caused toxicologically identical to another residues of both spinosad and by spinetoram as well as the NOAEL pesticide, spinetoram. This conclusion spinetoram would appear on the same and the lowest-observed-adverse-effect- is based on the following: Spinetoram food. Rather, EPA aggregated exposure level (LOAEL) from the toxicity studies and spinosad are large molecules with by either assuming that all commodities can be found at http:// nearly identical structures; and the contain spinosad residues (because side-

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by-side spinetoram and spinosad Section 408(b)(2)(F) of FFDCA states pesticides may dominate for each year. residue data indicated that spinetoram that the Agency may use data on the Typically, EPA uses USDA/National residues were less than or equal to actual percent of food treated for Agricultural Statistics Service (USDA/ spinosad residues) or summing the assessing chronic dietary risk only if: NASS) as the source for raw PCT data percentage of a crop that would be • Condition a: The data used are because it is publicly available. When a treated with spinosad and the reliable and provide a valid basis to specific use site is not surveyed by percentage that would be treated with show what percentage of the food USDA/NASS, EPA uses other sources spinetoram. derived from such crop is likely to including proprietary data. In conducting the chronic dietary contain the pesticide residue. An estimated PPCT, based on the • exposure assessment EPA used the food Condition b: The exposure estimate average PCT of the market leaders, is consumption data from the U.S. does not underestimate exposure for any appropriate for use in chronic dietary Department of Agriculture (USDA) significant subpopulation group. risk assessment. This method of • 1994–1996 and 1998 Continuing Condition c: Data are available on estimating PPCT for a new use of a Surveys of Food Intakes by Individuals pesticide use and food consumption in registered pesticide or a new pesticide (CSFII). As to residue levels in food, the a particular area, the exposure estimate produces high-end estimate that is chronic analysis assumed 100% crop does not understate exposure for the unlikely, in most cases, to be exceeded treated for all food crop commodities; population in such area. during the initial 5 years of actual use. average field-trial residues for apple, In addition, the Agency must provide Predominant factors that bear on Brassica leafy vegetables, citrus, fruiting for periodic evaluation of any estimates whether the PPCT could be exceeded vegetables, herbs, banana, and used. To provide for the periodic may include PCTs of similar strawberry; tolerance-level residues for evaluation of the estimate of PCT as chemistries, pests controlled by the remaining food crop commodities; required by FFDCA section 408(b)(2)(F), alternatives, pest prevalence in the DEEMtm (ver. 7.81) default processing EPA may require registrants to submit market and other factors. All relevant factors for all commodities excluding data on PCT. information currently available for The EPA assumed 100% crop treated orange juice, field corn (meal, starch, predominant factors has been for all food crop commodities; however, flour, and oil), grape juice, and wheat considered for the combined use of in calculating beef and dairy cattle (flour and germ) where the spinosad spinetoram and spinosad on each of dietary burdens, the Agency used processing factors were assumed. these several crops. Of greatest combined spinosad and spinetoram Residues in livestock were refined relevance here is that both spinosad and projected percent crop treated (PPCT) through the incorporation of a refined spinetoram control a relatively narrow information as follows: dietary burden (average feed-crop range of pests compared to the market 39% sweet corn forage. leaders. Based on this analysis, EPA residues and percent crop treated 50% leaves of root and tuber believes that it is unlikely that actual estimates) and through the vegetables. combined PCTs for spinetoram and incorporation of average residues from 5% sorghum grain. spinosad will exceed the corresponding the feeding and dermal magnitude of the 5% soybean seed meal. estimated PPCTs during the next 5 residue studies. EPA estimates an upper bound of years. iii. Cancer. Spinetoram is considered PPCT for a new pesticide use by The Agency believes that the three to be ‘‘not likely to be a carcinogen to assuming that its actual PCT during the conditions discussed in Unit III.C.1.iv. humans’’ based on its similarity to initial 5 years of use on a specific use have been met. With respect to another spynosin pesticide, spinosad. site will not exceed the average PCT of Condition a, PCT estimates are derived Preliminary results of a carcinogenicity the market leader (i.e., the one with the from Federal and private market survey study in mice indicate that spinetoram greatest PCT) on that site. EPA calls this data, which are reliable and have a valid is not carcinogenic to mice at doses up the market leader PPCT estimate. In this basis. The Agency is reasonably certain to 37.5 milligram/kilogram/day (mg/kg/ specific case, the new use to be that the percentage of the food treated day). Consequently, a quantitative estimated is the combined use of is not likely to be an underestimation. cancer exposure and risk assessment is spinosad together with that of As to Conditions b and c, regional not appropriate for spinetoram. spinetoram since most new use of consumption information and iv. Anticipated residue and percent spinetoram will likely replace previous consumption information for significant crop treated (PCT) information. Section use of spinosad. An average market subpopulations is taken into account 408(b)(2)(E) of FFDCA authorizes EPA leader PCT, based on three recent through EPA’s computer-based model to use available data and information on surveys of pesticide usage, if available, for evaluating the exposure of the anticipated residue levels of is used for chronic risk assessment. The significant subpopulations including pesticide residues in food and the actual average market leader PCT may be based several regional groups. Use of this levels of pesticide residues that have on one or two survey years if three are consumption information in EPA’s risk been measured in food. If EPA relies on not available. Also, with limited assessment process ensures that EPA’s such information, EPA must require availability of data, the average market exposure estimate does not understate pursuant to FFDCA section 408(f)(1) leader PCT may be based on a cross- exposure for any significant that data be provided 5 years after the section of state PCTs. Comparisons are subpopulation group and allows the tolerance is established, modified, or only made among pesticides of the same Agency to be reasonably certain that no left in effect, demonstrating that the pesticide type (i.e., the leading regional population is exposed to levels in food are not above the levels insecticide on the use site is selected for residue levels higher than those anticipated. For the present action, EPA comparison with the new insecticide), estimated by the Agency. Other than the will issue such Data Call-Ins as are or, for refined estimates, among data available through national food required by FFDCA section 408(b)(2)(E) pesticides targeting the same pests. The consumption surveys, EPA does not and authorized under FFDCA section market leader PCTs used to determine have available reliable information on 408(f)(1). Data will be required to be the average may consist of PCTs for the the regional consumption of food to submitted no later than 5 years from the same pesticide or for different pesticides which spinetoram may be applied in a date of issuance of these tolerances. for any year since the same or different particular area.

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2. Dietary exposure from drinking to both spinosad and spinetoram. Since based on reliable data that a different water.The Agency used screening level spinosad and spinetoram control the margin of safety will be safe for infants water exposure models in the dietary same pests, EPA concludes that these and children. This additional margin of exposure analysis and risk assessment products will not be used for the same safety is commonly referred to as the for spinetoram/spinosad in drinking uses in combination with each other FQPA safety factor (SF). In applying this water. These simulation models take and thus combining spinosad and provision, EPA either retains the default into account data on the physical, spinetoram residential exposures would value of 10X, or uses a different chemical, and fate/transport overstate exposure. Short-term additional safety factor when reliable characteristics of spinetoram/spinosad. residential inhalation risks were data available to EPA support the choice Further information regarding EPA estimated for adult residential handlers, of a different factor. drinking water models used in pesticide as well as short-term post-application 2. Prenatal and postnatal sensitivity. exposure assessment can be found at incidental oral risks for toddlers, based There is no evidence of increased http://www.epa.gov/oppefed1/models/ on applications to home lawns, home susceptibility of rat and rabbit fetuses to water/index.htm. gardens and ornamentals. in-utero exposure to spinosad or Based on the First Index Reservoir EPA notes that for spinosad the spinetoram. In the spinosad and Screening Tool (FIRST) and Screening registered fruit fly bait application spinetoram rat and rabbit Concentration in Ground Water (SCI- scenario permits application to non- developmental toxicity studies, no GROW) models, the estimated drinking crop vegetation and this use may result developmental toxicity was observed at water concentrations (EDWCs) of in residential exposures. Based on the dose levels that did not induce maternal spinetoram for acute exposures are application rates (fruit fly bait - 0.0003 toxicity. In the spinosad 2-generation estimated to be 14.419 parts per billion lb ai/acre; turf/ornamental - 0.41 lbs ai/ reproduction studies, maternal and (ppb) for surface water and 0.072 ppb acre), EPA concludes that residential offspring toxicity were equally severe, for ground water. For chronic exposures exposure resulting from the fruit fly indicating no evidence of increased for non-cancer assessments are application will be insignificant when susceptibility. In the spinetoram 2- estimated to be 6.171 ppb for surface compared to the exposure resulting from generation reproduction study, no water and 0.072 ppb for ground water. homeowner uses on the turf/ adverse effects were observed on the EDWCs for spinosad for acute exposures ornamentals. Therefore, quantitative offspring at dose levels that produced are estimated to be 34.5 ppb for surface analysis of the residential exposure parental toxicity. Therefore, there is no water and 1.1 ppb for ground water. For resulting from the fruit fly bait evidence of increased susceptibility and chronic exposures for non-cancer application was not performed. there are no concerns or residual assessments are estimated to be 10.5 4. Cumulative effects from substances uncertainties for pre-natal and/or post- ppb for surface water and 1.1 ppb for with a common mechanism of toxicity. natal toxicity. ground water. Section 408(b)(2)(D)(v) of FFDCA 3. Conclusion. EPA has determined Modeled estimates of drinking water requires that, when considering whether that reliable data show the safety of concentrations were directly entered to establish, modify, or revoke a infants and children would be into the dietary exposure model. For tolerance, the Agency consider adequately protected if the FQPA SF chronic dietary risk assessment, the ‘‘available information’’ concerning the were reduced to 1X. That decision is water concentration of value 10.5 ppb cumulative effects of a particular based on the following findings: was used to assess the contribution to pesticide’s residues and ‘‘other i. The toxicity database for spinetoram drinking water. substances that have a common is complete, except for immunotoxicity 3. From non-dietary exposure. The mechanism of toxicity.’’ testing. Recent changes to 40 CFR part term ‘‘residential exposure’’ is used in EPA has not found spinetoram/ 158 make immunotoxicity testing this document to refer to non- spinosad to share a common mechanism (OPPTS Harmonized Guideline occupational, non-dietary exposure of toxicity with any other substances, 870.7800) required for pesticide (e.g., for lawn and garden pest control, and spinetoram/spinosad does not registration; however, the existing data indoor pest control, termiticides, and appear to produce a toxic metabolite are sufficient for endpoint selection for flea and tick control on pets). produced by other substances. For the exposure/risk assessment scenarios, and The Agency has concluded that purposes of this tolerance action, for evaluation of the requirements under spinosad and spinetoram are therefore, EPA has assumed that the FQPA. toxicologically equivalent; therefore, spinetoram/spinosad does not have a There was some evidence of adverse residential exposure to both spinosad common mechanism of toxicity with effects on the organs of the immune and spinetoram was evaluated. other substances. For information system at the LOAEL in three short-term Spinosad is currently registered for regarding EPA’s efforts to determine studies with spinosad or spinetoram. In homeowner application to turf grass and which chemicals have a common these studies, anemia was observed in ornamentals. Spinetoram is registered mechanism of toxicity and to evaluate multiple species (rats, mice and dogs) for homeowner applications to gardens, the cumulative effects of such with the presence of histiocytic lawns/ornamentals and turf grass. No chemicals, see EPA’s website at http:// aggregates of macrophages in various dermal endpoints for either spinetoram www.epa.gov/pesticides/cumulative. organs and tissues (lymph nodes, or spinosad were identified. Therefore, spleen, thymus, and bone marrow). only short-term incidental oral D. Safety Factor for Infants and Aggregation of macrophages was exposures to toddlers were evaluated for Children indicative of immune stimulation in the registered turf and ornamental 1. In general. Section 408(b)(2)(c) of response to insults of the chemical application scenarios for spinosad and FFDCA provides that EPA shall apply exposure and was considered secondary spinetoram and short-term inhalation an additional tenfold (10X) margin of effects of the toxic effect to the exposure to handler/applicators for the safety for infants and children in the hematopoetic system. Therefore, these registered home garden, turf, and case of threshold effects to account for effects are not considered to be ornamental application scenarios. prenatal and postnatal toxicity and the indicative of frank immunotoxicity. In There is potential for residential completeness of the database on toxicity the chronic study with dogs, areteritis handler and post-application exposures and exposure unless EPA determines and necrosis of the areterial walls of the

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thymus was seen in one female dog at comparing aggregate exposure estimates through food and water, which has the HDT. This finding is attributed to to the aPAD and cPAD. The aPAD and already been addressed, and will not be the exacerbation of the spontaneous cPAD represent the highest safe greater than the chronic aggregate risk. arteritis present in genetically exposures, taking into account all 5. Aggregate cancer risk for U.S. predisposed Beagle dogs (‘‘Beagle Pain appropriate SFs. EPA calculates the population. The Agency considers Syndrome’’), not immunotoxicity. aPAD and cPAD by dividing the POD by spinetoram to be ‘‘Not Likely to be Further, a clear NOAEL was attained in all applicable UFs. For linear cancer Carcinogenic to Humans.’’ See Unit each of these studies, and the observed risks, EPA calculates the probability of III.C.iii. for more detailed information. histopathologies were generally additional cancer cases given the 6. Determination of safety. Based on observed in the presence of other organ estimated aggregate exposure. Short-, these risk assessments, EPA concludes toxicity. In addition, spinosad and intermediate-, and chronic-term risks that there is a reasonable certainty that spinetoram do not belong to a class of are evaluated by comparing the no harm will result to the general chemicals (e.g., the organotins, heavy estimated aggregate food, water, and population, or to infants and children metals, or halogenated aromatic residential exposure to the POD to from aggregate exposure to spinetoram/ hydrocarbons) that would be expected ensure that the MOE called for by the spinosad residues. to be immunotoxic. product of all applicable UFs is not Based on the above considerations, exceeded. IV. Other Considerations EPA does not believe that conducting a 1. Acute risk. An acute aggregate risk A. Analytical Enforcement Methodology special series 870.7800 immunotoxicity assessment takes into account exposure study will result in a POD less than the estimates from acute dietary FDA Multiresidue Methods (MRMs): NOAEL of 2.49 mg/kg/day already set consumption of food and drinking XDE-175-J, XDE-175-L, ND-J, NF-J, ND- for spinosad and spinetoram. water. No adverse effect resulting from L, and NF-L were screened through the Consequently, an additional database a single-oral exposure was identified Food and Drug Administration Pesticide uncertainty factor does not need to be and no acute dietary endpoint was Analytical Methods Volume I (PAM I) applied. selected. Therefore, spinetoram/ MRMs. None of the test substances were ii. There is no indication that spinosad is not expected to pose an found to be fluorescent using spinetoram/spinosad is a neurotoxic acute risk. procedures outlined in Protocol A. All chemical and there is no need for a 2. Chronic risk. Since there are no test substances were subjected to developmental neurotoxicity study or registered/proposed uses which result Protocol C, modules DG1, DG5, DG13, additional UFs to account for in chronic residential exposures, the DG17, and DG18. Test substances were neurotoxicity. chronic aggregate exposure assessment determined to be non- iii. There is no evidence that consists of exposure from food and chromatographable by the chosen gas spinetoram/spinosad results in water. Using the exposure assumptions chromatography modules described in increased susceptibility in in utero rats described in this unit for chronic Protocol C. Due to the poor sensitivity or rabbits in the prenatal developmental exposure, EPA has concluded that of the test substances to detection by studies or in young rats in the 2– chronic exposure to spinetoram/ methods described in Protocol C, no generation reproduction study. spinosad from food and water will further analyses were performed by iv. There are no residual uncertainties utilize 95% of the cPAD for children 1– Protocols D, E, or F. Since the test identified in the exposure databases. 2 years old the population group substances are not acids, phenols, or The dietary food exposure assessments receiving the greatest exposure. substituted ureas, analyses were not utilized 100 PCT and tolerance-level 3. Short-term risk. Short-term performed using Protocols B or G. The residues, and DEEMTM default aggregate exposure takes into account test substances were not detectable processing factors for all registered and short-term residential exposure plus through FDA PAM I Protocols A and C; proposed commodities and refined chronic exposure to food and water therefore, these methods are unsuitable livestock estimates. These refinements (considered to be a background for enforcement. The MRM results were are based on reliable data. The EPA exposure level). forwarded to the FDA. used PPCT information when Spinetoram/spinosad is currently Adequate enforcement methodology. calculating livestock dietary burdens for registered for uses that could result in Plants: Method GRM 05.03 (HPLC/MS/ sweet corn forage, leaves of root and short-term residential exposure and the MS). Livestock: Method GRM 05.15 tuber vegetables, sorghum grain, and Agency has determined that it is HPLC/mass spectrometry (MS) is soybean seed meal. EPA believes that appropriate to aggregate chronic available to enforce the tolerance the PPCT estimates used are exposure through food and water with expression. The method may be conservative estimates. EPA made short-term residential exposures to requested from: Chief, Analytical conservative (protective) assumptions in spinetoram/spinosad. Chemistry Branch, Environmental the ground water and surface water Using the exposure assumptions Science Center, 701 Mapes Rd., Ft. modeling used to assess exposure to described in this unit for short-term Meade, MD 20755–5350; telephone spinetoram/spinosad in drinking water. exposures, EPA has concluded the number: (410) 305–2905; e-mail address: EPA used similarly conservative combined short-term food, water, and [email protected]. assumptions to assess post-application residential exposures aggregated result B. International Residue Limits exposure of children as well as in aggregate MOEs of ≥160. Short-term incidental oral exposure of toddlers. aggregate risk does not exceed the LOC There are currently no established These assessments will not for EPA (MOE of <100). Codex, Canadian, or Mexican MRLs for underestimate the exposure and risks 4. Intermediate-term risk. Spinetoram/ residues of spinetoram on the requested posed by spinetoram/spinosad. spinosad is not registered for any use crops. patterns that would result in E. Aggregate Risks and Determination of intermediate-term residential exposure. C. Revisions to Petitioned-For Safety Therefore, the intermediate-term Tolerances EPA determines whether acute and aggregate risk is the sum of the risk from The tolerance expression for chronic pesticide exposures are safe by exposure to spinetoram/spinosad spinetoram includes residues of XDE-

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175-J, XDE-175-L, ND-J, and NF-J. EPA VI. Statutory and Executive Order Unfunded Mandates Reform Act of 1995 is establishing tolerances for the Reviews (UMRA) (Public Law 104–4). following commodities at levels higher This final rule establishes tolerances This action does not involve any than proposed: nut, tree, group 14 and under section 408(d) of FFDCA in technical standards that would require pistachio raised to 0.10 ppm; almond, response to a petition submitted to the Agency consideration of voluntary hulls raised to 19 ppm; pineapple to Agency. The Office of Management and consensus standards pursuant to section 0.04 ppm; and pineapple, processed Budget (OMB) has exempted these types 12(d) of the National Technology residue 0.15 ppm. These changes are of actions from review under Executive Transfer and Advancement Act of 1995 based on the residue field trial data and Order 12866, entitled Regulatory (NTTAA), Public Law 104–113, section the North American Free Trade Planning and Review (58 FR 51735, 12(d) (15 U.S.C. 272 note). Agreement (NAFTA) MRL Spreadsheet. October 4, 1993). Because this final rule VII. Congressional Review Act has been exempted from review under V. Conclusion The Congressional Review Act, 5 Executive Order 12866, this final rule is U.S.C. 801 et seq., generally provides Therefore, tolerances are established not subject to Executive Order 13211, that before a rule may take effect, the for combined residues of spinetoram, entitled Actions Concerning Regulations agency promulgating the rule must expressed as a combination of: That Significantly Affect Energy Supply, submit a rule report to each House of Distribution, or Use (66 FR 28355, May XDE-175-J: 1-H-as-indaceno[3,2-d] the Congress and to the Comptroller 22, 2001) or Executive Order 13045, General of the United States. EPA will oxacyclododecin-7,15-dione,2 2-[(6- entitled Protection of Children from deoxy-3-O-ethyl-2,4-di-O-methyl-a-L- submit a report containing this rule and Environmental Health Risks and Safety other required information to the U.S. mannopyranosyl)oxy]-13-[[(2R,5S,6R)-5- Risks (62 FR 19885, April 23, 1997). (dimethylamino)tetrahydro-6-methyl- Senate, the U.S. House of This final rule does not contain any Representatives, and the Comptroller 2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,4,5, information collections subject to OMB 5a,5b,6,9,10,11,12,13,14,16a,16b- General of the United States prior to approval under the Paperwork publication of this final rule in the hexadecahydro14-methyl-, Reduction Act (PRA), 44 U.S.C. 3501 et Federal Register. This final rule is not (2R,3aR,5aR,5bS,9S,13S, seq., nor does it require any special a ‘‘major rule’’ as defined by 5 U.S.C. 14R,16aS,16bR); considerations under Executive Order 804(2). XDE-175-L: 1H-as-indaceno[3,2- 12898, entitled Federal Actions to d]oxacyclododecin-7,15-dione, 2-[(6- Address Environmental Justice in List of Subjects in 40 CFR Part 180 deoxy-3-O-ethyl-2,4-di-O-methyl-a-L- Minority Populations and Low-Income Environmental protection, mannopyranosyl)oxy]-13-[[(2R,5S,6R)-5- Populations (59 FR 7629, February 16, Administrative practice and procedure, (dimethylamino)tetrahydro-6-methyl- 1994). Agricultural commodities, Pesticides 2H-pyran-2-yl]oxy]-9-ethyl- Since tolerances and exemptions that and pests, Reporting and recordkeeping 2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b- are established on the basis of a petition requirements. under section 408(d) of FFDCA, such as tetradecahydro-4,14-dimethyl-, Dated: July 31, 2009. (2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS); the tolerance in this final rule, do not require the issuance of a proposed rule, Lois Rossi, ND-J:(2R,3aR,5aR,5bS,9S,13S,14R, the requirements of the Regulatory Director, Registration Division, Office of 16aS,16bR)-9-ethyl-14-methyl-13- Flexibility Act (RFA) (5 U.S.C. 601 et Pesticide Programs. [[(2S,5S,6R)-6-methyl-5- seq.) do not apply. ■ Therefore, 40 CFR chapter I is (methylamino)tetrahydro-2H-pyran-2- This final rule directly regulates amended as follows: yl]oxy]-7,15-dioxo- growers, food processors, food handlers, 2,3,3a,4,5,5a,5b,6,7,9,10,11, and food retailers, not States or tribes, PART 180—[AMENDED] 12,13,14,15,16a,16b-octadecahydro-1H- nor does this action alter the ■ 1. The authority citation for part 180 as-indaceno[3,2-d]oxacyclododecin-2-yl relationships or distribution of power continues to read as follows: 6-deoxy-3-O-ethyl-2,4-di-O-methyl- and responsibilities established by Authority: 21 U.S.C. 321(), 346a and 371. alpha-L-mannopyranoside; and Congress in the preemption provisions ■ 2. Section 180.635 is amended by NF-J: (2R,3S,6S)-6- of section 408(n)(4) of FFDCA. As such, the Agency has determined that this revising the entries in the table in ([(2R,3aR,5aR,5bS,9S,13S, paragraph (a) for almond, hulls; nut, 14R,16aS,16bR)-2-[(6-deoxy-3-O-ethyl- action will not have a substantial direct effect on States or tribal governments, tree, group 14; and pistachio and 2,4-di-O-methyl-alpha-L- alphabetically adding entries for date; mannopyranosyl)o oxy]-9-ethyl-14- on the relationship between the national government and the States or tribal hop, dried cones; pineapple; pineapple, methyl-7,15-dioxo-2,3,3a,4,5,5a,5b,6,7, processed residue; pomegranate; and 9,10,11,12,13,14,15,16a,16b- governments, or on the distribution of power and responsibilities among the spice, subgroup 19b, except black octadecahydro-1H-as-indaceno[3,2- various levels of government or between pepper, to read as follows: d]oxacyclododecin-13-yl]oxy)-2- the Federal Government and Indian methyltetrahydro-2H-pyran-3- § 180.635 Spinetoram; tolerances for tribes. Thus, the Agency has determined residues. yl(methyl)formamide that Executive Order 13132, entitled (a) * * * in or on the following commodities is Federalism (64 FR 43255, August 10, increased to almond, hulls at 19 ppm; 1999) and Executive Order 13175, Commodity Parts per nut, tree, group 14 at 0.10 ppm; entitled Consultation and Coordination million pistachio at 0.10 ppm; date at 0.10 ppm; with Indian Tribal Governments (65 FR pomegranate at 0.30 ppm; pineapple ***** 67249, November 9, 2000) do not apply Almond, hulls ...... 19 0.04 ppm; pineapple, processed residue to this final rule. In addition, this final ***** at 0.15 ppm; spice, subgroup 19B, rule does not impose any enforceable Date ...... 0.10 except black pepper at 1.7 ppm; and duty or contain any unfunded mandate ***** hop, dried cones at 22 ppm. as described under Title II of the Hop, dried cones ...... 22

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Parts per 10,000 pounds GVWR for S5.4.3 and illuminated. For the horn control, Commodity million continues to be September 1, 2011. Table 2 specifies the horn symbol in Compliance date for the extension of Column 2, and the word ‘‘Horn’’ in ***** the standard’s control, indicator, and Column 3. Nut, tree, group 14 ...... 0.10 telltale requirements to vehicles at ***** II. 2005 and 2006 Final Rules 10,000 pounds GVWR or greater over Pineapple ...... 0.04 In a final rule published in the Pineapple, processed residue ...... 0.15 continues to be September 1, 2013. Pistachio ...... 0.10 Optional early compliance is Federal Register (70 FR 48295) on Pomegranate ...... 0.30 permitted as of the date today’s final August 17, 2005, NHTSA amended ***** rule is published. FMVSS No. 101 by extending the Spice, subgroup 19B, except Petitions for reconsideration: Petitions standard’s telltale and indicator black pepper ...... 1.7 for reconsideration of today’s final rule requirements to vehicles of Gross ***** must be received not later than Vehicle Weight Rating (GVWR) 4,536 September 28, 2009. kilograms (10,000 pounds) and over, * * * * * ADDRESSES: Petitions for reconsideration updating the standard’s requirements [FR Doc. E9–19195 Filed 8–12–09; 8:45 am] of the final rule must refer to the docket for multi-function controls and multi- BILLING CODE 6560–50–S number set forth above and be task displays to make the requirements submitted to the Administrator, appropriate for advanced systems, and National Highway Traffic Safety reorganizing the standard to make it DEPARTMENT OF TRANSPORTATION Administration, 1200 New Jersey easier to read. Table 1 and Table 2 Avenue, SE., Washington, DC 20590. continue to include only those symbols National Highway Traffic Safety and words previously specified in the FOR FURTHER INFORMATION CONTACT: For Administration non-legal issues you may call Ms. Gayle controls and displays standard or in Dalrymple, Office of Crash Avoidance another applicable FMVSS. 49 CFR Part 571 The final rule specified an effective Standards at (202) 366–5559. Her FAX date of February 13, 2006 for [Docket No. NHTSA–2009–0145] number is (202) 366–7002. For legal requirements applicable to passenger issues, you may call Ms. Dorothy RIN 2127–AK04 cars, multipurpose passenger vehicles, Nakama, Office of the Chief Counsel at trucks and buses under 4,536 kg GVWR (202) 366–2992. Her FAX number is Federal Motor Vehicle Safety (10,000 pounds).1 Standards; Controls, Telltales and (202) 366–3820. You may send mail to NHTSA received petitions for Indicators both of these officials at National reconsideration of the August 17, 2005 Highway Traffic Safety Administration, final rule, including one from the AGENCY: National Highway Traffic 1200 New Jersey Avenue, SE., Alliance. In the August 17, 2005 final Safety Administration (NHTSA), Washington, DC 20590. Department of Transportation (DOT). rule, the requirement that the identifier SUPPLEMENTARY INFORMATION: for each telltale must be in a color that ACTION: Final rule. I. Background stands out clearly against the background was extended to identifiers SUMMARY: In an August 2005 final rule, NHTSA issued Federal Motor Vehicle we updated our standard regulating for controls and indicators (see S5.4.3). Safety Standard (FMVSS) No. 101, The Alliance asked for reconsideration motor vehicle controls, telltales and Controls and Displays, in 1967 (32 FR indicators. The standard specifies of this requirement, stating that not all 2408) as one of the initial FMVSSs. The identifiers are in a color that stands out requirements for the location, standard applies to passenger cars, identification, and illumination of these clearly against the background. The multipurpose passenger vehicles Alliance further stated that it is not items. In May 2006, we published a (MPVs), trucks, and buses. The purpose response to four petitions for needed, citing as an example the horn of FMVSS No. 101 is to assure the identifier. reconsideration, including one asking us accessibility and visibility of motor to reconsider a requirement for color Most vehicle models use the horn vehicle controls and displays under symbol as the identifier, which is contrast between identifiers and their daylight and nighttime conditions, in backgrounds. We denied this petition molded into the air bag cover, without order to reduce the safety hazards a color ‘‘that stands out clearly against for reconsideration. caused by the diversion of the driver’s In response to another petition for the background’’ filled in. The Alliance attention from the driving task, and by commented that: ‘‘The symbol is the reconsideration from the Alliance of mistakes in selecting controls. Automobile Manufacturers (the same color as the background, but it can At present, FMVSS No. 101 specifies still be recognized because the Alliance) of the color contrast requirements for the location (S5.1), requirement, specifically for the horn embossment stands out against the identification (S5.2), and illumination background.’’ The Alliance petitioned control identifier, in this final rule, we (S5.3) of various controls and displays. amend the standard to provide that an for the regulatory text at S5.4.3 to be It specifies that those controls and changed to: ‘‘The identification required identifier is not required if the horn displays must be accessible and visible control is placed in the middle of the by Table 1 or Table 2 for a telltale, to a driver properly seated wearing his control or indicator shall contrast with steering wheel. If the horn control is or her safety belt. Table 1, ‘‘Controls, placed elsewhere in the motor vehicle, the background.’’ Telltales and Indicators with In the May 15, 2006 final rule, the control would be required to be Illumination or Color Requirements,’’ response to petitions for reconsideration identified by the specified horn symbol and Table 2, ‘‘Identifiers for Controls, (71 FR 27964), we noted that over the in a color that stands out clearly against Telltales and Indicators with No Color years, the agency had received the background. or Illumination Requirements,’’ indicate numerous complaints regarding the DATES: Effective Date: The effective date which controls and displays are subject for this final rule is February 9, 2010. to the identification requirements, and 1 The effective date was subsequently extended to The compliance date for vehicles under how they are to be identified, colored, September 1, 2006 (71 FR 3786, January 24, 2006).

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inability to locate the horn control. contrast cannot be assessed until the identification, color, and illumination of NHTSA’s Office of Defects materials and processes are defined’’ the control, telltale, or indicator.’’ The Investigation’s ARTEMIS database has and; horn control indicator is specified in recorded 120 complaints in the past ten • The UN working group considering Table 2. So that horn controls that are years from consumers reporting trouble a GTR 2 on controls and displays is the in the middle of the steering wheel locating the horn control. Of these 120 appropriate forum to understand and would not have to meet S5., in the complaints, consumers reported 12 discuss horn identification problems. NPRM, we proposed to amend S5.4.3 of crashes, 9 near misses, and an allegation On October 17, 2006, the Alliance FMVSS No. 101 to read: presented a data analysis to NHSTA of a fatality. In the +response, NHTSA Each identifier used for the identification explained that filling in the horn symbol staff of complaints regarding horn of a telltale, control or indicator must be in with a color that ‘‘that stands out clearly control identification on various a color that stands out clearly against the against the background’’ would make member companies’ vehicles. (The background. However, no identifier is the horn control more visible and would presentation has been placed in The required for a horn control activated by the help drivers to find the control more DOT Docket at NHTSA–2006–23651.) driver pressing on the center of the face plane readily. For these reasons, we denied The analysis revealed that as of the steering wheel. For vehicles with a this part of the Alliance’s petition. manufacturers have adopted membrane GVWR of under 4,536 kg (10,000 pounds), To minimize costs on industry switches in the center of the steering the compliance date for this provision is September 1, 2011. resulting from this requirement, NHTSA wheel to activate the horn, consumer delayed the compliance date to meet complaints about horn identification The word ‘‘symbol’’ was proposed to S5.4.3 for five years, to September 1, have decreased substantially. be changed to ‘‘identifier’’ to more accurately include words and 2011 to ‘‘allow manufacturers to IV. Grant of Petition for implement the necessary changes on abbreviations as identifiers which are Reconsideration and Notice of required to contrast with their most products during the planned Proposed Rulemaking product changes in normal product backgrounds, as was done in the development cycles.’’ In a Federal Register document of previous final rules to other sections of October 4, 2007 (72 FR 56713), NHTSA the standard. This was pointed out by III. Petition for Reconsideration of the stated that it has been persuaded by the the Alliance in its current petition. Color Contrast Requirement Alliance’s petition and accompanying NHTSA did not propose to amend In a submission dated June 29, 2006, data, and granted its petition for FMVSS No. 101 with the Alliance’s the Alliance petitioned for a reconsideration regarding S5.4.3. suggested language (‘‘The identification reconsideration of the color contrast NHTSA stated its belief that the required by Table 1 or Table 2 for a requirement for the horn symbol. This Alliance’s analysis provided on October telltale, control or indicator shall was the only issue raised in the petition. 17, 2006 has merit. Driver confusion as contrast with the background.’’) because Again, the Alliance petitioned for the to the location of the horn control has we stated our belief that the suggested regulatory text at S5.4.3 to be changed decreased as the horn control is language would allow non-contrasting to: ‘‘The identification required by Table returned where drivers intuitively identifiers for telltales, indicators and 1 or Table 2 for a telltale, control or expect to find it to the center of the controls whenever they appear in the indicator shall contrast with the steering wheel hub on more vehicles. If vehicle (such as the instrument panel). background.’’ In support of its petition, the horn control is located where most At present, S5.2.1 states in part: the Alliance stated that: drivers expect it, NHTSA stated its ‘‘* * * No identification is required for • NHTSA denied the Alliance’s belief that there is little safety benefit any horn (i.e., audible warning signal) previous petition based on a previously from the presence of the horn identifier. that is activated by a lanyard or for a undisclosed analysis of complaints; In fact, requiring the identifier on or turn signal * * *’’ To make S5.2.1 • ‘‘[I]t is unclear and cannot be adjacent to the control, may contribute consistent with the changes to S5.4.3, in evaluated whether the complaints to driver confusion as manufacturers opt the October 2007 NPRM, we proposed referred to by NHTSA were related to to place the identifier adjacent to the to revise the fourth sentence in S5.2.1 to actual horn symbol identification,’’ control, rather than too close to the state in part: ‘‘* * * No identification is • The complaint information should large, multi-colored, company logo required for any horn (i.e., audible be submitted to the DOT Docket; displayed on many vehicles at the warning signal) that is activated by a • ‘‘[S]ignificant cost and investment center of the wheel. lanyard or by the driver pressing on the will still be required across the In the NPRM, NHTSA stated that at center of the face plane of the steering industry,’’ to accomplish color contrast present, S5. Requirements of FMVSS wheel * * *’’ of the horn symbol on the background No. 101 states: ‘‘Each passenger car, V. Comments to the October 2007 of the steering wheel, despite the fact multipurpose passenger vehicle, truck NPRM and NHTSA Discussion of the that the Alliance agrees that the lead and bus that is fitted with a control, a Comments time afforded by the May 2006 final rule telltale or an indicator listed in Table 1 is adequate ‘‘for compliance with this or Table 2 must meet the requirements In response to the NPRM, we received section in order to minimize the of this standard for the location, comments from the Alliance, the associated financial impact * * *’’; Association of International Automobile • A ‘‘significant concern’’ is the 2 The United States participates in the United Manufacturers, Inc. (AIAM) and from ‘‘compatibility of materials that may be Nations/Economic Commission for Europe World Mr. Michael Tebbi, a private individual. used to assure long term symbol Forum for Harmonization of Vehicle Regulations Mr. Tebbi stated that he agreed with (also known as Working Party 29 or WP.29) under identification durability and contrast a 1990 agreement known as the 1998 Global the agency that the center of the steering * * *’’ and that this new combination Agreement. The 1998 Global Agreement provides wheel is where he expects the horn to of materials may ‘‘adversely affect airbag for the establishment of global technical regulations be, and ‘‘therefore no icon is needed.’’ cover performance, requiring further (GTRs) regarding, among other things, the safety of However, he expressed concern about motorized wheeled vehicles, equipment and parts. engineering development. The Agreement contains procedures for establishing the possibility that horns placed in the Environmental and manufacturing GTRs by either harmonizing existing regulations or centers of steering wheels could lead to issues related to providing horn symbol developing new ones. injuries since ‘‘a consumer will be

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honking the car’s horn as he collides seat area facilitating operation of the identification is voluntarily provided, with another vehicle. If the air bag heating/ventilation and audio system the horn symbol identification in Table deploys while the driver’s hand is functions by rear seat passengers.’’ In 2 or the word ‘‘horn’’ must be used. pressing against the center of the contrast, in the rulemaking at issue, all We would agree, however, that a steering wheel, I believe there may be a horn controls provided would be manufacturer could voluntarily use a possibility of injury to the driver’s arm operable by the driver, not by ‘‘rear seat horn symbol that is embossed, (i.e., or shoulder.’’ This rulemaking addresses passengers.’’ Thus, the Mazda letter without a contrasting color) to identify requirements for identification of the does not apply to the rulemaking at a horn control placed in the center of horn control. Since the horn control is issue. the face plane of the steering wheel. optional, we do not address where in a While in some situations NHTSA has Since no identification would be motor vehicle the horn control must be concluded that certain requirements do required in this situation, and since the placed. However, based on normal body not apply to items that are voluntarily embossed horn symbol would not cause kinematics during a crash, we believe provided or redundant, this is not a confusion, its use would be permissible. that it is very unlikely that in crashes general principle. In considering such The Alliance agreed with the proposal with deceleration great enough to cause an issue, the agency needs to consider but suggested changes in the regulatory air bag deployment, that the driver’s the specific situation and purpose of a text as ‘‘technical corrections’’ to hand will still be on the air bag cover particular requirement. ‘‘clarify’’ the agency’s intent. The at the time of the deployment. Since the AIAM argued that the second horn Alliance asked for ‘‘clarification on the introduction of driver air bags, the usual control would not be subject to FMVSS meaning of the term ‘center of the face location for the horn control has been No. 101 because the second control is plane of the steering wheel’ which under the air bag cover. No problems ‘‘voluntarily installed.’’ All horn could be narrowly interpreted and regarding horn use such as that controls are ‘‘voluntarily installed,’’ create potential questions of described by Mr. Tebbi have come to including those placed in the center of compliance.’’ The Alliance therefore NHTSA’s attention. the face plane of the steering wheel hub. suggested that S5.2.1 be changed to The AIAM supported the proposed Moreover, while the second horn read: amendment to FMVSS No. 101. AIAM control would be redundant, did not suggest changes to the proposed unidentified controls in unexpected S5.2.1 No identification is required for places, or controls identified in any horn (i.e., audible warning signal) that is regulatory text. However, AIAM activated by a lanyard or by the driver identified two related issues that it unfamiliar ways, may cause confusion pressing on the center area of the steering asked us to clarify in the preamble to to the driver. As a result of today’s final wheel hub * * * the final rule. The first was, if a rule, identification is not required for manufacturer provides a horn control those horn controls that are placed in NHTSA agrees that use of the word activated by pressing on the center of the center of the face plane of the ‘‘hub’’ provides clarification as to where the steering wheel 3 and provides a steering wheel hub. All other horn activation of the horn would occur. second horn control ‘‘off-center, near controls must meet all FMVSS No. 101 However, we believe the term ‘‘center’’ the edge of the hub, to identify the requirements that apply to horns. is clear, and decline to adopt ‘‘center supplemental horn control that operates AIAM also argued that ‘‘since no area.’’ There will be no compliance by tilting the plane of the hub’’ whether identifier is required for a horn control difficulty: The center of the hub is the second control must meet the S5.4.3 that is operated at the center of the located, the driver presses, and if the requirement for color contrast. As a steering wheel, any identifier that is horn sounds, the condition is met, and rationale for arguing that no voluntarily affixed there’’ would not no identification is necessary. identification should be required, AIAM have to meet S5.2 of FMVSS No. 101. The second issue raised by the stated that ‘‘[h]istorically, NHTSA has NHTSA does not agree with this Alliance is ‘‘the applicability of the taken the position that voluntarily position. The purpose of FMVSS No. proposed language when manufacturers installed items (i.e., items not mandated 101 is to: voluntarily mark horn controls that are by an FMVSS) are not subject to Assure the accessibility and visibility of activated by pressing on the center area regulation by NHTSA so long as such motor vehicle controls and displays under of the steering wheel hub * * * [I]f a items do not interfere with the operation daylight and nighttime conditions, in order manufacturer chooses to identify a horn of regulated systems or equipment.’’ In to reduce the safety hazards caused by the control activated by pressing on the support of its position, AIAM cited a diversion of the driver’s attention from the center area of the steering wheel hub, driving task, and by mistakes in selecting the proposed text could be interpreted January 28, 1992 letter to Honda and controls. what it described as an ‘‘undated’’ letter to require the symbol to be a contrasting to Mazda regarding redundant heating/ Permitting manufacturer-chosen color.’’ The Alliance offered the ventilator controls. The date of the letter identifications of a control for which following change to S5.4.3 to ‘‘clarify to Mazda is July 5, 1984. identification is specified in FMVSS No. this point.’’ NHTSA does not agree that the two 101 would not be consistent with the S5.4.3 Each identifier used for the cited interpretations are applicable to purpose of FMVSS No. 101. Such identification of a telltale, control or the rulemaking at issue. The 1992 letter alternative horn designations (with each indicator must be in a color that stands out to Honda interprets FMVSS No. 123, manufacturer possibly having a different clearly against the background. This Motorcycle controls and displays, not designation) would result in drivers requirement does not apply to the FMVSS No. 101. Further, the letter spending time trying to understand the identification of a horn control activated by meaning of the manufacturer-chosen the driver pressing on the center area of the addressed the nature of operation of a steering wheel hub. brake system, not the identification identification and would divert the required for a control. The July 5, 1984 ‘‘driver’s attention from the driving As earlier explained, we do not agree letter to Mazda, addresses a ‘‘secondary, task.’’ Such a result would not meet the with changing ‘‘center’’ to ‘‘center area.’’ redundant control placed in the rear need for safety. Therefore, in this final As to horn controls placed in the center rule, a horn control placed in the center of the face plane of the steering wheel, 3 A location where it was proposed in the NPRM, of the face plane of the steering wheel we agree, also for reasons discussed that no horn identifier would be required. need not be identified. However, if earlier, that a manufacturer could use a

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horn symbol (or the word horn) that is final rule, NHTSA excludes horn impact on a substantial number of small embossed in this situation, i.e., without controls activated by the driver pressing entities. a contrasting color. on the center of the face plane of the C. National Environmental Policy Act steering wheel from the standard’s VI. Leadtime requirement that an identifier be NHTSA has analyzed this rulemaking For vehicles under 10,000 pounds, the provided. This final rule will have no action for the purposes of the National compliance date for S5.4.3 continues to measurable effect on safety. As Environmental Policy Act. The agency be September 1, 2011. The compliance discussed above, driver confusion as to has determined that implementation of date for the extension of the standard’s the location of the horn control this action will not have any significant control, indicator, and telltale decreases as the horn control returns to impact on the quality of the human requirements to vehicles with at GVWR the center of the steering wheel hub, environment. of 4,536 kg (10,000 pounds) or greater where drivers intuitively expect to find continues to be September 1, 2013. it. If the horn control is located where D. Executive Order 13132 (Federalism) Optional early compliance is permitted drivers expect it, there is no apparent NHTSA has examined today’s final as of the date the final rule is published. safety benefit from the presence of the rule pursuant to Executive Order 13132 horn identifier. As a result of this final VII. Rulemaking Analyses and Notices (64 FR 43255, August 10, 1999) and rule, vehicle manufacturers are spared concluded that no additional A. Executive Order 12866 and DOT the costs of embossing a horn symbol in consultation with States, local Regulatory Policies and Procedures the center of the steering wheel hub and governments or their representatives is coloring in the symbol. Executive Order 12866, ‘‘Regulatory mandated beyond the rulemaking Because the economic effects of this Planning and Review’’ (58 FR 51735, process. The agency has concluded that final rule are minimal, no further the rule does not have federalism October 4, 1993), provides for making regulatory evaluation is necessary. determinations whether a regulatory implications, because the rule does not action is ‘‘significant’’ and therefore B. Regulatory Flexibility Act have ‘‘substantial direct effects on the States, on the relationship between the subject to Office of Management and Pursuant to the Regulatory Flexibility national government and the States, or Budget (OMB) review and to the Act (5 U.S.C. 601 et seq., as amended by on the distribution of power and requirements of the Executive Order. the Small Business Regulatory responsibilities among the various The Order defines a ‘‘significant Enforcement Fairness Act (SBREFA) of levels of government.’’ regulatory action’’ as one that is likely 1996), whenever an agency is required to result in a rule that may: to publish a notice of rulemaking for Further, no consultation is needed to (1) Have an annual effect on the any proposed or final rule, it must discuss the issue of preemption in economy of $100 million or more or prepare and make available for public connection with today’s rule. The issue adversely affect in a material way the comment a regulatory flexibility of preemption can arise in connection economy, a sector of the economy, analysis that describes the effect of the with NHTSA rules in at least two ways. productivity, competition, jobs, the rule on small entities (i.e., small First, the National Traffic and Motor environment, public health or safety, or businesses, small organizations, and Vehicle Safety Act contains an express State, local, or Tribal governments or small governmental jurisdictions). The preemptive provision: ‘‘When a motor communities; Small Business Administration’s vehicle safety standard is in effect under (2) Create a serious inconsistency or regulations at 13 CFR part 121 define a this chapter, a State or a political otherwise interfere with an action taken small business, in part, as a business subdivision of a State may prescribe or or planned by another agency; entity ‘‘which operates primarily within continue in effect a standard applicable (3) Materially alter the budgetary the United States.’’ (13 CFR to the same aspect of performance of a impact of entitlements, grants, user fees, § 121.105(a)). No regulatory flexibility motor vehicle or motor vehicle or loan programs or the rights and analysis is required if the head of an equipment only if the standard is obligations or recipients thereof; or agency certifies that the rule will not identical to the standard prescribed (4) Raise novel legal or policy issues have a significant economic impact on under this chapter.’’ 49 U.S.C. arising out of legal mandates, the a substantial number of small entities. 30103(b)(1). It is this statutory command President’s priorities, or the principles The SBREFA amended the Regulatory that unavoidably preempts State set forth in the Executive Order. Flexibility Act to require Federal legislative and administrative law, not We have considered the impact of this agencies to provide a statement of the today’s rulemaking, so consultation rulemaking action under Executive factual basis for certifying that a rule would be unnecessary. Order 12866 and the Department of will not have a significant economic Second, the Supreme Court has Transportation’s regulatory policies and impact on a substantial number of small recognized the possibility of implied procedures. This rulemaking document entities. preemption: In some instances, State was not reviewed by the Office of I have considered the effects of this requirements imposed on motor vehicle Management and Budget under E.O. rulemaking action under the Regulatory manufacturers, including sanctions 12866, ‘‘Regulatory Planning and Flexibility Act (5 U.S.C. 601 et seq.) and imposed by State tort law, can stand as Review.’’ The rulemaking action is also certify that this rule will not have a an obstacle to the accomplishment and not considered to be significant under significant economic impact on a execution of a NHTSA safety standard. the Department’s Regulatory Policies substantial number of small entities. When such a conflict is discerned, the and Procedures (44 FR 11034; February The rule does not impose any new Supremacy Clause of the Constitution 26, 1979). requirements but relieves a restriction. makes the State requirements For the following reasons, NHTSA For these reasons, and for the reasons unenforceable. See Geier v. American concludes that this final rule will not described in our discussion on Honda Motor Co., 529 U.S. 861 (2000). have any quantifiable cost effect on Executive Order 12866 and DOT However, NHTSA has considered the motor vehicle manufacturers. The rule Regulatory Policies and Procedures, nature and purpose of today’s rule and will not impose any new requirements NHTSA concludes that this final rule does not currently foresee any potential but instead relieves a restriction. In this will not have a significant economic State requirements that might conflict

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with it. Without any conflict, there Automotive Engineers (SAE). The ■ In consideration of the foregoing, 49 could not be any implied preemption. NTTAA directs the agency to provide CFR part 571 is amended as set forth Congress, through the OMB, E. Executive Order 12988 (Civil Justice below: explanations when we decide not to use Reform) available and applicable voluntary PART 571—FEDERAL MOTOR With respect to the review of the consensus standards. VEHICLE SAFETY STANDARDS promulgation of a new regulation, After conducting a search of available section 3(b) of Executive Order 12988, sources, we have determined that there ■ 1. The authority citation for part 571 ‘‘Civil Justice Reform’’ (61 FR 4729, is no applicable voluntary consensus continues to read as follows: standard for this final rule. February 7, 1996) requires that Authority: 49 U.S.C. 322, 30111, 30115, Executive agencies make every H. Unfunded Mandates Reform Act 30117, and 30166; delegation of authority at reasonable effort to ensure that the 49 CFR 1.50. regulation: (1) Clearly specifies the Section 202 of the Unfunded preemptive effect; (2) clearly specifies Mandates Reform Act of 1995 (UMRA) ■ 2. Section 571.101 is amended by the effect on existing Federal law or requires Federal agencies to prepare a revising the fourth sentence in S5.2.1, regulation; (3) provides a clear legal written assessment of the costs, benefits, adding a fifth sentence to S5.2.1, and by standard for affected conduct, while and other effects of proposed or final revising S5.4.3, to read as follows: promoting simplification and burden rules that include a Federal mandate reduction; (4) clearly specifies the likely to result in the expenditure by § 571.101 Standard No. 101, Controls, retroactive effect, if any; (5) adequately State, local or tribal governments, in the telltales, and indicators. defines key terms; and (7) addresses aggregate, or by the private sector, of * * * * * more than $100 million in any one year other important issues affecting clarity S5.2.1 * * * No identification is and general draftsmanship under any (adjusted for inflation with base year of 1995). Before promulgating a rule for required for any horn (i.e., audible guidelines issued by the Attorney warning signal) that is activated by a General. This document is consistent which a written statement is needed, section 205 of the UMRA generally lanyard or by the driver pressing on the with that requirement. center of the face plane of the steering Pursuant to this Order, NHTSA notes requires NHTSA to identify and consider a reasonable number of wheel hub; or for a turn signal control as follows. The issue of preemption is regulatory alternatives and adopt the that is operated in a plane essentially discussed above in connection with E.O. least costly, most cost-effective, or least parallel to the face plane of the steering 13132. NHTSA notes further that there burdensome alternative that achieves wheel in its normal driving position and is no requirement that individuals the objectives of the rule. The submit a petition for reconsideration or which is located on the left side of the provisions of section 205 do not apply pursue other administrative proceeding steering column so that it is the control when they are inconsistent with before they may file suit in court. on that side of the column nearest to the applicable law. Moreover, section 205 steering wheel face plane. However, if F. Paperwork Reduction Act allows NHTSA to adopt an alternative identification is provided for a horn other than the least costly, most cost- Under the Paperwork Reduction Act control in the center of the face plane of effective or least burdensome alternative of 1995, a person is not required to the steering wheel hub, the identifier if the agency publishes with the final respond to a collection of information must meet Table 2 requirements for the rule an explanation why that alternative by a Federal agency unless the horn. was not adopted. collection displays a valid Office of This final rule will not result in the * * * * * Management and Budget (OMB) control expenditure by State, local, or tribal number. This final rule does not require S5.4.3 Each identifier used for the governments, in the aggregate, or by the identification of a telltale, control or any collections of information, or private sector of more than $100 million recordkeeping or retention requirements indicator must be in a color that stands annually. Accordingly, this rule is not out clearly against the background. as defined by the OMB in 5 CFR Part subject to the requirements of sections 1320. However, this requirement does not 202 and 205 of the UMRA. apply to an identifier for a horn control G. National Technology Transfer and I. Regulation Identifier Number (RIN) in the center of the face plane of the Advancement Act The Department of Transportation steering wheel hub. For vehicles with a Section 12(d) of the National assigns a regulation identifier number GVWR of under 4,536 kg (10,000 Technology Transfer and Advancement (RIN) to each regulatory action listed in pounds), the compliance date for this Act of 1995 (NTTAA), Public Law 104– the Unified Agenda of Federal provision is September 1, 2011. For 113, section 12(d) (15 U.S.C. 272) Regulations. The Regulatory Information vehicles with a GVWR of 4,536 kg directs NHTSA to use voluntary Service Center publishes the Unified (10,000 pounds) or over, the compliance consensus standards in its regulatory Agenda in April and October of each date for this provision is September 1, activities unless doing so would be year. You may use the RIN contained in 2013. inconsistent with applicable law or the heading at the beginning of this * * * * * otherwise impractical. Voluntary document to find this action in the consensus standards are technical Unified Agenda. Issued on: August 7, 2009. standards (e.g., materials specifications, Ronald L. Medford, List of Subjects in 49 CFR Part 571 test methods, sampling procedures, and Acting Deputy Administrator. business practices) that are developed or Imports, Motor vehicle safety, Motor [FR Doc. E9–19396 Filed 8–12–09; 8:45 am] adopted by voluntary consensus vehicles, Rubber and rubber products, standards bodies, such as the Society of and Tires. BILLING CODE 4910–59–P

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Proposed Rules Federal Register Vol. 74, No. 155

Thursday, August 13, 2009

This section of the FEDERAL REGISTER your comments. Comments on electronically at the NRC’s Electronic contains notices to the public of the proposed rulemakings submitted in writing or Reading Room at http://www.nrc.gov/ issuance of rules and regulations. The electronic form will be made available NRC/reading-rm/adams.html. From this purpose of these notices is to give interested for public inspection. Because your page, the public can gain entry into persons an opportunity to participate in the comments will not be edited to remove ADAMS, which provides text and image rule making prior to the adoption of the final rules. any identifying or contact information, files of NRC’s public documents. If you the NRC cautions you against including do not have access to ADAMS or if there any information in your submissions are any problems in accessing the NUCLEAR REGULATORY that you do not want to be publicly documents located in ADAMS, contact COMMISSION disclosed. the NRC PDR Reference staff at (800) We request that any party soliciting or 397–4209, (301) 415–4737, or by e-mail 10 CFR Part 50 aggregating comments received from to [email protected]. RIN 3150–AH42 other persons for submission to the NRC FOR FURTHER INFORMATION CONTACT: inform those persons that the NRC will Barry Miller, Mail Stop O–9E3, Office of [NRC–2008–0332] not edit their comments to remove any Nuclear Reactor Regulation, U.S. identifying or contact information, and Nuclear Regulatory Commission, Performance-Based Emergency Core therefore they should not include any Washington, DC 20555–0001; telephone Cooling System Acceptance Criteria information in their comments that they (301) 415–4117, or e-mail AGENCY: Nuclear Regulatory do not want publicly disclosed. All [email protected]. Commission. commenters should ensure that SUPPLEMENTARY INFORMATION: ACTION: Advance notice of proposed sensitive or Safeguards Information is I. Background rulemaking. not contained in their responses or comments to this ANPR. In SECY–98–300, ‘‘Options for Risk- SUMMARY: This advance notice of Federal e-Rulemaking Portal: Go to Informed Revisions to 10 CFR part 50— proposed rulemaking (ANPR) presents a http://www.regulations.gov and search ‘Domestic Licensing of Production and conceptual approach that the Nuclear for documents filed under Docket ID Utilization Facilities,’ ’’ dated December Regulatory Commission (NRC) is NRC–2008–0332. Address questions 23, 1998 (ADAMS Accession number considering in a rulemaking effort to about NRC dockets to Carol Gallagher ML992870048), the NRC began to revise the acceptance criteria for (301) 492–3668; e-mail explore approaches to risk-informing its emergency core cooling systems (ECCSs) [email protected]. regulations for nuclear power reactors. for light-water nuclear power reactors as E-mail comments to: One alternative (termed ‘‘Option 3’’) currently required by NRC regulations [email protected]. If you involved making risk-informed changes that govern domestic licensing of do not receive a reply e-mail confirming to the specific requirements in the body production and utilization facilities. that we have received your comments, of Title 10 of the Code of Federal Revised ECCS acceptance criteria would contact us directly at (301) 415–1677. Regulations (10 CFR) Part 50. As the reflect recent research findings that Mail comments to: Secretary, U.S. NRC began to develop its approach to indicate the current criteria should be Nuclear Regulatory Commission, risk-informing these requirements, it re-evaluated for all fuel cladding Washington, DC 20555–0001, ATTN: sought stakeholder input in public materials in all potential conditions. Rulemakings and Adjudications Staff. meetings. Two of the regulations Further, the NRC is considering an Hand deliver comments to: 11555 identified by industry as potentially approach that would expand the Rockville Pike, Rockville, Maryland benefitting from risk-informed changes applicability of the rule to all current 20852, between 7:30 am and 4:15 pm were 10 CFR 50.44 and 10 CFR 50.46. and future cladding materials, modify during Federal workdays. (Telephone Section 50.44 specifies the requirements the reporting requirements, and address (301) 415–1677). for combustible gas control inside the issues raised in a petition for Fax comments to: Secretary, U.S. reactor containment structures and rulemaking (PRM) regarding crud and Nuclear Regulatory Commission at (301) § 50.46 specifies the requirements for oxide deposits and hydrogen content in 415–1101. You can access publicly light-water power reactor emergency fuel cladding. With this ANPR, the NRC available documents related to this core cooling systems. For § 50.46, the seeks comment on specific questions document using the following methods: potential was identified for making risk- and issues for consideration related to NRC’s Public Document Room (PDR): informed changes to requirements for this proposed conceptual approach to The public may examine and have both ECCS cooling performance and revising the ECCS acceptance criteria. copied for a fee, publicly available ECCS analysis acceptance criteria in DATES: Submit comments by October 27, documents at the NRC’s PDR, Public § 50.46(b). 2009. Comments received after this date File Area Room O1–F21, One White Additionally, on March 14, 2000, as will be considered if it is practical to do Flint North, 11555 Rockville Pike, amended on April 12, 2000, the Nuclear so, but the NRC is only able to ensure Rockville, Maryland. The PDR Energy Institute (NEI) submitted a PRM consideration of comments received on reproduction contractor will copy requesting that the NRC amend its or before this date. documents for a fee. regulations in §§ 50.44 and 50.46 (PRM– ADDRESSES: You may submit comments NRC’s Agencywide Document Access 50–71). The NEI petition noted that by any one of the following methods. and Management System (ADAMS): these two regulations apply to only two Please include the following number Publicly available documents created or specific zirconium-based fuel cladding RIN 3150–AH42 in the subject line of received at the NRC are available alloys (Zircaloy and ZIRLO TM). NEI

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stated that reactor fuel vendors had previously identified mechanisms. The Postulated Loss-of-Coolant Accidents’’ subsequently developed new cladding research results revealed that alloy (ADAMS Accession number materials other than Zircaloy and composition has a minor effect on ML082130389). ZIRLO TM and that in order for licensees embrittlement, but the cladding In response to the research findings to use these new materials under the corrosion which occurs as fuel burnup identified in RIL 0801, the NRC regulations, licensees had to request increases has a substantial effect on completed a preliminary safety NRC approval of exemptions from embrittlement. One of the major assessment of currently operating §§ 50.44 and 50.46. On September 16, findings of NRC’s research program was reactors (ADAMS Accession number 2003, (68 FR 54123), the NRC amended that hydrogen, which is absorbed in the ML090340073). This assessment found § 50.44 to include new, risk-informed cladding during the burnup-related that due to realistic fuel rod power requirements for combustible gas corrosion process under normal history, measured cladding performance control. The regulation was also operation, has a significant influence on under LOCA conditions, and current modified to be applicable to all boiling the embrittlement during a hypothetical analytical conservatisms, sufficient or pressurized water reactors regardless accident. Increased hydrogen content safety margin exists for operating of the type of fuel cladding material increases both the solubility of oxygen reactors. Therefore, any changes to the utilized. in zirconium and the rate at which it is ECCS acceptance criteria to account for On March 3, 2003, in response to absorbed, thus increasing the amount of the new findings can reasonably be SECY–02–0057, ‘‘Update to SECY–01– oxygen in the metal during high addressed through rulemaking. 0133, ‘Fourth Status Report on Study of temperature oxidation in LOCA Risk-Informed Changes to the Technical conditions. Oxygen is what ultimately After the NRC publicly released the Requirements of 10 CFR Part 50 (Option causes embrittlement in zirconium, but technical basis information in RIL 0801 3) and Recommendations on Risk- hydrogen content is a good indicator of on May 30, 2008, and NUREG/CR–6967, Informed Changes to 10 CFR 50.46 burnup embrittlement effects because of on July 31, 2008, it published a Federal (ECCS Acceptance Criteria)’ ’’, the its ability to allow this increased oxygen Register (FR) document on July 31, Commission issued a staff requirements absorption. Because of hydrogen’s 2008, (73 FR 44778), requesting that memorandum (SRM) (ADAMS effect, the embrittlement thresholds can public stakeholders comment on the Accession number ML030910476) be correlated with the pre-accident adequacy of the technical basis and directing the NRC staff to move forward hydrogen concentration. Further, the identify issues that may arise with to risk-inform its regulations in a NRC’s research program found that respect to experimental data number of specific areas. Among other oxygen from the oxide fuel pellets development, regulatory costs, or things, this SRM directed the NRC staff enters the cladding from the inner impacts of potential new requirements. to modify the ECCS acceptance criteria surface if a bonding layer exists between The comments received in response to to provide for a more performance-based the fuel pellet and the cladding, in this document can be found at http:// approach to meeting the ECCS addition to the oxygen that enters from www.regulations.gov by searching on requirements in § 50.46. the oxide layer on the outside of the docket ID NRC–2008–0332. On Separately from the Commission’s cladding. Moreover, under conditions September 24, 2008, the NRC held a efforts to modify its regulations to that might occur during a small-break public workshop to discuss stakeholder provide a more risk-informed, LOCA [such as an extended time-at- comments on the adequacy of the performance-based regulatory approach, temperature below 1000 degrees technical basis and to give the public the NRC had also undertaken a fuel Centigrade (°C) (1832 degrees and industry another opportunity to cladding research program intended to Fahrenheit (°F))], the accumulating provide further comment and input. The investigate the behavior of high oxide on the surface of the cladding can workshop included presentations and exposure fuel cladding under accident break up; this can allow large amounts open discussion between conditions. This research program of hydrogen to diffuse into the cladding, representatives of the NRC, included an extensive loss-of-coolant thus exacerbating the embrittlement international regulatory and research accident (LOCA) research and testing process. agencies, domestic and international program at Argonne National Laboratory The research results also confirmed commercial power firms, fuel vendors, (ANL), as well as jointly funded an older finding that if cladding rupture and the general public. The meeting programs at the Kurchatov Institute and occurs during a LOCA, large amounts of summary, including a list of attendees the Halden Reactor project, to develop hydrogen produced from the steam- and presentations, is available at the body of technical information cladding reaction can enter the cladding ADAMS Accession number needed to support the new regulations. inside surface near the rupture location. ML083010496. The effects of both alloy composition These research findings have been Since 2002, the NRC has met with the and fuel burnup (the extent to which summarized in Research Information Advisory Committee on Reactor fuel is used in a reactor) on cladding Letter (RIL) 0801, ‘‘Technical Basis for Safeguards (ACRS) multiple times to embrittlement (i.e., loss of ductility) Revision of Embrittlement Criteria in 10 discuss the progress of the LOCA under accident conditions were studied CFR 50.46,’’ (ADAMS Accession research program and rulemaking in this research program. The research number ML081350225) and the detailed proposals. Provided in the table below program identified new cladding experimental results from the program are the dates and ADAMS Accession embrittlement mechanisms and at ANL are contained in NUREG/CR– numbers of the relevant ACRS meetings expanded the NRC’s knowledge of 6967, ‘‘Cladding Embrittlement during and associated correspondence.

Date Meeting/letter ADAMS accession number

October 9, 2002 ...... Subcommittee Meeting ...... ML023030246 * October 10, 2002 ...... Full Committee Meeting ...... ML022980190 * October 17, 2002 ...... Letter from ACRS to NRC staff ...... ML022960640 December 9, 2002 ...... Response letter from NRC staff to ACRS ...... ML023260357 September 29, 2003 ...... Subcommittee Meeting ...... ML032940296 *

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Date Meeting/letter ADAMS accession number

July 27, 2005 ...... Subcommittee Meeting ...... ML052230093 * September 8, 2005 ...... Full Committee Meeting ...... ML052710235 * January 19, 2007 ...... Subcommittee Meeting ...... ML070390301 * February 2, 2007 ...... Full Committee Meeting ...... ML070430485 * May 23, 2007 ...... Letter from ACRS to NRC staff ...... ML071430639 July 11, 2007 ...... Response letter from NRC staff to ACRS ...... ML071640115 December 2, 2008 ...... Subcommittee Meeting ...... ML083520501 * & ML083530449 December 4, 2008 ...... Full Committee Meeting ...... ML083540616 * December 18, 2008 ...... Letter from ACRS to NRC staff ...... ML083460310 January 23, 2009 ...... Response letter from NRC staff to ACRS ...... ML0836640532 * ADAMS file is a transcript of the ACRS meeting.

On March 15, 2007, Mark Leyse On May 23, 2007, (72 FR 28902), the 65 FR 34599; May 31, 2000, and 73 FR submitted to the NRC a PRM (ADAMS NRC published a notice of receipt for 6600; November 6, 2008), to establish Accession number ML070871368). In this petition in the FR and requested requirements that apply to all the petition, which was docketed as public comment on the petition. The zirconium-based cladding alloys, PRM 50–84, the petitioner requested public comment period ended on including current and anticipated that all holders of operating licenses for August 6, 2007. After evaluating the alloys. The NRC’s high-burnup fuel nuclear power plants be required to public comments, the NRC resolved the research program investigated cladding operate such plants at operating Leyse petition by deciding that each of embrittlement in a number of different conditions (e.g., levels of power the petitioner’s issues should be zirconium-based cladding alloys and production, and light-water coolant considered in the rulemaking process. concluded that the results were chemistries) necessary to effectively The NRC’s determination was published applicable equally to all of the limit the thickness of crud 1 and/or in the FR on November 25, 2008, (73 FR zirconium-based alloys. Therefore, new oxide layers on fuel rod cladding 71564). zirconium-specific criteria can be surfaces. The petitioner requested the Because the issues raised in PRM–50– formulated in a performance-based NRC to conduct rulemaking in the 84 pertain to ECCS analysis and manner that would satisfy the request in following three specific areas: acceptance criteria, the need for PRM–50–71. Because this applicability (1) Establish regulations that require rulemaking to address the petitioner’s expansion may also aim to encompass licensees to operate light-water power technical concerns will be addressed in any potential new cladding materials reactors under conditions that are this rulemaking. Technical details developed in the future that are not effective in limiting the thickness of associated with the NRC’s evaluation of zirconium-based, the NRC notes that crud and/or oxide layers on zirconium- the rulemaking requests in PRM–50–84 such materials would still need an clad fuel in order to ensure compliance are discussed in Section III.4 of this extensive technical foundation to with § 50.46(b) ECCS acceptance document. receive NRC approval. However, this criteria; applicability expansion would eliminate II. Rulemaking Objectives (2) Amend Appendix K to 10 CFR part the need for licensees to request, and 50 to explicitly require that the steady- The scope of the rulemaking the NRC to review and approve, state temperature distribution and contemplated by this ANPR includes exemptions from § 50.46 for these stored energy in the reactor fuel at the four separate rulemaking objectives: potential new non-zirconium cladding onset of a postulated LOCA be Objective 1: Expand the applicability materials. calculated by factoring in the role that of § 50.46 to include any light-water Objective 2: Establish performance- the thermal resistance of crud deposits reactor fuel cladding material: based requirements and acceptance and/or oxide layers plays in increasing In this rulemaking, the NRC is criteria specific to zirconium-based the stored energy in the fuel (these considering expansion of the rule’s cladding materials that reflect recent requirements also need to apply to any applicability (which currently addresses research findings: NRC-approved, best-estimate ECCS only Zircaloy and ZIRLOTM cladding) to The second objective of this evaluation models used in lieu of include any light-water reactor fuel rulemaking is to enhance the Appendix K to Part 50, calculations); cladding material. As used in this performance-based features of § 50.46 by and ANPR, the term ‘‘fuel cladding’’ (or replacing the current § 50.46(b) (3) Amend § 50.46 to specify a simply ‘‘cladding’’) refers only to the prescriptive analytical limits with fuel maximum allowable percentage of cylindrical material that surrounds and cladding performance requirements and hydrogen content in [fuel rod] cladding. contains the nuclear fuel, not a fuel/ acceptance criteria. These performance cladding system. The rulemaking may requirements, based upon the recent 1 Crud is a foreign substance which may be findings from the NRC’s high burnup deposited on the surface of fuel cladding which can clarify the general applicability of impede the transfer of heat. Crud most frequently § 50.46 to require that all light-water research program, would ensure that an refers to deposits of iron or nickel metallic particles nuclear power reactors must be adequate level of cladding ductility is eroded from pipe and valve surfaces. These provided with an ECCS designed so that maintained throughout a postulated particles of stable isotopes may become ‘‘activated’’ LOCA. when they are irradiated in the reactor and after a postulated LOCA, a coolable core transform into radioactive isotopes such as cobalt- geometry would be maintained, Objective 3: Revise the LOCA 60. The NRC makes a distinction between crud and excessive combustible gases would not reporting requirements: pure zirconium oxidation layers. Although both be generated, and long-term cooling The third objective of this rulemaking materials contain metal oxides, crud does not originate at the fuel rod, while zirconium oxide would be assured. The applicability is to amend § 50.46(a)(3)(i) to emphasize forms on fuel cladding when the cladding material expansion would also encompass the the importance of reporting reduction in reacts with oxygen. request in PRM–50–71, filed by NEI (see margins to the acceptance criteria and

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the periodic reporting of susceptibility findings are only applicable to LWRs directly related to the growth of a to breakaway oxidation. with zirconium-based cladding alloys, zirconium dioxide layer on the cladding Objective 4: Address the issues raised detailed ECCS acceptance criteria for outside diameter. In the current in PRM–50–84, which relate to crud different cladding materials could not provision, the peak local oxidation limit deposits and hydrogen content in fuel now be specified in the regulations. is used as a surrogate to limit time at cladding: Therefore, the NRC is considering a elevated temperature and associated The fourth objective of this cladding-specific regulatory approach oxygen diffusion. This surrogate rulemaking is to amend § 50.46 as that would require applicants with non- approach is possible because both necessary to address the technical issues zirconium cladding materials to propose oxidation and diffusion share a strong on which the PRM–50–84 petitioner’s specific detailed criteria to demonstrate temperature dependence. In the recent three requests for rulemaking are based. how coolable core geometry, long-term LOCA research program, the Cathcart- The need for and extent of any changes cooling, and minimal generation of Pawel (CP) weight gain correlation was that may be needed to address these combustible gases would be ensured. In used to quantify the time at elevated issues will be determined during this order to develop such cladding-specific temperature at which ductility was lost rulemaking. criteria, applicants would need to fully (nil ductility). For this reason, the III. Specific Proposals develop and understand all of the proposed amendment would include a material’s degradation mechanisms, requirement that local cladding The NRC presents the following chemical and physical properties, and oxidation (which is being used as a conceptual approach to revising 10 CFR any other characteristics that may affect surrogate for limiting time-at- 50.46 under the outlined objectives: its behavior in the core during normal temperature) be calculated using the Objective 1: Expand the applicability operation and under LOCA conditions. of § 50.46 to include any light-water same Cathcart-Pawel correlation (see The NRC would review the applicant’s Regulatory Guide 1.157 regarding use of reactor fuel cladding material: proposed criteria and issue its approval This first conceptual approach the Cathcart-Pawel oxidation correlation only if the criteria ensure that the three rather than the Baker-Just correlation involves the applicability of the rule as general conditions are met, that the defined in § 50.46(a)(1)(i). Currently, cited in 10 CFR part 50, Appendix K, cladding-specific criteria can be Part I.A.5). this provision is limited to fuel rods demonstrated to be met during all TM To enhance the performance-based clad in Zircaloy or ZIRLO . The recent credible LOCA scenarios, and that they aspects of § 50.46 (and achieve an LOCA research program conducted are sufficient to ensure adequate objective of this rulemaking), the limits testing on a wide range of zirconium- protection of public health and safety. on peak cladding temperature and local based alloys such that research findings Section IV of this document requests oxidation would be replaced with and future testing requirements are comment on this conceptual approach specific cladding performance believed to be applicable to all to expanding the rule’s applicability. zirconium-based alloys. Therefore, the For LWRs using zirconium-based requirements and acceptance criteria NRC intends to expand the applicability alloys, cladding-specific criteria can and which ensure that an adequate level of of the rule to all zirconium-based alloys. will be specified in the regulations cladding ductility is maintained This would allow the introduction of based on the results of the NRC’s LOCA throughout the postulated LOCA. For future, advanced zirconium-based alloys research program. These criteria will example, the rule may specify that without the need for exemption retention of cladding ductility is defined ensure adequate cladding ductility is ≥ requests. However, NRC approval would maintained via specified performance as the accumulation of 1.00 percent still be required. requirements. A general discussion on permanent strain prior to failure during In addition, the NRC is considering the nature of these criteria is provided ring-compression loading at a ° further expansion of the rule’s below under Objective 2. temperature of 135 C and a applicability to include all light-water Objective 2: Establish performance- displacement rate of 0.033 millimeters reactors (LWRs) without regard to the based requirements and acceptance per second (mm/sec). Section IV of this type of fuel cladding material utilized in criteria specific to zirconium-based document requests comment on the design. Currently, § 50.46 states that cladding materials that reflect recent alternative ways to define an acceptable the ECCS must be designed so that its research findings: measure of ductility. This acceptance calculated cooling performance criterion would be used to define following postulated LOCAs conforms Cladding Ductility analytical limits for peak cladding to the five criteria set forth in § 50.46(b). In the current rule, the preservation of temperature and local oxidation based To accomplish such a change, the NRC cladding ductility, via compliance with on cladding performance during tests in is considering an approach where the regulatory criteria on peak cladding which cladding specimens are exposed proposed revision would specify that all temperature (§ 50.46(b)(1)) and local to double-sided steam oxidation up to a fuel cladding material used in LWRs, cladding oxidation (§ 50.46(b)(2)), specified peak oxidation temperature without regard to its composition, must ensures that the core remains amenable and CP–ECR. Analytical limits would be satisfy the three general conditions to cooling. The recent LOCA research calculated as a function of initial which currently exist as the criteria program identified new cladding cladding hydrogen content (weight parts specified in § 50.46(b)(3) Maximum embrittlement mechanisms which per million (wppm) in metal). The NRC hydrogen generation, § 50.46(b)(4) demonstrated that the current intends to issue a regulatory guide Coolable geometry, and § 50.46(b)(5) combination of peak cladding detailing an acceptable experimental Long-term cooling. The § 50.46(b)(3) temperature (2200 °F (1204 °C)) and test methodology for defining analytical criterion would be modified to limit local cladding oxidation (17 percent limits in accordance with these generation of any combustible gas, equivalent cladding reacted (ECR)) performance requirements. Included in rather than just hydrogen, with criteria do not always ensure post this test methodology would be recognition that different cladding quench ductility (PQD). It is important guidance for treating ring-compression materials could potentially react to to recognize that the loss of cladding test results which fail in such a way that produce different combustible gases. ductility is the result of oxygen permanent strain cannot be measured. Because the NRC’s recent research diffusion into the base metal and not The guidance would provide a

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relationship of permanent strain to an approach that would demonstrate The measured timing of the oxide offset-displacement. compliance with the proposed change phase transformation for each cladding This ANPR also provides two possible and illustrate this relationship. alloy, along with the experimental approaches for determining the Implementing any hydrogen based procedures and protocols used in their acceptability of current and future analytical limits, similar to the development, would be subject to NRC cladding alloys in accordance with the descriptions contained in the review and approval. Section IV of this proposed performance requirements. Appendices, requires an accurate, alloy- document seeks public comment on a Two approaches are described as specific hydrogen uptake model. draft experimental methodology for follows, however the NRC recognizes Section IV of this document seeks conducting breakaway oxidation testing there may be other alternatives. comment on the development of these with zirconium-based cladding alloys. Approach A—Analytical Limits models and how best to deal with the Application of the proposed Defined Within Regulatory Guidance: axial, radial, and circumferential breakaway oxidation criterion would The focal point of this approach variability in hydrogen concentration. involve new analytical requirements, would be a future regulatory guidance Two-Sided Oxidation including an additional break spectrum document which defines an acceptable, analysis to identify the limiting generically-applicable set of analytical Prompted by research which found combination of inputs that maximize limits for peak cladding temperature that oxygen from the inside diameter the time above elevated temperatures fuel bonding layer present in high and maximum allowable time-at- which are susceptible to breakaway burnup fuel rods may diffuse into the temperature (expressed as calculated oxidation for the given cladding alloy base metal of the cladding, the NRC is local oxidation, CP–ECR) as a function (e.g., 1200 °F (649 °C)). Each licensee of pre-transient hydrogen content in the proposing a new analytical requirement would be required to demonstrate that cladding metal, excluding hydrogen in to specifically account for the potential this calculated duration remained below the cladding oxide layer. These diffusion of oxygen from the cladding the measured minimum time to acceptable analytical limits would be inside diameter. Because the formation breakaway oxidation. As an alternative, based on the results of NRC’s LOCA of a fuel bonding layer may depend on the NRC is considering tying breakaway research program. Appendix A of this fuel rod design and power history, oxidation to the rule’s applicability document outlines the conceptual path licensees would be required to develop statement. For example, the proposed for approving both current and future and justify a burnup threshold above revision would only be applicable to cladding alloys using this approach. which this phenomenon would be Approach B—Cladding-Specific specifically accounted for within local zirconium-based alloys which do not Analytical Limits Defined by an cladding oxidation calculations. experience the breakaway phenomena Applicant: within a specified time period. This The second approach involves Breakaway Oxidation approach would eliminate the need for establishing cladding-specific and/or The NRC may also propose new each licensee to perform and maintain temperature-specific analytical limits requirements addressing breakaway a current updated final safety analysis for peak cladding temperature and oxidation. The recent LOCA research report (UFSAR) break spectrum analysis maximum allowable time-at- program discovered that the protective for breakaway oxidation. To set the temperature (expressed as calculated cladding oxide layer will undergo a specified time period within the local oxidation, CP–ECR) as a function phase transformation, become unstable, proposed rule’s applicability statement, of pre-transient hydrogen content in the and allow for the uptake of hydrogen the NRC is seeking information related cladding metal, excluding hydrogen in into the base metal. The timing of this to the maximum time span with the cladding oxide layer. This approach transformation is sensitive to many cladding surface temperature above ° ° would provide optimum flexibility for parameters including the cladding 1200 F (649 C) for the full range of defining more specific analytical limits manufacturing process. Licensees would piping break sizes and nuclear steam to gain margin to the ECCS performance be responsible for ensuring that the supply system (NSSS)/ECCS design criteria. However, unlike citing timing of the oxide phase combinations. If successful, this analytical limits within a regulatory transformation is measured for each alternative approach would include a guide, this approach places the burden cladding alloy utilized in their core to simpler pass/fail breakaway testing of proof on the applicant to validate determine susceptibility to early requirement up to this specified time their analytical limits and address breakaway oxidation. The proposed rule period (as opposed to searching for and experimental variability and would specify the required testing quantifying the limiting time to repeatability. As a result, this approach method, along with an acceptable breakaway). Section IV of this document would necessitate a larger number of measure of breakaway oxidation seeks to obtain this input. PQD tests (relative to confirming the behavior. The NRC intends to issue a Objective 3: Revise the LOCA applicability of the regulatory guide). regulatory guide detailing an acceptable reporting requirements. Analytical limits, along with the experimental methodology for defining Redefining a Significant Change or experimental procedures, protocols, and new criteria under these requirements. Error: specimen test results used in their For example, the proposed rule may The reporting requirement in 10 CFR development, would be subject to NRC specify that the minimum measured 50.46(a)(3)(i) currently defines a review and approval. Appendix B of time until the onset of breakaway significant change or error as one that this document includes further oxidation, defined as when hydrogen results in a calculated peak cladding discussion to illustrate the possible uptake reaches 200 wppm anywhere on temperature (PCT) different by more implementation of this approach. a cladding segment subjected to high than 50 °F (28 °C) from the temperature Cladding embrittlement is highly temperature steam oxidation ranging calculated for the limiting transient sensitive to both hydrogen content and from 1200 °F to 1875 °F (649 °C to 1024 using the last acceptable model, or is a peak oxidation temperature, and this °C), shall remain greater than the cumulation of changes and errors such relationship is applicable to both calculated duration that cladding that the sum of the absolute magnitudes approaches. The discussion in the surface temperature anywhere on the of the respective temperature changes is Appendices to this document describes fuel rod remains above 1200 °F (649 °C). greater than 50 °F (28 °C).

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The NRC is considering revising the margin to the relevant acceptance calculated by factoring in the role that reporting requirements by redefining criteria. Section IV of this document the thermal resistance of crud deposits what constitutes a significant change or seeks specific comment on this and/or oxide layers plays in increasing error in such a manner as to make the approach to modifying the reporting the stored energy in the fuel (these reporting requirements dependent upon requirements. requirements also need to apply to any NRC-approved, best-estimate ECCS the margin between the acceptance Breakaway Oxidation Susceptibility evaluation models used in lieu of criteria limits and the calculated values Reporting of the respective parameters (i.e., PCT or Appendix K to part 50, calculations); CP–ECR). The redefinition would aim to The NRC is also considering reporting and capture the importance of being close to requirements related to breakaway (3) Amend § 50.46 to specify a the limits by making reporting of a oxidation. Different zirconium-based maximum allowable percentage of change dependent upon the margin to alloys have varying susceptibility to hydrogen content in [fuel rod] cladding. the acceptance criteria. The NRC breakaway oxidation that is dependent on factors such as alloy content, PRM–50–84 Rulemaking Requests 1 and believes this redefinition should also 2 expand the current reporting scope to manufacturing process, and surface include CP–ECR, in addition to PCT, as preparation, among others. The NRC is Because the petitioner’s first two a parameter required for reporting. The concerned that during the life-cycle of requests for rulemaking are technically timeliness requirements for reporting an alloy used by a fuel vendor, both related, they are addressed together in would remain the same (i.e., 30 days for intentional and unintentional changes the following discussion. When a significant change or error). The may be made in the aforementioned evaluating PRM–50–84, the NRC following definitions exemplify a conditions. The effect of the changes reviewed the technical information provided by the petitioner and by all specific approach the NRC is can only be determined by testing public commenters. The NRC’s detailed considering: samples throughout the life-cycle of an analysis of all public comments was If the calculated parameter (PCT or alloy of the current cladding material for published in the FR on November 25, CP–ECR) has margin greater than 5 breakaway oxidation potential. The NRC 2008 (73 FR 71564). A summary of key percent of its acceptance criterion limit, plans to propose to include periodic comments that influenced the NRC’s then a significant change or error is one testing of cladding samples as part of conclusions follows. that results in: the annual licensee report pertaining to ° ° the LOCA licensing basis. The new The NEI opposed granting PRM–50– (i) A PCT change of 100 F (56 C) or 84 because the petition relies heavily on greater, requirement would be consistent with the following concept: licensees would atypical operating experiences at four (ii) A CP–ECR change of 2 percent or plants: River Bend (1998–1999 and greater, or report to the NRC at least annually as specified in §§ 50.4 or 52.3, as 2001–2003), Three Mile Island Unit 1 (iii) An accumulation of changes and (1995), Palo Verde Unit 2 (1997), and errors such that the sum of the absolute applicable, results of testing of each type of zirconium-based cladding alloy Seabrook (1997), where thick crud magnitudes of the changes and errors is layers developed during normal greater than 100 °F (56 °C) or 2 percent, employed in their reactor core for susceptibility to breakaway oxidation. If operation. NEI stated that the incidents respectively. cited by the petitioner were isolated If the calculated parameter (PCT or a cladding alloy is found to have greater operational events and would not have CP–ECR) is within 5 percent of its susceptibility to breakaway oxidation been prevented by imposing specific acceptance criterion limit, then a than would be acceptable for the regulatory limits on crud thickness. NEI significant change or error is one that corresponding time-at-temperature of noted that the industry is actively results in a calculated 10 percent or the ECCS performance analysis, the pursuing root cause evaluations and has greater reduction in the remaining affected licensee would be required to developed corrective actions to mitigate margin. propose immediate steps to reduce the further cases of excessive crud The following table gives an example impact of breakaway oxidation on their formation. for how the PCT criterion reporting ECCS performance analysis. Section IV of this document seeks specific NEI also stated that reactor licensees would be ‘‘triggered’’ for a plant with a use approved fuel performance models PCT limit of 2200 °F. comment on this approach to modifying the reporting requirements. to determine fuel rod conditions at the start of a LOCA. NEI stated that the Calculated PCT Reporting trigger Objective 4: Address the issues raised in PRM–50–84, which relate to crud impact of crud and oxidation on fuel < 2090 (i.e., not with- Any change ≥ 100 °F. deposits and hydrogen content in fuel temperatures and pressures may be in 5 percent of cladding: determined explicitly or implicitly in 2200 °F limit). In this ANPR, the NRC addresses the the system of models used. NEI 2090–2099 °F ...... Any change ≥ 11 °F. three requests for rulemaking in PRM– referenced the NRC review guidance in 2100–2109 °F ...... Any change ≥ 10 °F. 50–84: the Standard Review Plan (SRP) 2110–2119 °F ...... Any change ≥ 9 °F. (1) Establish regulations that require (NUREG–0800) noting that SRP Section ° ≥ ° 2120–2129 F ...... Any change 8 F. licensees to operate light-water power 4.2 states that the impact of corrosion on 2130–2139 °F ...... Any change ≥ 7 °F. 2140–2149 °F ...... Any change ≥ 6 °F. reactors under conditions that are thermal and mechanical performance 2150–2159 °F ...... Any change ≥ 5 °F. effective in limiting the thickness of should be considered in the fuel design 2160–2169 °F ...... Any change ≥ 4 °F. crud and/or oxide layers on zirconium- analysis, when comparing to the design 2170–2179 °F ...... Any change ≥ 3 °F. clad fuel in order to ensure compliance stress and strain limits. NEI and 2180–2189 °F ...... Any change ≥ 2 °F. with § 50.46(b) ECCS acceptance industry commenters in general 2190–2199 °F ...... Any change ≥ 1 °F. criteria; opposed issuing new regulations related (2) Amend Appendix K to 10 CFR part to crud, stating that the existing The NRC recognizes that there are 50 to explicitly require that the steady- regulations and voluntary guidance other possible approaches for state temperature distribution and regarding crud are sufficient. implementing the concept that the stored energy in the reactor fuel at the The NRC agrees with NEI that new reporting obligation depends upon the onset of a postulated LOCA be requirements imposing specific

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regulatory limits on crud thickness accident analyses to demonstrate that a oxidation, hydriding, and crud levels and would not necessarily have prevented nuclear reactor has an ECCS that is demonstrate their acceptability. These levels the occurrences of heavy crud deposits designed so its calculated performance should be presumed to exist in items (i) and that were the unexpected consequences meets the acceptance criteria in (ii) above. The effect of crud on thermal hydraulic considerations and neutronic of the operational events cited in PRM– § 50.46(b) on peak clad temperature 2 ° (AOA) considerations are reviewed as 50–84. Nevertheless, formation of (2200 F) and maximum local oxidation described in SRP Sections 4.3 and 4.4. cladding crud and oxide layers is an (17 percent). Licensees must evaluate a expected condition at nuclear power plant’s ECCS by calculating its Page 4.2–15 of SRP Section 4.2 also plants. Although the thickness of these performance with an acceptable states that the calculational models used layers is usually limited, the amount of evaluation model. An acceptable model to determine fuel temperature and accumulated crud and oxidation varies is one that either complies with the stored energy should include from plant to plant and from one fuel required and acceptable features in phenomenological models addressing cycle to another. Intended or Appendix K to Part 50—ECCS ‘‘Thermal conductivity of the fuel, inadvertent changes to plant operational Evaluation Models; or, for best-estimate cladding, cladding crud and oxidation practices may result in unanticipated models, complies with the layers’’ and ‘‘Cladding oxide and crud levels of crud deposition. The NRC § 50.46(a)(1)(i) requirement that there is layer thickness.’’ Review criteria in SRP agrees with the petitioner that crud and/ a high level of probability that the Section 4.4 specifically note that the or oxide layers may directly increase the calculated cooling performance will not thickness of oxidation layers and crud stored energy in reactor fuel by exceed the acceptance criteria in deposits must be accounted for in increasing the thermal resistance of § 50.46(b). The NRC reviews and critical heat flux calculations and when cladding-to-coolant heat transfer, and approves all licensee evaluation models determining the pressure drop may also indirectly increase the stored to determine if they are acceptable. throughout the reactor coolant system. energy through an increase in the fuel For best-estimate evaluation models, The NRC review guidance in the SRP rod internal pressure. § 50.46(a)(1)(i) requires that ‘‘The supports interpreting § 50.46(a) and As previously discussed, NEI evaluation model must include Appendix K to Part 50 to include crud commented that reactor licensees use sufficient supporting justification to as a required parameter in these approved fuel performance models to show that the analytical technique analyses. However, because crud is not determine fuel rod conditions at the realistically describes the behavior of explicitly identified in the regulations start of a LOCA and that the impact of the reactor coolant system during a loss- and the regulatory guidance in the SRP crud and oxidation on fuel temperatures of-coolant accident.’’ For Appendix K is not an enforceable requirement, there and pressures may be determined models, section I.B. of Appendix K to is ambiguity in the current explicitly or implicitly by the system of Part 50 states, ‘‘The calculations of fuel requirements. The NRC is considering models used. The NRC believes that to and cladding temperatures as a function amending its regulations to explicitly accurately model fuel performance on time shall use values for gap identify crud as one of the parameters during normal and postulated accident conductance and other thermal that must be addressed in ECCS analysis conditions, it is essential that fuel parameters as functions of temperature models. This change would eliminate performance and LOCA evaluation and other applicable time-dependent any ambiguity between the current rule models include the thermal effects of variables.’’ Crud accumulation and its language and the current SRP review both crud and oxidation whenever their effects are not explicitly identified as guidance. Licensee evaluation models accumulation changes the calculated required parameters to be included in could be formulated to calculate the results. Recently, power reactor best-estimate or Appendix K to Part 50 accumulation of crud or assume an licensees have been submitting an models. expected maximum thickness. The increased number of license amendment However, based on these resulting effects on fuel temperatures applications requesting significant requirements, the NRC has prepared would be determined based on the increases in licensed power levels. In regulatory review guidance that predicted or assumed thickness of some cases, these increases have addresses the accumulation of crud and deposits. reduced the margin between calculated oxidation deposits on fuel cladding ECCS performance and current ECCS The NRC also notes that licensees are surfaces. This guidance is in the format acceptance criteria. This trend further required to operate their facilities supports the need to ensure that the of review criteria in NUREG–0800, within the boundaries of the calculated effects of both crud and oxidation are ‘‘Standard Review Plan (SRP)’’ which ECCS performance. During or properly accounted for in ECCS are used by the NRC staff to review immediately after plant operation, if analyses. The technical concerns related licensees’ evaluation models. SRP actual crud layers on reactor fuel are to the thermal effects of oxidation and Section 4.2, ‘‘Fuel System Design,’’ implicitly determined or visually crud raised by the petitioner’s Section 4.3, ‘‘Nuclear Design,’’ and observed after shutdown to be greater rulemaking requests are addressed Section 4.4, ‘‘Thermal and Hydraulic than the levels predicted by or assumed separately below. Design’’ all contain specific criteria in the evaluation model, licensees Oxidation. The accumulation of related to the accumulation of crud and would be required to determine the cladding oxidation and its associated oxidation on fuel cladding surfaces. For effects of the increased crud on the effects on fuel cladding acceptance example, on page 4.2–6 of SRP Section calculated ECCS results. In many cases, criteria are being addressed by the 4.2.2, fuel system damage acceptance engineering judgment or simple ongoing work to revise the ECCS criterion iv. states: calculations could be used to evaluate acceptance criteria. Thus, the concerns iv. Oxidation, hydriding, and the buildup the effects of increased crud levels; of corrosion products (crud) should be related to oxidation raised by the therefore, detailed LOCA reanalysis may limited, with a limit specified for each fuel not be required. In other cases, new petitioner’s rulemaking requests are system component. These limits should be encompassed by Objective 2 of this established based on mechanical testing to analyses would be performed to section. demonstrate that each component maintains determine the effect the new crud Crud. 10 CFR 50.46 requires the acceptable strength and ductility. The safety licensee of a facility to perform LOCA analysis report should discuss allowable 2 AOA means Axial Offset Anomaly.

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conditions have on the final calculated the actual thickness of crud on the fuel. document and expanded upon in the results. Section IV of this document requests Appendices, where limits on peak The NRC would consider the comment on the potential addition of cladding temperature and local deposition of a previously unanalyzed such a requirement. oxidation would be replaced with amount of crud to be the same as specific cladding performance PRM–50–84 Rulemaking Request 3 making a change to or finding an error requirements that define an adequate in an approved evaluation model or in The petitioner’s third request for level of ductility which must be the application of such a model. In these rulemaking—that the NRC amend maintained throughout a postulated cases, § 50.46(a)(3)(i) requires licensees § 50.46 to specify a maximum allowable LOCA. In addition to general comments to determine if the change or error is percentage of hydrogen content in on these approaches, the NRC also seeks significant. For significant changes, cladding—pertains to the effects on fuel specific comment on the following § 50.46(a)(3)(ii) requires licensees to cladding embrittlement caused by related items: provide, within 30 days, a report to the hydrogen in the cladding. The cladding a. The NRC requests any further PQD NRC including a schedule for providing embrittlement issue will be technically ring-compression test data that may be a reanalysis or taking other action as resolved by revising the ECCS analysis available to expand the empirical may be needed to show compliance embrittlement acceptance criteria under database as shown in Appendix A of with the § 50.46 requirements. In rulemaking Objective 2. These new this document. situations when the § 50.46(b) acceptance criteria will address the b. Because no cladding segments acceptance criteria are not exceeded, the embrittlement effects of cladding tested in the NRC’s LOCA research licensee could either change the ECCS hydrogen content and other pertinent program exhibited an acceptable level of analysis of record to conform to the new variables. ductility beyond a hydrogen crud level or make changes to plant concentration of 550 wppm (metal), design or operation (e.g., adjust water IV. Issues for Consideration analytical limits may be restricted to coolant chemistry) to reduce crud Based on the specific proposals and terminate at this point. Are any further deposits to the level assumed in the discussion above, the NRC requests PQD ring-compression test data original analysis. Situations where a comment on the following questions available at hydrogen concentrations model change or error correction results and issues. In submitting comments, the beyond 550 wppm which exhibited an in calculated ECCS performance that NRC asks that each comment be acceptable level of ductility? does not conform to the acceptance referenced to its corresponding question c. Ring-compression tests conducted criteria in § 50.46(b) would be or issue number, as indicated below. on cladding segments with identical reportable events as described in hydrogen concentrations oxidized to the Applicability Considerations §§ 50.55(e), 50.72, and 50.73. In these same CP–ECR often exhibited a range of situations, the licensee would be 1. Objective 1 describes a conceptual measured offset displacement. The required under § 50.46(a)(3)(ii) to approach to expanding the applicability variability, repeatability, and statistical propose immediate steps to demonstrate of § 50.46 to all fuel cladding materials. treatment of these test results must be compliance or bring the plant design or Should the rule be expanded to include evaluated for defining generic PQD operation into compliance with § 50.46 any cladding material, or only be analytical limits. The NRC requests requirements. expanded to include all zirconium- comments on the variability, In summary, to address the technical based cladding alloys? The NRC also repeatability, and statistical treatment of concerns related to crud in the PRM– requests comment on the potential ductility measurements from samples 50–84 petitioner’s requests for advantages and disadvantages of the exposed to high-temperature steam rulemaking, the NRC is considering specific approach described that would oxidation. amending § 50.46(a) to specifically expand the applicability beyond 5. Implementation of a hydrogen- identify crud as a parameter to be zirconium-based alloys. Is there a better dependent PQD criterion requires an considered in best-estimate and approach that could achieve the same NRC-approved hydrogen uptake model. Appendix K to Part 50 ECCS evaluation objective? The sensitivity of hydrogen pickup models. Compliance with this 2. The rulemaking objectives do not fraction to external factors (e.g., requirement during plant operation include expanding the applicability of manufacturing process, proximity to would be determined by the process § 50.46 to include fuel other than dissimilar metals, plant coolant outlined in the scenarios above. uranium oxide fuel (UO2). Is there any chemistry, oxide thickness, crud, Under this approach, the NRC would need for, or available information to burnup, etc.) must be properly propose new rule language defining justify, expanding the applicability of calibrated in the development and crud as a foreign substance (other than this rule to mixed oxide fuel rods? validation of this model. zirconium oxide) which may be a. The NRC requests information on deposited on the surface of fuel New Embrittlement Criteria the size and depth of the current hot- cladding and which impedes the Considerations cell hydrogen database(s) and the transfer of heat due to thermal 3. The NRC requests information industry’s ability to segregate the resistance and/or flow area reduction. A related to the maximum time span with sensitivity of each cladding alloy to requirement would be added stating that cladding surface temperature above each external factor and to quantify the ECCS evaluation models must consider 1200 °F (649 °C) for the full range of level of uncertainty. the effects of crud deposition on fuel piping break sizes and NSSS/ECCS b. Pre-test characterization of some cladding at the highest level of buildup design combinations. This information irradiated cladding segments revealed expected during a fuel cycle. In may be used to set a specified minimum significant variability in axial, radial, addition, to ensure that plant-specific time to breakaway in the proposed and circumferential hydrogen crud levels are bounded by the levels rule’s applicability statement. concentrations. analyzed in the ECCS model, the NRC 4. The NRC requests comment on the i. What information exists that could is considering adding a requirement that two approaches to establishing quantify this asymmetric distribution in licensees inspect one or more fuel analytical limits for cladding alloys, as the development of a hydrogen uptake assemblies every fuel cycle to determine described in Section III.2 of this model?

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ii. What information exists that could 7. The proposed revisions to § 50.46 11. What information exists to inform the treatment of this asymmetric include a new testing requirement facilitate developing an acceptable crud hydrogen distribution as a function of related to breakaway oxidation. Due to deposition model that could correlate fuel rod burnup? the observed effects of manufacturing crud deposition with measured primary iii. This asymmetric hydrogen controlled parameters (e.g., surface water coolant chemistry (e.g., iron-oxide distribution could be addressed in roughness, minor alloying, etc.) on the concentration)? For boiling water future PQD ring compression tests on breakaway phenomena, the proposed reactors, it is difficult to perform visual irradiated material by such approach would include periodic inspections or poolside measurements requirements as orienting ring samples testing requirements to ensure that both of fuel rod crud thickness without first such that the maximum asymmetric planned and unplanned changes in removing the channel box. A crud hydrogen concentration is aligned with manufacturing processes do not deposition model would facilitate the the maximum stress point or in pre- adversely affect the performance of the confirmation of design crud layers hydrided material by introducing cladding under LOCA conditions. assumed in the ECCS evaluations and asymmetric distribution during a. The NRC requests comment on the provide an indicator to reactor operators hydriding. The NRC requests comment testing frequency and sample size when crud levels approach unanalyzed on these or other methods to treat provided in the breakaway oxidation conditions. Are there ongoing or asymmetric hydrogen distribution. testing methodology (ADAMS planned industry efforts to monitor Testing Considerations Accession number ML090840258) and water coolant chemistry for comparison technical basis for the proposed to observed crud deposition? If so, what 6. A draft proposed cladding breakaway oxidation testing oxidation and PQD testing methodology amount of success has been obtained? requirement. is provided at ADAMS Accession Could a properly correlated crud model b. Is there any ongoing or planned number ML090900841. be sufficiently accurate to preclude the a. The NRC requests comment on the testing to further understand the need for crud measurements at the end details of the draft experimental sensitivity of breakaway oxidation to of each fuel cycle? parameters controlled during the methodology, including sample Cost Considerations preparation and characterization, manufacturing process? experimental protocols, laboratory Revised Reporting Requirements 12. The U.S. commercial nuclear techniques, sample size, statistical Considerations power industry claims that treatment, and data reporting. implementation of the proposed rule b. The NRC requests information on 8. The NRC requests comment on the proposed concept that the reporting would be a significant burden in both any ongoing or planned testing money and resources. The industry has programs that could exercise the draft obligation in § 50.46 depend upon the margin to the relevant acceptance discussed an implementation cost of experimental methodology to approximately $250 million (NRC– independently confirm its adequacy. criteria. Please also comment on the specific approach to implement this 2008–0332–0008.1 at http:// c. Unirradiated cladding specimens www.regulations.gov). pre-charged with hydrogen appear to be objective as described under Objective 3 viable surrogates for testing on in Section III of this document. a. What options are available to irradiated cladding segments. However, 9. The NRC requests comment on the reduce this implementation cost? the NRC’s position remains that future proposed concept of adding the results b. Are there changes in core operating testing to support cladding approval of breakaway oxidation susceptibility limits, fuel management, or cladding reviews include irradiated material testing to the annual reporting material that would reduce the cost and without further confirmatory work to requirement. Are there other burden of implementing the proposed directly compare the embrittlement implementation approaches that could hydrogen based PQD criterion without behavior of irradiated material to help ensure that a zirconium-based negatively impacting operations? hydrogen pre-charged material at the alloy does not become more susceptible c. A staged implementation would be same hydrogen level. The NRC’s LOCA to breakaway during its manufacturing more manageable for both the NRC and research program reports PQD test and production life-cycle? industry. One potential approach results on twenty irradiated fuel Crud Analysis Considerations involves characterizing the plants based cladding segments of varying zirconium upon safety margin and deferring alloys and hydrogen concentrations that 10. The NRC requests comment on the underwent quench cooling. The NRC proposed regulatory approach in which implementation for the licensees with requests information on any ongoing or crud is required to be considered in the largest safety margin (e.g., lowest planned testing aimed at replicating ECCS evaluation models. If actual crud calculated CP–ECR). The NRC requests these twenty PQD tests for the purpose levels should exceed the levels comment on this implementation of validating a pre-hydrided surrogate. considered in the evaluation model, the approach. d. The NRC is considering defining an situation would be considered Available Supporting Documents acceptable measure of cladding ductility equivalent to discovering an error in the as the accumulation of ≥1.00 percent ECCS model. The licensee would then The following documents provide permanent strain prior to failure during be subject to the reporting and additional background and supporting ring-compression loading at a corrective action process specified in information regarding this rulemaking temperature of 135 °C and a § 50.46(a)(3) to resolve the discrepancy. activity and corresponding technical displacement rate of 0.033 mm/sec. The NRC also requests comment on the basis. The documents can be found in Recognizing the difficulty of measuring imposition of a requirement that one or the NRC’s Agencywide Document permanent strain, the NRC requests more fuel assemblies be inspected at the Access and Management System comment on alternative regulatory end of each fuel cycle to demonstrate (ADAMS). Instructions for accessing criteria defining an acceptable measure the validity of crud levels analyzed in ADAMS were provided under the of cladding ductility. the ECCS model. ADDRESSES section of this document.

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Date Document ADAMS accession number

July 31, 2008 ...... NUREG/CR–6967, ‘‘Cladding Embrittlement ML082130389. During Postulated Loss-of-Coolant Acci- dents’’. May 30, 2008...... Research Information Letter (RIL) 0801, ML081350225. ‘‘Technical Basis for Revision of Embrittle- ment Criteria in 10 CFR 50.46’’. September 24, 2008 ...... Public Meeting Summary ...... ML083010496. February 23, 2009 ...... Plant Safety Assessment of RIL 0801 ...... ML090340073. July 31, 2008 ...... Federal Register Notice (73 FR 44778), ‘‘No- Reference the Federal Register at 73 FR tice of Availability and Solicitation of Public 44778. Comments on Documents Under Consider- ation To Establish the Technical Basis for New Performance-Based Emergency Core Cooling System Requirements’’. March 30, 2009 ...... Supplemental research material—additional ML090690711. PQD tests. March 30, 2009 ...... Supplemental research material—additional ML090700193. breakaway testing. March 31, 2009 ...... Draft proposed procedure for Conducting Oxi- ML090900841. dation and Post-Quench Ductility Tests With Zirconium-based Cladding Alloys. March 23, 2009...... Draft proposed procedure for Conducting ML090840258. Breakaway Oxidation Tests With Zirconium- Based Cladding Alloys. January 8, 2009 ...... Update on Breakaway Oxidation of Westing- ML091330334. house ZIRLO Cladding. May 7, 2009...... Impact of Specimen Preparation on Break- ML091350581. away Oxidation (Non-Proprietary).

List of Subjects in 10 CFR Part 50 For the Nuclear Regulatory Commission. metal (excluding hydrogen in the cladding R.W. Borchardt, oxide layer). These acceptable analytical Antitrust, Classified information, Executive Director for Operations. limits would be developed using NRC’s Criminal penalties, Fire protection, empirical database with consideration of Intergovernmental relations, Nuclear APPENDIX A experimental variability and repeatability. power plants and reactors, Radiation An Approach for Determining the Figure A shows the results of ring- protection, Reactor siting criteria, Acceptability of Zirconium-Based Cladding compression tests conducted on as- Reporting and recordkeeping Alloys: Analytical Limits Defined Within fabricated, hydrogen charged, and irradiated Regulatory Guidance specimens of Zircaloy-2, Zircaloy-4, requirements. ZIRLOTM and M5 cladding material This approach would include a future The authority citation for this document is regulatory guidance document that defines (documented in NUREG/CR–6967). Note that 42 U.S.C. 2201. an acceptable, generically-applicable set of hydrogen concentrations were slightly adjusted (± 5 wppm) to illustrate results of Dated at Rockville, MD, this 29th day of analytical limits for peak cladding multiple ring-compression tests run at the July 2009. temperature and maximum allowable time- at-temperature (expressed as calculated local same CP–ECR and hydrogen concentration. oxidation, CP–ECR) as a function of pre- Peak oxidation temperature is identified for transient hydrogen content in the cladding samples tested below 2200 °F (1204 °C).

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The analytical limit on PCT would be limits defined within the Regulatory Guide. charged cladding specimens has been restricted to the peak oxidation temperature A TR would need to include the results of accepted as a surrogate for testing on during testing of the cladding specimens testing, conducted in accordance with NRC’s irradiated cladding segments. If sufficient used in the development of this limit. acceptable experimental methodology, which justification for the use of hydrogen charged Furthermore, caveats on the applicability of demonstrates that the embrittlement behavior cladding specimens has not been accepted as the analytical limits may be required to of the new cladding alloy is consistent with a surrogate for testing on irradiated cladding capture limiting aspects of the steam the embrittlement behavior of the cladding segments, approving new cladding alloys oxidation temperature profile used during alloys tested in NRC’s LOCA research would require PQD testing of irradiated the testing. For example, if the calculated program by comparing test results to the material. Section IV of this ANPR requests time at the specified PCT is less than the time defined analytical limit. This would likely information on any ongoing or planned at peak oxidation temperature of the require testing of the new cladding alloy with testing aimed at validating this pre-hydrided supporting empirical database (for a given varying hydrogen contents, which are surrogate. CP–ECR), or the calculated quench oxidized to calculated oxidation levels (CP– APPENDIX B temperature is lower than 800 °C, then an ECR) at or near the analytical limit for that applicability caveat may be required. hydrogen level as provided in regulatory An Approach for Determining the guidance. Demonstrating ductile behavior in Acceptability of Zirconium-Based Cladding Existing Cladding Alloys cladding samples with calculated oxidation Alloys: Cladding-Specific Analytical Limits No PQD testing would be required to levels at or near the analytical limit may Defined by an Applicant approve cladding alloys included in the serve to confirm the applicability of the This approach involves establishing NRC’s LOCA research program. Under this analytical limit to a new cladding alloy. The cladding-specific and/or temperature-specific approach, a fuel vendor would submit a range of hydrogen contents in test samples analytical limits for peak cladding topical report (TR) seeking NRC approval of required may be limited by proposing temperature and maximum allowable time- each zirconium-based cladding alloy’s cladding hydrogen design limits based on hot at-temperature (expressed as calculated local analytical limits on PCT and time-at- cell examinations of irradiated samples of the oxidation, CP–ECR) as a function of pre- temperature (CP–ECR, as a function of new cladding alloy following lead test transient hydrogen content in the cladding cladding hydrogen content). The TR would assembly campaigns. Regulatory guidance metal (excludes hydrogen in the cladding reference the acceptable analytical limits would be provided to address the variability oxide layer). This approach would provide within the Regulatory Guide. in measured offset strain of ring-compression optimum flexibility for defining more test results. Section IV of this ANPR specific analytical limits to gain margin to New Cladding Alloys specifically seeks comment on the treatment the ECCS performance criteria. However, Under this approach, a fuel vendor would of variability in ductility measurements of unlike citing analytical limits within a submit a TR which demonstrates that the ring-compression tests. regulatory guide, this approach places the results of PQD tests on a specific new alloy For this description, it is assumed that burden of proof on the applicant to validate are applicable to the acceptable analytical sufficient justification for the use of hydrogen their analytical limits and address

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experimental variability and repeatability. As new analytical limits. The PQD test results and reload-by-reload confirmation. This a result, this approach would necessitate a on irradiated cladding segments documented approach also relies on tacit assumptions larger number of PQD tests (relative to in NUREG/CR–6967 would need to be regarding the currently approved LOCA confirming the applicability of the regulatory considered in the development of analytical model’s ability to accurately simulate the guide). Analytical limits, along with the limits. PQD testing would be required to (1) thermal-hydraulic conditions in every region experimental procedures, protocols, and establish analytical limits in accordance with of the reactor core (as opposed to simulating specimen test results used in their the performance requirements that would be a core average response or pseudo hot development, would be subject to NRC specified within the rule, and (2) channel location). Modeling uncertainties review and approval. demonstrate the applicability of the NUREG/ with respect to predicting local conditions This approach would require that the PQD CR–6967 empirical database. A TR could throughout the reactor core would need to be test results on irradiated cladding segments document that the PQD testing had been addressed. documented in NUREG/CR–6967 be conducted to strictly adhere to the accepted Using an approved hydrogen uptake model considered in the development of analytical experimental protocols documented in for a new cladding alloy, the TR would need limits. Deviations in cladding performance regulatory guidance documents, or if to provide the methodology to convert the relative to this empirical database must be alternative testing procedures were used, hydrogen-based analytical limits to some unit identified and dispositioned. then NRC review and approval of those of measure more readily applied within laboratory procedures would be required. reload safety analyses (e.g., fuel rod burnup Existing Cladding Alloys For this approach, defining analytical or fuel duty). Uncertainties related to In the case of existing cladding alloys, the limits for new cladding alloys would likely hydrogen uniformity and uncertainties rule may specify the following performance require testing at a range of hydrogen introduced by the conversion from hydrogen requirement to ensure an adequate retention contents, with ring-compression test results to another unit of measure would need to be of cladding ductility: at multiple calculated oxidation levels. Test addressed. Accumulation of ≥ 1.00 percent permanent samples with calculated oxidation levels For this description, it is assumed that strain prior to failure during ring- sufficient to display brittle behavior, as well sufficient justification for the use of hydrogen compression loading at a temperature of 135 as test samples with calculated oxidation charged cladding specimens has been °C and a displacement rate of 0.033 mm/sec levels which display ductile behavior, would accepted as a surrogate for testing on on a cladding specimen exposed to double- be necessary to define the transition from irradiated cladding segments. If sufficient sided steam oxidation up to a specified peak ductile to brittle behavior. Regulatory justification for the use of hydrogen charged oxidation temperature and CP–ECR. guidance would be provided to address the cladding specimens has not been accepted as Analytical limits on allowable time-at- variability in measured offset strain of ring- a surrogate for testing on irradiated cladding temperature (CP–ECR) and peak cladding compression test results. Section IV of this segments, approving new cladding alloys temperature would need to be defined as a ANPR specifically seeks comment on the would require PQD testing of irradiated function of initial cladding hydrogen content treatment of variability in ductility material. Section IV of this ANPR requests (wppm in metal) to demonstrate this measurements of ring-compression tests. The information on any ongoing or planned performance requirement is met. A topical range of hydrogen contents in test samples testing aimed at validating this pre-hydrided report (TR) would be generated to document required may be limited by proposing surrogate. the basis for the new analytical limits. cladding hydrogen design limits based on hot [FR Doc. E9–19423 Filed 8–12–09; 8:45 am] Existing alloys which were included in the cell examinations of irradiated samples of the BILLING CODE 7590–01–P NRC high-burnup research program may new cladding alloy following lead test reference the test results documented in assembly campaigns. NUREG/CR–6967 in the development of new Multifaceted Analytical Limits analytical limits. This data was generated DEPARTMENT OF TRANSPORTATION following experimental protocols acceptable Recognizing that higher burnup fuel rods to the NRC, so no further justification related (with higher hydrogen concentrations) Federal Aviation Administration to its validity would be required. operate at a reduced power level (relative to Using an approved hydrogen uptake model lower burnup fuel rods), defining analytical 14 CFR Part 39 for an existing cladding alloy, the TR would limits for maximum allowable ECR at provide the methodology to convert the multiple peak oxidation temperatures would [Docket No. FAA–2009–0713; Directorate hydrogen-based analytical limits to some unit also be possible. For example, a TR could Identifier 2007–NM–303–AD] of measure more readily applied within document the results of testing conducted at RIN 2120–AA64 reload safety analyses (e.g., fuel rod burnup peak oxidation temperatures of 2200 °F (1204 ° ° ° ° ° or fuel duty). Uncertainties related to C), 2000 F (1093 C), and 1800 F (982 C), Airworthiness Directives; Airbus Model hydrogen uniformity and uncertainties which are targeted at low burnup (low A318 Series Airplanes introduced by the conversion from hydrogen corrosion), medium burnup (medium to another unit of measure would need to be corrosion), and high burnup (high corrosion) AGENCY: Federal Aviation addressed. fuel rods, respectively. Testing to support Administration (FAA), DOT. these new limits would require testing at a New Cladding Alloys range of hydrogen contents, with ring- ACTION: Notice of Proposed Rulemaking In the case of new cladding alloys, the rule compression test results at multiple (NPRM). may specify the following performance calculated oxidation levels to define the SUMMARY: requirement to ensure an adequate retention transition from ductile to brittle behavior. In We propose to adopt a new of cladding ductility: this case, it may be necessary to elect to airworthiness directive (AD) for the Accumulation of ≥ 1.00 percent permanent strictly adhere to the accepted experimental products listed above. This proposed strain prior to failure during ring- protocols documented in regulatory guidance AD results from mandatory continuing compression loading at a temperature of 135 documents, thereby limiting regulatory airworthiness information (MCAI) °C and a displacement rate of 0.033 mm/sec exposure related to testing procedures and originated by an aviation authority of on a cladding specimen exposed to double- the validity of the data. another country to identify and correct sided steam oxidation up to a specified peak Implementation of the multifaceted an unsafe condition on an aviation oxidation temperature and CP–ECR. analytical limits would require separating all product. The MCAI describes the unsafe Analytical limits on allowable time-at- of the fuel rods in the core into three temperature (CP–ECR) and peak cladding categories and then ensuring that all fuel rods condition as: temperature would need to be defined as a within each category satisfies their respective Some operators have reported airframe function of initial cladding hydrogen content analytical limits on both CP–ECR and PCT. vibration under specific flight conditions (wppm in metal) to demonstrate this While it is anticipated that this approach including gusts. performance requirement is met. A TR would would provide flexibility, it would also Investigations have revealed that under be generated to document the basis for the necessitate a more complex LOCA analysis such conditions, vibrations may occur when

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the hinge moment of the elevator is close to closing date and may amend this policies. Any such differences are zero, associated to elevator free-play. proposed AD based on those comments. highlighted in a NOTE within the * * * * * We will post all comments we proposed AD. The unsafe condition is excessive receive, without change, to http:// Costs of Compliance vibration of the elevators, which could www.regulations.gov, including any result in reduced structural integrity personal information you provide. We We estimate that this proposed AD and reduced controllability of the will also post a report summarizing each would affect about 11 products of U.S. airplane. substantive verbal contact we receive registry. We also estimate that it would about this proposed AD. take about 2 work-hours per product to DATES: We must receive comments on comply with the basic requirements of this proposed AD by September 14, Discussion this proposed AD. The average labor 2009. The European Aviation Safety Agency rate is $80 per work-hour. Based on ADDRESSES: You may send comments by (EASA), which is the Technical Agent these figures, we estimate the cost of the any of the following methods: for the Member States of the European proposed AD on U.S. operators to be • Federal eRulemaking Portal: Go to Community, has issued EASA $1,760, or $160 per product. http://www.regulations.gov. Follow the Airworthiness Directive 2007–0163, instructions for submitting comments. dated June 11, 2007 (referred to after Authority for This Rulemaking • Fax: (202) 493–2251. this as ‘‘the MCAI’’), to correct an unsafe Title 49 of the United States Code • Mail: U.S. Department of condition for the specified products. specifies the FAA’s authority to issue Transportation, Docket Operations, M– The MCAI states: rules on aviation safety. Subtitle I, 30, West Building Ground Floor, Room Some operators have reported airframe section 106, describes the authority of W12–140, 1200 New Jersey Avenue, SE., vibration under specific flight conditions the FAA Administrator. ‘‘Subtitle VII: Washington, DC 20590. including gusts. Aviation Programs,’’ describes in more • Hand Delivery: U.S. Department of Investigations have revealed that under detail the scope of the Agency’s Transportation, Docket Operations, M– such conditions, vibrations may occur when authority. 30, West Building Ground Floor, Room the hinge moment of the elevator is close to We are issuing this rulemaking under zero, associated to elevator free-play. W12–40, 1200 New Jersey Avenue, SE., the authority described in ‘‘Subtitle VII, Washington, DC, between 9 a.m. and 5 * * * * * Part A, Subpart III, Section 44701: p.m., Monday through Friday, except The unsafe condition is excessive General requirements.’’ Under that Federal holidays. vibration of the elevators, which could section, Congress charges the FAA with result in reduced structural integrity promoting safe flight of civil aircraft in Examining the AD Docket and reduced controllability of the air commerce by prescribing regulations You may examine the AD docket on airplane. The corrective action includes for practices, methods, and procedures the Internet at http:// inspecting the elevators for excessive the Administrator finds necessary for www.regulations.gov; or in person at the freeplay and repairing the elevator or safety in air commerce. This regulation Docket Operations office between 9 a.m. servo controls, if necessary. You may is within the scope of that authority and 5 p.m., Monday through Friday, obtain further information by examining because it addresses an unsafe condition except Federal holidays. The AD docket the MCAI in the AD docket. that is likely to exist or develop on contains this proposed AD, the FAA’s Determination and Requirements products identified in this rulemaking regulatory evaluation, any comments of This Proposed AD action. received, and other information. The street address for the Docket Operations This product has been approved by Regulatory Findings the aviation authority of another office (telephone (800) 647–5527) is in We determined that this proposed AD country, and is approved for operation the ADDRESSES section. Comments will would not have federalism implications in the United States. Pursuant to our be available in the AD docket shortly under Executive Order 13132. This bilateral agreement with the State of after receipt. proposed AD would not have a Design Authority, we have been notified substantial direct effect on the States, on FOR FURTHER INFORMATION CONTACT: Tim of the unsafe condition described in the the relationship between the national Dulin, Aerospace Engineer, MCAI. We are proposing this AD Government and the States, or on the International Branch, ANM–116, because we evaluated all pertinent distribution of power and Transport Airplane Directorate, FAA, information and determined an unsafe responsibilities among the various 1601 Lind Avenue, SW., Renton, condition exists and is likely to exist or levels of government. Washington 98057–3356; telephone develop on other products of the same (425) 227–2141; fax (425) 227–1149. type design. For the reasons discussed above, I SUPPLEMENTARY INFORMATION: certify this proposed regulation: Differences Between This AD and the 1. Is not a ‘‘significant regulatory Comments Invited MCAI or Service Information action’’ under Executive Order 12866; We invite you to send any written We have reviewed the MCAI and, in 2. Is not a ‘‘significant rule’’ under the relevant data, views, or arguments about general, agree with their substance. But DOT Regulatory Policies and Procedures this proposed AD. Send your comments we might have found it necessary to use (44 FR 11034, February 26, 1979); and to an address listed under the different words from those in the MCAI 3. Will not have a significant ADDRESSES section. Include ‘‘Docket No. to ensure the AD is clear for U.S. economic impact, positive or negative, FAA–2009–0713; Directorate Identifier operators and is enforceable. In making on a substantial number of small entities 2007–NM–303–AD’’ at the beginning of these changes, we do not intend to differ under the criteria of the Regulatory your comments. We specifically invite substantively from the information Flexibility Act. comments on the overall regulatory, provided in the MCAI. We prepared a regulatory evaluation economic, environmental, and energy We might also have proposed of the estimated costs to comply with aspects of this proposed AD. We will different actions in this AD from those this proposed AD and placed it in the consider all comments received by the in the MCAI in order to follow FAA AD docket.

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List of Subjects in 14 CFR Part 39 200–001 of the A318/A319/A320/A321 (or their delegated agent). You are required Aircraft Maintenance Manual (AMM). to assure the product is airworthy before it Air transportation, Aircraft, Aviation is returned to service. safety, Safety. (i) Within 20 months since the date of issuance of the original French, German, or (3) Reporting Requirements: For any The Proposed Amendment EASA airworthiness certificate or the date of reporting requirement in this AD, under the issuance of the original French, German, or provisions of the Paperwork Reduction Act, Accordingly, under the authority EASA export certificate of airworthiness, or the Office of Management and Budget (OMB) delegated to me by the Administrator, within 3 months after the effective date of has approved the information collection the FAA proposes to amend 14 CFR part this AD, whichever occurs later. requirements and has assigned OMB Control 39 as follows: (ii) Within 20 months since the last Number 2120–0056. inspection of the elevators for excessive Related Information PART 39—AIRWORTHINESS freeplay performed in accordance with Task DIRECTIVES 27–34–00–200–001 of the Airbus A320 (h) Refer to MCAI EASA Airworthiness Airplane Maintenance Manual. Directive 2007–0163, dated June 11, 2007, for 1. The authority citation for part 39 (2) If any inspection required by paragraph related information. continues to read as follows: (f)(1) of this AD indicates that the freeplay in Issued in Renton, Washington, on August Authority: 49 U.S.C. 106(g), 40113, 44701. the elevator exceeds 7 millimeters, before 3, 2009. further flight, repair the elevator or servo Ali Bahrami, § 39.13 [Amended] controls in accordance with a method Manager, Transport Airplane Directorate, 2. The FAA amends § 39.13 by adding approved by the Manager, International Branch, ANM–116, Transport Airplane Aircraft Certification Service. the following new AD: Directorate, FAA; or the EASA (or its [FR Doc. E9–19419 Filed 8–12–09; 8:45 am] Airbus: Docket No. FAA–2009–0713; delegated agent). BILLING CODE 4910–13–P Directorate Identifier 2007–NM–303–AD. FAA AD Differences Comments Due Date Note 2: This AD differs from the MCAI DEPARTMENT OF TRANSPORTATION (a) We must receive comments by and/or service information as follows: September 14, 2009. (1) The EASA AD applies to Airbus Model Federal Aviation Administration Affected ADs A318, A319, A320, and A321 series airplanes, but the FAA AD applies only to (b) None. Airbus Model A318 series airplanes. The 14 CFR Part 39 Applicability actions required by the EASA AD for Airbus [Docket No. FAA–2009–0712; Directorate Model A319, A320, and A321 series Identifier 2007–NM–152–AD] (c) This AD applies to all Airbus Model airplanes are addressed in FAA AD 2001–16– A318 series airplanes; certificated in any 09, amendment 39–12377, and FAA AD RIN 2120–AA64 category. 2005–22–10 R1, amendment 39–14354. Subject (2) This FAA AD does not require Airworthiness Directives; Bombardier modification of the elevator neutral setting as Model DHC–8–100 and DHC–8–200 (d) Air Transport Association (ATA) of specified in paragraph 2. of the EASA AD Series Airplanes, and Model DHC–8– America Code 27: Flight Controls. because this modification is already part of 301, –311, and –315 Airplanes Reason the FAA-approved type design for Airbus (e) The mandatory continuing Model A318 series airplanes. AGENCY: Federal Aviation airworthiness information (MCAI) states: (3) This FAA AD does not require a Administration (FAA), Department of detailed inspection to determine the position Transportation (DOT) ‘‘Some operators have reported airframe of each tail cone triangle as specified in vibration under specific flight conditions paragraph 3. of the EASA AD because that ACTION: Notice of Proposed Rulemaking including gusts. action was already accomplished on all (NPRM). ‘‘Investigations have revealed that under Airbus Model A318 series airplanes during such conditions, vibrations may occur when production. SUMMARY: The FAA proposes to adopt a the hinge moment of the elevator is close to new airworthiness directive (AD) for zero, associated to elevator free-play.’’ Other FAA AD Provisions certain Bombardier Model DHC–8–100 * * * * * (g) The following provisions also apply to and DHC–8–200 series airplanes, and The unsafe condition is excessive vibration this AD: DHC–8–301, –311, and –315 airplanes. of the elevators, which could result in (1) Alternative Methods of Compliance This proposed AD would require reduced structural integrity and reduced (AMOCs): The Manager, International implementing a corrosion prevention controllability of the airplane. The corrective Branch, FAA, has the authority to approve and control program (CPCP) either by action includes inspecting the elevators for AMOCs for this AD, if requested using the accomplishing specific tasks or by excessive freeplay, and repairing the elevator procedures found in 14 CFR 39.19. Send or servo controls, if necessary. information to ATTN: Tim Dulin, Aerospace revising the maintenance inspection program to include a CPCP. This Actions and Compliance Engineer, International Branch, ANM–116, Transport Airplane Directorate, FAA, 1601 proposed AD results from the (f) Unless already done, do the following Lind Avenue, SW., Renton, Washington determination that, as airplanes age, actions. 98057–3356; telephone (425) 227–2141; fax they are more likely to exhibit (1) At the later of the times specified in (425) 227–1149. Before using any approved indications of corrosion. We are paragraphs (f)(1)(i) and (f)(1)(ii) of this AD, AMOC on any airplane to which the AMOC inspect the elevators for excessive freeplay, proposing this AD to prevent structural applies, notify your principal maintenance failure of the airplane due to corrosion. using a load application tool and a spring inspector (PMI) or principal avionics scale assembly, in accordance with a method inspector (PAI), as appropriate, or lacking a DATES: We must receive comments on approved by the Manager, International principal inspector, your local Flight this proposed AD by September 14, Branch, ANM–116, Transport Airplane Standards District Office. 2009. Directorate, FAA; or the European Aviation (2) Airworthy Product: For any requirement ADDRESSES: Safety Agency (EASA) (or its delegated in this AD to obtain corrective actions from You may send comments by agent). Repeat the inspection at intervals not any of the following methods: a manufacturer or other source, use these • to exceed 20 months. actions if they are FAA-approved. Corrective Federal eRulemaking Portal: Go to Note 1: Guidance on the inspection actions are considered FAA-approved if they http://www.regulations.gov. Follow the procedures can be found in Task 27–34–00– are approved by the State of Design Authority instructions for submitting comments.

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• Fax: 202–493–2251. We will post all comments we continued airworthiness of these • Mail: U.S. Department of receive, without change, to http:// airplanes in Canada. Transportation, Docket Operations, M– www.regulations.gov, including any Levels of Corrosion 30, West Building Ground Floor, Room personal information you provide. We W12–140, 1200 New Jersey Avenue, SE., will also post a report summarizing each The Canadian Airworthiness Directive Washington, DC 20590. substantive verbal contact we receive refers to levels of corrosion. For the • Hand Delivery: U.S. Department of about this proposed AD. purposes of this proposed AD, the levels Transportation, Docket Operations, M– are defined in Part 1 of the Bombardier 30, West Building Ground Floor, Room Discussion (de Havilland) DHC–6 Twin Otter, Dash W12–140, 1200 New Jersey Avenue, SE., Transport Canada Civil Aviation 7 & Dash 8 Corrosion Prevention and Washington, DC 20590, between 9 a.m. (TCCA), which is the airworthiness Control Manual PSM 1–GEN–5, and 5 p.m., Monday through Friday, authority for Canada, notified us that an Revision 3, dated November 30, 1998, as except Federal holidays. unsafe condition may exist on certain follows: For service information identified in Bombardier Model DHC–8–100 and • Level 1 corrosion: this proposed AD, contact Bombardier, DHC–8–200 series airplanes, and Model 1. Occurs between repetitive Inc., 400 Coˆte-Vertu Road West, Dorval, DHC–8–301, –311, and –315 airplanes. inspections, is local, and can be Que´bec H4S 1Y9, Canada; telephone TCCA advises that, as airplanes age, reworked within certain limits; or 514–855–5000; fax 514–855–7401; e- they are more likely to exhibit 2. Is local but exceeds allowable mail [email protected]; indications of corrosion. Operators must limits and is attributed to an event not Internet http://www.bombardier.com. implement a Corrosion Prevention and typical of the usage of the other You may review copies of the Control Program (CPCP) that identifies airplanes in the operator’s fleet; or referenced service information at the specific areas to be inspected to 3. Exceeds allowable limits but for FAA, Transport Airplane Directorate, minimize and control deterioration of which only light corrosion has been 1601 Lind Avenue, SW., Renton, the airplane from corrosion. This found in previous inspections. Washington. For information on the condition, if not corrected, could result • Level 2 corrosion: availability of this material at the FAA, in structural failure of the airplane. call 425–227–1221 or 425–227–1152. 1. Occurs between repetitive Relevant Service Information inspections and exceeds allowable Examining the AD Docket limits, necessitating a repair or complete You may examine the AD docket on Bombardier has issued Part 1, Section replacement of a structural significant the Internet at http:// 3, Structural Inspection Program, of the element; or www.regulations.gov; or in person at the following de Havilland Dash 8 2. Occurs between repetitive Docket Management Facility between 9 Maintenance Program MRB inspections, is widespread, and requires a.m. and 5 p.m., Monday through (Maintenance Review Board) Reports. In a rework approaching allowable limits. Friday, except Federal holidays. The AD this proposed AD, we refer to these • Level 3 corrosion is found during docket contains this proposed AD, the publications as the ‘‘manual.’’ initial or repetitive inspections and is • regulatory evaluation, any comments Program Support Manual (PSM) determined to be a potentially urgent received, and other information. The 1–8–7, Revision 22, dated November 1, unsafe condition necessitating street address for the Docket Office 2008, for Bombardier Model DHC–8– expeditious action. (telephone 800–647–5527) is in the 100 series airplanes. FAA’s Determination and Requirements ADDRESSES section. Comments will be • PSM 1–82–7, Revision 13, dated of the Proposed AD available in the AD docket shortly after November 1, 2008, for Bombardier receipt. Model DHC–8–200 series airplanes. These airplanes are manufactured in • FOR FURTHER INFORMATION CONTACT: PSM 1–83–7, Revision 22, dated Canada and are type certificated for Pong K. Lee, Aerospace Engineer, November 1, 2008, for Bombardier operation in the United States under the Airframe and Mechanical Systems Model DHC–8–300 series airplanes. provisions of section 21.29 of the Branch, ANE–171, FAA, New York The manual provides a basic Federal Aviation Regulations (14 CFR Aircraft Certification Office, 1600 structural inspection schedule, which is 21.29) and the applicable bilateral Stewart Avenue, Suite 410, Westbury, intended to ensure continuous airworthiness agreement. Pursuant to New York 11590; telephone (516) 228– airworthiness. Only primary structures this bilateral airworthiness agreement, 7324; fax (516) 794–5531. defined as Structurally Significant Items TCCA has kept the FAA informed of the SUPPLEMENTARY INFORMATION: (SSIs) and secondary structures whose situation described above. We have failure may adversely affect the systems’ examined TCCA’s findings, evaluated Comments Invited functions are included in the manual. all pertinent information, and We invite you to send any written Canadian airworthiness requirements determined that we need to issue an AD relevant data, views, or arguments about state that the aircraft maintenance for airplanes of this type design that are this proposed AD. Send your comments program must identify specific certificated for operation in the United to an address listed under the inspections under the CPCP. For the States. ADDRESSES section. Include ‘‘Docket No. affected airplanes, the CPCP includes a Therefore, we are proposing this AD, FAA–2009–0712; Directorate Identifier complete re-analysis of the structural which would require implementing a 2007–NM–152–AD’’ at the beginning of inspection program, supported by in- CPCP either by accomplishing specific your comments. We specifically invite service engineering findings. New and tasks or by revising the maintenance comments on the overall regulatory, revised tasks identified as CPCP are inspection program to include a CPCP. economic, environmental, and energy annotated in the manual as ED/CPCP. The proposed AD would require you to aspects of this proposed AD. We will ED stands for ‘‘environmental damage.’’ use the manual described previously to consider all comments received by the TCCA mandated the service perform these actions. The proposed AD closing date and may amend this information and issued Canadian also would require you to report proposed AD because of those Airworthiness Directive CF–2007–06, findings of Level 3 corrosion to the comments. dated April 10, 2007, to ensure the airplane manufacturer and to the FAA.

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Costs of Compliance implications under Executive Order § 39.13 [Amended] This proposed AD would affect about 13132. This proposed AD would not 2. The Federal Aviation 154 airplanes of U.S. registry. There are have a substantial direct effect on the Administration (FAA) amends § 39.13 between 16 and 17 specific inspections, States, on the relationship between the by adding the following new depending on the applicable manual national Government and the States, or airworthiness directive (AD): on the distribution of power and identified in Table 1 of this AD. The Bombardier, Inc. (Formerly de Havilland, proposed inspections would take about responsibilities among the various levels of government. Inc.): Docket No. FAA–2009–0712; 53 work hours per airplane, per Directorate Identifier 2007–NM–152–AD. inspection cycle, at an average labor rate For the reasons discussed above, I of $80 per work hour. Based on these certify that the proposed regulation: Comments Due Date 1. Is not a ‘‘significant regulatory figures, the estimated cost of the (a) The FAA must receive comments on action’’ under Executive Order 12866; proposed AD for U.S. operators is this AD action by September 14, 2009. 2. Is not a ‘‘significant rule’’ under the $652,960, or $4,240 per airplane, per DOT Regulatory Policies and Procedures Affected ADs inspection cycle. (44 FR 11034, February 26, 1979); and (b) None. Authority for This Rulemaking 3. Will not have a significant Applicability economic impact, positive or negative, Title 49 of the United States Code (c) This AD applies to Bombardier Model on a substantial number of small entities specifies the FAA’s authority to issue DHC–8–101, DHC–8–102, DHC–8–103, DHC– under the criteria of the Regulatory rules on aviation safety. Subtitle I, 8–106, DHC–8–201, DHC–8–202, DHC–8– Flexibility Act. Section 106, describes the authority of 301, DHC–8–311, and DHC–8–315 airplanes, We prepared a regulatory evaluation the FAA Administrator. Subtitle VII, certificated in any category; serial numbers of the estimated costs to comply with Aviation Programs, describes in more 003 and subsequent. this proposed AD and placed it in the detail the scope of the Agency’s Subject AD docket. See the ADDRESSES section authority. for a location to examine the regulatory (d) Air Transport Association (ATA) of We are issuing this rulemaking under evaluation. America Codes 32: Landing Gear, 51: the authority described in Subtitle VII, Standard Practices/Structures; 52: Doors; 53: Part A, Subpart III, Section 44701, List of Subjects in 14 CFR Part 39 Fuselage; 54: Nacelles/Pylons; 55: Stabilizers; and 57: Wings. ‘‘General requirements.’’ Under that Air transportation, Aircraft, Aviation section, Congress charges the FAA with safety, Incorporation by reference, Unsafe Condition promoting safe flight of civil aircraft in Safety. (e) This AD results from the determination air commerce by prescribing regulations that, as airplanes age, they are more likely to for practices, methods, and procedures The Proposed Amendment exhibit indications of corrosion. We are the Administrator finds necessary for Accordingly, under the authority issuing this AD to prevent structural failure safety in air commerce. This regulation delegated to me by the Administrator, of the airplane due to corrosion. is within the scope of that authority the FAA proposes to amend 14 CFR part Compliance because it addresses an unsafe condition 39 as follows: that is likely to exist or develop on (f) You are responsible for having the products identified in this rulemaking PART 39—AIRWORTHINESS actions required by this AD performed within the compliance times specified, unless the action. DIRECTIVES actions have already been done. Regulatory Findings 1. The authority citation for part 39 Manual References We have determined that this continues to read as follows: (g) This AD refers to the manuals listed in proposed AD would not have federalism Authority: 49 U.S.C. 106(g), 40113, 44701. Table 1 of this AD.

TABLE 1—APPLICABLE MANUALS

Bombardier model Manual

(1) DHC–8–101, –102, –103, and –106 air- Part 1, Section 3, Structural Inspection Program, of the Dash 8 Maintenance Program MRB planes. (Maintenance Review Board) Report Program Support Manual (PSM) 1–8–7, Revision 22, dated November 1, 2008. (2) DHC–8–201 and DHC–8–202 airplanes ...... Part 1, Section 3, Structural Inspection Program, of the Dash 8 Maintenance Program MRB Report PSM 1–82–7, Revision 13, dated November 1, 2008. (3) Model DHC–8–301, DHC–8–311, and DHC– Part 1, Section 3, Structural Inspection Program, of the Dash 8 Maintenance Program MRB 8–315 airplanes. Report PSM 1–83–7, Revision 22, dated November 1, 2008.

Inspections (1) Within 24 months after the effective this AD, the FAA may approve the (h) At the later of the times specified in date of this AD. incorporation into the operator’s approved paragraphs (h)(1) and (h)(2) of this AD, do (2) At the compliance time specified in the maintenance/inspection program of the CPCP each of the Environmental Damage/Corrosion ‘‘Threshold’’ column of the applicable specified in the applicable manual identified Protection and Control Program (ED/CPCP) manual identified in Table 1 of this AD since in Table 1 of this AD; or the equivalent inspections, including re-protection tasks, as the date of issuance of the original Canadian program that is approved in accordance with applicable, in accordance with the applicable airworthiness certificate or the date of this AD. In all cases, the initial corrosion task manual identified in Table 1 of this AD. issuance of the original Canadian export for each airplane area must be completed by Except as provided by paragraph (i) of this certificate of airworthiness. If there is no the initial compliance time specified in AD, repeat each task thereafter at intervals value in the ‘‘Threshold’’ column, use the paragraph (h) of this AD. not to exceed the compliance time specified time specified in the ‘‘Repeat’’ column. (1) Any operator complying with paragraph in the ‘‘Repeat’’ column of the applicable (i) After accomplishment of each initial (i) of this AD may use an alternative manual identified in Table 1 of this AD. ED/CPCP task required by paragraph (h) of recordkeeping method to that otherwise

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required by section 91.417 (‘‘Maintenance accomplish the applicable task on the Office. The AMOC approval letter must records’’) or section 121.380 (‘‘Maintenance remainder of the airplanes in the operator’s specifically reference this AD. recording requirements’’) of the Federal fleet that are subject to this AD. Aviation Regulations (14 CFR 91.417 or 14 Related Information CFR 121.380, respectively) for the actions Limiting Future Corrosion Findings (o) Canadian airworthiness directive CF– required by this AD, provided that the (l) If corrosion findings that exceed Level 2007–06, dated April 10, 2007, also addresses recordkeeping method is approved by the 1 are found in any area during any repeat of the subject of this AD. FAA and is included in a revision to the any CPCP task after the initial Issued in Renton, Washington, on August maintenance/inspection program. For the accomplishment required by paragraph (h) of 3, 2009. purposes of this paragraph, ‘‘the FAA’’ is this AD: Within 60 days after such finding, defined as the cognizant Principal implement a means approved by the FAA to Ali Bahrami, Maintenance Inspector (PMI) for operators reduce future findings of corrosion in that Manager, Transport Airplane Directorate, that are assigned a PMI (i.e., part 121, 125, area to Level 1 or better. For the purposes of Aircraft Certification Service. and 135 operators), and the cognizant Flight this paragraph, ‘‘the FAA’’ is defined as the [FR Doc. E9–19420 Filed 8–12–09; 8:45 am] Standards District Office for other operators cognizant PMI for operators that are assigned (i.e., part 91 operators). a PMI (i.e., part 121, 125, and 135 operators), BILLING CODE 4910–13–P (2) After the initial accomplishment of the and the cognizant Flight Standards District ED/CPCP tasks required by paragraph (h) of Office for other operators (i.e., part 91 this AD, any extension of the repetitive operators). DEPARTMENT OF TRANSPORTATION intervals specified in the manual must be approved by the Manager, New York Aircraft Scheduling Corrosion Tasks for Transferred Federal Aviation Administration Certification Office (ACO), FAA. Airplanes (m) Before any airplane subject to this AD 14 CFR Part 39 Corrective Actions is transferred and placed into service by an (j) If any corrosion is found during operator: Establish a schedule for [Docket No. FAA–2009–0745; Directorate accomplishment of any action required by accomplishing the CPCP tasks required by Identifier 2009–CE–036–AD] paragraph (h) of this AD: Before further this AD in accordance with paragraph (m)(1) flight, rework, repair, or replace, as or (m)(2) of this AD, as applicable. applicable, in accordance with a method (1) For airplanes on which the CPCP tasks RIN 2120–AA64 approved by either the Manager, New York required by this AD have been accomplished ACO, FAA; or Transport Canada Civil previously at the schedule established by this Airworthiness Directives; American Aviation (TCCA) (or its delegated agent). AD: Perform the first CPCP task in each area Champion Aircraft Corp. Models 7ECA, in accordance with the previous operator’s Reporting Requirements for Level 3 7GCAA, 7GCBC, 7KCAB, 8KCAB, and schedule, or in accordance with the new 8GCBC Airplanes Corrosion Findings operator’s schedule, whichever results in an (k) If any Level 3 corrosion, as defined in earlier accomplishment of that CPCP task. AGENCY: Federal Aviation Part 1 of the Bombardier (de Havilland) After the initial accomplishment of each Administration (FAA), Department of DHC–6 Twin Otter, Dash 7 & Dash 8 CPCP task in each area as required by this Transportation (DOT). Corrosion Prevention and Control Manual paragraph, repeat each CPCP task in PSM 1–GEN–5, Revision 3, dated November accordance with the new operator’s schedule. ACTION: Notice of Proposed Rulemaking 30, 1998, is found during the (2) For airplanes on which the CPCP tasks (NPRM). accomplishment of any action required by required by this AD have not been this AD, do paragraphs (k)(1), (k)(2), and accomplished previously, or have not been SUMMARY: We propose to adopt a new (k)(3) of this AD. Under the provisions of the accomplished at the schedule established by airworthiness directive (AD) for all Paperwork Reduction Act, the Office of this AD: The new operator must perform American Champion Aircraft Corp. Management and Budget (OMB) has each initial CPCP task in each area before Models 7ECA, 7GCAA, 7GCBC, 7KCAB, approved the information collection further flight or in accordance with a 8KCAB, and 8GCBC airplanes, requirements and has assigned OMB Control schedule approved by the FAA. For the manufactured prior to 1989 and Number 2120–0056. purposes of this paragraph, ‘‘the FAA’’ is equipped with folding rear seat backs. (1) Within 3 days after the finding of Level defined as the cognizant Principal 3 corrosion, report findings to the Manager, Maintenance Inspector (PMI) for operators This proposed AD would require New York ACO, FAA, in accordance with the that are assigned a PMI (i.e., part 121, 125, inspection of the rear seat back hinge Bombardier (de Havilland) DHC–6 Twin and 135 operators), and the cognizant Flight areas for cracking and excessive Otter, Dash 7 & Dash 8 Corrosion Prevention Standards District Office for other operators elongation of the rear seat hinge bolt and Control Manual PSM 1–GEN–5, Revision (i.e., part 91 operators). hole and, if cracking or excessive 3, dated November 30, 1998. Alternative Methods of Compliance elongation is found, replacement of the (2) Within 10 days after the finding of rear seat frame. This proposed AD Level 3 corrosion, either submit a plan to the (AMOCs) FAA to identify a schedule for accomplishing (n)(1) The Manager, New York ACO, FAA, results from an occurrence of the rear the applicable CPCP task on the remainder of has the authority to approve AMOCs for this seat hinge area failing in flight. We are the airplanes in the operator’s fleet that are AD, if requested using the procedures found proposing this AD to detect and correct subject to this AD, or provide data in 14 CFR 39.19. Send information to ATTN: cracking of the rear seat back hinge area substantiating that the Level 3 corrosion that Pong K. Lee, Aerospace Engineer, Airframe and excessive elongation of the rear seat was found is an isolated case. The FAA may and Mechanical Systems Branch, ANE–171, hinge bolt hole, either of which could impose a schedule other than that proposed FAA, New York Aircraft Certification Office, result in failure of the seat back. This in the plan upon finding that a change to the 1600 Stewart Avenue, Suite 410, Westbury, failure could lead to a rear-seated pilot schedule is needed to ensure that any other New York 11590; telephone (516) 228–7324; Level 3 corrosion is detected in a timely fax (516) 794–5531. or passenger inadvertently interfering manner. For the purposes of this paragraph, (2) To request a different method of with the control stick while attempting ‘‘the FAA’’ is defined as the cognizant compliance or a different compliance time to not roll to the rear of the airplane Principal Maintenance Inspector (PMI) for for this AD, follow the procedures in 14 CFR upon seat back failure. Consequently, operators that are assigned a PMI (i.e., part 39.19. Before using any approved AMOC on this failure could result in loss of 121, 125, and 135 operators), and the any airplane to which the AMOC applies, control. cognizant Flight Standards District Office for notify your principal maintenance inspector other operators (i.e., part 91 operators). (PMI) or principal avionics inspector (PAI), DATES: We must receive comments on (3) Within the time schedule approved in as appropriate, or lacking a principal this proposed AD by September 28, accordance with paragraph (k)(2) of this AD, inspector, your local Flight Standards District 2009.

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ADDRESSES: Use one of the following comments to an address listed under the pilot or passenger inadvertently addresses to comment on this proposed ADDRESSES section. Include the docket interfering with the control stick while AD: number, ‘‘FAA–2009–0745; Directorate attempting to not roll to the rear of the • Federal eRulemaking Portal: Go to Identifier 2009–CE–036–AD’’ at the airplane upon seat back failure. http://www.regulations.gov. Follow the beginning of your comments. We Consequently, this failure could result instructions for submitting comments. specifically invite comments on the in loss of control. • Fax: (202) 493–2251. overall regulatory, economic, Relevant Service Information • Mail: U.S. Department of environmental, and energy aspects of Transportation, Docket Operations, M– the proposed AD. We will consider all We have reviewed American 30, West Building Ground Floor, Room comments received by the closing date Champion Aircraft Corp. Service Letter W12–140, 1200 New Jersey Avenue, SE., and may amend the proposed AD in No. 431, dated July 20, 2009. Washington, DC 20590. light of those comments. The service information describes • Hand Delivery: U.S. Department of We will post all comments we procedures for inspecting the rear seat Transportation, Docket Operations, M– receive, without change, to http:// hinge areas for cracking and excessive 30, West Building Ground Floor, Room www.regulations.gov, including any elongation of the rear seat hinge bolt W12–140, 1200 New Jersey Avenue, SE., personal information you provide. We and, if cracking or excessive elongation Washington, DC 20590, between 9 a.m. will also post a report summarizing each is found, replacing the rear seat frame. and 5 p.m., Monday through Friday, substantive verbal contact we receive except Federal holidays. concerning this proposed AD. FAA’s Determination and Requirements of the Proposed AD For service information identified in Discussion this proposed AD, contact American We received information that during a We are proposing this AD because we Champion Aircraft Corporation, P.O. training flight on an American evaluated all information and Box 37, 32032 Washington Ave., Champion Aircraft Corp. Model 8KCAB determined the unsafe condition Rochester, Wisconsin 53167; telephone: airplane the rear seat hinge failed. While described previously is likely to exist or (262) 534–6315; fax: (262) 534–2395; performing spins, with the student pilot develop on other products of the same Internet: http:// in the front seat and the instructor pilot type design. This proposed AD would www.amerchampionaircraft.com/ in the rear seat, the rear seat hinge require inspecting the rear seat back Technical/Technical.html. broke, which resulted in the rear seat hinge areas for cracking and excessive FOR FURTHER INFORMATION CONTACT: back failing. The instructor pilot elongation of the rear seat hinge bolt Wess Rouse, Aerospace Engineer, 2300 partially fell into the baggage area. The hole and, if cracking or excessive East Devon Avenue, Room 107, Des student and the instructor were able to elongation is found, replacing the rear Plaines, Illinois 60018; telephone: (847) recover from the spins and landed safely seat frame. 294–8113; fax: (847) 294–7834. at the airport. Costs of Compliance SUPPLEMENTARY INFORMATION: The Models 7GCAA, 7GCBC, 7KCAB, and 8GCBC airplanes incorporate the We estimate that this proposed AD Comments Invited same or similar seat configuration. would affect 2,000 airplanes in the U.S. We invite you to send any written This condition, if not corrected, could registry. relevant data, views, or arguments result in failure of the rear seat back. We estimate the following costs to do regarding this proposed AD. Send your This failure could lead to a rear-seated the proposed inspection:

Total cost per Total cost on Labor cost Parts cost airplane U.S. operators

.5 work-hour × $80 per hour = $40 ...... Not applicable ...... $40 $80,000

We estimate the following costs to do be required based on the results of the determining the number of airplanes any necessary replacements that would proposed inspection. We have no way of that may need this replacement:

Labor cost Parts cost Total cost per airplane

1.5 work-hours × $80 per hour = $120 ...... Remanufactured seat $200, New standard Remanufactured seat $320, New standard seat $645, New wide seat $765. seat $765, New wide seat $885.

Authority for This Rulemaking section, Congress charges the FAA with Regulatory Findings Title 49 of the United States Code promoting safe flight of civil aircraft in We have determined that this specifies the FAA’s authority to issue air commerce by prescribing regulations proposed AD would not have federalism rules on aviation safety. Subtitle I, for practices, methods, and procedures implications under Executive Order Section 106, describes the authority of the Administrator finds necessary for 13132. This proposed AD would not the FAA Administrator. Subtitle VII, safety in air commerce. This regulation have a substantial direct effect on the Aviation Programs, describes in more is within the scope of that authority States, on the relationship between the detail the scope of the Agency’s because it addresses an unsafe condition national government and the States, or authority. that is likely to exist or develop on on the distribution of power and We are issuing this rulemaking under products identified in this rulemaking responsibilities among the various the authority described in Subtitle VII, action. levels of government. Part A, Subpart III, Section 44701, For the reasons discussed above, I ‘‘General requirements.’’ Under that certify that the proposed regulation:

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1. Is not a ‘‘significant regulatory List of Subjects in 14 CFR Part 39 Affected ADs action’’ under Executive Order 12866; Air transportation, Aircraft, Aviation (b) None. 2. Is not a ‘‘significant rule’’ under the safety, Incorporation by reference, DOT Regulatory Policies and Procedures Applicability Safety. (44 FR 11034, February 26, 1979); and (c) This AD applies to Models 7ECA, 3. Will not have a significant The Proposed Amendment 7GCAA, 7GCBC, 7KCAB, 8KCAB, and economic impact, positive or negative, 8GCBC airplanes, all serial numbers, that are: Accordingly, under the authority on a substantial number of small entities (1) Manufactured prior to 1989; under the criteria of the Regulatory delegated to me by the Administrator, (2) Equipped with folding rear seat backs; Flexibility Act. the FAA proposes to amend 14 CFR part and We prepared a regulatory evaluation 39 as follows: (3) Certificated in any category. of the estimated costs to comply with PART 39—AIRWORTHINESS Unsafe Condition this proposed AD and placed it in the DIRECTIVES AD docket. (d) This AD results from an occurrence of the rear seat frame failing in flight. We are 1. The authority citation for part 39 Examining the AD Docket proposing this AD to detect and correct continues to read as follows: You may examine the AD docket that cracking of the rear seat back hinge area and contains the proposed AD, the Authority: 49 U.S.C. 106(g), 40113, 44701. excessive elongation of the rear seat hinge regulatory evaluation, any comments bolt hole, which could result in failure of the § 39.13 [Amended] rear seat back. This failure could lead to a received, and other information on the 2. The FAA amends § 39.13 by adding Internet at http://www.regulations.gov; rear-seated pilot or passenger inadvertently the following new AD: interfering with the control stick while or in person at the Docket Management American Champion Aircraft Corp.: Docket attempting to not roll to the rear of the Facility between 9 a.m. and 5 p.m., airplane upon seat back failure. Monday through Friday, except Federal No. FAA–2009–0745; Directorate Identifier 2009–CE–036–AD. Consequently, this failure could result in loss holidays. The Docket Office (telephone of control. (800) 647–5527) is located at the street Comments Due Date Compliance address stated in the ADDRESSES section. (a) We must receive comments on this Comments will be available in the AD airworthiness directive (AD) action by (e) To address this problem, you must do docket shortly after receipt. September 28, 2009. the following, unless already done:

Actions Compliance Procedures

(1) Inspect the rear seat back hinge area for Within the next 25 hours time-in-service (TIS) Follow American Champion Aircraft Corp. cracking and elongation of the rear seat after the effective date of this AD and repet- Service Letter No. 431, dated July 20, hinge bolt hole. itively thereafter at intervals not to exceed 2009. every 100 hours TIS or every 12 months, whichever occurs first. (2) If cracking or excessive elongation of the Before further flight after the inspection where Follow American Champion Aircraft Corp. rear seat bolt hole is found during any in- cracking or excessive elongation of the rear Service Letter No. 431, dated July 20, spection required in paragraph (e)(1) of this seat bolt hole is found. 2009. AD, replace the seat frame with a factory re- manufactured seat frame, a new part number (P/N) 7–1500 (standard) seat frame, or a new P/N 7–1501 (wide) seat frame. Replace- ment of the seat frame terminates the repet- itive inspections requirements of this AD. (3) You may at any time replace the rear seat Not applicable...... Follow American Champion Aircraft Corp. frame with a factory remanufactured seat Service Letter No. 431, dated July 20, frame, a new part number (P/N) 7–1500 2009. (standard) seat frame, or a new P/N 7–1501 (wide) seat frame to terminate the repetitive inspection requirements of this AD.

Alternative Methods of Compliance Related Information Issued in Kansas City, Missouri, on August (AMOCs) (g) To get copies of the service information 7, 2009. (f) The Manager, Chicago Aircraft referenced in this AD, contact American Scott A. Horn, Certification Office, FAA, has the authority to Champion Aircraft Corporation, P.O Box 37, Acting Manager, Small Airplane Directorate, approve AMOCs for this AD, if requested 32032 Washington Ave., Rochester, Aircraft Certification Service. using the procedures found in 14 CFR 39.19. Wisconsin 53167; telephone: (262) 534–6315; [FR Doc. E9–19448 Filed 8–12–09; 8:45 am] Send information to ATTN: Wess Rouse, fax: (262) 534–2395; Internet: http:// BILLING CODE 4910–13–P Aerospace Engineer, 2300 East Devon www.amerchampionaircraft.com/Technical/ Avenue, Room 107, Des Plaines, Illinois Technical.html. To view the AD docket, go 60018; telephone: (847) 294–8113; fax: (847) to U.S. Department of Transportation, Docket 294–7834. Before using any approved AMOC Operations, M–30, West Building Ground on any airplane to which the AMOC applies, Floor, Room W12–140, 1200 New Jersey notify your appropriate principal inspector Avenue, SE., Washington, DC 20590, or on (PI) in the FAA Flight Standards District the Internet at http://www.regulations.gov. Office (FSDO), or lacking a PI, your local FSDO.

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CONSUMER PRODUCT SAFETY other sensitive or protected information party conformity assessment bodies to COMMISSION electronically. Such information should assess conformity with specific laws or be submitted in writing. regulations, and the Commission has 16 CFR Part 1112 Docket: For access to the docket to published several notices of [CPSC Docket No. CPSC–2009–0061] read background documents or requirements in the Federal Register comments received, go to http:// (see 73 FR 54564 (September 22, 2008) Audit Requirements for Third Party www.regulations.gov. (Notice of Requirements for Conformity Assessment Bodies FOR FURTHER INFORMATION CONTACT: Accreditation of Third Party Conformity Randy Butturini, U.S. Consumer Assessment Bodies to Assess AGENCY: Consumer Product Safety Product Safety Commission, 4330 East Conformity with part 1301 of Title 16, Commission. West Highway, Bethesda, Maryland Code of Federal Regulations)); 73 FR ACTION: Proposed rule. 20814; 301–504–7562; e-mail: 62965 (October 22, 2008) (Notice of [email protected]. Requirements for Accreditation of Third SUMMARY: The Consumer Product Safety Party Conformity Assessment Bodies to Commission (‘‘CPSC’’ or ‘‘Commission’’) SUPPLEMENTARY INFORMATION: Assess Conformity With Part 1508, Part is proposing to issue regulations I. Introduction 1509, and/or Part 1511 of Title 16, Code establishing requirements for the Section 14(a)(1) of the CPSA (15 of Federal Regulations)); 73 FR 67838 periodic audit of third party conformity (November 17, 2008) (Notice of assessment bodies as a condition for U.S.C. 2063(a)(1)), as amended by the CPSIA (Pub. L. 110–314, 122 Stat. 3016), Requirements for Accreditation of Third their continuing accreditation. The Party Conformity Assessment Bodies to proposed rule would implement section requires that the manufacturer (including the importer) and the private Assess Conformity With part 1501 of 14(d) of the Consumer Product Safety Title 16, Code of Federal Regulations); Act (‘‘CPSA’’), as amended by section labeler, if any, of a product that is subject to an applicable consumer and 73 FR 78331 (December 22, 2008) 102(b) of the Consumer Product Safety (Notice of requirements for accreditation Improvement Act of 2008 (‘‘CPSIA’’). product safety rule under the CPSA, or any similar rule, ban, standard, or of third party conformity assessment DATES: Submit written or electronic bodies to assess conformity with the 600 comments on the proposed rule by regulation under any other Act enforced by the CPSC, issue a certificate which parts per million (‘‘ppm’’) and 300 ppm October 13, 2009. Submit comments on lead content limits in metal and metal information collection issues under the certifies ‘‘based on a test of each product or upon a reasonable testing program, alloy parts of children’s metal jewelry Paperwork Reduction Act of 1995 by established by the Consumer Product September 14, 2009, (see the that such product complies with all rules, bans, standards, or regulations Safety Improvement Act of 2008)). ‘‘Paperwork Reduction Act’’ section of Section 14(d)(1) of the CPSA, as applicable to the product under this Act this document). added by the CPSIA, requires the or any other Act enforced by the ADDRESSES: You may submit comments, Commission to establish ‘‘requirements Commission’’ and specifies each rule, identified by Docket No. CPSC–2009– for the periodic audit of third party ban, standard, or regulation applicable 0061, by any of the following methods: conformity assessment bodies as a to the product. This requirement applies condition for the continuing Electronic Submissions to any such product manufactured on or accreditation of such conformity after November 12, 2008. Section Submit electronic comments in the assessment bodies’’ under section 14(a)(4) of the CPSA gives the CPSC the following way: 14(a)(3)(C) of the CPSA. Federal eRulemaking Portal: http:// authority to designate, by rule, one or This proposed rule, if finalized, www.regulations.gov. Follow the more of these parties to issue the would implement section 14(d)(1) of the instructions for submitting comments. required certificate and to relieve the CPSA. To ensure timely processing of other parties enumerated in section 14 comments, the Commission is no longer of the CPSA from the requirement to II. Description of the Proposed Rule accepting comments submitted by furnish certificates. The CPSC issued a The proposal would create a new part electronic mail (e-mail) except through final rule in the Federal Register on 1112, titled ‘‘Audit Requirements for www.regulations.gov. November 18, 2008 (73 FR 68328) Third Party Conformity Assessment pertaining to such certificates of Bodies,’’ in Title 16 of the Code of Written Submissions compliance. Federal Regulations. Submit written submissions in the Section 14(a)(2) of the CPSA following way: establishes a third party testing A. Proposed § 1112.1—Purpose Mail/Hand delivery/Courier (for requirement for children’s products that Proposed § 1112.1 would describe the paper, disk, or CD–ROM submissions), are subject to a children’s product safety purpose behind the new part 1112. In preferably in five copies, to: Office of rule. In general, section 14(a)(2) of the brief, proposed § 1112.1 would state that the Secretary, Consumer Product Safety CPSA states, in part, that every part 1112 ‘‘establishes the audit Commission, Room 502, 4330 East West manufacturer or private labeler (if the requirements for third party conformity Highway, Bethesda, MD 20814; children’s product bears a private label) assessment bodies pursuant to section telephone (301) 504–7923. of such products shall submit sufficient 14(d)(1) of the Consumer Product Safety Instructions: All submissions received samples of the product, or samples that Act (CPSA) (15 U.S.C. 2063(d)(1)).’’ must include the agency name and are identical in all material respects to Under section 14(d)(1) of the CPSA, docket number for this rulemaking. All the product, to an accredited third party compliance with the requirements in comments received may be posted conformity assessment body to be tested part 1112 would be a condition for the without change, including any personal for compliance with such children’s continuing accreditation of such third identifiers, contact information, or other product safety rule. Section 14(a)(3) of party conformity assessment bodies. personal information provided, to the CPSA establishes various time lines Section 14(f)(2)(C) of the CPSA, http://www.regulations.gov. Do not for accreditation and requires the ‘‘Testing and Certification of Art submit confidential business Commission to publish notice of the Materials and Products,’’ states that a information, trade secret information, or requirements for accreditation of third certifying organization as defined in 16

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CFR 1500.14(b)(8), Appendix A, ‘‘(or be presented to the advisory board for Standard ISO/IEC 17025:2005, ‘General any successor regulation or ruling) arbitration.’’ Requirements for the Competence of meets the requirements of [section Thus, because section 14(f)(2)(A) of Testing and Calibration Laboratories’ ’’ 14(f)(2)(A) of the CPSA] with respect to the CPSA considers organizations that and any test methods or consumer the certification of art material and art follow the guideline listed at Appendix product safety requirements specified in products required under this section or A to 16 CFR 1500.14(b)(8) to be third the relevant notice of requirements by regulations prescribed under the party conformity assessment bodies and issued by the Commission and is a Federal Hazardous Substances Act (15 because the ‘‘Guidelines for a Certifying signatory to the International Laboratory U.S.C. 1261 et seq.).’’ These certifying Organization’’ establish a mechanism Accreditation Cooperation—Mutual organizations certify that art materials for reviewing the toxicologist’s work Recognition Arrangement. The proposed conform to the requirements of ASTM (either periodically or in response to a definition of ‘‘accreditation body’’ D–4236 under the Labeling of disagreement), the proposed rule would reflects the basic elements the Hazardous Art Materials Act (LHAMA), not subject these certifying Commission has specified in its notices 15 U.S.C. 1277, which provided that the organizations to the audit requirements of requirements for the accreditation of provisions of ASTM D–4236 shall be in part 1112. third party conformity assessment deemed a regulation issued by the B. Proposed § 1112.3—Definitions bodies. Additionally, the phrase ‘‘at a Commission. Those requirements are minimum’’ recognizes that some codified at 16 CFR 1500.14(b)(8). Proposed § 1112.3 would define accreditation bodies may, as part of the various terms used in part 1112. accreditation process, demand that a LHAMA and the standard it mandated Proposed § 1112.3(a) would define provide certain requirements for art third party conformity assessment body ‘‘accreditation’’ as: A procedure by demonstrate its conformance with materials. Under these requirements, the which an authoritative body gives producer or repackager of an art specific methods or programs in formal recognition that a third party addition to demonstrating conformance material must submit the product’s conformity assessment body is formulation or reformulation to a with ISO/IEC 17025 and with any test competent to perform specific tasks. methods identified in the relevant toxicologist who will review the Accreditation recognizes a third party formulation to determine if the art notices of requirements issued by the conformity assessment body’s technical Commission. material has potential to produce competence and is usually specific for chronic adverse health effects through ISO/IEC 17025 incorporates by tests of the systems, products, reference the definitions in ISO/IEC customary or reasonably foreseeable components, or materials for which the 17000, and ISO/IEC 17000 defines use. If the toxicologist does determine third party conformity assessment body ‘‘accreditation body’’ as an that the art material has this potential, claims proficiency. ‘‘authoritative body that performs the toxicologist will recommend The proposed definition is based on a accreditation.’’ However, for purposes of appropriate chronic hazard labeling, description used by the International the proposed rule, the Commission and the producer or repackager must Organization for Standardization (ISO) believes that the proposed definition is use suitable precautionary labeling on in relation to ISO Standard ISO/IEC more explanatory and, in this instance, the product. If the art material presents 17025:2005, ‘‘General Requirements for more consistent with the notices of an acute hazard, the labeling also must the Competence of Testing and requirements for the accreditation of contain an acute hazard warning. Calibration Laboratories’’ (see third party conformity assessment Under LHAMA, the producer or International Organization for bodies. manufacturer of the art material must Standardization, ‘‘Accreditation,’’ Proposed § 1112.3(c) would define submit to the Commission a written accessed on the Internet at http:// ‘‘audit’’ as ‘‘a systematic, independent, description of the criteria the www.isoiec17025.com/wst_page4.html), documented process for obtaining toxicologist uses to determine whether except that it uses the term ‘‘third party records, statements of fact, or other the producer/repackager’s product has conformity assessment body’’ instead of relevant information, and assessing the potential to produce chronic adverse ‘‘lab’’ and refers to ‘‘technical them objectively to determine the extent health effects and a list of art materials competence’’ instead of ‘‘technical to which specified requirements are that require chronic hazard warning capability.’’ The term ‘‘third party fulfilled.’’ The proposed definition is labels. A conformance statement conformity assessment body’’ is used in almost identical to the definition of indicating that the product has been section 14(a)(3)(C) of the CPSA. The ‘‘audit’’ in ISO/IEC 17000. Proposed reviewed in accordance with the Commission is aware that ISO/IEC § 1112.3(c) also would explain that, for standard as required must appear either 17025, by reference, incorporates the purposes of part 1112, an audit is on the product, at point of sale, or on definitions set forth in ISO/IEC composed of two parts: (1) An an invoice. Furthermore, the 17000:2004, ‘‘Conformity Assessment— examination by an accreditation body to ‘‘Guidelines for a Certifying Vocabulary and General Principles,’’ but determine whether the third party Organization,’’ which can be found as ISO/IEC 17000’s definition of conformity assessment body meets or Appendix A to 16 CFR 1500.14(b)(8), ‘‘accreditation’’ incorporates several continues to meet the conditions for state, in part, that an ‘‘advisory board other definitions by implied reference. accreditation (a process known more composed of not less than three or more Therefore, the proposed rule would commonly as a ‘‘reassessment’’ and than five toxicologists, at least one of adopt a more explanatory definition which the remainder of this preamble whom is certified in toxicology by a rather than adopt a definition from ISO/ will refer to as a ‘‘reassessment’’); and nationally recognized certification IEC 17000 whose terms necessitate (2) the resubmission of the ‘‘Consumer board’’ should conduct periodic reviews additional definition themselves. Product Conformity Assessment Body of a toxicologist’s reviews and that, ‘‘In Proposed § 1112.3(b) would define Acceptance Registration Form’’ (CPSC cases where there is a disagreement by ‘‘accreditation body’’ as ‘‘an entity that Form 223) by the third party conformity participating producers or participating accredits or has accredited a third party assessment body and the CPSC’s users, with the determination of the conformity assessment body as meeting, examination of the resubmitted CPSC toxicologist(s), there should be a method at a minimum, the International Form 223 (which the remainder of this whereby the toxicologist’s decision can Organization for Standardization (ISO) preamble will refer to as an

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‘‘examination’’ by the CPSC). For definition is patterned after the the CPSC’s examination may include example, assume that a third party explanation of the quality manager’s verification to ensure that the entity conformity assessment body is role in ISO/IEC 17025, section 4.1.5. continues to meet the appropriate accredited as conforming to ISO/IEC Proposed § 1112.3(f) would explain statutory criteria pertaining to such 17025 and to the testing pertaining to 16 that, unless otherwise stated, the conformity assessment bodies. CFR part 1501 (which pertains to definitions of section 3 of the CPSA and Under proposed § 1112.7(a), the ‘‘Method for Identifying Toys and Other additional definitions in the CPSIA reassessment portion of the audit may Articles Intended for Use by Children apply for purposes of part 1112 of this cover the management systems, specific Under 3 Years of Age Which Present title. Thus, for example, the CPSIA’s tests, types of tests, calibrations, or Choking, Aspiration, or Ingestion definition of ‘‘third party conformity types of calibrations that are the subject Hazards Because of Small Parts’’). The assessment body,’’ which includes of the third party conformity assessment ‘‘reassessment’’ portion of the audit, in independent conformity assessment body’s accreditation. For example, if an this example, would consist of the bodies, government-owned or accreditation body accredited a third assessment or reassessment of the third government-controlled conformity party conformity assessment body on party conformity assessment body by assessment bodies (subject to certain the latter’s conformity with ISO/IEC the accreditation body relative to ISO/ requirements in section 14(f)(2)(B) of the 17025 and additional method(s) or IEC 17025 and the testing pertaining to CPSA), and ‘‘firewalled’’ conformity programs from the accreditation body or 16 CFR part 1501. The ‘‘examination’’ assessment bodies (subject to certain tests identified in the relevant notice of portion of the audit would consist of the requirements in section 14(f)(2)(D) of requirements issued by the Commission, third party conformity assessment body the CPSA), would apply to part 1112, the reassessment portion of the audit re-registering at the CPSC through the and the term ‘‘third party conformity could have the accreditation body assess completion of a new CPSC Form 223 assessment body’’ in part 1112 would be the third party conformity assessment and the CPSC’s review of the understood as including all three types body’s conformity with ISO/IEC 17025 information in the resubmitted form. If of conformity assessment bodies. and assess whether the third party conformity assessment body is qualified the third party conformity assessment C. Proposed § 1112.5—Who Is Subject to to use the specific method(s) or body is a ‘‘firewalled’’ conformity These Audit Requirements? assessment body or a government- programs from the accreditation body or owned or government-controlled Proposed § 1112.5 would explain that the tests identified in the relevant notice conformity assessment body, the CPSC’s the requirements in part 1112 apply to of requirements. The examination examination may include verification to third party conformity assessment portion of the audit conducted by the ensure that the entity continues to meet bodies operating pursuant to section CPSC would consist of the third party the appropriate statutory criteria 14(a)(2) of the CPSA and would reiterate conformity assessment body’s pertaining to such conformity that third party conformity assessment resubmission of a CPSC Form 223, the assessment bodies. (A ‘‘firewalled’’ bodies must comply with the audit CPSC’s examination of the resubmitted conformity assessment body is a requirements as a continuing condition form, and a check by the CPSC to see conformity assessment body that is of the Commission’s acceptance of their whether the third party conformity ‘‘owned, managed, or controlled by a accreditation. However, as explained assessment body continues to meet the manufacturer or private labeler,’’ and earlier in part II.A of this preamble, statutory requirements applicable to it. such conformity assessment bodies are certifying organizations described in It is important to note that, with one subject to certain statutory requirements Appendix A to 16 CFR 1500.14(b)(8) exception, the proposed rule would not and are accredited by the Commission (pertaining to LHAMA and the specify the precise scope of a by order (see section 14(f)(2)(D) of the certification of art material and art reassessment by an accreditation body. CPSA). Section 14(f)(2)(B) of the CPSA products) are not subject to the audit The Commission recognizes that also allows a third party conformity requirements. accrediting bodies often have the flexibility to determine whether a third assessment body to be ‘‘owned or D. Proposed § 1112.7—What Must an party conformity assessment body controlled in whole or in part by a Audit Address or Cover? Who Conducts continues to conform with its government’’ under certain statutory the Audit? conditions or requirements. The accreditation requirements and to statutory requirements for ‘‘firewalled’’ As described earlier in part II.B of this decide what systems or test methods to and government-owned or government- document, proposed § 1112.3(c) would examine as part of the reassessment controlled conformity assessment explain that, for purposes of part 1112, process. Thus, the proposed rule would bodies are in addition to those an audit is composed of two parts: (1) state that the reassessment portion of pertaining to third party conformity An examination by an accreditation the audit ‘‘may’’ (rather than ‘‘must’’) assessment bodies generally.) body to determine whether the third cover the management systems, specific Proposed § 1112.3(d) would define party conformity assessment body meets tests, types of tests, calibrations, or ‘‘Commission’’ as meaning the or continues to meet the conditions for types of calibrations that are the subject Consumer Product Safety Commission. accreditation (the ‘‘reassessment’’ of the third party conformity assessment Proposed § 1112.3(e) would define portion of the audit); and (2) the body’s accreditation. Proposed ‘‘quality manager’’ as an individual resubmission of the ‘‘Consumer Product § 1112.7(a) would, however, expressly ‘‘(however named) who, irrespective of Conformity Assessment Body require each reassessment to examine other duties and responsibilities, has Acceptance Registration Form’’ (CPSC the third party conformity assessment defined responsibility and authority for Form 223) by the third party conformity body’s management systems to ensure ensuring that the management system assessment body and the CPSC’s that the third party conformity related to quality is implemented and examination of the resubmitted CPSC assessment body is free from any undue followed at all times and has direct Form 223. If the third party conformity influence regarding its technical access to the highest level of assessment body is a ‘‘firewalled’’ judgment. Such an examination would management at which decisions are conformity assessment body or a be consistent with ISO/IEC 17025, made on the conformity assessment government-owned or government- section 4.1, ‘‘Organization,’’ and note 2 body’s policy or resources.’’ This controlled conformity assessment body, to section 4.1.4 states that:

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If the laboratory wishes to be recognized as assessment body to the CPSC and the conducted by the CPSC may include a third-party laboratory, it should be able to CPSC’s examination of the resubmitted verification that the government-owned demonstrate that it is impartial and that its form. As explained later in part II.E of or government-controlled conformity personnel are free from any undue assessment body continues to meet the commercial, financial and other pressures this document, resubmission of the which might influence their technical CPSC Form 223 would occur in two five criteria set forth in section judgment. The third-party testing or ways: (1) There would be a continuing 14(f)(2)(B) of the CPSA. In brief, section calibration laboratory should not engage in obligation to ensure that the information 14(f)(2)(B) of the CPSA states that the any activities that may endanger trust in its submitted on CPSC Form 223 is current, term ‘‘third party conformity assessment independence of judgment and integrity in such that a third party conformity body’’ may include a government- relation to its testing or calibration activities. assessment body would submit a new owned or government-controlled entity (See International Organization for CPSC Form 223 whenever the if: Standardization, ISO/IEC 17025: information changes; and (2) in the (i) Private labelers located in any nation are 2005(E), ‘‘General Requirements for the absence of any changes that would permitted to choose conformity assessment Competence of Testing and Calibration necessitate the submission of a new bodies that are not owned or controlled by Laboratories,’’ at page 2.) Such an CPSC Form 223, the third party the government of that nation; examination also would be consistent conformity assessment body would re- (ii) The entity’s testing results are not with section 14(f)(2)(D)(ii) of the CPSA, register at the CPSC every two years subject to undue influence by any other person, including another governmental which requires ‘‘firewalled’’ conformity using CPSC Form 223. entity; assessment bodies to have established Additionally, proposed § 1112.7(c) (iii) The entity is not accorded more procedures to ensure that: would contain specific requirements for favorable treatment than other third party (I) Its test results are protected from undue the CPSC’s examination of ‘‘firewalled’’ conformity assessment bodies in the same influence by the manufacturer, private and government-owned or government- nation who have been accredited under labeler or other interested party; controlled conformity assessment [section 14 of the CPSA]; (II) The Commission is notified bodies. For ‘‘firewalled’’ conformity (iv) The entity’s testing results are immediately of any attempt by the assessment bodies, proposed accorded no greater weight by other manufacturer, private labeler or other governmental authorities than those of other § 1112.7(c)(1) would state that the third party conformity assessment bodies interested party to hide or exert undue examination portion of the audit influence over test results; and accredited under [section 14 of the CPSA]; (III) Allegations of undue influence may be conducted by the CPSC may include and reported confidentially to the Commission. verification to ensure that the (v) The entity does not exercise undue ‘‘firewalled’’ conformity assessment influence over other governmental Proposed § 1112.7(b) would require body continues to meet the criteria set authorities on matters affecting its operations the third party conformity assessment forth in section 14(f)(2)(D) of the CPSA. or on decisions by other governmental body to have the accreditation body that authorities controlling distribution of Section 14(f)(2)(D) of the CPSA states accredited the third party conformity products based on outcomes of the entity’s that: assessment body perform the conformity assessments. reassessment portion of the audit. For Upon request, the Commission may Thus, for example, under proposed example, if a third party conformity accredit a conformity assessment body that is § 1112.7(c)(2), the CPSC could examine assessment body was accredited by an owned, managed, or controlled by a manufacturer or private labeler as a third whether a government-owned accreditation body named AB–1, then party conformity assessment body if the conformity assessment body has AB–1 would conduct the reassessment. Commission by order finds that— procedures in place to ensure that its If, however, the same third party (i) Accreditation of the conformity testing results are not subject to undue conformity assessment body changes its assessment body would provide equal or influence by any other person. CPSC accreditation, so that it becomes greater consumer safety protection than the staff is considering whether to specify accredited by a different accreditation manufacturer’s or private labeler’s use of an the types of documents government- body named AB–2, then AB–2 would independent third party conformity owned or government-controlled conduct the reassessment. assessment body; and conformity assessment bodies should The proposed rule contemplates that (ii) The conformity assessment body has have to demonstrate compliance with accrediting bodies performing a established procedures to ensure that— (I) Its test results are protected from undue section 14(f)(2)(B) of the CPSA; reassessment will conform to ISO/IEC influence by the manufacturer, private however, because such details may be 17011, ‘‘Conformity Assessment— labeler or other interested party; more appropriately considered to be General Requirements for Accreditation (II) The Commission is notified part of the accreditation or acceptance Bodies Accrediting Conformity immediately of any attempt by the of accreditation processes rather than Assessment Bodies.’’ Certain provisions manufacturer, private labeler or other part of an ‘‘audit,’’ the Commission may in ISO/IEC 17011, notably sections 7.11, interested party to hide or exert undue amend the previously-published notices ‘‘Reassessment and Surveillance,’’ 7.12, influence over test results; and of requirements and/or include such ‘‘Extending Accreditation,’’ and 7.13, (III) Allegations of undue influence may be information in any future notices of reported confidentially to the Commission. ‘‘Suspending, Withdrawing, or requirements. Reducing Accreditation,’’ may be Thus, for example, under proposed particularly relevant when conducting a § 1112.7(c)(1), the CPSC could examine E. Proposed § 1112.9—When Must an reassessment. whether a ‘‘firewalled’’ conformity Audit Be Conducted? As for the examination portion of the assessment body’s established Proposed § 1112.9(a) would state that, audit, proposed § 1112.7(c) would procedures continue to exist and at a minimum, each third party explain that the third party conformity examine its mechanisms for confidential conformity assessment body must be assessment body must have the reporting of allegations of undue reassessed at the frequency established examination portion of the audit influence. For government-owned or by its accreditation body for conducted by the Commission. The government-controlled conformity reassessments of the accreditation. For examination portion of the audit would assessment bodies, proposed example, if the accreditation body consist of resubmission of CPSC Form § 1112.7(c)(2) would state that the would conduct a reassessment to 223 by the third party conformity examination portion of the audit reexamine a third party conformity

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assessment body’s accreditation after assessment bodies that have gone out of invalid data), proposed § 1112.11(b) two years, the minimum reassessment business or discontinued testing of would require the quality manager to frequency for that third party products subject to the CPSC’s document that he/she notified the conformity assessment body, under jurisdiction and remove such third party relevant parties within the third party proposed § 1112.9(a), would be two conformity assessment bodies from its conformity assessment body to take years. list of accredited third party conformity immediate corrective action and also Third party conformity assessment assessment bodies. document the action(s) taken. bodies are free to have themselves If a third party conformity assessment Proposed § 1112.11(c) would require reassessed more frequently (such as body has registered more than once with the quality manager to notify the CPSC annually or on any other predetermined the CPSC, has registered at different if the accreditation body decides to schedule) and may wish to consider times, and has no changes in reduce, suspend, or withdraw the third having reassessments conducted if a information that would warrant the party conformity assessment body’s change has occurred that may affect submission of a new CPSC Form 223, accreditation, and the reduction, their capabilities. For example, if a third the first examination portion of the suspension, or withdrawal of party conformity assessment body audit, under proposed § 1112.9(b)(3), accreditation is relevant to the third desires to perform an additional would be performed two years after the party conformity assessment body’s method, it may wish to consider being last registration date, and then every activities pertaining to a CPSC reassessed at an earlier date so that the two years thereafter. For example, regulation or test method. For example, reassessment examines the third party assume that a third party conformity assume that a third party conformity conformity assessment body’s assessment body registers in 2009 to test assessment body is accredited by its conformance with ISO/IEC 17025 and for lead paint and later registers in 2010 accreditation body to perform lead paint all methods covered by the to test for small parts. The examination testing and to perform tests to detect the accreditation(s). As another example, portion of the audit would occur in presence of a specific substance (which accreditation bodies themselves may 2012, and subsequent examination this example will refer to as Test 2), have shorter intervals between initial portions of the audit would be at 2014, where the latter test is not done to accreditation and a reassessment or 2016, etc. If the third party conformity determine whether children’s products allow for another type of action called assessment body has made changes that conform to an applicable children’s ‘‘surveillance.’’ Section 7.11.3 of ISO/ warranted the submission of a new product safety rule and also is not IEC 17011 discusses various dates for CPSC Form 223, then, under proposed within the scope of the CPSC’s reassessment and/or surveillance of a § 1112.9(b)(4), the first examination acceptance of the accreditation for the third party conformity assessment portion of the audit would be performed third party conformity assessment body. body’s accreditation. ISO/IEC 17011 two years after the submission of the Assume further that the accreditation defines ‘‘surveillance’’ as a ‘‘set of new CPSC Form 223. body finds the third party conformity activities, except reassessment, to assessment body to remain competent to F. Proposed § 1112.11—What Must a monitor the continued fulfillment by conduct the lead tests, but withdraws Third Party Conformity Assessment accredited [conformity assessment accreditation with respect to Test 2. Body Do After an Audit? bodies] of requirements for Under this example, the quality accreditation.’’ ‘‘Surveillance,’’ In general, once the accreditation manager would not have to notify the therefore, is distinct from body has conducted its reassessment of CPSC that the accreditation body has ‘‘reassessment.’’ Section 7.11.3 of ISO/ a third party conformity assessment withdrawn accreditation for Test 2 IEC 17011 directs accreditation bodies body, the accreditation body will because Test 2 was not relevant to the to design a plan for reassessment and present its initial findings along with third party conformity assessment surveillance and recommends that the any supporting evidence to the quality body’s testing of children’s products. first on-site surveillance be conducted manager for the third party conformity In circumstances when a notification ‘‘no later than 12 months from the date assessment body. The accreditation is required, the notification would be of initial accreditation.’’ body may give the third party sent to the Assistant Executive Director, As for the examination portion of the conformity assessment body’s personnel Office of Hazard Identification and audit conducted by the CPSC, proposed the opportunity to present any Reduction, within five business days of § 1112.9(b)(1) would require each third objections they have to the initial the accreditation body’s notification to party conformity assessment body to findings. The accreditation body may the third party conformity assessment ensure that the information it submitted then adjust its findings in response to body. This provision will help ensure on CPSC Form 223 is current and to any valid objections. that the CPSC is notified about third submit a new CPSC Form 223 whenever When the accreditation body presents party conformity assessment bodies that the information, such as the third party its findings to the third party conformity have their accreditation suspended or conformity assessment body’s address, assessment body, proposed § 1112.11(a) withdrawn or have the scope of their telephone number, or ownership, would require the third party accreditation reduced after a changes. This will ensure that the conformity assessment body’s quality reassessment. If a third party conformity information available to CPSC reflects manager to receive the findings and, if assessment body does not notify the the most current information for a necessary, to initiate corrective action in CPSC as proposed § 1112.11(c) would particular third party conformity response to the findings. Proposed require, such non-compliance may be assessment body. In the absence of any § 1112.11(b) would require the quality grounds for withdrawal of acceptance of changes that would necessitate the manager to prepare a resolution report; the accreditation by the Commission submission of a new CPSC Form 223, the resolution report would identify the itself under section 14(e)(1)(B) of the proposed § 1112.9(b)(2) would require corrective actions taken and any follow- CPSA for failure to ‘‘comply with an the third party conformity assessment up activities. If immediate corrective applicable * * * requirement body to re-register at the CPSC every action is necessary (as may be the case established by the Commission’’ under two years using CPSC Form 223. This if the findings identify problems the audit regulations. re-registration requirement may help associated with incorrect procedures, Proposed § 1112.11(d) would explain CPSC identify third party conformity invalid actions, or the creation or use of that the CPSC will notify the third party

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conformity assessment body if the CPSC records relating to the last three Title: Audit Requirements for Third finds that the third party conformity reassessments (or however many Party Conformity Assessment Bodies. assessment body no longer meets the reassessments have been conducted if Description: The proposed rule would conditions contained in CPSC Form 223 the third party conformity assessment require third party conformity or in the relevant statutory provisions body has been reassessed less than three assessment bodies to comply with the applying to that third party conformity times) and to make such records audit requirements. As part of these assessment body. The CPSC also will available to the CPSC upon request. requirements, the proposed rule would, identify the condition or statutory The Commission also proposes to if finalized, require the third party provision that is no longer met and require third party conformity conformity assessment bodies to specify a time by which the third party assessment bodies to retain records complete an on-line form to begin the conformity assessment body must notify relating to the last three reassessments examination portion of the audit the CPSC of the steps that it intends to because such records may reveal process. This form asks for certain take to correct the deficiency and when whether a pattern of problems with identifying information pertaining to the it will complete such steps. Proposed accreditation exists and how quickly third party conformity assessment body, § 1112.11(d) also would require the such problems are addressed and information concerning whether the quality manager to document that he/ resolved. third party conformity assessment body she notified the relevant parties within III. Paperwork Reduction Act is owned, managed, or controlled by the third party conformity assessment manufacturers or private labelers of body to take corrective action and also This proposed rule contains information collection requirements that children’s products, whether the third document the action(s) taken. party conformity assessment body is Proposed § 1112.11(e) would describe are subject to public comment and review by the Office of Management and owned or controlled by a government the possible consequences if a third entity, the laboratory accreditation party conformity assessment body fails Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– certificate for the third party conformity to remedy the deficiency in a timely assessment body, and, for ‘‘firewalled’’ fashion. In brief, proposed § 1112.11(e) 3520). This part of the preamble to the conformity assessment bodies, training would state that the CPSC ‘‘shall take proposed rule describes the provisions materials. Additionally, the proposed whatever action it deems appropriate in this section of the document with an rule would require third party under the circumstances, up to and estimate of the annual reporting burden. conformity assessment bodies to retain including withdrawing the CPSC’s Our estimate includes the time for records relating to a reassessment and accreditation of the third party reviewing instructions, searching all records pertaining to the third party conformity assessment body or the existing data sources, gathering and conformity assessment body’s resolution CPSC’s acceptance of the third party maintaining the data needed, and or plans for resolving nonconformities conformity assessment body’s completing and reviewing each identified by the reassessment. The accreditation.’’ collection of information. The Commission invites comments proposal also would require third party G. Proposed § 1112.13—What Records on: (1) Whether the collection of conformity assessment bodies to retain Should a Third Party Conformity information is necessary for the proper such records relating to the last three Assessment Body Retain Regarding an performance of the CPSC’s functions, reassessments (or however many Audit? including whether the information will reassessments have been conducted if Proposed § 1112.13 would require a have practical utility; (2) the accuracy of the third party conformity assessment third party conformity assessment body the CPSC’s estimate of the burden of the body has been reassessed less than three to retain all records relating to an audit proposed collection of information, times). Proposed § 1112.13 would and all records pertaining to the third including the validity of the require the third party conformity party conformity assessment body’s methodology and assumptions used; (3) assessment body to make such records resolution of or plans for resolving ways to enhance the quality, utility, and available to the CPSC upon request. nonconformities identified by the audit. clarity of the information to be Description of Respondents: Persons Such nonconformities could be collected; and (4) ways to minimize the who are third party conformity identified through a reassessment by an burden of the collection of information assessment bodies pursuant to section accreditation body or through an on respondents, including through the 14(a) of the Consumer Product Safety examination by the CPSC. The proposal use of automated collection techniques, Act (CPSA) (15 U.S.C. 2063(a)). also would require third party when appropriate, and other forms of The CPSC estimates the burden of this conformity assessment bodies to retain information technology. collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN

Frequency Total 16 CFR Section Number of of annual Hours per Total hours respondents responses responses response

1112.9(b)(1) ...... 150 1 150 1 150 1112.9(b)(2) ...... 3 1 3 0.25 0.75 1112.13 ...... 150 1 150 4 600

Total ...... 750.75 There are no capital costs or operating and maintenance costs associated with this collection of information.

Our estimates are based on the • As of June 5, 2009, 153 third party because the CPSC expects to receive following information: conformity assessment bodies had additional registrations and because registered with the CPSC. However, section 14(a)(3)(B)(vi) of the CPSA

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requires the Commission to issue a examination by the CPSC. The proposal IV. Regulatory Flexibility Act notice of requirement for ‘‘all other also would require third party The CPSC has examined the impacts children’s product safety rules,’’ it is conformity assessment bodies to retain of the proposed rule under the anticipated that many more third party records relating to the last three Regulatory Flexibility Act (5 U.S.C. conformity assessment bodies will reassessments (or however many 601–612). The Regulatory Flexibility register. Therefore, the Commission reassessments have been conducted if Act requires agencies to analyze tentatively estimates the number of the number of reassessments is less than regulatory options that would minimize third party conformity assessment three). The number of third party any significant impact of a rule on small bodies to be 300. • conformity assessment bodies to be entities. Because the required Under proposed § 1112.9(b)(1), reassessed in a given year cannot be third party conformity assessment information is minimal and the costs determined at this time, but, for bodies would be required to resubmit associated with the audits are low, the purposes of this analysis, the CPSC will CPSC Form 223. At a minimum, Commission certifies that the proposed assuming there are no changes to the assume that half will be reassessed in rule would not have a significant information that a third party any given year. Thus, the estimated economic impact on a substantial conformity assessment body has number of respondents is 150 (300 third number of small entities. party conformity assessment bodies × submitted previously in its CPSC Form A. Objectives and Legal Basis for the 223, the resubmission would occur 0.5 reassessments annually per third Draft Proposed Rule every two years from the date of the party conformity assessment bodies = previous submission. As all third party 150 reassessments annually). As for the Section 102(b) of the CPSIA requires conformity assessment bodies have not time required to retain such records, it the Commission to establish submitted their first CPSC Form 223s at is difficult to estimate such time with requirements for the periodic audit of the same time, only some would be precision because the amount of time is the third party conformity assessment expected to resubmit a CPSC Form 223 likely to vary among the third party bodies in order for them to maintain in any one year. The percentage of third conformity assessment bodies. Third their accreditation. The draft proposed party conformity assessment bodies that party conformity assessment bodies that rule would implement the CPSIA’s will resubmit a CPSC Form 223 in a are accredited in more than one field or audit requirement. The purpose of a periodic audit is to ensure that an given year cannot be determined at this that have scopes that include a large accredited third party conformity time, so, for purposes of this analysis, number of tests are likely to require assessment body is still competent to the CPSC will assume that half of the more time to manage the records perform the testing services for which it third party conformity assessment generated during an audit than those bodies will resubmit a CPSC Form 223 has been accredited. In the case of who are accredited in only one field or accredited third party conformity in any given year. Thus, the estimated whose scopes are limited to only a few number of respondents for proposed assessment bodies that are owned, tests. It is also likely that third party managed, or controlled by a § 1112.9(b)(1) is 150 (300 total third conformity assessment bodies at which party conformity assessment bodies × manufacturer (or ‘‘firewalled’’ a large number of nonconformities are conformity assessment bodies) or that 0.5 resubmissions annually per third discovered during a reassessment audit party conformity assessment bodies = are owned or controlled in whole or in will require more time to maintain the 150 resubmissions annually). part by a government entity, the audit records since more records are likely to Furthermore, the CPSC estimates the requirements provide the Commission be generated in correcting the burden hour for each resubmission to be with an opportunity to ensure that the one hour, so the total burden associated nonconformities. Nevertheless, the third party conformity assessment body with proposed § 1112.9(b)(1) would be CPSC tentatively estimates that it will continues to comply with the CPSIA’s 150 hours (150 resubmissions × 1 hour take 4 hours per third party conformity requirements for ‘‘firewalled’’ and per resubmission = 150 hours). assessment body, so the overall government-owned or government- • Under proposed § 1112.9(b)(2), recordkeeping burden will be 600 hours controlled conformity assessment third party conformity assessment (150 reassessments per year × 4 hours bodies. bodies would be required to ensure that per record per reassessment = 600 hours). Most respondents probably will B. Firms Subject to the Requirement for the information submitted on CPSC Periodic Audits Form 223 is current and to submit a new need less time to maintain records, but CPSC Form 223 whenever the some can be expected to require more The requirement for periodic audits information changes. Based on current time due to factors such as the number will only affect those third party experience with third party conformity of nonconformities found that might conformity assessment bodies that seek assessment bodies, the CPSC estimates require the preparation of additional to be able to provide the CPSIA-required that only one percent of third party documents. third-party conformity assessment services for manufacturers or private conformity assessment bodies will The total burden, therefore, is 750.75 labelers of children’s products. Third revise or update their information, so hours, which the CPSC will round up to party conformity assessment bodies that the estimated number of respondents is 751 hours. 3 (300 third party conformity do not intend to offer third party assessment bodies × 0.01 revisions per In compliance with the Paperwork conformance testing for children’s conformity assessment body = 3 Reduction Act of 1995 (44 U.S.C. products are not affected by the revisions per year). 3507(d)), the CPSC has submitted the requirements for accreditation or • Under proposed § 1112.13, third information collection requirements of periodic audits. party conformity assessment bodies will this rule to OMB for review. Interested As of June 5, 2009, the CPSC had have to retain records pertaining to an persons are requested to fax comments accepted the accreditations of 153 third audit and their resolution of or plans for regarding information collection by party conformity assessment bodies. Of resolving nonconformities identified September 14, 2009, to the Office of these, 40 are located within the United through a reassessment by an Information and Regulatory Affairs, States. Of the third party conformity accrediting body or through an OMB (see ADDRESSES). assessment bodies located in the United

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States, six of the locations are owned by facilitate the acceptance of the testing to the third party conformity assessment very large, foreign-based companies; results of accredited laboratories both body usually will be $3,000 to $4,000 nine are affiliated with large, United within and across national boundaries. per field (e.g., chemical, electrical, or States-based companies; and the balance The ILAC–MRA includes requirements mechanical testing) in which the third or 25 (about 63 percent) are affiliated for the initial assessment of laboratories party conformity assessment body is with companies that could be small and periodic reassessments. accredited. Therefore, a third party businesses according to the criteria Laboratories that do not submit to the conformity assessment body that is established by the Small Business periodic reassessments lose their accredited for testing conformance to Administration (SBA), which for a accredited status. both chemical and mechanical testing laboratory (NAICS code 541380) Under the proposed rule, the periodic standards could expect an assessment or is a company with less than $12.5 audit of a third party conformity reassessment to cost $6,000 to $8,000. million in annual revenue. assessment body would consist of two Another cost of a reassessment by an It is likely that the number of third parts. The first part would be a accrediting body is the cost of the time party conformity assessment bodies reassessment by the accrediting body to that third party conformity assessment with CPSC-accepted accreditations will determine whether it continues to meet body personnel spend cooperating with increase over the next several months or the conditions for accreditation. The the assessors. This includes the time years as the CPSIA’s third party testing second part of the audit would be the required to prepare or assemble requirements are implemented or resubmission to the CPSC of CPSC Form documents needed by the auditors and become effective. (The Commission, in 223 and its review by the CPSC. to explain or demonstrate the a notice published in the Federal All signatories to the ILAC–MRA have procedures used at the third party Register on February 9, 2009 (74 FR requirements for the periodic conformity assessment body. No 6396), announced a stay of enforcement reassessment of accredited laboratories. empirical estimates of this cost were pertaining to certain provisions of The ILAC–MRA harmonized procedures found, but one might expect that the section 14(a) of the CPSA; those for surveillance and reassessment of amount of time spent by third party provisions, in general, required testing accredited laboratories (available on the conformity assessment body personnel and issuance of certificates of Internet at http://www.ilac.org/ during a reassessment would be close to compliance by manufacturers, and the documents/ILAC_G10_1996_harm_ the amount of time spent by the stay is to remain in effect until February proced_for_surve_and_reass_of_accrd_ assessor. If the average reassessment 10, 2010. Additionally, section labs.pdf) recommend that the time takes 2.5 days (or 20 hours) and the 14(a)(3)(B) of the CPSA establishes a between reassessments be no more than wage of the employees involved is about timeline for accreditation and directs 60 months provided that the accrediting $44 an hour, then the cost of the time the CPSC to publish ‘‘notices of body undertakes somewhat less of the third party conformity assessment requirements’’ for accreditation of third comprehensive surveillance visits at body’s personnel spent cooperating with party conformity assessment bodies; as least every 18 months. However, many the reassessment would be about $880. more notices of requirements issue, it is accrediting bodies opt to undertake (The median hourly wage of reasonable to expect that the number of more frequent full reassessments rather architecture and engineering third party conformity assessment than conduct surveillance visits. occupations in testing laboratories bodies seeking accreditation will According to ISO/IEC 17011, if an (NAICS code 541380) is $31.65 (U.S. increase.) Therefore, it is not possible to accreditation body does not conduct Department of Labor, Bureau of Labor state with certainty how many third surveillance visits, full reassessments of Statistics, National Occupational party conformity assessment bodies will accredited laboratories must take place Employment and Wage Estimates, May ultimately be accredited. CPSC staff at least once every two years. 2008 (data extracted on June 17, 2009 believes that the number of third party The resubmission of CPSC Form 223 from http://www.bls.gov/data/). In 2008, conformity assessment bodies in the is intended to give the CPSC an wages and salaries represented about United States that are ultimately opportunity to ensure that the third 71.9 percent of total compensation for accredited for testing children’s party conformity assessment body is professional and related occupations in products may reach 120. If 63 percent of still accredited by an ILAC–MRA private industry (U.S. Department of these meet the SBA criteria for a small signatory and still complies with the Labor, Bureau of Labor Statistics, business, then about 76 small U.S. requirements of section 102 of the Employer cost for Employee businesses would be affected by this CPSIA with respect to ‘‘firewalled’’ and Compensation (data extracted on June proposed rule. government-owned or government- 17, 2009)).) The cost could be higher if controlled conformity assessment a reassessment took longer than 2.5 days C. Requirements of the Draft Proposed bodies. The CPSC is proposing that or higher paid employees were involved Rule and Possible Impacts on Small CPSC Form 223 be kept current or that, in the reassessment. Businesses in the absence of any changes to the Another requirement would be the The notices of requirements issued by information that a third party resubmission of CPSC Form 223, which the CPSC for the accreditation of third conformity assessment body has must be done every two years. The cost party conformity assessment bodies previously submitted, be resubmitted to resubmit this form is probably low for state that, as a baseline requirement, every two years. most third party conformity assessment third party conformity assessment The cost of the periodic audit bodies, unless there have been bodies must be accredited by an includes the cost of the time of the significant changes in the third party accreditation body that is a signatory to accrediting body’s assessor to conduct conformity assessment body’s the International Laboratory the assessment, the cost of the assessor’s ownership or internal practices since Accreditation Cooperation—Mutual travel to the site, and the cost of lodging the last time it submitted the form. On Recognition Arrangement (ILAC–MRA). and meals while the assessor is average, the CPSC estimates that it will ILAC is an international cooperation of conducting the reassessment. According take one hour to complete this form and laboratory accreditation bodies that to a representative of an accrediting submit it electronically. If the form is seeks to harmonize laboratory body, a reassessment will typically take completed by a manager, the cost would accreditation procedures so as to two to three days, and the cost charged average $68, assuming the median

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hourly compensation for a general or conformity assessment bodies. The time conformity assessment bodies is operations manager in a testing periods between audits will vary to determined by the accrediting bodies, laboratory. (The median hourly wage of some degree between accrediting not the CPSC. The CPSC could reduce a general or operations managers in bodies, but a typical period is about the frequency that CPSC Form 223 must testing laboratories (NAICS code every two years. Therefore, the annual be resubmitted. However, it probably 541380) is $48.73 (U.S. Department of average cost of the periodic audits takes a third party conformity Labor, Bureau of Labor Statistics, would be approximately $2,000 to assessment body an average of 1 hour to National Occupational Employment and $2,500 per field in which the third party review and resubmit CPSC Form 223 Wage Estimates, May 2008 (data conformity assessment body is and any supplemental materials. extracted on June 17, 2009 from accredited. Therefore, the annual cost to Therefore, reducing the frequency that http://www.bls.gov/data/)). In 2008, a third party conformity assessment this form has to be resubmitted would wages and salaries represented about body accredited in three fields (e.g., not significantly lower the cost of the 71.9 percent of total compensation for chemical, mechanical, and electrical) periodic audits. professional and related occupations in would be approximately $6,000 to private industry (U.S. Department of $7,500. V. Environmental Considerations Labor, Bureau of Labor Statistics, As noted earlier, the SBA considers a This proposed rule falls within the Employer cost for Employee testing laboratory to be a small business scope of the Commission’s Compensation (data extracted on June if its annual revenue is less than $12.5 environmental review regulations at 16 17, 2009)).) The cost could be somewhat million. According to the 2002 CFR 1021.5(c)(2) which provide a higher than average for ‘‘firewalled’’ and Economic Census, a very high categorical exclusion from any government-owned or government- percentage of testing laboratories would requirement for the agency to prepare an controlled conformity assessment be considered to be small businesses. In environmental assessment or bodies. ‘‘Firewalled’’ conformity 2002, almost 97 percent of all testing environmental impact statement for assessment bodies will need to provide laboratories had revenue of less than product certification rules. the CPSC staff with the updated $10 million, and almost 50 percent had VI. Effective Date information and documents that revenue of less than $500,000 (see U.S. describe the training that the Department of Commerce, Bureau of the The Commission is proposing that ‘‘firewalled’’ conformity assessment Census, 2002 Economic Census (release any final rule based on this proposal body employees receive for reporting to date November 15, 2005); accessed at become effective 60 days after its date the CPSC any allegation of an attempt http://factfinder.census.gov/servlet/ of publication in the Federal Register. _ by a manufacturer, private labeler, or IBQTable? bm=y&- List of Subjects in 16 CFR Part 1112 other interested party to hide or exert ds_name=EC0254SSSZ4&- undue influence over test results. NAICS2002=541380 (June 4, 2008)). Consumer protection, Third party Government-owned or government- Also, about 63 percent of the third party conformity assessment body, Audit. controlled conformity assessment conformity assessment bodies that have For the reasons stated above, the bodies might need to provide updated been accredited so far for testing Commission proposes to amend Title 16 information to demonstrate that the children’s products appear to be small of the Code of Federal Regulations by government entity does not exert undue businesses. Therefore, it is likely that adding a new part 1112 to read as influence on the operation of the third the proposed rule will impact a follows: party conformity assessment body or the substantial number of small businesses. testing results and that the third party However, it is unlikely that the rule will PART 1112—AUDIT REQUIREMENTS conformity assessment body is not have significant adverse impact on FOR THIRD PARTY CONFORMITY treated more favorably than other many third party conformity assessment ASSESSMENT BODIES accredited third party conformity bodies. The only third party conformity Sec. assessment bodies in the same nation. assessment bodies that will seek 1112.1 Purpose. The draft proposed rule also would accreditation for testing children’s 1112.3 Definitions. require that third party conformity products are those that expect to receive 1112.5 Who Is Subject to These Audit assessment bodies keep the information substantial revenue from the testing Requirements? on CPSC Form 223 current. Based on required by the CPSIA. Those third 1112.7 What Must an Audit Address or the experience to date, the CPSC staff party conformity assessment bodies that Cover? Who Conducts the Audit? expects that about one percent of the do not expect substantial revenue from 1112.9 When Must an Audit be Conducted? 1112.11 What Must a Third Party third party conformity assessment the testing required by the CPSIA will Conformity Assessment Body Do After bodies will need to provide updates to not seek to be accredited for the testing an Audit? the form during the year. These updates or they will not renew their 1112.13 What Records Should a Third Party should take about 15 minutes to accreditation if they had initially sought Conformity Assessment Body Retain complete online. accreditation, but the expected revenue Regarding an Audit? The periodic audits that would be did not materialize. Authority: Public Law 110–314, Sec. 3, 122 required would cost third party Stat. 3016, 3017 (2008); 15 U.S.C. 2063. conformity assessment bodies about D. Alternatives Considered to the Draft $4,000 to $5,000 (rounded to the nearest Proposed Rule § 1112.1 Purpose. thousand) per field in which the third Given that the CPSC is relying upon This part establishes the audit party conformity assessment body is accrediting bodies that are signatories to requirements for third party conformity accredited. This cost includes the cost the ILAC–MRA to accredit and reassess assessment bodies pursuant to section of the accrediting body’s assessors as the third party conformity assessment 14(d)(1) of the Consumer Product Safety well as the time of the third party bodies, there are no realistic alternatives Act (CPSA) (15 U.S.C. 2063(d)(1)). conformity assessment body personnel to the draft proposed rule that would Compliance with these requirements is that is spent on the audit, and other substantially lower the cost of the a condition for the continuing costs, such as the cost of providing the periodic audits. The frequency of the accreditation of such third party materials required of ‘‘firewalled’’ reassessments of the third party conformity assessment bodies pursuant

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to section 14(a)(3)(C) of the CPSA. controlled conformity assessment body, body named AB–2, then AB–2 would However, this part does not apply to the CPSC’s examination may include conduct the reassessment. certifying organizations under the verification to ensure that the entity (c) The third party conformity Labeling of Hazardous Art Materials Act continues to meet the appropriate assessment body must have the even if such organizations are third statutory criteria pertaining to such examination portion of the audit party conformity assessment bodies. conformity assessment bodies. conducted by the CPSC. The (d) ‘‘CPSC’’ means the Consumer examination portion of the audit will § 1112.3 Definitions. Product Safety Commission. consist of resubmission of the The following definitions apply for (e) ‘‘Quality manager’’ means an ‘‘Consumer Product Conformity purposes of this part: individual (however named) who, Assessment Body Acceptance (a) ‘‘Accreditation’’ means a irrespective of other duties and Registration Form’’ (CPSC Form 223) by procedure by which an authoritative responsibilities, has defined the third party conformity assessment body gives formal recognition that a responsibility and authority for ensuring body and the CPSC’s examination of the third party conformity assessment body that the management system related to resubmitted CPSC Form 223. is competent to perform specific tasks. quality is implemented and followed at (1) For ‘‘firewalled’’ conformity Accreditation recognizes a third party all times and has direct access to the assessment bodies, the CPSC’s conformity assessment body’s technical highest level of management at which examination may include verification to capability and is usually specific for decisions are made on the conformity ensure that the ‘‘firewalled’’ conformity tests of the systems, products, assessment body’s policy or resources. assessment body continues to meet the components, or materials for which the (f) Unless otherwise stated, the criteria set forth in section 14(f)(2)(D) of third party conformity assessment body definitions of section 3 of the CPSA and the CPSA. claims proficiency. additional definitions in the Consumer (2) For government-owned or (b) ‘‘Accreditation body’’ means an Product Safety Improvement Act of entity that: government-controlled conformity 2008, Pub. L. 110–314, apply for assessment bodies, the CPSC’s (1) Accredits or has accredited a third purposes of part 1112 of this title. party conformity assessment body as examination may include verification to meeting, at a minimum, the § 1112.5 Who Is Subject to These Audit ensure that the government-owned or International Organization for Requirements? government-controlled conformity Standardization (ISO) Standard ISO/IEC Except for certifying organizations assessment body continues to meet the 17025:2005, ‘‘General Requirements for described in 16 CFR 1500.14(b)(8), these criteria set forth in section 14(f)(2)(B) of the Competence of Testing and audit requirements apply to third party the CPSA. Calibration Laboratories’’ and any test conformity assessment bodies operating § 1112.9 When Must an Audit be methods or consumer product safety pursuant to section 14(a)(2) of the Conducted? requirements specified in the relevant CPSA. Third party conformity (a) At a minimum, each third party notice of requirements issued by the assessment bodies must comply with conformity assessment body must be Commission; and the audit requirements as a continuing reassessed at the frequency established (2) Is a signatory to the International condition of the CPSC’s acceptance of by its accreditation body. Laboratory Accreditation Cooperation— their accreditation. Mutual Recognition Arrangement. (b) For the examination portion of the (c) ‘‘Audit’’ means a systematic, § 1112.7 What Must an Audit Address or audit, which is conducted by the CPSC: independent, documented process for Cover? Who Conducts the Audit? (1) Each third party conformity obtaining records, statements of fact, or (a) The reassessment portion of an assessment body must ensure that the other relevant information, and audit may cover the management information it submitted on CPSC Form assessing them objectively to determine systems, specific tests, types of tests, 223 is current and submit a new CPSC the extent to which specified calibrations, or types of calibrations that Form 223 whenever the information requirements are fulfilled. An audit, for are the subject of the third party changes. purposes of this part, is composed of conformity assessment body’s (2) In the absence of any changes that two parts: accreditation. Each reassessment would necessitate the submission of a (1) An examination by an portion of an audit also must examine new CPSC Form 223, the third party accreditation body to determine the third party conformity assessment conformity assessment body must re- whether the third party conformity body’s management systems to ensure register at the CPSC every two years assessment body meets or continues to that the third party conformity using CPSC Form 223. meet the conditions for accreditation (a assessment body is free from any undue (3) If the third party conformity process known more commonly as a influence regarding its technical assessment body has registered more ‘‘reassessment’’); and judgment. than once with the CPSC, has registered (2) The resubmission of the (b) The third party conformity at different times, and has no changes in ‘‘Consumer Product Conformity assessment body must have the information that would warrant the Assessment Body Acceptance reassessment portion of the audit submission of a new CPSC Form 223, Registration Form’’ (CPSC Form 223) by conducted by the same accreditation the first examination portion of the the third party conformity assessment body that accredited the third party audit should be performed two years body and the Consumer Product Safety conformity assessment body. For after the last registration date, and then Commission’s (‘‘CPSC’s’’) examination example, if a third party conformity every two years thereafter. of the resubmitted CPSC Form 223. If assessment body was accredited by an (4) If the third party conformity the third party conformity assessment accreditation body named AB–1, then assessment body has made changes that body is owned, managed, or controlled AB–1 would conduct the reassessment. warranted the submission of a new by a manufacturer or private labeler If, however, the same third party CPSC Form 223, then the first (also known as a ‘‘firewalled’’ conformity assessment body changes its examination portion of the audit would conformity assessment body) or is a accreditation, so that it becomes be performed two years after the government-owned or government- accredited by a different accreditation submission of the new CPSC Form 223.

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§ 1112.11 What Must a Third Party CPSC’s acceptance of the third party other property margining, guaranteeing, Conformity Assessment Body Do After an conformity assessment body’s or securing such positions) that are Audit? accreditation. commingled with positions in (a) When the accreditation body commodity contracts of the futures presents its findings to the third party § 1112.13 What Records Should a Third account class (and the money, conformity assessment body, the third Party Conformity Assessment Body Retain Regarding an Audit? securities, and/or other property party conformity assessment body’s margining, guaranteeing, or securing quality manager must receive the A third party conformity assessment such positions), pursuant to an order findings and, if necessary, initiate body must retain all records relating to issued by the Commission. corrective action in response to the an audit and all records pertaining to DATES: the third party conformity assessment Submit comments on or before findings. September 14, 2009. (b) The quality manager must prepare body’s resolution of or plans for a resolution report identifying the resolving nonconformities identified ADDRESSES: You may submit comments, corrective actions taken and any follow- through a reassessment by an identified by RIN number, by any of the up activities. If findings indicate that accreditation body or through an following methods: • immediate corrective action is examination by the CPSC. A third party Federal eRulemaking Portal: http:// necessary, the quality manager must conformity assessment body also must www.regulations.gov. Follow the document that he/she notified the retain such records relating to the last instructions for submitting comments. • relevant parties within the third party three reassessments (or however many Agency Web Site: http:// conformity assessment body to take reassessments have been conducted if www.cftc.gov. Follow the instructions immediate corrective action and also the third party conformity assessment for submitting comments on the Web document the action(s) taken. body has been reassessed less than three site. • (c) If the accreditation body decides to times) and make such records available E-mail: [email protected]. Include reduce, suspend, or withdraw the third to the CPSC upon request. the RIN number in the subject line of party conformity assessment body’s the message. Dated: August 7, 2009. accreditation, and the reduction, • Fax: 202–418–5521. suspension, or withdrawal of Todd A. Stevenson, • Mail: David A. Stawick, Secretary of accreditation is relevant to the third Secretary. the Commission, Commodity Futures party conformity assessment body’s [FR Doc. E9–19443 Filed 8–12–09; 8:45 am] Trading Commission, Three Lafayette activities pertaining to a CPSC BILLING CODE 6355–01–P Centre, 1155 21st Street, NW., regulation or test method, the quality Washington, DC 20581. manager must notify the CPSC. Such • Hand Delivery/Courier: Same as notification must be sent to the COMMODITY FUTURES TRADING mail above. Assistant Executive Director, Office of COMMISSION FOR FURTHER INFORMATION CONTACT: Hazard Identification and Reduction, Robert B. Wasserman, Associate Consumer Product Safety Commission, 17 CFR Part 190 Director, Division of Clearing and 4330 East West Highway, Bethesda, RIN 3038–AC82 Intermediary Oversight, 202–418–5092, Maryland 20814, within five business [email protected]; or Nancy days of the accreditation body’s Account Class Schnabel, Attorney-Advisor, Division of notification to the third party Clearing and Intermediary Oversight, conformity assessment body. AGENCY: Commodity Futures Trading 202–418–5344, [email protected]; (d) If the CPSC finds that the third Commission. Commodity Futures Trading party conformity assessment body no ACTION: Notice of proposed rulemaking. Commission, Three Lafayette Centre, longer meets the conditions specified in 1155 21st Street, NW., Washington, DC CPSC Form 223 or in the relevant SUMMARY: The Commodity Futures 20581. Trading Commission (the statutory provisions applicable to that SUPPLEMENTARY INFORMATION: third party conformity assessment body, ‘‘Commission’’) proposes amending its the CPSC will notify the third party regulations (the ‘‘Regulations’’) to create I. Net Equity a sixth and separate ‘‘account class,’’ conformity assessment body, identify A. Authority of Commission To Define applicable only to the bankruptcy of a the condition or statutory provision that ‘‘Net Equity’’ and To Prescribe commodity broker that is a futures is no longer met, and specify a time by Procedures for Its Calculation which the third party conformity commission merchant (‘‘FCM’’), for assessment body shall notify the CPSC positions in cleared over-the-counter The Commission is empowered by of the steps it intends to take to correct (‘‘OTC’’) derivatives (and money, Section 20 of the Commodity Exchange the deficiency and when it will securities, and/or other property Act (the ‘‘Act’’),1 (i) to define the ‘‘net complete such steps. The quality margining, guaranteeing, and securing equity’’ of a customer of a commodity manager must document that he/she such positions). In general, the concept broker 2 in bankruptcy, and (ii) to notified the relevant parties within the of ‘‘account class’’ governs the manner prescribe, by rule or regulation,3 the third party conformity assessment body in which the trustee calculates the net procedures for calculating such ‘‘net to take corrective action and also equity (i.e., claims against the estate) document the action(s) taken. and the allowed net equity (i.e., pro rata 1 7 U.S.C. 24. (e) If the third party conformity share of the estate) for each customer of 2 Section 101(6) of the Bankruptcy Code (11 U.S.C. 101(6)) defines ‘‘commodity broker’’ as a assessment body fails to remedy the a commodity broker in bankruptcy. The ‘‘futures commission merchant, foreign futures deficiency in a timely fashion, the CPSC Commission further proposes amending commission merchant, clearing organization, shall take whatever action it deems the Regulations to codify the leverage transaction merchant, or commodity appropriate under the circumstances, up appropriate allocation, in a bankruptcy options dealer, as defined in section 761 of this title, with respect to which there is a customer, as to and including withdrawing the of any commodity broker, of positions defined in section 761 of this title.’’ CPSC’s accreditation of the third party in commodity contracts of one account 3 The regulations of the Commission can be found conformity assessment body or the class (and the money, securities, and/or at 17 CFR Chapter 1.

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equity.’’ Moreover, Section 761(17) of in § 1.3(hh) of this chapter, may be Commission created the concept of the Bankruptcy Code 4 subjects the commingled with the equity balance of such ‘‘account class,’’ in order to ensure that, definition of ‘‘net equity’’ in the case of customer in any domestic commodity futures in a bankruptcy of a commodity broker, a commodity broker to ‘‘such rules and contract pursuant to regulations under the customers that hold positions in Act, the aggregate shall be treated for regulations as the Commission purposes of this part as being held in a commodity contracts (and deposit 5 promulgates under the Act.’’ Section futures account.10 money, securities, and/or other property 20 of the Act states, in pertinent part, to margin, guarantee, or secure such that: 2. Rationale for the Concept of Account positions) subject to one requirement Notwithstanding title 11 of the United Class would benefit from the specific protections afforded by such States Code, the Commission may provide, In general, the Regulations apply requirement. As the Commission stated with respect to a commodity broker that is a different requirements to the treatment debtor under chapter 7 of title 11 of the in the Proposing Release: United States Code, by rule or regulation— of positions in different types of The reason for identifying classes of * * * (5) how the net equity of a customer commodity contracts (and to the money, customer accounts is to permit the is to be determined.6 securities, and/or other property margining, guaranteeing, or securing implementation of the principle of pro rata The Commission has exercised its distribution so that the differing segregation power under Section 20 of the Act in such positions) based on the underlying requirements with respect to different classes promulgating Regulation 190.07(b), characteristics of those contracts. For of accounts benefit customer claimants based which defines ‘‘net equity’’ as: example, the segregation requirements on the class of account for which they were in Regulations 1.20 through 1.30 11 imposed.15 [T]he total claim of a customer against the would generally apply to positions in As the Commission further stated in estate of the debtor based on the commodity commodity futures contracts that are contracts held by the debtor for or on behalf the Proposing Release: traded on a designated contract market of such customer less any indebtedness of the Obviously, much of the benefit of customer to the debtor.7 (i.e., futures contracts), and to the money, securities, and/or other property segregation would be lost if property In addition, the Commission has margining, guaranteeing, or securing segregated on behalf of a particular account exercised its power under Section 20 of class could be allocated to pay the claims of such positions. In contrast, the customers of a different account class for the Act in promulgating the remainder requirements in Regulation 30.7 12 of Regulation 190.07 (Calculation of which less stringent segregation requirements would generally apply to positions in were in effect.16 Allowed Net Equity). According to the commodity futures contracts that are The Commission codified the proposing release for Regulation Part traded on foreign boards of trade (i.e., 8 aforementioned intent by promulgating 190 (the ‘‘Proposing Release’’), the foreign futures or foreign options Regulation 190.08(c), which states: Commission intended Regulation 190.07 contracts), and to the money, securities, to constitute a ‘‘step-by-step method for and/or other property margining, [P]roperty held by or for the account of a calculating the estate’s liability to a guaranteeing, or securing such customer, which is segregated on behalf of a customer (i.e., the customer’s net equity) positions.13 specific account class * * * must be and of the pro rata share of the assets Under the Regulations, requirements allocated to the customer estate of the account class for which it is segregated. available to pay that claim (i.e., the for the treatment of positions (and the 9 ***17 customer’s allowed net equity claim).’’ money, securities, and/or other property To further such intent, the Commission margining, guaranteeing, or securing C. The Use of Account Class in the set forth the concept of ‘‘account class’’ such positions) may differ in stringency, in Regulation 190.07, and defined the Calculation of Net Equity and Allowed and therefore in the degree of protection Net Equity term ‘‘account class’’ in Regulation that they afford customers of a 190.01(a). commodity broker in bankruptcy. For As mentioned above, the concept of ‘‘account class’’ governs the manner in B. Account Class example, the segregation requirements in Regulations 1.20 through 1.30 are which the trustee calculates the net 1. Definition more stringent than the requirements in equity and the ‘‘allowed net equity’’ for Regulation 190.01(a) currently defines Regulation 30.7.14 Thus, the each customer of a commodity broker in ‘‘account class’’ as follows: bankruptcy. 10 In general, Regulation 190.07(b) Each of the following types of customer 17 CFR 190.01(a). 11 17 CFR 1.20–1.30. requires a trustee to calculate net equity accounts which must be recognized as a 18 12 separately for each account class. separate class of account by the trustee: [i] 17 CFR 30.7. futures accounts, [ii] foreign futures 13 As discussed in further detail below, the Specifically, Regulation 190.07(b)(2) accounts, [iii] leverage accounts, [iv] Commission has the power under Section 4d of the directs the trustee to ‘‘aggregate the Act (7 U.S.C. 6d) to issue an order permitting credit and debit equity balances of all commodity option accounts and [v] delivery positions in foreign futures contracts (and the accounts as defined in § 190.05(a)(2): money, securities, and/or property margining, accounts of the same class held by a Provided, however, That to the extent that the guaranteeing, or securing such positions), to be customer in the same capacity’’ while equity balance, as defined in § 190.07, of a commingled, in either an FCM or DCO account, calculating net equity.19 customer in a commodity option, as defined with positions in futures contracts (and the money, securities, and/or other property margining, 15 Proposing Release, supra, note 9 at 57536. guaranteeing, or securing such positions). 4 Section 761(17) of the Bankruptcy Code (11 16 Id. at 57554. 14 When the Commission promulgated Regulation U.S.C. 761(17)) is one provision in Subchapter IV 17 Part 190 in 1983, the Regulations had no 17 CFR 190.08(c). of Chapter 7 of the Bankruptcy Code (11 U.S.C. 761 18 17 CFR 190.07(b). et seq.), which governs commodity broker requirements for the treatment of money, securities, 19 17 CFR 190.07(b)(2). liquidations (‘‘Subchapter IV’’). and/or other property that were used to margin, guarantee, or secure commodity futures contracts Regulation 190.07(b)(3) (17 CFR 190.07(b)(3)) 5 11 U.S.C. 761(17). traded on foreign boards of trade. In 1987, however, provides a limited exception to Regulation 6 7 U.S.C. 24. the Commission promulgated Regulation 30.7, 190.07(b)(2), by permitting the trustee, while 7 17 CFR 190.07(a). which applies different and less stringent calculating net equity, to offset ‘‘[a] negative equity 8 See Proposed Rulemaking: 17 CFR Part 190 requirements to such money, securities, and/or balance with respect to one customer account class’’ (Bankruptcy), 46 FR 57535 (November 24, 1981). other property than the segregation requirements in against ‘‘a positive equity balance in any other 9 Id. at 57546. Regulations 1.20 through 1.30. Continued

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Regulation 190.07(a) states that Commission does not intend for of Subchapter IV (and, in turn, ‘‘allowed net equity’’ shall ‘‘be equal to ‘‘cleared OTC derivatives’’ to constitute Regulation Part 190) to cleared OTC the aggregate of the funded balances of a sixth and separate account class with derivatives under the Commodity such customer’s net equity claim for respect to a bankruptcy of a commodity Futures Modernization Act of 2000 (the each account class plus or minus’’ broker that is not an FCM. ‘‘CFMA’’),25 and (ii) to address a certain adjustments.20 Regulation The Commission is also proposing to scenario that the Statement on Cleared 190.07(c), in turn, defines ‘‘funded amend Regulation 190.01 to define OTC Derivatives did not reference. The balance’’ as: ‘‘* * * a customer’s pro ‘‘cleared OTC derivatives.’’ In its Commission is proposing the rata share of the customer estate with Interpretative Statement, dated amendments at this time because of respect to each account class available September 26, 2008 (the ‘‘Statement on increased interest among DCOs in as of the primary liquidation date for Cleared OTC Derivatives’’), the clearing OTC derivatives, and the need distribution to customers of the same Commission defined ‘‘cleared-only to enhance certainty regarding the class.’’ 21 contracts’’ as those contracts that treatment of cleared OTC derivatives in As this definition provides, ‘‘although not executed or traded on a the bankruptcy of a commodity broker Regulation 190.07(c) requires a trustee Designated Contract Market or a that is an FCM. to calculate funded balance separately Derivatives Transaction Execution for each account class. Specifically, Facility, are subsequently submitted for 1. To Reflect the Extension of Regulation 190.07(c)(1) requires the clearing through a Futures Commission Subchapter IV to Cleared OTC trustee to calculate, with respect to a Merchant * * * to a Derivatives Derivatives particular account class held by a 23 Clearing Organization.’’ In the The Commission promulgated the particular customer of a commodity definition of ‘‘cleared OTC derivatives’’ current version of Regulation 190.01(a) broker in bankruptcy, the ratio between in the proposed amendment to in 1983. At that time, cleared OTC (i) the net equity of such customer for Regulation 190.01, the Commission is derivatives, if they existed, were not such account class, and (ii) the net proposing to incorporate the definition ‘‘commodity contracts’’ within the equity of all customers for such account for ‘‘cleared-only contracts’’ from the meaning of Section 761(4) of the class. Regulation 190.07(c)(1) then Statement on Cleared OTC Derivatives. Bankruptcy Code.26 Therefore, neither requires the trustee to multiply such However, consistent with the intentions Subchapter IV nor Regulation Part 190 ratio against the value of any money, 24 specified in the Proposing Release, the applied to cleared OTC derivatives. securities or other property that the Commission proposes to limit ‘‘cleared commodity broker held on behalf of OTC derivatives’’ to only those The CFMA, however, created the commodity contracts in such account opportunity for OTC derivatives to be positions in ‘‘cleared-only contracts’’ 27 class. Finally, to calculate allowed net that (along with the money, securities, cleared. In addition, the CFMA equity, Regulation 190.07(a) requires the and/or other property margining, extended Subchapter IV (and, in turn, trustee to aggregate the funded balances guaranteeing, or securing such Regulation Part 190) to cleared OTC across account classes, and to make positions) are required to have been derivatives. As mentioned in the certain adjustments, thus generating the (i) segregated in accordance with a rule, Statement on Cleared OTC Derivatives, total amount that each customer is regulation, or order issued by the Section 761(4)(A) of the Bankruptcy entitled to recover from all money, Commission, or (ii) held in a separate Code defines ‘‘commodity contract,’’ securities, and/or other property held on account for ‘‘cleared-only contracts’’ in with respect to an FCM, as a ‘‘contract behalf of such customer. accordance with the rules or bylaws of for the purchase or sale of a commodity for future delivery on, or subject to the II. Proposed Amendments To Include a DCO. The Commission does not rules of, a contract market or board of Cleared OTC Derivatives as a Separate intend to specify substantive trade.’’ 28 The CFMA amended the Account Class requirements for the treatment of cleared OTC derivatives (and the definition of ‘‘contract market’’ in A. Description money, securities, and/or other property Section 761(7) of the Bankruptcy Code As mentioned above, Regulation margining, guaranteeing, or securing to include reference to a ‘‘registered 190.01(a) currently sets forth five such derivatives). Rather, the entity.’’ As mentioned in the Statement separate account classes: (i) Futures Commission proposes to define ‘‘cleared on Cleared OTC Derivatives, Section accounts; (ii) foreign futures accounts; OTC derivatives’’ in such a manner as 761(8) of the Bankruptcy Code (iii) leverage accounts; (iv) commodity incorporates by reference the definition to specify the sources from which such 29 option accounts; and (v) delivery substantive requirements may originate. of ‘‘registered entity’’ in the Act. accounts. The Commission is proposing Moreover, by including contracts that Therefore, the CFMA first permitted to amend Regulation 190.01(a) to ‘‘are required to be segregated * * * or cleared OTC derivatives, which are designate ‘‘cleared OTC derivatives’’ as to be held in a separate account’’ for subject to the rules of a DCO, to become a sixth and separate account class with ‘‘cleared-only contracts,’’ the ‘‘commodity contracts’’ within the respect to the bankruptcy of a Commission seeks to avoid the need to meaning of Section 761(4) of the commodity broker that is an FCM. The engage in fact-intensive post-bankruptcy Bankruptcy Code, specifically with Commission is also proposing to make inquiries regarding compliance with respect to a commodity broker that is an certain conforming changes to such requirements. FCM. Regulation 190.07(b)(2)(viii) and Form 4 (Proof of Claim) in Appendix A to B. Rationale 25 Appendix E of Pub. L. 106–554, 114 Stat. 2763 Regulation Part 190 (Bankruptcy As detailed further below, the (2000). 26 Forms).22 As described below, the Commission is proposing these 11 U.S.C. 761(4). 27 See Sections 2(d) and 2(e) of the Act (7 U.S.C. amendments (i) to reflect the extension §§ 2(d), (e)). account class of such customer held in the same 28 Id. capacity.’’ 23 73 FR 65514 (November 4, 2008). 29 11 U.S.C. 761(8). The term ‘‘registered entity’’ 20 17 CFR 190.07(a). 24 See supra notes 16 and 17, and the is defined in Section 1a(29) of the Act (7 U.S.C. 21 17 CFR 190.07(c). corresponding quotations from the Proposing § 1a(29)) to include ‘‘(iii) a derivatives clearing 22 17 CFR pt. 190, app. A, form 4. Release in the text of this preamble. organization registered under Section 5b * * *.’’

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As detailed in the Statement on securities, and/or other property class as opposed to the foreign futures Cleared OTC Derivatives, in a margining, guaranteeing or securing account class or another account class.34 bankruptcy of a commodity broker that such positions), to be commingled with As mentioned above, the Commission is an FCM, claims arising out of cleared (and, therefore, to be accorded the same subsequently issued the Statement on OTC derivatives should be included in protections in bankruptcy as) positions Cleared OTC Derivatives, which extends the determination of net equity (and in commodity contracts of the futures the conclusion in the Statement on therefore, by inference, in the account class (and the money, Commingling Foreign Futures Positions determination of allowed net equity), for securities, and/or other property to cover cleared OTC derivatives that purposes of Subchapter IV and margining, guaranteeing or securing have been placed in domestic Regulation Part 190.30 Consequently, such positions), in either an FCM or segregation pursuant to Commission the Commission is proposing DCO account. Specifically, Section 4d of order. Specifically, the Commission amendments to provide a regulatory the Act states that: stated that: framework to accomplish this goal. In accordance with such terms and [I]n October 2004, the Commission issued 2. To Address a Scenario Not conditions as the Commission may prescribe an interpretation regarding the appropriate Referenced in the Statement on Cleared by rule, regulation, or order, * * * money, account class for funds attributable to OTC Derivatives securities, and property of the customers of contracts traded on non-domestic boards of such futures commission merchant may be trade, and the assets margining such In the Statement on Cleared OTC commingled and deposited * * * with any contracts, that are included in accounts Derivatives, the Commission explained other money, securities, and property segregated in accordance with Section 4d of that, for purposes of Regulation Part received by such futures commission the Act pursuant to Commission Order. In 190: merchant and required by the Commission to that context, the Commission concluded that the claim is properly against the Section 4d be separately accounted for and treated and A claim arising out of a cleared-only account class because customers whose contract, or the property margining such a dealt with as belonging to the customers of assets are deposited in such an account contract, would be includable in the futures such futures commission merchant. pursuant to Commission Order should account class, where, pursuant to benefit from that pool of assets. The same Commission Order, the contract or property The Commission has issued two rationale supports the Commission’s is included in an account segregated in interpretations stating that, for purposes conclusion that a claim arising out of a accordance with Section 4d of the Act.31 of Regulation Part 190, if positions in cleared-only contract, or the property However, the Commission did not commodity contracts (and relevant margining such a contract, would be address the treatment, under Regulation money, securities, and/or other includable in the futures account class, property) of one account class, are, where, pursuant to Commission Order, the Part 190, of positions in cleared OTC contract or property is included in an derivatives (and the money, securities, pursuant to a Commission order, commingled with positions in account segregated in accordance with and/or other property margining, Section 4d of the Act.35 guaranteeing, or securing such commodity contracts (and relevant The Commission is proposing to positions), in a scenario where there is money, securities, and/or other codify explicitly, in Regulation no applicable Section 4d Order (as such property) of the futures account class, 190.01(a), a generalized version of the term is defined below). Therefore, as then, the former positions (and relevant Statement on Commingling Foreign mentioned above, the Commission is money, securities, and/or other Futures Positions and the Statement on proposing amendments to create, only property) shall be treated as part of the Cleared OTC Derivatives. This version with respect to the bankruptcy of a futures account class. First, the shall apply to positions in all commodity broker that is an FCM, a Commission issued an Interpretative commodity contracts (and money, sixth and separate account class, to Statement on October 21, 2004 (the securities, and/or other property which cleared OTC derivatives (as well ‘‘Statement on Commingling Foreign margining, guaranteeing, or securing as the money, securities, and/or other Futures Positions’’), stating that such positions). The Commission property margining, guaranteeing, or ‘‘collateral supporting foreign futures believes that these amendments would securing such derivatives) could be placed in domestic segregation pursuant remove any concerns regarding whether allocated. By creating such an account to Commission Order should be treated the Statement on Commingling Foreign class, the Commission is effectively as in a futures account, not a foreign Futures Positions and the Statement on specifying the manner in which the futures account, for purposes of Part 33 Cleared OTC Derivatives would be trustee in the bankruptcy of a 190.’’ In the Statement on limited to the specific factual patterns commodity broker that is an FCM must Commingling Foreign Futures Positions, addressed therein. To be clear, it is the treat, in the absence of an applicable the Commission indicated that it would belief of the Commission that the Section 4d Order, claims arising out of accord similar treatment to positions in Statement on Commingling Foreign cleared OTC derivatives when other commodity contracts (and the Futures Positions and the Statement on determining net equity and allowed net relevant money, securities, and/or other Cleared OTC Derivatives are equity. property) that are placed in domestic segregation. Specifically, the nonetheless effective without such III. Proposed Amendment To Clarify Commission stated that: explicit codification. Appropriate Allocation of Collateral to In a situation whereby Commission order IV. Related Matters Certain Account Classes or direction, customers are required or The Commission has the power under allowed to contribute to a Commission A. Regulatory Flexibility Act Section 4d of the Act 32 to issue an order Regulation 1.20 segregated account, those The Regulatory Flexibility Act (a ‘‘Section 4d Order’’) permitting customers also should benefit from the (‘‘RFA’’) 36 requires Federal agencies, in positions in commodity contracts of one distribution of that account proportionately promulgating regulations, to consider account class (and the money, to their contributions in the event of the impact of those regulations on small insolvency. Such claims should be treated as 30 73 FR 65514, 65515 (November 4, 2008). encompassed within the futures account 34 Id. 31 73 FR 65514, 65516 (November 4, 2008). 35 73 FR 65514, 65516 (November 4, 2008). 32 7 U.S.C. 6d. 33 69 FR 69510, 69511 (November 30, 2004). 36 5 U.S.C. 601 et seq.

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businesses. The amendments proposed necessary or appropriate to protect the securities, and/or other property), and herein will affect only FCMs and DCOs. public interest or to effectuate any of the (ii) providing certainty to FCMs and The Commission has previously provisions or to accomplish any of the DCOs regarding the allocation between established certain definitions of ‘‘small purposes of the Act. account classes, in a commodity broker entities’’ to be used by the Commission The Commission has evaluated the bankruptcy, of customer positions (and in evaluating the impact of its costs and benefits of the amendments, relevant money, securities, and/or other regulations on small entities in in light of the specific considerations property) subject to a Section 4d Order. accordance with the RFA.37 The identified in Section 15(a) of the Act, as 5. Other Public Considerations Commission has previously determined follows: that FCMs 38 and DCOs 39 are not small Recent market events, including 1. Protection of Market Participants and disruptions in global credit markets, entities for the purpose of the RFA. the Public Accordingly, pursuant to 5 U.S.C. render it prudent to enhance certainty 605(b), the Chairman, on behalf of the The amendments would benefit FCMs regarding the treatment of customer Commission, certifies that the and DCOs, as well as customers of the positions (and relevant money, amendments will not have a significant futures and options markets, by securities, and/or other property) in a economic impact on a substantial providing greater certainty (i) in a commodity broker bankruptcy. number of small entities. bankruptcy of a commodity broker that Accordingly, after considering the five is an FCM, regarding the treatment of factors enumerated in the Act, the B. Paperwork Reduction Act cleared OTC derivatives, and (ii) in a Commission has determined to propose The Paperwork Reduction Act bankruptcy of any commodity broker, the regulations set forth below. 40 regarding the allocation of positions in (‘‘PRA’’) imposes certain List of Subjects in 17 CFR Part 190 requirements on Federal agencies in commodity contracts (and relevant connection with their conducting or money, securities, and/or other Bankruptcy, Brokers, Commodity sponsoring any collection of property) of one account class that are Futures. information as defined by the PRA. The commingled in an FCM or DCO account, For the reasons stated in the amendments do not require the new pursuant to an order from the preamble, the Commission proposes to collection of information on the part of Commission, with positions in amend 17 CFR part 190 as follows: any entities subject to such commodity contracts (and relevant amendments. Accordingly, for purposes money, securities, and/or other PART 190—BANKRUPTCY of the PRA, the Commission certifies property) of the futures account class. 1. The authority citation for part 190 that the amendments, if promulgated in 2. Efficiency and Competition continues to read as follows: final form, would not impose any new reporting or recordkeeping The amendments are not expected to Authority: 7 U.S.C. 1a, 2, 4a, 6c, 6d, 6g, 7a, 12, 19, and 24, and 11 U.S.C. 362, 546, 548, requirements. have an effect on efficiency or competition. 556, and 761–766, unless otherwise noted. C. Cost-Benefit Analysis 2. In § 190.01, revise paragraph (a) 3. Financial Integrity of Futures Markets and add paragraph (oo) to read as Section 15(a) of the Act requires that and Price Discovery the Commission, before promulgating a follows: The amendments would enhance the regulation under the Act or issuing an § 190.01 Definitions. order, consider the costs and benefits of protection, in the bankruptcy of a its action. By its terms, Section 15(a) of commodity broker that is an FCM, of * * * * * the Act does not require the customers with positions in cleared (a) Account class means each of the Commission to quantify the costs and OTC derivatives, by providing an following types of customer accounts benefits of a new regulation or account class in which to hold such which must be recognized as a separate determine whether the benefits of the positions (and relevant money, class of account by the trustee: futures regulation outweigh its costs. Rather, securities, and/or other property). The accounts, foreign futures accounts, Section 15(a) of the Act simply requires amendments would enhance certainty leverage accounts, commodity option the Commission to ‘‘consider the costs regarding the treatment, in a bankruptcy accounts, delivery accounts as defined and benefits’’ of its action. of any commodity broker, of customers in § 190.05(a)(2), and, only with respect Section 15(a) of the Act further with positions (and relevant money, to the bankruptcy of a commodity specifies that costs and benefits shall be securities, and/or other property) broker that is a futures commission evaluated in light of the following subject to a Section 4d Order, by merchant, cleared OTC derivatives considerations: (1) Protection of market removing concerns regarding whether accounts; Provided, however, That to the participants and the public; (2) the Statement on Commingling Foreign extent that the equity balance, as efficiency, competitiveness, and Futures Positions and the Statement on defined in § 190.07, of a customer in a financial integrity of futures markets; (3) Cleared OTC Derivatives would be commodity option, as defined in price discovery; (4) sound risk limited to the specific factual patterns § 1.3(hh) of this chapter, may be management practices; and (5) other addressed therein. Thus, the proposed commingled with the equity balance of public interest considerations. regulations would contribute to the such customer in any domestic Accordingly, the Commission could, in financial integrity of the futures and commodity futures contract pursuant to its discretion, give greater weight to any options markets as a whole. regulations under the Act, the aggregate shall be treated for purposes of this part one of the five considerations and could 4. Sound Risk Management Practices determine that, notwithstanding its as being held in a futures account; costs, a particular regulation was The amendments would reinforce the Provided, further, that, if positions in sound risk management practices commodity contracts of one account 37 47 FR 18618 (Apr. 30, 1982). already required of FCMs and DCOs, by class (and the money, securities, and/or 38 Id. at 18619. (i) providing an account class in which other property margining, guaranteeing, 39 66 FR 45604, 45609 (Aug. 29, 2001). to hold positions in cleared OTC or securing such positions), are, 40 44 U.S.C. 3501 et seq. derivatives (and relevant money, pursuant to a Commission order,

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commingled with positions in account, specify whether exchange-traded or ADDRESSES: You may submit comments, commodity contracts of the futures dealer), ‘‘delivery’’ account, or, only with identified by ‘‘MT–029–FOR’’ or Docket account class (and the money, respect to a bankruptcy of a commodity ID number OSM–2008–0022, using any securities, and/or other property broker that is a futures commission of the following methods: margining, guaranteeing, or securing merchant, a cleared OTC derivatives account. A ‘‘delivery’’ account is one which contains • Federal eRulemaking Portal: http:// such positions), then the former only documents of title, commodities, cash, www.regulations.gov. The proposed rule positions (and the relevant money, or other property identified to the claimant has been assigned Docket ID OSM– securities, and/or other property) shall and deposited for the purposes of making or 2008–0022. If you would like to submit be treated, for purposes of this part, as taking delivery on a commodity underlying comments via the Federal eRulemaking being held in an account of the futures a commodity contract or for payment of the portal, go to http://www.regulations.gov account class. strike price upon exercise of an option. and do the following. Click on the * * * * * * * * * * ‘‘Advanced Docket Search’’ button on (oo) Cleared OTC derivatives shall Issued in Washington, DC, on July 31, the right side of the screen. Type in the mean positions in commodity contracts 2009, by the Commission. Docket ID ‘‘OSM–2008–0022’’ and click that have not been entered into or David A. Stawick, on the ‘‘Submit’’ button at the bottom of traded on a contract market (as such Secretary of the Commission. the page. The next screen will display term is defined in § 1.3(h) of this [FR Doc. E9–18853 Filed 8–12–09; 8:45 am] the Docket Search Results for the rule chapter) or on a derivatives transaction making. If you click on ‘‘OSM–2008– execution facility (within the meaning BILLING CODE P 0022’’, you can view the proposed rule of Section 5a of the Act), but which and submit a comment. You can also nevertheless are submitted by a view supporting material and any commodity broker that is a futures DEPARTMENT OF THE INTERIOR comments submitted by others. commission merchant (as such term is [SATS No. MT–029–FOR; Docket ID: OSM– • defined in § 1.3(p) of this chapter) for 2008–0022] Mail, Hand Delivery/Courier: Jeff clearing by a clearing organization (as Fleischman, Director, Casper Field such term is defined in this section), Office of Surface Mining Reclamation Office, Office of Surface Mining along with the money, securities, and/ and Enforcement Reclamation and Enforcement, Federal or other property margining, Building, 150 East B Street, Room 1018, guaranteeing, or securing such 30 CFR Part 926 Casper, WY 82601–1018, (307) 261– positions, which are required to be 6550. Fax: (307) 261–6552. Montana Regulatory Program segregated, in accordance with a rule, Instructions: All submissions received regulation, or order issued by the AGENCY: Office of Surface Mining must include the agency name and MT– Commission, or which are required to Reclamation and Enforcement, Interior. 029–FOR. For detailed instructions on be held in a separate account for cleared ACTION: Proposed rule; reopening and submitting comments and additional OTC derivatives only, in accordance extension of public comment period on information on the rulemaking process, with the rules or bylaws of a clearing proposed amendment. see the ‘‘Public Comment Procedures’’ organization (as such term is defined in heading of the SUPPLEMENTARY this section). SUMMARY: We are announcing the INFORMATION section of this document. 4. In § 190.07, revise paragraph receipt of revisions pertaining to a (b)(2)(viii) to read as follows: Docket: Access to the docket to review previously proposed amendment to the copies of the Montana program, this § 190.07 Calculation of allowed net equity. Montana regulatory program amendment, a listing of any scheduled (b) * * * (hereinafter, the ‘‘Montana program’’) public hearings, and all written (2) * * * under the Surface Mining Control and comments received in response to this (viii) Subject to paragraph (b)(2)(ix) of Reclamation Act of 1977 (‘‘SMCRA’’ or document, may be obtained at the this section, the futures accounts, ‘‘the Act’’). Montana proposes additions addresses listed below during normal leverage accounts, options accounts, of rules and revisions to the business hours, Monday through Friday, foreign futures accounts, and cleared Administrative Rules of Montana (ARM) excluding holidays. You may receive OTC derivatives accounts of the same concerning Normal Husbandry one free copy of the amendment by person shall not be deemed to be held Practices. Montana intends to revise its contacting the Office of Surface Mining in separate capacities: Provided, program to improve operational Reclamation and Enforcement’s (OSM’s) however, That such accounts may be efficiency. Casper Field Office. In addition, you aggregated only in accordance with This document gives the times and may review a copy of the amendment paragraph (b)(3) of this section. locations that the Montana program and during regular business hours at the proposed amendment to that program * * * * * following locations: are available for your inspection, the 5. Amend ‘‘bankruptcy appendix form Jeff Fleischman, Director, Casper Field 4—proof of claim’’ in Appendix A to comment period during which you may submit written comments on the Office, Office of Surface Mining Part 190 by revising paragraph a in Reclamation and Enforcement, section III to read as follows: amendment, and the procedures that we will follow for the public hearing, if one Federal Building, 150 East B Street, Appendix A to Part 190—Bankruptcy is requested. Room 1018, Casper, WY 82601–1018, Forms DATES: We will accept written Telephone: (307) 261–6550, E-mail: * * * * * comments on this amendment until 4 [email protected]. Bankruptcy Appendix Form 4—Proof of p.m., mountain daylight time September Neil Harrington, Chief, Industrial and Claim 14, 2009. If requested, we will hold a Energy Minerals Bureau, Montana * * * * * public hearing on the amendment on Department of Environmental Quality, III. * * * September 8, 2009. We will accept P.O. Box 200901, Helena, MT 59620– a. Whether the account is a futures, foreign requests to speak until 4 p.m., mountain 0901, Telephone: (406) 444–2544, E- futures, leverage, option (if an option daylight time, on August 28, 2009. mail: [email protected].

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Or anytime at: http:// the proposed revisions for Normal because it is essentially irrelevant to www.regulations.gov, Docket ID OSM– Husbandry Practices that would be used reclamation activities at Montana coal 2008–0022. for erosion and settling repair and mines. FOR FURTHER INFORMATION CONTACT: Jeff landscaping activities. We notified OSM also expressed concerns about Fleischman (307) 261–6550. Montana of our concerns by letter dated the use of fertilization and other SUPPLEMENTARY INFORMATION: April 16, 2009 (Administrative Record facilitating practices, i.e. irrigation, that No. OSM–2008–0022–0009). Montana were mentioned in the incorporated I. Background on the Montana Program responded in a letter dated May 12, NRCS reference for Critical Area II. Description of the Proposed Amendment III. Public Comment Procedures 2009, by submitting a revised Planting (342) or elsewhere (e.g. 412— IV. Procedural Determinations amendment proposal (Administrative Grassed Waterway). Montana must Record No. OSM–2008–0022–0010). demonstrate that fertilization and other I. Background on the Montana Program The full text of the revised program facilitating practices will only be Section 503(a) of the Act permits a amendment is also available for you to allowed where these practices can be State to assume primacy for the read at the locations listed above under expected to continue as part of the regulation of surface coal mining and ADDRESSES. postmining land use; or if the practices reclamation operations on non-Federal In response to our concerns, Montana discontinue after the liability period and non-Indian lands within its borders made the following changes to its July expires, the probability of permanent by demonstrating that its State program 3, 2008, amendment proposal. OSM vegetation success will not be reduced. includes, among other things, ‘‘a State expressed concerns regarding Guideline To clarify the use and intent of law which provides for the regulation of Number 7, Erosion and settling repair. fertilizers for erosion and settling repair, surface coal mining and reclamation Guidance concerning the repair of rills Montana added language stating that operations in accordance with the and gullies is found in the September 2, ‘‘the use of fertilization or other requirements of this Act * * *; and 1983, Federal Register notice (48 FR facilitating practices (i.e. irrigation), as rules and regulations consistent with 40157). In this FR notice, OSM states mentioned in some normal husbandry regulations issued by the Secretary that the regulatory authority could allow practices (e.g. 342—Critical Area pursuant to this Act.’’ See 30 U.S.C. the repair of rills and gullies as a Planting and 412—Grassed Waterway) 1253(a)(1) and (7). On the basis of these husbandry practice without restarting will not be approved unless it can be criteria, the Secretary of the Interior the liability period only if the general demonstrated that the practice will conditionally approved the Montana standards of 30 CFR 816.116(c)(4) are continue as part of the postmining land program on April 1, 1980. You can find met and after consideration of the use or if discontinuance of the practice background information on the Montana normal conservation practices within after the liability period expires will not program, including the Secretary’s the region. reduce the probability of permanent findings, the disposition of comments, To clarify the intent of Guideline vegetation success.’’ OSM is satisfied and conditions of approval of the Number 7, Erosion and settling repair, with Montana’s edits to the July 3 Montana program in the April 1, 1980, Montana removed National Resource amendment proposal regarding erosion Federal Register (45 FR 21560). You can Conservation Standard (NRCS) No. 578 and settling repair. also find later actions concerning (stream crossings) from its list of For Guideline Number 9, Agricultural Montana’s program and program applicable NRCS standards. In our April activities, Montana omitted NRCS amendments at 30 CFR 926.15, 926.16, 16, 2009, letter to Montana, OSM standard numbers 441 (micro-irrigation and 926.30. advised the state to justify why stream system), 442 (sprinkler irrigation crossings would be applicable to all system), 443 (surface and subsurface II. Description of the Proposed crossing types cited in the incorporated irrigation systems), and 449 (irrigation Amendment NRCS reference, at any time during the water management) for consistency, By letter dated July 3, 2008, Montana liability period without extending the since these practices were omitted from sent us a proposed amendment to its period of responsibility, or define Guideline Number 7 (Erosion and program (SATS No. MT–029–FOR) reasonable limits. OSM was particularly settling repair) and Guideline Number under SMCRA (30 U.S.C. 1201 et seq.). concerned about large projects, such as 10 (Landscaping activities) to satisfy Montana sent the amendment to include a bridge associated with a road crossing OSM’s concerns. changes made at its own initiative. The that may be installed near the end of the To clarify the intent of Guideline full text of the original program liability period. We believe that in Number 10 (Landscaping activities), amendment is available for you to read general, stream crossings should be Montana removed numbers 422 at the locations listed above under restricted and clearly stated under what (hedgerow planting), 441 (micro- ADDRESSES. conditions, and what types of stream irrigation system), 442 (sprinkler We announced receipt of the crossings should be included, or at least irrigation system), 449 (irrigation water proposed amendment in the November which would be prohibited. OSM management), 578 (stream crossing), 657 10, 2008, Federal Register (73 FR requested that Montana also include a (wetland restoration), 658 (wetland 66569), provided an opportunity for a reasonable time limit to demonstrate the creation), and 659 (wetland public hearing or meeting on its stability of such crossings; and that no enhancement) from its list of applicable substantive adequacy, and invited negative consequences are reasonably NRCS standards. public comment on its adequacy likely after Phase III bond release. The In our April 16, 2009, letter to (Administrative Record No. OSM–2008– type of stream crossings allowed, under Montana, OSM expressed concerns 0022–0001). Because no one requested a what conditions, and time period regarding the NRCS standard public hearing or meeting, none was restrictions should be supported by conservation practices for irrigation, held. The public comment period ended appropriate literature references. specifically micro-irrigation systems on December 10, 2008. We received one Montana omitted stream crossings (441), sprinkler irrigation systems (442), comment that was not relevant to the from the list of standard practices that surface and subsurface irrigation amendment proposal. can be employed for erosion and systems (443), and irrigation water During our review of the amendment, sediment control. Montana explained management (449). 30 CFR 816.116(c)(4) we identified concerns with regard to that stream crossings was deleted specifically excludes augmentative

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irrigation as being approved as a III. Public Comment Procedures To assist the transcriber and ensure an husbandry practice. However, the Under the provisions of 30 CFR accurate record, we request, if possible, preamble to the 1979 revegetation 732.17(h), we are seeking your that each person who speaks at a public regulations (44 FR 15238, March 13, comments on whether the amendment hearing provide us with a written copy 1979) clearly states that ‘‘the augmented satisfies the applicable program of his or her comments. The public seeding, fertilizing and irrigation does approval criteria of 30 CFR 732.15. If we hearing will continue on the specified not apply to cropland and pastureland approve the amendment, it will become date until everyone scheduled to speak that can be expected to have a similar part of the Montana program. has been given an opportunity to be postmining use and which should be heard. If you are in the audience and managed in accordance with acceptable Electronic or Written Comments have not been scheduled to speak and local agricultural practices’’. OSM Send your written comments to OSM wish to do so, you will be allowed to explained in the September 7, 1988, at the addresses given above. Your speak after those who have been Federal Register (FR 53 3640) that ‘‘the comments should be specific, pertain scheduled. We will end the hearing after preamble to the 1979 revegetation only to the issues proposed in this everyone scheduled to speak and others regulations which explained that rulemaking, and include explanations in present in the audience who wish to fertilization, seeding and irrigation in support of your recommended speak, have been heard. accordance with local agricultural change(s). We appreciate any and all IV. Procedural Determinations practices on cropland or pasture land is comments, but those most useful and not considered a prohibited likely to influence decisions on the final Executive Order 12630—Takings augmentative practice’’. Furthermore, 30 regulations will be those that either This rule does not have takings CFR 816.116(c)(4) specifically requires involve personal experience or include implications. This determination is that any approved husbandry practice citations to and analyses of SMCRA, its based on the analysis performed for the must be expected to continue as part of legislative history, its implementing counterpart Federal regulation. the postmining land use, or if the regulations, case law, other pertinent practices are discontinued after the Tribal or Federal laws or regulations, Executive Order 12866—Regulatory liability period expires, cessation will technical literature, or other relevant Planning and Review not reduce the probability of permanent publications. This rule is exempted from review by vegetation success. We will not consider or respond to the Office of Management and Budget OSM requested that Montana justify your comments when developing the (OMB) under Executive Order 12866. why irrigation would be applicable to final rule if they are received after the all land uses without extending the close of the comment period (see Dates). Executive Order 12988—Civil Justice period of responsibility, or define when We will make every attempt to log all Reform and on what land use such irrigation comments into the administrative The Department of the Interior has practices would be applicable under the record, but comments delivered to an conducted the reviews required by constraints cited in the regulations, address other than the Casper Field section 3 of Executive Order 12988 and thereby specifying when such irrigation Office may not be logged in. has determined that this rule meets the practices could be reasonably applicable standards of subsections (a) considered to be a normal husbandry Public Availability of Comments and (b) of that section. However, these practice. Before including your address, phone standards are not applicable to the In response, Montana removed the number, e-mail address, or other actual language of State regulatory following NRCS standard practices from personal identifying information in your programs and program amendments the list of approved normal husbandry comment, you should be aware that because each program is drafted and practices for Landscaping activities: 422 your entire comment—including your promulgated by a specific State, not by (hedgerow planting), 441 (micro personal identifying information—may OSM. Under sections 503 and 505 of irrigation system), 442 (sprinkler be made publicly available at any time. SMCRA (30 U.S.C. 1253 and 1255) and irrigation system), 449 (irrigation water While you can ask us in your comment the Federal regulations at 30 CFR management), 578 (stream crossing), 657 to withhold your personal identifying 730.11, 732.15, and 732.17(h)(10), (wetland restoration), 658 (wetland information from public review, we decisions on proposed State regulatory creation), and 659 (wetland cannot guarantee that we will be able to programs and program amendments enhancement). Montana explained that do so. submitted by the States must be based a proposal for the use of irrigation Public Hearing solely on a determination of whether the systems will be addressed during the submittal is consistent with SMCRA and permitting or permit revision process If you wish to speak at the public its implementing Federal regulations and will be required to address OSM’s hearing, contact the person listed under and whether the other requirements of limitations on the use of irrigation. FOR FURTHER INFORMATION CONTACT by 4 30 CFR parts 730, 731, and 732 have Regarding wetland related work, OSM p.m., mountain daylight time on August been met. expressed concerns that any activity 28, 2009. If you are disabled and need that requires more than minor reasonable accommodations to attend a Executive Order 13132—Federalism stabilization, interseeding, or replanting public hearing, contact the person listed This rule does not have federalism would need to be completed at least six under FOR FURTHER INFORMATION implications. SMCRA delineates the (6) years prior to Phase III bond release. CONTACT. We will arrange the location roles of the Federal and State In response to this, Montana omitted and time of the hearing with those governments with regard to the numbers 657 (wetland restoration), 658 persons requesting the hearing. If no one regulation of surface coal mining and (wetland creation), and 659 (wetland requests an opportunity to speak, we reclamation operations. One of the enhancement) from its list of applicable will not hold the hearing. If only one purposes of SMCRA is to ‘‘establish a NRCS standards used for Landscaping person expresses an interest, a public nationwide program to protect society activities. Montana will address these meeting rather than a hearing may be and the environment from the adverse items through normal reclamation held, with the results included in the effects of surface coal mining practices and time frames. docket for this rulemaking. operations.’’ Section 503(a)(1) of

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SMCRA requires that State laws under the Regulatory Flexibility Act (5 DEPARTMENT OF HOMELAND regulating surface coal mining and U.S.C. 601 et seq.). The State submittal, SECURITY reclamation operations be ‘‘in which is the subject of this rule, is based accordance with’’ the requirements of upon counterpart Federal regulations for Coast Guard SMCRA. Section 503(a)(7) requires that which an economic analysis was State programs contain rules and prepared and certification made that 33 CFR Part 117 regulations ‘‘consistent with’’ such regulations would not have a regulations issued by the Secretary significant economic effect upon a [Docket No. USCG–2009–0348] pursuant to SMCRA. substantial number of small entities. In Executive Order 13175—Consultation making the determination as to whether RIN 1625–AA09 and Coordination With Indian Tribal this rule would have a significant Governments economic impact, the Department relied Drawbridge Operation Regulations; upon the data and assumptions for the East River, New York City, NY In accordance with Executive Order counterpart Federal regulations. 13175, we have evaluated the potential AGENCY: Coast Guard, DHS. effects of this rule on Federally Small Business Regulatory Enforcement ACTION: Notice of proposed rulemaking. recognized Indian Tribes and have Fairness Act determined that the rule does not have SUMMARY: The Coast Guard proposes to substantial direct effects on one or more This rule is not a major rule under 5 temporarily change the drawbridge Indian Tribes, on the relationship U.S.C. 804(2) of the Small Business operating regulations governing the between the Federal government and Regulatory Enforcement Fairness Act. operation of the Roosevelt Island Bridge, Indian Tribes, or on the distribution of This rule: mile 6.4, across the East River at New power and responsibilities between the a. Does not have an annual effect on York City, New York. This proposed Federal government and Indian Tribes. the economy of $100 million. rule would allow the Roosevelt Island The rule does not involve or affect Bridge to remain in the closed position Indian Tribes in any way. b. Will not cause a major increase in costs or prices for consumers, for eleven months to facilitate a major Executive Order 13211—Regulations individual industries, Federal, State, or rehabilitation of the bridge. That Significantly Affect the Supply, local government agencies, or DATES: Comments and related material Distribution, or Use of Energy geographic regions. must be received by the Coast Guard on On May 18, 2001, the President issued c. Does not have significant adverse or before September 14, 2009. Executive Order 13211 which requires effects on competition, employment, ADDRESSES: You may submit comments agencies to prepare a Statement of investment, productivity, innovation, or identified by Coast Guard docket Energy Effects for a rule that is (1) the ability of U.S. based enterprises to number USCG–2009–0348 using any considered significant under Executive compete with foreign-based enterprises. one of the following methods: Order 12866, and (2) likely to have a This determination is based upon the (1) Federal Rulemaking Portal: significant adverse effect on the supply, fact that the State submittal which is the http://www.regulations.gov. distribution, or use of energy. Because (2) Fax: 202–493–2251. this rule is exempt from review under subject of this rule is based upon counterpart Federal regulations for (3) Mail: Docket Management Facility Executive Order 12866 and is not (M–30), U.S. Department of expected to have a significant adverse which an analysis was prepared and a determination made that the Federal Transportation, West Building ground effect on the supply, distribution, or use floor, Room W12–140, 1200 New Jersey of energy, a Statement of Energy Effects regulation was not considered a major rule. Avenue, SE., Washington, DC 20590– is not required. 0001. National Environmental Policy Act Unfunded Mandates (4) Hand Delivery: Same as address This rule does not require an This rule will not impose an above, between 9 a.m. and 5 p.m., environmental impact statement unfunded mandate on State, local, or Monday through Friday, except, Federal because section 702(d) of SMCRA (30 tribal governments or the private sector holidays. The telephone number is (202) 366–9329. U.S.C. 1292(d)) provides that agency of $100 million or more in any given decisions on proposed State regulatory year. This determination is based upon To avoid duplication, please use only program provisions do not constitute the fact that the State submittal, which one of these methods. See the ‘‘Public major Federal actions within the is the subject of this rule, is based upon Participation and Request for meaning of section 102(2)(C) of the counterpart Federal regulations for Comments’’ portion of the National Environmental Policy Act (42 which an analysis was prepared and a SUPPLEMENTARY INFORMATION section below for instructions on submitting U.S.C. 4321 et seq.). determination made that the Federal comments. Paperwork Reduction Act regulation did not impose an unfunded mandate. FOR FURTHER INFORMATION CONTACT: If This rule does not contain you have questions on this proposed information collection requirements that List of Subjects in 30 CFR Part 926 rule, call or e-mail Mr. Joe Arca, Project require approval by OMB under the Officer, First Coast Guard District, Paperwork Reduction Act (44 U.S.C. Intergovernmental relations, Surface telephone 212–668–7165, 3501 et seq.). mining, Underground mining. [email protected]. If you have questions Regulatory Flexibility Act Dated: June 12, 2009. on viewing or submitting material to the The Department of the Interior Allen D. Klein, docket, call Renee V. Wright, Program certifies that this rule will not have a Regional Director, Western Region. Manager, Docket Operations, telephone significant economic impact on a [FR Doc. E9–19365 Filed 8–12–09; 8:45 am] 202–366–9826. substantial number of small entities BILLING CODE 4310–05–P SUPPLEMENTARY INFORMATION:

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Public Participation and Request for ‘‘Open Docket Folder’’ in the ‘‘Actions’’ the draw in the closed position may do Comments column. You may also visit either the so at all times. This temporary rule is We encourage you to participate in Docket Management Facility in Room necessary to facilitate the rehabilitation this rulemaking by submitting W12–140 on the ground floor of the construction at the Roosevelt Island comments and related material. All Department of Transportation West Bridge. Vessel traffic should not be comments received will be posted, Building, 1200 New Jersey Avenue, SE., adversely affected since they may transit without change, to http:// Washington, DC 20590, between 9 a.m. around the other side of Roosevelt www.regulations.gov and will include and 5 p.m., Monday through Friday, Island as an alternate traffic route. except Federal holidays. We have an any personal information you have Regulatory Analysis provided. agreement with the Department of Transportation to use the Docket We developed this proposed rule after Submitting Comments Management Facility. considering numerous statutes and executive orders related to rulemaking. If you submit a comment, please Privacy Act Below we summarize our analysis based include the docket number for this Anyone can search the electronic on 13 of these statutes or executive rulemaking (USCG–2009–0348), form of all comments received into any orders. indicate the specific section of this of our dockets by the name of the document to which each comment Regulatory Planning and Review individual submitting the comment (or applies, and give the reason for each signing the comment), if submitted on This proposed rule is not a comment. You may submit your behalf of an association, business, labor ‘‘significant regulatory action’’ under comments and material on line (http:// union, etc.). You may review a Privacy section 3(f) of Executive Order 12866, www.regulations.gov), or by fax, mail or Act, system of records notice regarding Regulatory Planning and Review, and hand delivery, but please use only one our public dockets in the January 17, does not require an assessment of of these means. If you submit a 2008 issue of the Federal Register (73 potential costs and benefits under comment online via FR 3316). section 6(a)(3) of that Order. The Office www.regulations.gov, it will be of Management and Budget has not considered received by the Coast Guard Public Meeting reviewed it under that Order. when you successfully transmit the We do not now plan to hold a public This proposed rule is not a significant content. If you fax, hand deliver, or mail meeting. But you may submit a request regulatory action. This conclusion is your comment, it will be considered as for one using one of the four methods based upon the fact that vessel traffic having been received by the Coast specified under ADDRESSES. Please will still be able to transit the East River Guard when it is received at the Docket explain why one would be beneficial. If using the alternate route around the Management Facility. We recommend we determine that one would aid this island. that you include your name and mailing rulemaking, we will hold one at a time Small Entities address, an e-mail address, or a phone and place announced by a later notice number in the body of your document in the Federal Register. Under the Regulatory Flexibility Act so that we can contact you if we have (5 U.S.C. 601–612), we have considered questions regarding your submission. Background and Purpose whether this proposed rule would have To submit your comment online, go to The Roosevelt Island Bridge has a a significant economic impact on a http://www.regulations.gov, click on the vertical clearance of 40 feet at mean substantial number of small entities. ‘‘submit a comment’’ box, which will high water, and 47 feet at mean low The term ‘‘small entities’’ comprises then become highlighted in blue. In the water in the closed position. The small businesses, not-for-profit ‘‘Document Type’’ drop down menu existing drawbridge operating organizations that are independently select ‘‘Proposed Rules’’ and insert regulations listed at 33 CFR 117.781, owned and operated and are not ‘‘USCG–2009–0348’’ in the ‘‘Keyword’’ require the bridge to open on signal if dominant in their fields, and box. Click ‘‘Search’’ then click on the at least a two hour advance notice is governmental jurisdictions with balloon shape in the ‘‘Actions’’ column. given. populations of less than 50,000. If you submit your comments by mail or The bridge owner, New York City The Coast Guard certifies under hand delivery, submit them in an Department of Transportation, has section 5 U.S.C. 605(b) that this unbound format, no larger than 81⁄2 by requested a temporary rule to facilitate proposed rule would not have a 11 inches, suitable for copying and electrical and mechanical rehabilitation significant economic impact on a electronic filing. If you submit them by at the Roosevelt Island Bridge. substantial number of small entities. mail and would like to know that they Under this temporary rule the This conclusion is based on the fact reached the Facility, please enclose a Roosevelt Island Bridge would remain that vessel traffic will still be able to stamped, self-addressed postcard or in the closed position from October 1, transit the East River using the alternate envelope. We will consider all 2009 through August 31, 2010. route round the island. comments and material received during If you think that your business, the comment period and may change Discussion of Proposed Rule organization, or governmental the rule based on your comments. This proposed change would amend jurisdiction qualifies as a small entity 33 CFR 117.781 by suspending and that this rule would have a Viewing Comments and Documents paragraph (c) and adding a new significant economic impact on it, To view comments, as well as temporary paragraph (d) that would list please submit a comment (see documents mentioned in this preamble the drawbridge operation regulations for ADDRESSES) explaining why you think it as being available in the docket, go to the Roosevelt Island Bridge. qualifies and how and to what degree http://www.regulations.gov, click on the This proposed change would allow this rule would economically affect it. ‘‘read comments’’ box, which will then the Roosevelt Island Bridge to need not become highlighted in blue. In the open for the passage of vessel traffic Assistance for Small Entities ‘‘Keyword’’ box insert ‘‘USCG–2009– from October 1, 2009 through August Under section 213(a) of the Small 0348’’ and click ‘‘Search.’’ Click the 31, 2010. Vessels that can pass under Business Regulatory Enforcement

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Fairness Act of 1996 (Pub. L. 104–121), Protection of Children Environment we want to assist small entities in We have analyzed this proposed rule understanding this proposed rule so that We have analyzed this proposed rule under Executive Order 13045, under Department of Homeland they can better evaluate its effects on Security Management Directive 0023.1, them and participate in the rulemaking. Protection of Children from Environmental Health Risks and Safety and Commandant Instruction If the rule would affect your small M16475.1D, which guides the Coast business, organization, or governmental Risks. This rule is not an economically significant rule and would not create an Guard in complying with the National jurisdiction and you have questions Environmental Policy Act of 1969 concerning its provisions or options for environmental risk to health or risk to safety that might disproportionately (NEPA) (42 U.S.C. 4321–4370f), and compliance, please contact, Commander have made a preliminary determination affect children. (dpb), First Coast Guard District, Bridge that this action is one of a category of Branch, One South Street, New York, Indian Tribal Governments actions which do not individually or NY, 10004. The telephone number is cumulatively have a significant effect on (212) 668–7165. The Coast Guard will This rule does not have tribal the human environment because it not retaliate against small entities that implications under Executive Order simply promulgates the operating question or complain about this 13175, Consultation and Coordination regulations or procedures for proposed rule or any policy or action of with Indian Tribal Governments, drawbridges. We seek any comments or the Coast Guard. because it would not have a substantial information that may lead to the Collection of Information direct effect on one or more Indian discovery of a significant environmental tribes, on the relationship between the impact from this proposed rule. This proposed rule would call for no Federal Government and Indian tribes, new collection of information under the or on the distribution of power and List of Subjects in 33 CFR Part 117 Paperwork Reduction Act of 1995 (44 responsibilities between the Federal Bridges. U.S.C. 3501–3520.). Government and Indian tribes. For the reasons discussed in the Federalism Energy Effects preamble, the Coast Guard proposes to amend 33 CFR part 117 as follows: A rule has implications for federalism We have analyzed this proposed rule under Executive Order 13132, under Executive Order 13211, Actions PART 117—DRAWBRIDGE Federalism, if it has a substantial direct Concerning Regulations That OPERATION REGULATIONS effect on State or local governments and Significantly Affect Energy Supply, would either preempt State law or 1. The authority citation for part 117 Distribution, or Use. We have impose a substantial direct cost of continues to read as follows: determined that it is not a ‘‘significant compliance on them. We have analyzed Authority: 33 U.S.C. 499; 33 CFR 1.05– energy action’’ under that order because this proposed rule under that Order and 1(g); Department of Homeland Security it is not a ‘‘significant regulatory action’’ have determined that it does not have Delegation No. 0170.1. under Executive Order 12866 and is not implications for federalism. likely to have a significant adverse effect 2. From, October 1, 2009 through Unfunded Mandates Reform Act on the supply, distribution, or use of August 31, 2010, § 117.781 is amended energy. The Administrator of the Office by suspending paragraph (c) and adding The Unfunded Mandates Reform Act of Information and Regulatory Affairs a temporary paragraph (d) to read as of 1995 (2 U.S.C. 1531–1538) requires has not designated it as a significant follows: Federal agencies to assess the effects of energy action. Therefore, it does not their discretionary regulatory actions. In § 117.781 East River. require a Statement of Energy Effects particular, the Act addresses actions * * * * * under Executive Order 13211. that may result in the expenditure by a (d) The draw of the Roosevelt Island State, local, or tribal government, in the Technical Standards Bridge at mile 6.4, at New York City, aggregate, or by the private sector of need not open for the passage of vessel $100,000,000 or more in any one year. The National Technology Transfer traffic from October 1, 2009 through Though this proposed rule would not and Advancement Act (NTTAA) (15 August 31, 2010. result in such an expenditure, we do U.S.C. 272 note) directs agencies to use Dated: July 6, 2009. voluntary consensus standards in their discuss the effects of this rule elsewhere Dale G. Gabel, in this preamble. regulatory activities unless the agency provides Congress, through the Office of Rear Admiral, U.S. Coast Guard, Commander, First Coast Guard District. Taking of Private Property Management and Budget, with an explanation of why using these [FR Doc. E9–19435 Filed 8–12–09; 8:45 am] This proposed rule would not affect a BILLING CODE 4910–15–P taking of private property or otherwise standards would be inconsistent with have taking implications under applicable law or otherwise impractical. Executive Order 12630, Governmental Voluntary consensus standards are technical standards (e.g., specifications ENVIRONMENTAL PROTECTION Actions and Interference with AGENCY Constitutionally Protected Property of materials, performance, design, or operation; test methods; sampling Rights. 40 CFR Part 52 procedures; and related management Civil Justice Reform systems practices) that are developed or [EPA–R05–OAR–2007–1129; FRL–8942–1] This proposed rule meets applicable adopted by voluntary consensus standards bodies. Approval and Promulgation of Air standards in sections 3(a) and 3(b)(2) of Quality Implementation Plans; Ohio; Executive Order 12988, Civil Justice This proposed rule does not use Consumer Products Rule Reform, to minimize litigation, technical standards. Therefore, we did eliminate ambiguity, and reduce not consider the use of voluntary AGENCY: Environmental Protection burden. consensus standards. Agency (EPA).

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ACTION: Proposed rule. submittal and anticipates no adverse detailed rationale for the approval is set comments. A detailed rationale for the forth in the direct final rule. If no SUMMARY: EPA is proposing to approve approval is set forth in the direct final adverse comments are received in a request submitted by the Ohio rule. If we do not receive any adverse response to this action, no further Environmental Protection Agency (Ohio comments in response to this rule, we activity is contemplated. If EPA receives EPA) on October 5, 2007, to revise the do not contemplate taking any further adverse comments, the direct final rule Ohio State Implementation Plan (SIP) action. If EPA receives adverse will be withdrawn and all public under the Clean Air Act. The State has comments, we will withdraw the direct comments received will be addressed in submitted new volatile organic final rule, and will address all public a subsequent final rule based on this compounds (VOCs) control rules for comments in a subsequent final rule proposed rule. EPA will not institute a approval under Chapter 3745–112 of the based on this proposed rule. EPA will second comment period. Any parties Ohio Administrative Code (OAC). The not institute a second comment period. interested in commenting on this action rules include OAC 3745–112–01 to OAC Any parties interested in commenting should do so at this time. 3745–112–08 and are intended to assist on this action should do so at this time. DATES: the State in achieving and/or Comments must be received in Please note that if EPA receives adverse writing by September 14, 2009. maintaining the national 8-hour ground comment on an amendment, paragraph, level ozone standard through the ADDRESSES: Submit your comments, or section of this rule and if that identified by Docket ID Number EPA– regulation of VOCs in consumer provision may be severed from the products. R03–OAR–2008–0591 by one of the remainder of the rule, EPA may adopt following methods: DATES: Comments must be received on as final those provisions of the rule that A. http://www.regulations.gov. Follow or before September 14, 2009. are not the subject of an adverse the on-line instructions for submitting ADDRESSES: Submit your comments, comment. For additional information, comments. identified by Docket ID No. EPA–R05– see the direct final rule, which is B. E-mail: [email protected]. OAR–2007–1129, by one of the located in the Final Rules section of this C. Mail: EPA–R03–OAR–2008–0591, following methods: Federal Register. Carol Febbo, Chief, Energy, Radiation 1. http://www.regulations.gov: Follow Dated: July 28, 2009. and Indoor Environment Branch, the on-line instructions for submitting Walter W. Kovalick, Jr., Mailcode 3AP23, U.S. Environmental comments. Acting Regional Administrator, Region 5. Protection Agency, Region III, 1650 2. E-mail: [email protected]. Arch Street, Philadelphia, Pennsylvania 3. Fax: (312) 692–2551. [FR Doc. E9–19306 Filed 8–12–09; 8:45 am] 19103. 4. Mail: John M. Mooney, Chief, BILLING CODE 6560–50–P D. Hand Delivery: At the previously- Criteria Pollutant Section, Air Programs listed EPA Region III address. Such Branch (AR–18J), U.S. Environmental deliveries are only accepted during the Protection Agency, 77 West Jackson ENVIRONMENTAL PROTECTION Docket’s normal hours of operation, and Boulevard, Chicago, Illinois 60604. AGENCY 5. Hand Delivery: John M. Mooney, special arrangements should be made Chief, Criteria Pollutant Section, Air 40 CFR Part 52 for deliveries of boxed information. Instructions: Direct your comments to Programs Branch (AR–18J), U.S. [EPA–R03–OAR–2008–0591; FRL–8941–5] Environmental Protection Agency, 77 Docket ID No. EPA–R03–OAR–2008– West Jackson Boulevard, Chicago, Approval and Promulgation of Air 0591. EPA’s policy is that all comments Illinois 60604. Such deliveries are only Quality Implementation Plans; received will be included in the public accepted during the Regional Office Pennsylvania; Revised Motor Vehicle docket without change, and may be normal hours of operation, and special Emission Budgets for the York-Adams made available online at http:// arrangements should be made for Counties 8-Hour Ozone Maintenance www.regulations.gov, including any deliveries of boxed information. The Area personal information provided, unless Regional Office official hours of the comment includes information business are Monday through Friday, AGENCY: Environmental Protection claimed to be Confidential Business 8:30 a.m. to 4:30 p.m., excluding Agency (EPA). Information (CBI) or other information Federal holidays. ACTION: Proposed rule. whose disclosure is restricted by statute. Please see the direct final rule which Do not submit information that you is located in the Final Rules section of SUMMARY: EPA proposes to approve the consider to be CBI or otherwise this Federal Register for detailed State Implementation Plan (SIP) protected through http:// instructions on how to submit revision submitted by the www.regulations.gov or e-mail. The comments. Commonwealth of Pennsylvania for the http://www.regulations.gov Web site is purpose of amending the 8-hour ozone an anonymous access system, which FOR FURTHER INFORMATION CONTACT: maintenance plan for the York-Adams means EPA will not know your identity Andy Chang, Environmental Engineer, 8-Hour Ozone Maintenance Area. This or contact information unless you Criteria Pollutant Section, Air Programs revision amends the maintenance plan’s provide it in the body of your comment. Branch (AR–18J), Environmental 2009 and 2018 motor vehicle emissions If you send an e-mail comment directly Protection Agency, Region 5, 77 West budgets (MVEBs) by unequally dividing to EPA without going through http:// Jackson Boulevard, Chicago, Illinois the overall MVEBs into two sub-regional www.regulations.gov, your e-mail 60604, (312) 886–0258, MVEBs for each county comprising the address will be automatically captured [email protected]. area. In the Final Rules section of this and included as part of the comment SUPPLEMENTARY INFORMATION: In the Federal Register, EPA is approving the that is placed in the public docket and Final Rules section of this Federal Commonwealth’s SIP submittal as a made available on the Internet. If you Register, EPA is approving the State’s direct final rule without prior proposal submit an electronic comment, EPA SIP submittal as a direct final rule because the Agency views this as a recommends that you include your without prior proposal because the noncontroversial submittal and name and other contact information in Agency views this as a noncontroversial anticipates no adverse comments. A the body of your comment and with any

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disk or CD–ROM you submit. If EPA ACTION: Proposed rule. requirements subject to the Paperwork cannot read your comment due to Reduction Act of 1995, Public Law 104– technical difficulties and cannot contact SUMMARY: The Commission has before it 13. In addition, therefore, it does not you for clarification, EPA may not be a petition for rulemaking filed by contain any proposed information able to consider your comment. Multimedia Holdings Corporation collection burden ‘‘for small business (‘‘MHC’’), the permittee of station Electronic files should avoid the use of concerns with fewer than 25 KNAZ–TV, channel 2, Flagstaff, special characters, any form of employees,’’ pursuant to the Small encryption, and be free of any defects or Arizona. MHC is currently operating on its allotted pre-transition DTV channel Business Paperwork Relief Act of 2002, viruses. Public Law 107–198, see 44 U.S.C. Docket: All documents in the 22 pursuant to Special Temporary 3506(c)(4). electronic docket are listed in the Authority (‘‘STA’’). MHC requests the http://www.regulations.gov index. substitution of channel 22 for channel 2 Provisions of the Regulatory Although listed in the index, some at Flagstaff. Flexibility Act of 1980 do not apply to information is not publicly available, DATES: Comments must be filed on or this proceeding. Members of the public i.e., CBI or other information whose before August 28, 2009, and reply should note that from the time a Notice disclosure is restricted by statute. comments on or before September 8, of Proposed Rule Making is issued until Certain other material, such as 2009. the matter is no longer subject to copyrighted material, is not placed on ADDRESSES: Federal Communications Commission consideration or court the Internet and will be publicly Commission, Office of the Secretary, review, all ex parte contacts are available only in hard copy form. 445 12th Street, SW., Washington, DC prohibited in Commission proceedings, Publicly available docket materials are such as this one, which involve channel available either electronically in http:// 20554. In addition to filing comments with the FCC, interested parties should allotments. See 47 CFR 1.1204(b) for www.regulations.gov or in hard copy rules governing permissible ex parte during normal business hours at the Air serve counsel for petitioner as follows: contacts. Protection Division, U.S. Environmental Marnie Sarver, Esq., Wiley Rein LLP, Protection Agency, Region III, 1650 1776 K Street, NW., Washington, DC For information regarding proper Arch Street, Philadelphia, Pennsylvania 20006 filing procedures for comments, see 47 19103. Copies of the Commonwealth FOR FURTHER INFORMATION CONTACT: CFR 1.415 and 1.420. submittal are available at the Joyce L. Bernstein, Pennsylvania Department of [email protected], Media Bureau, List of Subjects in 47 CFR Part 73 Environmental Protection, Bureau of Air (202) 418–1600. Television, Television broadcasting. Quality, P.O. Box 8468, 400 Market SUPPLEMENTARY INFORMATION: This is a For the reasons discussed in the Street, Harrisburg, Pennsylvania. synopsis of the Commission’s Notice of FOR FURTHER INFORMATION CONTACT: Proposed Rule Making, MB Docket No. preamble, the Federal Communications Martin Kotsch, (215) 814–3335, or by 08–110, adopted August 4, 2009, and Commission proposes to amend 47 CFR e-mail at [email protected]. released August 5, 2009. The full text of Part 73 as follows: SUPPLEMENTARY INFORMATION: For this document is available for public PART 73—RADIO BROADCAST further information, please see the inspection and copying during normal SERVICES information provided in the direct final business hours in the FCC’s Reference action, with the same title, that is Information Center at Portals II, CY– 1. The authority citation for part 73 located in the Rules and Regulations A257, 445 12th Street, SW., continues to read as follows: section of this Federal Register Washington, DC, 20554. This document publication. will also be available via ECFS (http:// Authority: 47 U.S.C. 154, 303, 334, 336. www.fcc.gov/cgb/ecfs/). (Documents Dated: July 28, 2009. § 73.622(i) [Amended] William C. Early, will be available electronically in ASCII, Acting Regional Administrator, Region III. Word 97, and/or Adobe Acrobat.) This 2. Section 73.622(i), the Post- document may be purchased from the [FR Doc. E9–18865 Filed 8–12–09; 8:45 am] Transition Table of DTV Allotments Commission’s duplicating contractor, BILLING CODE 6560–50–P under Arizona, is amended by adding Best Copy and Printing, Inc., 445 12th DTV channel 22 and removing DTV Street, SW., Room CY–B402, channel 2 at Flagstaff. Washington, DC 20554, telephone FEDERAL COMMUNICATIONS 1–800–478–3160 or via e-mail Federal Communications Commission. COMMISSION www.BCPIWEB.com. To request this Clay C. Pendarvis, 47 CFR Part 73 document in accessible formats Associate Chief, Video Division, Media (computer diskettes, large print, audio Bureau. [DA 09–1755; MB Docket No. 08–110; RM– recording, and ), send an e-mail [FR Doc. E9–19330 Filed 8–12–09; 8:45 am] 11453] to [email protected] or call the BILLING CODE 6712–01–P Television Broadcasting Services; Commission’s Consumer and Flagstaff, AZ Governmental Affairs Bureau at (202) 418–0530 (voice), (202) 418–0432 AGENCY: Federal Communications (TTY). This document does not contain Commission. proposed information collection

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Notices Federal Register Vol. 74, No. 155

Thursday, August 13, 2009

This section of the FEDERAL REGISTER the collection of information unless it Need and Use of the Information: The contains documents other than rules or displays a currently valid OMB control various forms and narrative statements proposed rules that are applicable to the number. required are collected from eligible public. Notices of hearings and investigations, applicants that are public and private, Rural Utilities Service committee meetings, agency decisions and for-profit and not-for-profit rural rulings, delegations of authority, filing of Title: 7 CFR part 1786, Prepayment of petitions and applications and agency community facilities, schools, libraries, statements of organization and functions are RUS Guaranteed and Insured Loans to hospitals, and medical facilities. The examples of documents appearing in this Electric and Telephone Borrowers. purpose of this information is to section. OMB Control Number: 0572–0088. determine such factors as: eligibility of Summary of Collection: The Rural the applicant; the specific nature of the Electrification (RE) Act of 1936, as proposed project; the purposes for DEPARTMENT OF AGRICULTURE amended, authorizes and empowers the which loan and grant funds will be Administrator of RUS to make loans in used; project financial and technical Submission for OMB Review; the States and Territories of the United feasibility; and compliance with Comment Request States for rural electrification and for applicable laws and regulations. August 10, 2009. the purpose of furnishing and Description of Respondents: Business The Department of Agriculture has improving electric and telephone or other for-profit; Not-for-profit submitted the following information service in rural areas and to assist institutions; State, Local or Tribal collection requirement(s) to OMB for electric borrowers to implement Government. review and clearance under the demand side management, energy Number of Respondents: 230. Paperwork Reduction Act of 1995, conservation programs, and on-grid and Frequency of Responses: Public Law 104–13. Comments off-grid renewable energy systems. 7 Recordkeeping; Reporting: On occasion. regarding (a) Whether the collection of CFR part 1786, subparts E and F are Total Burden Hours: 13,451. authorized by this section. information is necessary for the proper Rural Utilities Service performance of the functions of the Need and Use of the Information: The agency, including whether the information will be collected from Title: 7 CFR part 1703–H, Deferments information will have practical utility; borrowers requesting to prepay their of RUS Loan Payments for Rural (b) the accuracy of the agency’s estimate notes and to determine that the Development Projects. of burden including the validity of the borrower is qualified to prepay under OMB Control Number: 0572–0097. methodology and assumptions used; (c) the authorizing statues. The overall goal Summary of Collection: Subsection (b) ways to enhance the quality, utility and of subparts E and F is to allow RUS of section 12 of the Rural Electrification clarity of the information to be borrowers to prepay their RUS loan and Act (RE Act) of 1936, as amended (7 collected; (d) ways to minimize the the overall goal of subpart G is to U.S.C. 912), a Rural Utilities Service burden of the collection of information refinance. (RUS) electric or telephone borrower on those who are to respond, including Description of Respondents: Business may defer the payment of principal and through the use of appropriate or other for-profit; Not-for-profit interest on any insured or direct loan automated, electronic, mechanical, or institutions. made under the RE Act invest the other technological collection Number of Respondents: 5. deferred amounts in rural development techniques or other forms of information Frequency of Responses: Reporting: projects. The Deferment program is used technology should be addressed to: Desk On occasion. to encourage borrowers to invest in and Officer for Agriculture, Office of Total Burden Hours: 16. promote rural development and rural job creation projects that are based on Information and Regulatory Affairs, Rural Utilities Service Office of Management and Budget sound economic and financial analyses. (OMB), Title: 7 CFR 1703, subparts D, E, F, Need and Use of the Information: [email protected] or and G, Distance Learning and RUS will collect information to fax (202) 395–5806 and to Departmental TelemedicineLoan and Grant Program. determine eligibility; specific purposes Clearance Office, USDA, OCIO, Mail OMB Control Number: 0572–0096. for which the deferment amount will be Stop 7602, Washington, DC 20250– Summary of Collection: The Rural utilized; the term of the deferment the 7602. Comments regarding these Utilities Service (RUS) is a credit agency borrower will receive; the cost of the information collections are best assured of the Department of Agriculture and is total project and degree of participation of having their full effect if received authorized by Chapter 1 of subtitle D of in the financing from other sources; within 30 days of this notification. the Food, Agriculture, Conservation and verification that the purposes will not Copies of the submission(s) may be Trade Act of 1990. The purpose of the violate limitations established in 7 CFR obtained by calling (202) 720–8681. Distance Learning and Telemedicine 1703–H. If the information were not An agency may not conduct or Loan and Grant Program is to improve collected, RUS would be unable to sponsor a collection of information telemedicine services and distance determine eligibility for a project. unless the collection of information learning services in rural areas through Description of Respondents: Not-for- displays a currently valid OMB control the use of telecommunications, profit; Business or other for-profit. number and the agency informs computer networks, and related Number of Respondents: 1. potential persons who are to respond to advanced technologies by students, Frequency of Responses: the collection of information that such teachers, medical professionals and Recordkeeping; Reporting: On occasion. persons are not required to respond to rural residents. Total Burden Hours: 11.

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Rural Utilities Service availability of telecommunications needed benefits to borrowers while also Title: Lien Accommodations and services for improved business, maintaining the integrity of RUS loans Subordinations 7 CFR part 1717, educational, and medical services; (3) and their repayment of taxpayer’s subparts R and S. must encourage computer networks and monies. Description of Respondents: Not-for- OMB Control Number: 0572–0100. information highways for subscribers in profit institutions. Summary of Collection: The Rural rural areas; (4) must provide for subscribers in rural areas to be able to Number of Respondents: 45. Electrification Act (RE Act) of 1936, 7 Frequency of Responses: Reporting: U.S.C. 901 et seq., as amended, receive through telephone lines: (a) conference calling; (b) video images; On occasion. authorizes and empowers the Total Burden Hours: 424. Administrator of the Rural Utilities and (c) data at a rate of 1 million bits Service (RUS) to make loans in the of information per second; and, the Charlene Parker, several States and Territories of the proper routing of information to Departmental Information Collection United States for rural electrification subscribers. Clearance Officer. Need and Use of the Information: The and the furnishing electric energy to [FR Doc. E9–19427 Filed 8–12–09; 8:45 am] Rural Utilities Service (RUS) persons in rural areas who are not BILLING CODE 3410–15– P telecommunications program staff will receiving central station service. The RE review the Modernization Plan and Act also authorizes and empowers the approve the plans, if it complies with Administrator of RUS to provide DEPARTMENT OF AGRICULTURE the requirements of the regulation. If the financial assistance to borrowers for proposed Modernization Plan is Submission for OMB Review; purposes provided in the RE Act by approved, RUS will notify the developer Comment Request accommodating or subordinating loans of the approval. If not, RUS will make made by the National Rural Utilities August 10, 2009. specific written comments and Cooperative Finance Corporation, the The Department of Agriculture has suggestions for modifying the proposed Federal Financing Bank, and other submitted the following information Modernization Plan so that it will lending agencies. collection requirement(s) to OMB for comply with the requirements of the Need and Use of the Information: review and clearance under the regulation. If the information is not RUS will used the information to Paperwork Reduction Act of 1995, collected, RUS’ authority to make loans determine an applicant’s eligibility for a Public Law 104–13. Comments under the Rural Electrification Act will lien accommodation or lien regarding (a) Whether the collection of be restricted. subordination under the RE Act; information is necessary for the proper Description of Respondents: Business facilitates an applicant’s solicitation and performance of the functions of the or other for-profit; Not-for-profit acquisition of non-RUS loans as to agency, including whether the institutions. converse available Government funds; Number of Respondents: 1. information will have practical utility; monitor the compliance of borrowers Frequency of Responses: Reporting: (b) the accuracy of the agency’s estimate with debt covenants and regulatory On occasion. of burden including the validity of the requirements in order to protect loan Total Burden Hours: 350. methodology and assumptions used; (c) security; and subsequently to granting ways to enhance the quality, utility and the lien accommodation of lien Rural Utilities Service clarity of the information to be subordination, administer each so as to Title: 7 CFR part 1721, Extensions of collected; (d) ways to minimize the minimize its cost to the Government. If Payments of Principal and Interest. burden of the collection of information the information were not collected, RUS OMB Control Number: 0572–0123. on those who are to respond, including would not be able to accomplish its Summary of Collection: The Rural through the use of appropriate statutory goals. Utilities Service (RUS) electric program automated, electronic, mechanical, or Description of Respondents: Not-for- provides loans and loan guarantees to other technological collection profit institutions; Business or other for- borrowers at interest rates and on terms techniques or other forms of information profit. that are more favorable than those technology should be addressed to: Desk Number of Respondents: 15. generally available from the private Officer for Agriculture, Office of Frequency of Responses: Reporting: sector. Procedures and conditions Information and Regulatory Affairs, On occasion. which borrowers may request Office of Management and Budget Total Burden Hours: 290. extensions of the payment of principal (OMB), and interest are authorized, as amended, [email protected] or Rural Utilities Service in section 12 of the Rural Electrification fax (202) 395–5806 and to Departmental Title: 7 CFR 1751 subpart B/State Act of 1936, and section 236 of the Clearance Office, USDA, OCIO, Mail Telecommunications Modernization Disaster Relief Act of 1970. As a result Stop 7602, Washington, DC 20250– Plan. of obtaining Federal financing, RUS 7602. Comments regarding these OMB Control Number: 0572–0104. borrowers receive economic benefits information collections are best assured Summary of Collection: The Rural that exceed any direct economic costs of having their full effect if received Electrification Loan Restructuring Act associated with complying with (RUS) within 30 days of this notification. (RELRA, Pub. L. 103–129), November 1, regulations and requirements. Copies of the submission(s) may be 1993, amended the Rural Electrification Need and Use of the Information: The obtained by calling (202) 720–8958. Act of 1936, 7 U.S.C. 901 et seq. (the RE collection of information occurs only An agency may not conduct or Act). RELRA required that a State when the borrower requests an sponsor a collection of information Telecommunications Modernization extension of principal and interest. unless the collection of information Plan (Modernization Plan or Plan), meet Eligible purposes include financial displays a currently valid OMB control all the statutory requirements of RELRA hardship, energy resource conservation number and the agency informs (part 1751, Subpart B). The plan at a loans, renewable energy project, and potential persons who are to respond to minimum must provide for: (1) The contributions-in-aid of construction. the collection of information that such elimination of party line service; (2) the The collections are made to provide persons are not required to respond to

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the collection of information unless it SUMMARY: The USDA Forest Service will practical with a priority on treatment of displays a currently valid OMB control prepare an Environmental Impact new infestations (LRMP, page 4–45). number. Statement (EIS) to document and The Pacific Northwest Region’s Invasive disclose the potential environmental Plant Program for Preventing and Office of the Assistant Secretary for effects of proposed invasive plant Managing Invasive Plants Record of Civil Rights treatments. The Proposed Action is to Decision (PNW ROD, 2005), an Title: USDA/1994 Tribal Scholars apply a combination of herbicide, amendment to the Wenatchee and Program. mechanical, manual, cultural and Okanogan LRMPs, directs that invasive OMB Control Number: 0503–0016. biological treatment methods to control plant populations be prioritized for Summary of Collection: The USDA/ invasive plants on approximately 15,246 treatment and a long term strategy be 1994 Tribal Scholars Program, within acres on the Okanogan-Wenatchee developed for restoring/revegetating the Office of the Assistant Secretary for National Forest in Washington. The invasive plant sites (PNW ROD, page Civil Rights, Office of Outreach and proposed action includes treatment of 20). Diversity, is an annual joint human invasive species on 216 acres within Invasive plants on the Forest are capital initiative between USDA and the congressionally designated wilderness compromising the ability for the Forest Nation’s thirty-two 1994 Land-Grant areas on the Forest. The Proposed Service to manage for healthy native Tribal Colleges and Universities (1994 Action would also establish criteria for ecosystems. Invasive plants create a host TCUs). The purpose of the USDA/1994 responding to the spread of infestations of environmental and other effects, most Tribal Scholars Program is to: (1) into currently unoccupied areas. of which are harmful to native Strengthen the long-term partnership DATES: Comments concerning the scope ecosystem processes, including: between USDA and the 1994 Land- displacement of native plants; reduction Grant Tribal Colleges and Universities of this analysis must be received by September 10, 2009. The draft in functionality of habitat and forage for Institutions; (2) Increase the number of wildlife and livestock; loss of students studying agriculture, food, environmental impact statement is expected January 2010 and the final threatened, endangered, and sensitive natural resources sciences, or other species; increased soil erosion and related disciplines; and (3) Offer career environmental impact statement is expected summer 2010. reduced water quality; alteration of opportunities to USDA/1994 Tribal physical and biological properties of ADDRESSES: Scholars at the U.S. Department of Send written comments to soil, including reduced soil Agriculture. Tribal Scholars are required Jodi Leingang, Naches Ranger Station, productivity; changes to the intensity to study in the food and agricultural and Okanogan-Wenatchee National Forest, and frequency of fires; high cost (dollars related sciences, so defined by the 10237 Highway 12, Naches, WA 98942 spent) of controlling invasive plants; National Agricultural Research, Comments can also be sent via e-mail to _ _ __ and loss of recreational opportunities. Extension, and Teaching Policy Act of okawen forestwide invasives eis New and existing invasive plant 1977 (U.S.C. 3103 (8)). @fs.fed.us or via facsimile to (509) 653– populations on the Forest require Need and Use of the Information: 2638, Attention: Jodi Leingang. analysis to implement new or more This program offers a combination of Comments received in response to effective and cost-efficient treatments, work experience and academic study this solicitation, including names and including the Regional EIS updated list leading to career positions within USDA addresses of those who comment, will of herbicides. The most recent inventory through a Student Career Experience become part of the public record for this shows that 15,246 acres are infested on Program designed to integrate classroom proposed action. Comments submitted the Forest. There are likely additional study with paid work experience. anonymously will be accepted and infestations that are not yet discovered, Without the information, USDA would considered; however, anonymous and these, as well as known sites, will be unable to award scholarships to comments will not provide the continue to expand and spread every students. respondent with standing to participate year without effective treatment. Description of Respondents: in subsequent administrative review or Without action, invasive plant Individuals or households. judicial review. populations will become increasingly Number of Respondents: 1,440. FOR FURTHER INFORMATION CONTACT: Jodi difficult and costly to control and will Frequency of Responses: Reporting: Leingang, Naches Ranger Station, 10237 further degrade native ecosystems. Annually. Highway 12, Naches, WA 98942; 509– The purpose of this action is to Total Burden Hours: 4,320. 653–1450. provide a rapid and more Ruth Brown, Individuals who use comprehensive, up to date approach to Departmental Information Collection telecommunication devices for the deaf control and eradicate invasive plants on Clearance Officer. (TDD) may call the Federal Information the Forest. The purpose of controlling or [FR Doc. E9–19428 Filed 8–12–09; 8:45 am] Relay Service (FIRS) at 1–800–877–8339 eradicating weed populations is to between 8 a.m. and 8 pm, Eastern Time, BILLING CODE 3410–11–P maintain or improve the diversity, Monday through Friday. function and sustainability of native SUPPLEMENTARY INFORMATION: plant communities, and other resources that depend on them. Specifically, there DEPARTMENT OF AGRICULTURE Purpose and Need for Action is a need to: (1) contain and reduce the Forest Service The Wenatchee National Forest Land extent of invasive plants at existing and Resource Management Plan (LRMP, inventoried sites, and (2) quickly detect Okanogan-Wenatchee National Forest, 1990) requires that existing populations and rapidly respond to new and Washington; Forest-Wide Site- of invasive species (termed ‘‘noxious changing invasive plant populations. Specific; Invasive Plant Management weeds’’) be contained, controlled or Environmental Impact Statement eradicated as the budget allows (page Proposed Action AGENCY: Forest Service, USDA. IV–89). The Okanogan National Forest The Okanogan-Wenatchee National Land and Resource Management Plan Forest Supervisor proposes to treat ACTION: Notice of Intent to Prepare an (LRMP, 1989) requires that noxious currently existing invasive species on Environmental Impact Statement. weeds be controlled to the extent 15,246 acres across the Okanogan-

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Wenatchee National Forest, including retreated in subsequent years, until (any combination of seeding, mulching, approximately 1,712 acres on the control objectives are met. Site-specific or planting). Some sites will require Chelan Ranger District, 1,968 acres on treatment prescriptions would be active re-vegetation to achieve the the Cle Elum Ranger District, 2,346 developed based on the ability to desired future condition. acres on the Entiat Ranger District, 799 eradicate, control, contain, suppress or In 2002, the Okanogan-Wenatchee acres on the Methow Valley Ranger tolerate an infestation. Selection of National Forest adopted an invasive District, 3,299 acres on the Naches treatment methods and prioritization of weeds prevention strategy which Ranger District, 4,399 acres on the sites would follow amended LRMP includes best management practices for Tonasket Ranger District, and 723 acres direction, and take into account the the prevention of weed spread and on the Wenatchee River Ranger District. biology of the particular invasive introduction. These practices would Infestations that occur on 216 acres species, its proximity to water and other continue to be an important part of the within congressionally designated sensitive resources (values at risk), and Forest’s invasive species management Wilderness areas would also be treated. the size of the infestation. strategy under the proposed action The proposed invasive species The Proposed Action would also described above. treatments would begin in 2010 and allow for treatment of infestations that This project does not include span the next 15 years. Under the are not currently inventoried through an herbicide application directly to water, proposed action those treatment early detection/rapid response (EDRR) use of any pesticides other than methods and herbicides analyzed in the strategy and annual implementation herbicides, treatment of aquatic invasive Pacific Northwest Region Invasive Plant planning. To these ends, this EIS will plants (floating and submerged), or include analysis associated with the Program: Preventing and Managing treatment of native vegetation. treatment of currently documented Invasive Plants, Final Environmental infestations (sites) as well as areas Possible Alternatives Impact Statement (FEIS) (USDA 2005) where invasive species are not currently would be used, along with one The No Action alternative will serve present but are most likely to spread additional herbicide. Invasive plants as a baseline for comparison of and establish over time. The EIS will would be treated using one or a alternatives. Under the No Action include analysis of approximately combination of manual (e.g. hand- alternative, the Okanogan-Wenatchee 16,448 additional acres of treatment pulling, digging with hand tools, National Forest would continue to treat associated with EDRR. Ongoing invasive plant species as authorized clipping), mechanical (e.g. mowing, inventories would continually locate weed whacking, road brushing, root and confirm infestation locations. under existing National Environmental tilling, steaming, infrared), cultural (e.g. Treatment recommendations for Policy Act (NEPA) documents competitive seeding/planting, mulching, presently uninventoried infestations including; current noxious weed, dry adding soil amendments/fertilizer), would be similar to that described for forest restoration, and other site-specific biological, and chemical methods (e.g. known infestations, in that, herbicides projects. Additional action alternatives spot spraying, wicking, and limited would be part of the initial prescription; may be developed to respond to broadcast application). Proposed with manual, mechanical, biological significant issues, if any. herbicide mixtures would include one and cultural methods becoming the Responsible Official or more of the following active common control measure over time. ingredients: chlorosulfuron, clopyralid, Treatment prescriptions for these The responsible official for this glyphosate, imazapic, imazapyr, presently undocumented sites would be project is the Okanogan-Wenatchee metsulfuron methyl, picloram, strict enough to ensure that adverse National Forest Supervisor Rebecca sethoxydim, sulfometuron methyl, and effects are minimized to remain within Lockett Heath. triclopyr. In addition to the herbicides the scope of effects analyzed in this EIS, Nature of the Decision To Be Made analyzed in the 2005 Invasive Plant and still be flexible enough to adapt to FEIS, the proposed action would changing conditions over time (i.e. The Okanogan-Wenatchee National include application of aminopyralid. adaptive management). Forest Supervisor will decide whether Herbicide treatments would be part of The total number of acres of invasive or not invasive species will be treated the initial prescription for currently species treatment that would be on the Forest, and if so, what mitigation identified sites on 15,246 acres. On approved in this document and decision measures and monitoring requirements many sites, the use of herbicides would for known and EDRR is 31,694 acres; will be required for implementation. be expected to decline in subseuqent 15,246 acres of presently known Preliminary Issues entries with manual, mechanical, infestation and 16,448 acres under the biological and cultural methods early detection rapid response strategy. Several analysis efforts related to the becoming the common control measure The number of acres treated in any treatment of invasive species on over time. Therefore, within the 15,246 given year would not exceed this total. National Forests in Washington and acres identified for chemical treatment; However, provided the recent history of Oregon (Region 6) have been completed other treatments could also occur funding available to accomplish this or are currently on-going at this time. including; 450 acres of manual work, it is very unlikely that we would Preliminary issues identified during the treatment, 350 acres of mechanical treat the total in any given year. scoping process associated with these treatment, 1,750 acres of cultural Monitoring would evaluate the efforts have included: Human health/ treatment, and 3,500 acres of biological effectiveness of past treatments and public and worker exposure to treatment. In other cases, although direct adaptive management needs over herbicides, effects of herbicide on native herbicide use would would continue as time. and non-target vegetation including the preferred treatment method through A connected action of the Proposed threatened, endangered and special time, the amount of herbicide applied Action is the restoration of treatment status plants, and the effects of would greatly diminish as the sites with desirable vegetation to herbicide on wildlife including infestation is brought nearer to prevent re-infestation. The restoration threatened, endangered and special eradication. Infested acres would be objectives may be passive (allowing status animals and aquatic organisms, treated with an initial prescription, and native plants to fill in a site) or active including special status fish.

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Scoping Process Dated: August 7, 2009. DEPARTMENT OF COMMERCE Stuart Woolley, This notice of intent initiates the Acting Forest Supervisor. International Trade Administration scoping process, which guides the [A–475–059] development of the environmental [FR Doc. E9–19451 Filed 8–12–09; 8:45 am] BILLING CODE 3410–11–P impact statement. To assist the Forest Pressure Sensitive Plastic Tape From Service in identifying and considering Italy: Final Results of Expedited issues and concerns about the proposed DEPARTMENT OF AGRICULTURE Sunset Review action, public comment opportunities AGENCY: Import Administration, will continue to be provided throughout Forest Service the EIS process. In addition to taking International Trade Administration, written comments, the Forest Service Eastern Arizona Counties Resource Department of Commerce. SUMMARY: On May 1, 2009, the will hold a series of public meetings Advisory Committee across the Forest during the late Department of Commerce (the Department) initiated a sunset review of summer/early fall of 2009 to ensure that AGENCY: Forest Service, USDA. the antidumping duty finding on those who are interested have every ACTION: Notice of meeting. pressure sensitive plastic tape (PSP opportunity to provide additional Tape) from Italy pursuant to section information or comments and to SUMMARY: The Eastern Arizona Counties 751(c) of the Tariff Act of 1930, as identify any issues or concerns they Resource Advisory Committee will meet amended (the Act). The Department may have relative to the proposed in Show Low, Arizona. The purpose of conducted an expedited (120-day) action. the meeting is to review organizational sunset review of this finding. As a result It is important that reviewers provide processes, operating guidelines, and of this sunset review, the Department their comments at such times and in legal requirements of Resource Advisory finds that revocation of the antidumping such a way that they are useful to the Committee members in accordance with duty finding would be likely to lead to Agency’s preparation of the EIS. Public Law 110–343 (the Secure Rural continuation or recurrence of dumping. Therefore, comments should be Schools and Community Self The dumping margins are identified in the Final Results of Review section of provided prior to the close of the Determination Act). comment period and should clearly this notice. articulate the reviewer’s concerns and DATES: The meeting will be held August DATES: Effective Date: August 13, 2009. contentions. The submission of timely 24, 2009 starting at 1 p.m. FOR FURTHER INFORMATION CONTACT: and specific comments can affect a ADDRESSES: The meeting will be held in Terre Keaton Stefanova or Brandon reviewer’s ability to participate in the conference room at the Holiday Inn Farlander, AD/CVD Operations, Import subsequent administrative review or Express, 151 West Deuce of Clubs, Show Administration, International Trade judicial review. Low, Arizona 85901. Send written Administration, U.S. Department of Commerce, 14th Street & Constitution Comments received in response to comments to Robert Dyson, Eastern Avenue, NW., Washington, DC 20230; this solicitation, including names and Arizona Counties Resource Advisory telephone: (202) 482–1280 or (202) 482– addresses of those who comment, will Committee, c/o Forest Service, USDA, 0182, respectively. be considered part of the public record P.O. Box 640, Springerville, Arizona SUPPLEMENTARY INFORMATION: on this proposed action and will be 85938 or electronically to available for public inspection. [email protected]. Background Comments submitted anonymously will FOR FURTHER INFORMATION CONTACT: On May 1, 2009, the Department be accepted and considered; however, Robert Dyson, Public Affairs Officer, published the notice of initiation of the respondents who submit anonymous Apache-Sitgreaves National Forests, sunset review of the antidumping duty comments will not be granted standing (928)333–4301. finding on PSP Tape from Italy pursuant to appeal the subsequent decision under to section 751(c) of the Act. See 36 CFR Part 215 or judicial review. SUPPLEMENTARY INFORMATION: The Initiation of Five-Year Sunset Review, Additionally, pursuant to 7 CFR 1.27(d), meeting is open to the public. This is an 74 FR 20286 (May 1, 2009). The any person may request the agency to administrative and organizational Department received a Notice of Intent withhold a submission from the public meeting only and no project proposals to Participate on behalf of 3M Company record by showing how the Freedom of will be reviewed. Committee discussion (3M), a domestic producer of PSP Tape, Information Act (FOIA) permits such is limited to Forest Service staff and within the deadline specified in 19 CFR confidentiality. Persons requesting such Committee members. However, persons 351.218(d)(1)(i). 3M claimed interested confidentiality should be aware that, who wish to bring Public Law 110–343 party status, under section 771(9)(C) of under the FOIA, confidentiality may be related matters to the attention of the the Act, as a producer of a domestic like granted in only very limited Committee may file written statements product in the United States. We circumstances, such as to protect trade with the Committee staff before or after received a complete substantive secrets. The Forest Service will inform the meeting. Opportunity for public response from 3M within the 30-day the requester of the agency’s decision input will be provided. deadline specified in 19 CFR 351.218(d)(3)(i). The Department did regarding the request for confidentiality, Dated: August 6, 2009. and where the request is denied; the not receive substantive responses from Chris Knopp, agency will return the submission and respondent interested parties. As a notify the requester that the comments Forest Supervisor, Apache-Sitgreaves result, pursuant to section 751(c)(3)(B) National Forests. of the Act and 19 CFR may be resubmitted with or without [FR Doc. E9–19287 Filed 8–12–09; 8:45 am] 351.218(e)(1)(ii)(C)(2), the Department name and address within a specified BILLING CODE 3410–11–M conducted an expedited (120-day) number of days. sunset review of this finding.

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Scope of Review conversion to judicial protective orders the investigation are cooperating and The products covered in this review is hereby requested. Failure to comply determines that the investigation is are shipments of PSP Tape measuring with the regulations and terms of an extraordinarily complicated and that over one and three-eighths inches in APO is a violation which is subject to ‘‘additional time is necessary to the width and not exceeding four sanction. make the preliminary determination.’’ millimeters in thickness. The above The Department is issuing and The Department is currently described PSP Tape is classified under publishing the results and notice in investigating a number of complex Harmonized Tariff Schedule of the accordance with sections 751(c), 752, alleged subsidy programs, including United States (HTSUS) subheadings and 777(i)(1) of the Act. various loan programs, grants, income 3919.90.20 and 3919.90.50. The HTS Dated: August 7, 2009. tax incentives, and the provision of subheadings are provided for Ronald K. Lorentzen, goods and services for less than convenience and for customs purposes. Acting Assistant Secretary for Import adequate remuneration. Due to the The written description remains Administration. number and complexity of the alleged dispositive. [FR Doc. E9–19430 Filed 8–12–09; 8:45 am] subsidy programs being investigated, we find that this investigation is BILLING CODE 3510––P Analysis of Comments Received extraordinarily complicated and that All issues raised in this review are additional time is necessary to make the addressed in the ‘‘Issues and Decision DEPARTMENT OF COMMERCE preliminary determination. Therefore, Memorandum for the Final Results of in accordance with section 703(c)(1)(B) the Expedited Sunset Review of the International Trade Administration of the Act, we are fully extending the Antidumping Duty Finding on Pressure due date for the preliminary [C–570–950] Sensitive Plastic Tape from Italy’’ determination to no later than 130 days (Decision Memo), which is hereby Wire Decking from the People’s after the day on which the investigation adopted by this notice. The issues Republic of China: Notice of was initiated. The deadline for discussed in the Decision Memo include Postponement of Preliminary completion of the preliminary the likelihood of continuation or Determination in the Countervailing determination is now November 2, recurrence of dumping and the Duty Investigation 2009. magnitude of the margins likely to This notice is issued and published prevail if the finding were to be AGENCY: Import Administration, pursuant to section 703(c)(2) of the Act. revoked. Parties can find a complete International Trade Administration, discussion of all issues raised in this Department of Commerce. Dated: August 7, 2009. Ronald K. Lorentzen, review and the corresponding EFFECTIVE DATE: August 13, 2009. recommendations in this public Acting Assistant Secretary for Import FOR FURTHER INFORMATION CONTACT: Administration. memorandum which is on file in the Robert Copyak, AD/CVD Operations, [FR Doc. E9–19429 Filed 8–12–09; 8:45 am] Central Records Unit, room 1117 of the Office 3, Import Administration, main Commerce building. International Trade Administration, BILLING CODE 3510–DS–S In addition, a complete version of the U.S. Department of Commerce, 14th Decision Memo can be accessed directly Street and Constitution Avenue, NW, on the Web at http://ia.ita.doc.gov/frn/ DEPARTMENT OF COMMERCE Washington, DC 20230; telephone 202– index.html. The paper copy and 482–2209. electronic version of the Decision Memo National Oceanic and Atmospheric are identical in content. SUPPLEMENTARY INFORMATION: Administration Final Results of Review Background Deadline Extension for Applications The Department determines that On July 2, 2009, the Department of for Seat on the Monterey Bay National revocation of the antidumping duty Commerce (the Department) initiated Marine Sanctuary Advisory Council the countervailing duty investigation of finding on PSP Tape from Italy would AGENCY: Office of National Marine be likely to lead to continuation or wire decking from the People’s Republic of China. See Wire Decking From the Sanctuaries (ONMS), National Ocean recurrence of dumping at the following Service (NOS), National Oceanic and weighted-average percentage margins: People’s Republic of China: Initiation of Countervailing Duty Investigation, 74 FR Atmospheric Administration (NOAA), 31700 (July 2, 2009). Department of Commerce (DOC). Manufacturers/exporters/pro- Weighted-av- erage margin ACTION: Deadline Extension Notice and ducers Postponement of Due Date for (percent) request for applications. Preliminary Determination Comet SARA, S.p.A ...... 10 Section 703(b)(1) of the Tariff Act of SUMMARY: The ONMS is extending the Tyco Adhesives Italia S.p.A 1 10 All Others ...... 10 1930, as amended (the Act), requires the deadline for applications for the Department to issue the preliminary following vacant seat on the Monterey 1 Tyco Adhesives Italia S.p.A is the suc- determination in a countervailing duty Bay National Marine Sanctuary cessor-in-interest to Manuli Tapes S.p.A. investigation within 65 days after the Advisory Council: Education. This notice also serves as the only date on which the Department initiated Applicants are chosen based upon their reminder to parties subject to the investigation. However, the particular expertise and experience in administrative protective orders (APO) Department may postpone making the relation to the seat for which they are of their responsibility concerning the preliminary determination until no later applying; community and professional return or destruction of proprietary than 130 days after the date on which affiliations; philosophy regarding the information disclosed under APO in the administering authority initiated the protection and management of marine accordance with 19 CFR 351.305. investigation if, pursuant to section resources; and possibly the length of Timely notification of the return or 703(c)(1)(B) of the Act, the Department residence in the area affected by the destruction of APO materials or concludes that the parties concerned in sanctuary. Applicants who are chosen

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should expect to serve until February management agencies, user groups, DEPARTMENT OF COMMERCE 2011. researchers, educators, policy makers, National Oceanic and Atmospheric DATES: and other various groups that help to Applications are due by Administration September 11, 2009. focus efforts and attention on the central California coastal and marine ADDRESSES: Application kits may be RIN 0648–XQ94 ecosystems. obtained from 299 Foam Street, New England Fishery Management The Advisory Council functions in an Monterey, CA 93940. Completed Council; Public Meeting applications should be sent to the same advisory capacity to the Sanctuary address. Superintendent and is instrumental in AGENCY: National Marine Fisheries FOR FURTHER INFORMATION CONTACT: helping develop policies, program goals, Service (NMFS), National Oceanic and Nicole Capps, 299 Foam Street, and identify education, outreach, Atmospheric Administration (NOAA), Monterey, CA 93940, (831) 647–4206, research, long-term monitoring, resource Commerce. [email protected]. protection, and revenue enhancement ACTION: Notice of a public meeting. priorities. The Advisory Council works SUPPLEMENTARY INFORMATION: On July SUMMARY: The New England Fishery in concert with the Sanctuary 20, 2009, ONMS published a request for Management Council (Council) is application to fill a vacancy on the Superintendent by keeping him or her scheduling a public meeting of its MBNMS Advisory Council (74 FR informed about issues of concern Scallop Committee in September, 2009 35160). The original deadline for throughout the Sanctuary, offering to consider actions affecting New submitting applications was August 21, recommendations on specific issues, England fisheries in the exclusive 2009. ONMS is extending that deadline and aiding the Superintendent in economic zone (EEZ). until September 11, 2009. achieving the goals of the Sanctuary Recommendations from this group will The MBNMS Advisory Council was program within the context of be brought to the full Council for formal established in March 1994 to assure California’s marine programs and consideration and action, if appropriate. continued public participation in the policies. DATES: This meeting will be held on management of the Sanctuary. Since its Authority: 16 U.S.C. Sections 1431, et seq. Tuesday, September 1, 2009 at 9 establishment, the Advisory Council has a.m.and Wednesday, September 2, 2009 played a vital role in decisions affecting (Federal Domestic Assistance Catalog at 9 a.m. Number 11.429 Marine Sanctuary Program) the Sanctuary along the central ADDRESSES: This meeting will be held at California coast. Dated: August 4, 2009. the Hotel Providence, 139 Mathewson The Advisory Council’s twenty voting Daniel J. Basta, Street, Providence, RI 02903; telephone: members represent a variety of local Director, Office of National Marine (401) 861–8000; fax: (401) 861–8002. user groups, as well as the general Sanctuaries, National Ocean Service, Council address: New England public, plus seven local, State and National Oceanic and Atmospheric Fishery Management Council, 50 Water Federal governmental jurisdictions. In Administration. Street, Mill 2, Newburyport, MA 01950. addition, the respective managers or [FR Doc. E9–19288 Filed 8–12–09; 8:45 am] FOR FURTHER INFORMATION CONTACT: Paul superintendents for the four California BILLING CODE 3510–NK–M J. Howard, Executive Director, New National Marine Sanctuaries (Channel England Fishery Management Council; Islands National Marine Sanctuary, telephone: (978) 465–0492. Cordell Bank National Marine DEPARTMENT OF COMMERCE SUPPLEMENTARY INFORMATION: The Sanctuary, Gulf of the Farallones committee will clarify any outstanding National Marine Sanctuary and the Bureau of Industry and Security issues related to alternatives under Monterey Bay National Marine consideration in Amendment 15. Sanctuary) and the Elkhorn Slough Materials Technical Advisory Specifically, the committee will review National Estuarine Research Reserve sit Committee; Notice of Partially Closed recommendations from the PDT related as non-voting members. Meeting; Postponed to updated fishing power adjustment Four working groups support the alternatives for stacking and leasing Advisory Council: The Research Activity The Materials Technical Advisory alternatives, recommendations from the Panel (‘‘RTP’’) chaired by the Research Committee scheduled for on August 13, SSC related to setting ABC control rule, Representative, the Sanctuary Education 2009, 10 a.m., Herbert C. Hoover and other outstanding issues. The Panel (‘‘SEP’’) chaired by the Education committee will also review some Representative, the Conservation Building, Room 3884, 14th Street between Constitution & Pennsylvania preliminary impact analyses of Working Group (‘‘CWG’’) chaired by the measures under consideration. The Avenues, NW., Washington, DC has Conservation Representative, and the committee will begin developing been postponed. The new meeting date Business and Tourism Activity Panel measures for Framework 21. (‘‘BTAP’’) chaired by the Business/ is forthcoming. Specifically, the committee will review Industry Representative, each dealing For more information, call Yvette input from the PDT about projections with matters concerning research, Springer at (202) 482–2813. for fishing year 2010 and possible education, conservation and human use. Dated: August 10, 2009. fishery specifications. Other measures The working groups are composed of under discussion are possible experts from the appropriate fields of Yvette Springer, consideration of a new scallop access interest and meet monthly, or bi- Committee Liaison Officer. area closure in the Great South Channel monthly, serving as invaluable advisors [FR Doc. E9–19436 Filed 8–12–09; 8:45 am] with high scallop recruitment, minor to the Advisory Council and the BILLING CODE P modifications to the observer set-aside Sanctuary Superintendent. program, and compliance with the The Advisory Council represents the recent turtle biological opinion. coordination link between the Although non-emergency issues not Sanctuary and the State and Federal contained in this agenda may come

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before this group for discussion, in National MPA Center Web site at SUMMARY: Notice is hereby given that accordance with the Magnuson-Stevens http://www.mpa.gov). the Estuarine Reserves Division, Office Fishery Conservation and Management SUPPLEMENTARY INFORMATION: The of Ocean and Coastal Resource Act (Magnuson-Stevens Act), those Committee, composed of external, Management, National Ocean Service, issues may not be the subject of formal knowledgeable representatives of National Oceanic and Atmospheric action during this meeting. Actions will stakeholder groups, was established by Administration (NOAA), U.S. be restricted to those issues specifically the Department of Commerce (DOC) to Department of Commerce is announcing identified in this notice and any issues provide advice to the Secretaries of a thirty day public comment period on arising after publication of this notice Commerce and the Interior on the Jacques Cousteau National Estuarine that require emergency action under implementation of section 4 of Research Reserve Management Plan Revision. Section 305(c) of the Magnuson-Stevens Executive Order 13158 on MPAs. The The Jacques Cousteau National Act, provided the public has been meeting will be open to public Estuarine Research Reserve consists of notified of the Council’s intent to take participation from 4:30 p.m. to 5:30 p.m. final action to address the emergency. public lands within the Mullica River- on Wednesday, September 9, 2009. and Great Bay watershed of New Jersey and Special Accommodations from 8:35 a.m. to 9:30 a.m. on Friday, managed by a variety of local, state, and September 11, 2009. In general, each This meeting is physically accessible federal agencies. The site was individual or group will be limited to a to people with disabilities. Requests for designated as the Jacques Cousteau total time of five (5) minutes. If sign language interpretation or other National Estuarine Research Reserve in members of the public wish to submit auxiliary aids should be directed to Paul 1998 pursuant to Section 315 of the written statements, they should be J. Howard, Executive Director, at (978) Coastal Zone Management Act of 1972, submitted to the Designated Federal 465–0492, at least 5 days prior to the as amended, 16 U.S.C. 1461. The reserve Official by September 4, 2009. meeting date. has been operating in partnership with Matters To Be Considered: The The Institute of Marine and Coastal Authority: 16 U.S.C. 1801 et seq. Committee meeting will include two Sciences of Rutgers, the State University Dated: August 7, 2009. expert panel presentations, one on how of New Jersey under a management plan Tracey L. Thompson, the national system can contribute to approved in 1997. Pursuant to 15 CFR Acting Director, Office of Sustainable ecological resilience in the face of 921.33(c), a state must revise their Fisheries, National Marine Fisheries Service. climate change, and one, including management plan every five years. The [FR Doc. E9–19377 Filed 8–12–09; 8:45 am] invited management agencies and submission of this plan fulfills this BILLING CODE 3510–22–S stakeholders, on marine protected areas requirement and sets a course for in Alaska. The Scientific and Technical successful implementation of the goals Subcommittee and the Review and and objectives of the reserve. A DEPARTMENT OF COMMERCE Evaluation Subcommittee will meet to boundary expansion and land finalize recommendations, and will conservation initiative, new facilities, National Oceanic and Atmospheric report back to the full MPA FAC for and updated programmatic objectives Administration (NOAA) deliberations and action. The meeting are notable revisions to the 1997 also will include elections of a new approved management plan. Marine Protected Areas Federal MPA FAC Chair and Vice Chair. The The revised management plan Advisory Committee; Public Meeting agenda is subject to change. The latest outlines the administrative structure; AGENCY: National Ocean Service, version will be posted at http:// the research, coastal training, education NOAA, Department of Commerce. www.mpa.gov. and outreach, and stewardship goals of the reserve; and the plans for future ACTION: Notice of open meeting Dated: August 3, 2009. land acquisition and facility David M. Kennedy, SUMMARY: Notice is hereby given of a development to support reserve Director, Office of Ocean and Coastal operations. This management plan meeting of the Marine Protected Areas Resource Management. describes how the reserve will focus on Federal Advisory Committee [FR Doc. E9–19286 Filed 8–12–09; 8:45 am] (Committee) in Anchorage. Alaska. three key coastal management issues: BILLING CODE M Nutrient inputs into coastal waters; DATES: The meeting will be held human alteration of habitat and water Wednesday, September 9, 2009, from 9 quality; and effects of climate change on a.m. to 5:30 p.m., Thursday, September DEPARTMENT OF COMMERCE coastal and estuarine systems. 10, from 8:30 a.m. to 5 p.m., and Friday, Since 1997, the reserve has completed September 11, from 8:30 am. to 4:30 National Oceanic and Atmospheric Administration a site profile that characterizes the p.m. These times and the agenda topics reserve; they have also expanded the described below are subject to change. coastal training, research and Refer to the Web page listed below for National Estuarine Research Reserve System monitoring, stewardship and education the most up-to-date meeting agenda. programs significantly. A new ADDRESSES: The meeting will be held at AGENCY: Estuarine Reserves Division, administrative building, the Jacques the Hilton Anchorage, 500 West Third Office of Ocean and Coastal Resource Cousteau Coastal Center, and a new Avenue, Anchorage, Alaska. Management, National Ocean Service, interpretive exhibit, ‘‘Life on the Edge’’ FOR FURTHER INFORMATION CONTACT: National Oceanic and Atmospheric at the Tuckerton Seaport, have been Lauren Wenzel, Designated Federal Administration, U.S. Department of built to support the growth of reserve Officer, MPA FAC, National Marine Commerce. programs. Protected Areas Center, 1305 East West With the approval of this management ACTION: Notice of Public Comment Highway. Silver Spring, Maryland plan, the Jacques Cousteau National Period for the Revised Management Plan 20910. (Phone: 301–713–3100 x136. Estuarine Research Reserve will expand for the Jacques Cousteau National Fax: 301–713–3110); e-mail: their total acreage from 114,665 acres to Estuarine Research Reserve. [email protected]; or visit the 114,873 acres. This change is

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attributable to the acquisition of four affirmative findings were based on Salvador, the Government of Mexico, parcels within the Mullica River review of documentary evidence and the Government of Spain, as well as watershed through a partnership with submitted separately by the evidence obtained from the IATTC and New Jersey Conservation Foundation Governments of Ecuador, El Salvador, the Department of State and has and the continued implementation of Mexico, and Spain and obtained from determined that Ecuador, El Salvador, the Mullica River Conservation the Inter-American Tropical Tuna Mexico and Spain have each met the Initiative. The acquisition of Bear Creek Commission (IATTC) and the U.S. MMPA’s requirements to receive annual Preserve (100 acres), Hanselman Department of State. affirmative finding renewals. Preserve (57 acres), Rudolph Property DATES: The affirmative finding renewals After consultation with the (31 acres), and Lee Property (20 acres) are effective from April 1, 2009, through Department of State, the Assistant provides additional buffer areas (mixed March 31, 2010. Administrator issued annual affirmative pitch pine-scrub oak upland, Atlantic FOR FURTHER INFORMATION CONTACT: finding renewals to the Governments of white cedar forest) for key land and Regional Administrator, Southwest Ecuador, El Salvador, Mexico, and water areas (salt marsh flats, tidal Region, NMFS, 501 West Ocean Spain, allowing the continued wetlands). Boulevard, Suite 4200, Long Beach, CA importation into the United States of FOR FURTHER INFORMATION CONTACT: 90802–4213; phone 562–980–4000; fax yellowfin tuna and products derived Michael Migliori at (301) 563–1126 or 562–980–4018. from yellowfin tuna harvested in the Laurie McGilvray at (301) 563–1158 of SUPPLEMENTARY INFORMATION: The ETP by Ecuadorian-flag, El Salvadorian- NOAA’s National Ocean Service, MMPA, 16 U.S.C. 1361 et seq., allows flag, Mexican-flag or Spanish-flag purse Estuarine Reserves Division, 1305 East- the entry into the United States of seine vessels or purse seine vessels West Highway, N/ORM5, 10th floor, yellowfin tuna harvested by purse seine operating under the jurisdiction of these Silver Spring, MD 20910. For copies of vessels in the ETP under certain nations. These annual renewals of the Jacques Cousteau Management Plan conditions. If requested by the affirmative findings for Ecuador, El revision, visit http://www.jcnerr.org/. harvesting nation, the Assistant Salvador, Mexico and Spain will remain valid through March 31, 2010. Dated: August 3, 2009. Administrator for Fisheries (Assistant Dated: August 7, 2009. David M. Kennedy, Administrator) will determine whether to make an affirmative finding based Samuel D. Rauch III, Director, Office of Ocean and Coastal Resource Management, National Oceanic and upon documentary evidence provided Deputy Assistant Administrator for Atmospheric Administration. by the government of the harvesting Regulatory Programs, National Marine Fisheries Service. [FR Doc. E9–19284 Filed 8–12–09; 8:45 am] nation, the IATTC, and the Department of State. [FR Doc. E9–19470 Filed 8–12–09; 8:45 am] BILLING CODE 3510–08–M The affirmative finding process BILLING CODE 3510–22–S requires that the harvesting nation is DEPARTMENT OF COMMERCE meeting its obligations under the IDCP and obligations of membership in the DEPARTMENT OF DEFENSE National Oceanic and Atmospheric IATTC. Every 5 years, the government of Administration the harvesting nation must request an Department of the Army, Corps of affirmative finding and submit the Engineers RIN 0648–XQ83 required documentary evidence directly RIN 0710–ZA04 Taking and Importing of Marine to the Assistant Administrator. On an Mammals annual basis, NMFS reviews the Proposed Suspension and affirmative finding and determine Modification of Nationwide Permit 21 AGENCY: National Marine Fisheries whether the harvesting nation continues Service (NMFS), National Oceanic and to meet the requirements. A nation may AGENCY: United States Army Corps of Atmospheric Administration (NOAA), provide information related to Engineers, Department of Defense, Commerce. compliance with IDCP and IATTC ACTION: Notice; extension of comment ACTION: Notice; annual affirmative measures directly to NMFS on an period. finding renewals. annual basis or may authorize the IATTC to release the information to SUMMARY: In the July 15, 2009, issue of SUMMARY: The Assistant Administrator NMFS to annually renew an affirmative the Federal Register (74 FR 34311) the for Fisheries, NMFS (Assistant finding determination without an U.S. Army Corps of Engineers published Administrator), has renewed the application from the harvesting nation. a proposal to take two actions affirmative findings for the Government An affirmative finding will be concerning Nationwide Permit 21, of Ecuador, the Government of El terminated, in consultation with the which authorizes discharges of dredged Salvador, the Government of Mexico Secretary of State, if the Assistant or fill material into waters of the United and the Government of Spain under the Administrator determines that the States for surface coal mining activities. Marine Mammal Protection Act requirements of 50 CFR 216.24(f) are no The two proposed actions are to (MMPA). These affirmative findings will longer being met or that a nation is suspend NWP 21 to prohibit its use to allow yellowfin tuna harvested in the consistently failing to take enforcement authorize surface coal mining activities eastern tropical Pacific Ocean (ETP) in actions on violations, thereby in the Appalachian region of Kentucky, compliance with the International diminishing the effectiveness of the Ohio, Pennsylvania, Tennessee, Dolphin Conservation Program (IDCP) IDCP. Virginia, and West Virginia, and then to by Ecuadorian-flag, El Salvadorian-flag, As a part of the affirmative finding modify NWP 21 to make that Mexican-flag or Spanish-flag purse seine process set forth in 50 CFR 216.24(f), the prohibition permanent until NWP 21 vessels or purse seine vessels operating Assistant Administrator considered expires on March 18, 2012. The July 15, under Ecuadorian, El Salvadorian, documentary evidence submitted 2009, notice stated that public Mexican, or Spanish jurisdiction to be separately by the Government of comments and any requests for a public imported into the United States. These Ecuador, the Government of El hearing must be received by August 14,

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2009. We have received several requests associated with surface coal mining Electronic Reporting Rule (CROMERR) to extend the comment period. We are activities in the Appalachian region of was published in the Federal Register extending the comment period to these six States. The Corps is also (70 FR 59848) and codified as part 3 of September 14, 2009. proposing to suspend NWP 21 to title 40 of the CFR. CROMERR DATES: Comments must be received by provide immediate environmental establishes electronic reporting as an September 14, 2009. protection while it evaluates the acceptable regulatory alternative to ADDRESSES: You may submit comments, comments received in response to the paper reporting and establishes identified by docket number COE– proposal to modify NWP 21. requirements to assure that electronic 2009–0032, by any of the following The application of NWP 21 to surface documents are as legally dependable as methods: coal mining activities in the rest of the their paper counterparts. Subpart D of Federal eRulemaking Portal: http:// United States would not be affected by CROMERR, requires that State, tribal or www.regulations.gov. Follow the this proposed modification or the local government agencies that receive, instructions for submitting comments. proposed suspension. or wish to begin receiving, electronic Mail: U.S. Army Corps of Engineers, Several entities have requested an reports under their EPA-authorized Attn: CECW–CO (Attn: Ms. Desiree extension of the comment period for the programs must apply to EPA for a Hann), 441 G Street, NW., Washington, proposed rule. We have determined that revision or modification of those DC 20314–1000. a 30-day extension of the comment programs and get EPA approval. Subpart Hand Delivery/Courier: Due to period for this proposed rule is D provides standards for such approvals security requirements, we cannot warranted. Therefore, the comment based on consideration of the electronic receive comments by hand delivery or period for these proposed actions is document receiving systems that the courier. extended until September 14, 2009. state, tribe, or local government will use We will not accept e-mailed or faxed Dated: August 10, 2009. Approved By: to implement the electronic reporting. comments. We will post all comments Jonathan A. Davis, Additionally, in § 3.1000(b) through (e) on http://www.regulations.gov under of 40 CFR part 3, subpart D provides Deputy Chief, Operations, Directorate of Civil docket number COE–2009–0032. Works. special procedures for program revisions and modifications to allow FOR FURTHER INFORMATION CONTACT: Ms. [FR Doc. E9–19446 Filed 8–12–09; 8:45 am] electronic reporting, to be used at the Desiree Hann or Mr. David Olson, BILLING CODE 3710–92–P Headquarters, Operations and option of the state, tribe or local Regulatory Community of Practice, government in place of procedures Washington, DC. Ms. Hann can be available under existing program- ENVIRONMENTAL PROTECTION specific authorization regulations. An reached at 202–761–4560 and Mr. Olson AGENCY can be reached at 202–761–4922. application submitted under the subpart SUPPLEMENTARY INFORMATION: In the July [FRL–8945–5] D procedures must show that the State, 15, 2009, issue of the Federal Register tribe or local government has sufficient Cross-Media Electronic Reporting Rule (74 FR 34311) the U.S. Army Corps of legal authority to implement the State Authorized Program Revision/ Engineers published a proposal to take electronic reporting components of its Modification Approvals: State of two actions concerning Nationwide authorized programs covered by the Washington Permit 21, which authorizes discharges application and will use electronic document receiving systems that meet of dredged or fill material into waters of AGENCY: Environmental Protection the applicable subpart D requirements. the United States for surface coal Agency (EPA). On October 10, 2008, the State of mining activities. ACTION: Notice. First, the Corps proposes to modify Washington Department of Ecology NWP 21 to prohibit its use to authorize SUMMARY: This notice announces EPA’s (WAECY) submitted an application for discharges of dredged or fill material approval, under regulations for Cross- its enterprise-wide electronic document into waters of the United States for Media Electronic Reporting, of the State receiving system for revision or surface coal mining activities in the of Washington’s request to revise/ modification of multiple EPA- Appalachian region of the following modify programs to allow electronic authorized programs under title 40 CFR. states: Kentucky, Ohio, Pennsylvania, reporting for certain of their EPA- EPA reviewed WAECY’s request to Tennessee, Virginia, and West Virginia authorized programs under title 40 of revise/modify their EPA-authorized until it expires on March 18, 2012. The the CFR. programs and, based on this review, EPA determined the application met the proposed modification would enhance DATES: EPA’s approval is effective on standards for approval of authorized environmental protection of aquatic August 13, 2009. resources by requiring surface coal program revisions/modifications set out FOR FURTHER INFORMATION CONTACT: Evi mining projects in the affected region to in 40 CFR part 3, subpart D. In Huffer, U.S. Environmental Protection obtain individual permit coverage under accordance with 40 CFR 3.1000(d), this Agency, Office of Environmental the Clean Water Act, which includes notice of EPA’s decision to approve Information, Mail Stop 2823T, 1200 increased public and agency Washington’s request for revision/ Pennsylvania Avenue, NW., involvement in the permit review modification to certain of their Washington, DC 20460, (202) 566–1697, process, including an opportunity for authorized programs is being published [email protected], or David Schwarz, public comment on individual projects. in the Federal Register. Second, the Corps is proposing to U.S. Environmental Protection Agency, Specifically, EPA has approved suspend NWP 21 to provide an interim Office of Environmental Information, WAECY’s request for revisions/ means of requiring individual permit Mail Stop 2823T, 1200 Pennsylvania modifications to the following of their reviews in Appalachia, while proposing Avenue, NW., Washington, DC 20460, authorized programs to allow electronic to undertake the longer-term measure of (202) 566–1704, reporting under 40 CFR parts 51, 60–63, modifying NWP 21 to prohibit its use to [email protected]. 70, 122–124, 144–147, and 280: authorize discharges of dredged or fill SUPPLEMENTARY INFORMATION: On • Part 52—Approval and material into waters of the United States October 13, 2005, the final Cross-Media Promulgation of Implementation Plans;

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• Part 61—National Emission applicant indicates that MIEX® DOC water from a shallow aquifer, which Standards For Hazardous Air Pollutants; Resin is necessary to the MIEX® contains problematic levels of iron, • Part 62—Approval and process, a treatment process evaluated manganese, hydrogen sulfide, ammonia, Promulgation of State Plans for in pilot studies and selected for organic nitrogen, and organic carbon. Designated Facilities and Pollutants; implementation. While the majority of Based on the results of pilot studies, the • Part 63—National Emission other equipment is manufactured in the City chose to use a combination of Standards For Hazardous Air Pollutants U.S., the MIEX® DOC Resin is only greensand filtration and the MIEX® For Source Categories; manufactured in Australia. It is patented process to treat this water supply. The • Part 70—State Operating Permit and no alternative exists which can be community chose this treatment process Programs; used with the MIEX® process. The over the alternatives of ultrafiltration or • Part 123—State Program Acting Regional Administrator is nanofiltration because the capital costs Requirements (National Pollutant making this determination based on the are significantly lower, the electrical Discharge Elimination System Permit review and recommendations of the consumption is significantly less, and Program); Drinking Water Unit. The City has there is much less water wasted during • Part 147—State, Tribal, and EPA- provided sufficient documentation to the treatment process. administered Underground Injection support their request. The City’s submission clearly Control Programs; and DATES: Effective Date: July 24, 2009. articulates entirely reasonable reasons • Part 282—Approved Underground FOR FURTHER INFORMATION CONTACT: Rick for choosing the type of technology that Storage Tank Programs. Green, DWSRF Coordinator, Drinking it chose for this project and has WAECY was notified of EPA’s Water Unit (DWU), Office of Water & provided sufficient documentation that determination to approve its application Watersheds (OWW), (206) 553–8504, the relevant manufactured goods are not with respect to the authorized programs U.S. EPA Region 10 (OWW–136), 1200 produced in the United States in listed above in a letter dated August 6, Sixth Avenue, Suite 900, Seattle, WA sufficient and reasonably available 2009. 98101. quantity and of a satisfactory quality to meet its technical specifications. Dated: August 6, 2009. SUPPLEMENTARY INFORMATION: The April 28, 2009 EPA HQ Lisa Schlosser, In accordance with ARRA Section Memorandum, Implementation of Buy Director, Office of Information Collection. 1605(c), the EPA hereby provides notice American provisions of Pubilc Law [FR Doc. E9–19463 Filed 8–12–09; 8:45 am] that it is granting a project waiver of the 111–5, the ‘‘American Recovery and BILLING CODE 6560–50–P requirements of Section 1605(b)(2) of Reinvestment Act of 2009’’, defines Public Law 111–5, Buy American ‘‘reasonably available quantity’’ as the requirements, to the City for the ® quantity of iron, steel, or relevant ENVIRONMENTAL PROTECTION acquisition of resin beads (MIEX DOC manufactured good is available or will AGENCY Resin) supplied by Orica Ltd, in be available at the time needed and Victoria, Australia and manufactured in [FRL–8945–4] place needed, and in the proper form or Australia. The applicant indicates that specification as specified in the project ® MIEX DOC Resin is necessary to the plans and design. The City has Notice of a Regional Waiver of Section ® 1605 (Buy American Requirement) of MIEX process, a treatment process incorporated specific technical design the American Recovery and evaluated in pilot studies at the City and features for the proposed project based Reinvestment Act of 2009 (ARRA) to selected for use. While the majority of on pilot studies which demonstrated other equipment is manufactured in the that the combination of greensand the City of Ocean Shores (the City), ® Washington for the Purchase of Resin U.S., the MIEX DOC Resin is only filtration and MIEX treatment is the best Beads (Miex® DOC Resin) manufactured in Australia. It is patented alternative. and no alternative exists which can be The City has provided information to Manufactured Outside of the United ® States Under the Section 1605 Waiver used with the MIEX process. Section the EPA representing that there are Authority Based on the Conclusion 1605 of the ARRA requires that none of currently no resin beads manufactured That Iron, Steel, and the Relevant the appropriated funds may be used for in the United States that have the exact Manufactured Goods Are Not the construction, alteration, same product specifications in place. Produced in the United States in maintenance, or repair of a public The City has also provided certification Sufficient and Reasonably Available building or public work unless all of the from its supplier representing that there Quantities and of a Satisfactory Quality iron, steel, and manufactured goods are no beads of comparable quality used in the project is produced in the available from a domestic manufacturer AGENCY: Environmental Protection United States unless a waiver is to meet its exact specifications. Agency (EPA). provided to the recipient by EPA. A Based on additional research by EPA’s ACTION: Notice. waiver may be provided if EPA consulting contractor (Cadmus), and to determines that (1) applying these the best of the Region’s knowledge at SUMMARY: The Acting Regional requirements would be inconsistent this time, there does not appear to be Administrator of EPA Region 10, is with public interest; (2) iron, steel, and other resin beads available to meet the hereby granting a waiver of the Buy the relevant manufactured goods are not City’s specifications. America requirements of ARRA Section produced in the United States in Furthermore, the purpose of the 1605 under the authority of Section sufficient and reasonably available ARRA provisions was to stimulate 1605(b)(2) [manufactured goods are not quantities and of a satisfactory quality; economic recovery by funding current produced in the United States in or (3) inclusion of iron, steel, and the infrastructure construction, not to delay sufficient and reasonably available relevant manufactured goods produced projects that are already shovel ready by quantities and of a satisfactory quality] in the United States will increase the requiring entities, like the City, to revise to the City for the purchase of resin cost of the overall project by more than their design and potentially choose a beads (MIEX® DOC Resin) supplied by 25 percent. more costly and less efficient project. Orica Ltd, in Victoria, Australia and The construction project being The imposition of ARRA Buy American manufactured in Australia. The undertaken by the City is treatment of requirements on such projects eligible

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for DWSRF assistance would result in FEDERAL DEPOSIT INSURANCE personnel-related information unreasonable delay and thus displace CORPORATION maintained by GAO and exchanged the ‘‘shovel ready’’ status for this with the U.S. Department of project. To further delay construction is Notice of Agency Meeting Agriculture’s National Finance Center (USDA/NFC) and the U.S. Department in direct conflict with the most Pursuant to the provisions of the of the Treasury’s HR Connect program fundamental economic purposes of ‘‘Government in the Sunshine Act’’ (5 (Treasury/HR Connect). To support its ARRA; to create or retain jobs. U.S.C. 552b), notice is hereby given that human capital management activities, at 9:03 a.m. on Tuesday, August 11, The Drinking Water Unit (DWU) has GAO has entered into interagency 2009, the Board of Directors of the reviewed this waiver request and has agreements with these two Federal Federal Deposit Insurance Corporation determined that the supporting Executive Branch agencies as shared met in closed session to consider documentation provided by the City is service providers. USDA/NFC provides matters related to the Corporation’s sufficient to meet the following criteria payroll and personnel information listed under Section 1605(b) and in the resolution activities. In calling the meeting, the Board processing (Department of Agriculture, April 28, 2009, Implementation of Buy determined, on motion of Director Systems of Record Notice OP–1), and American provisions of Public Law Thomas J. Curry (Appointive), seconded Treasury/HR Connect operates a human 111–5, the ‘‘American Recovery and by Vice Chairman Martin J. Gruenberg, capital management support system Reinvestment Act of 2009’’ concurred in by Ms. Julie L. Williams, (Department of Treasury .001—Treasury Memorandum: Iron, steel, and the acting in the place and stead of Director Payroll and Personnel System). The manufactured goods are not produced in John C. Dugan (Comptroller of the policies and procedures described in the United States in sufficient and Currency), Director John E. Bowman this notice are intended to ensure that reasonably available quantities and of a (Acting Director, Office of Thrift personal information contained in satisfactory quality. Supervision), and Chairman Sheila C. GAO’s personnel records is protected as provided by GAO’s privacy regulation. The basis for this project waiver is the Bair, that Corporation business required DATES: authorization provided in Section its consideration of the matters which Comments may be submitted on or before September 14, 2009. 1605(b)(2), due to the lack of production were to be the subject of this meeting on of this product in the United States in less than seven days’ notice to the ADDRESSES: Comments should be sent sufficient and reasonably available public; that no earlier notice of the to: Government Accountability Office, Privacy Office, Room 1127, 441 G St., quantities and of a satisfactory quality meeting was practicable; that the public NW., Washington, DC 20548, or by e- in order to meet the City’s design interest did not require consideration of mail to [email protected]. Please include specifications. the matters in a meeting open to public observation; and that the matters could reference to ‘‘Comment: Human Capital The March 31, 2009 Delegation of be considered in a closed meeting by Management System of Records’’ at the Authority Memorandum provided authority of subsections (c)(4), (c)(6), top of a comment letter or in the subject Regional Administrators with the (c)(8), (c)(9)(A)(ii), and (c)(9)(B) of the line of an e-mail. authority to issue exceptions to Section ‘‘Government in the Sunshine Act’’ (5 FOR FURTHER INFORMATION CONTACT: For 1605 of ARRA within the geographic U.S.C. 552b(c)(4), (c)(6), (c)(8), information about GAO human capital boundaries of their respective regions (c)(9)(A)(ii), and (c)(9)(B)). information management, contact the and with respect to requests by The meeting was held in the Board Chief Human Capital Officer, individual grant recipients. Room of the FDIC Building located at Government Accountability Office, Having established both a proper 550–17th Street, NW., Washington, DC. Room 1157, 441 G St., NW., basis to specify the particular good Dated: August 11, 2009. Washington, DC 20548; e-mail, required for this project, and that this Federal Deposit Insurance Corporation. [email protected]. For information about GAO privacy protections, contact manufactured good was not available Robert E. Feldman, the Chief Agency Privacy Officer, from a producer in the United States, Executive Secretary. Government Accountability Office, the City is hereby granted a waiver from [FR Doc. E9–19492 Filed 8–12–09; 8:45 am] Room 1127, 441 G St., NW., the Buy American requirements of BILLING CODE P Washington, DC 20548; e-mail, privacy Section 1605(a) of Public Law 111–5 for @gao.gov. the purchase of resin beads (MIEX® SUPPLEMENTARY INFORMATION: DOC Resin) supplied by Orica Ltd, in GOVERNMENT ACCOUNTABILITY Victoria, Australia and manufactured in OFFICE Background Australia as specified in the City’s A. GAO. GAO is an independent, request of June 26, 2009. This System of Personnel Records nonpartisan Legislative Branch agency supplementary information constitutes AGENCY: Government Accountability that examines a wide range of the detailed written justification Office. government activities and provides required by Section 1605(c) for waivers ACTION: Notice of Establishment of analyses, recommendations, and other based on a finding under subsection (b). Human Capital Management System of assistance to help Congress make sound oversight, policy, and funding Authority: Pubic Law 111–5, section 1605. Records. decisions. As a Legislative Branch Issued on: July 28, 2009. SUMMARY: The Government agency, GAO is not subject to the Michelle Pirzadeh, Accountability Office (GAO) proposes to privacy and information security laws Acting Regional Administrator, EPA, Region establish a new system of personnel applicable to Executive Branch 10. records under its privacy regulations, agencies, such as the Privacy Act of [FR Doc. E9–19465 Filed 8–12–09; 8:45 am] Privacy Procedures for Personnel 1974 (Privacy Act), Federal Information Records. This Human Capital Security Management Act of 2002 BILLING CODE 6560–50–P Management System of Records (FISMA), the E-Government Act of 2002 encompasses GAO payroll- and (E-Government Act), and Office of

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Management and Budget (OMB) and information is securely transmitted to national origin), education, and National Institute of Standards and and from GAO and its shared service disabilities. Employment information Technology (NIST) guidance issued providers and their contractors as includes compensation (e.g., salary, date under those laws. Nonetheless, it is necessary to support agreed upon of salary increases, pay plan, pay basis, GAO’s policy to conduct its activities in human capital management activities sick and annual leave balances), benefits a manner consistent with the spirit of (e.g., employment application (e.g., pension, Thrift Savings Plan, those laws and guidance generally processing, recruiting, hiring, pay, health insurance, life insurance, applicable to Executive Branch promotions, employee awards Medicare and Federal Employees agencies, and related best practices. processing, and compiling reports). Compensation Act benefits), Notwithstanding the similarities with For a description of the privacy employment actions (e.g., promotions, privacy and information security laws, protections provided by USDA/NFC and demotions, removals), performance regulations, or policies applicable to Treasury/HR Connect, as required by appraisals (e.g., individual ratings), Executive Branch agencies, GAO’s law of Executive Branch agencies, see veterans preference, military service, application of, or compliance with, the following: Treasury/HR Connect work schedule (e.g., telework and those laws, regulations, or policies shall Privacy Act System of Records Notice, alternate work schedule), awards, dates not be interpreted as controlling legal http://www.ustreas.gov/foia/privacy/ of probationary periods, type of position authorities over GAO. The GAO treas001.html; Treasury/HR Connect appointment, and changes in position regulation, 4 CFR Part 83, Privacy Privacy Impact Assessment (PIA), (e.g. position identification number, Procedures for Personnel Records, http://www.treas.gov/pia/HRCPIA05–01 occupational series, organization provides the basis for this notice. –2008v10Final.pdf; NFC Privacy Act location, and accounting classification B. GAO Human Capital Management. System of Records Notice (Personnel codes), payroll data such as earnings The GAO Human Capital Management and Payroll System for USDA/NFC and deductions (e.g., Federal, State, and System of Records, managed by GAO’s Employees USDA/NFC/OP–1), http:// local taxes), time and attendance data, Human Capital Office (HCO), is www.ocio.usda.gov/OP%20-%201.txt; and training courses attended. Both comprised of information supporting and NFC PIA, http://www.usda.gov/ biographic and employment information _ _ _ GAO human capital activities, primarily documents/NFC Mainframe GSS may be maintained in electronic and _ relating to pay, benefits, performance, Redacted PIA.doc. Privacy protections paper format. recruitment, and personnel actions. This for GAO information maintained by information is maintained in paper and contractors of those agencies are AUTHORITY FOR MAINTENANCE OF THE SYSTEM: electronic formats, including in the provided under contracts between the 4 CFR Part 83; System of Personnel GAO Competency Based Performance agencies and their contractors. The text Records. System (CBPS), which tracks employee of GAO’s human capital management performance reviews; My Locator, system of records is set forth below. PURPOSE: which compiles contact information of The purpose of this system of records GAO employees and contractors; and SYSTEM NAME: is to maintain records relating to current WebTA, which records time and Government Accountability Office, and former GAO employees and attendance for GAO employees. Human Capital Management System of applicants for GAO employment as are GAO Human Capital Management Records. relevant and necessary to efficiently and information is also maintained and SYSTEM LOCATION: effectively conduct authorized GAO managed in systems of records operated human capital management activities. by two Federal human capital shared Information maintained in this system service providers: the U.S. Department of records is located at GAO ROUTINE USES OF RECORDS MANTAINED IN THE of Agriculture (USDA), and the U.S. headquarters in Washington, DC, and SYSTEM, INCLUDING CATEGORIES OF USERS AND Department of the Treasury (Treasury), GAO field offices. GAO human capital THE PURPOSES OF SUCH USES: and contractors supporting these information exchanged with Federal All or a portion of personal agencies. In order to streamline its shared service providers (i.e., USDA/ information maintained in this system human capital processes, reduce costs, NFC and Treasury/HR Connect) is of records may only be disclosed as and improve efficiencies, GAO has maintained in those agencies’ systems of permitted under 4 CFR Part 83, http:// entered into agreements for the records. GAO human capital www.access.gpo.gov/nara/cfr/ provision of human capital management information maintained by contractors waisidx_09/4cfr83_09.html. services with these agencies. of those shared service providers is Specifically, such information shall not The USDA’s National Finance Center maintained at information processing be disclosed to any person or entity (NFC) provides payroll processing and facilities under the control of those without the written consent of the related services. The Treasury HR contractors. individual to whom the information Connect program operates an automated CATEGORIES OF INDIVIDUALS COVERED BY THE pertains, except as permitted under human resources system to support SYSTEM: § 83.4 and § 83.5. As permitted under human capital management activities in This system of records contains § 83.4(a) and § 83.19, personal Treasury and other Federal agencies information on current GAO employees, information in this system of records through cross-servicing agreements. former GAO employees, and applicants may be disclosed to those GAO Implementation of GAO’s agreements for GAO employment. employees and contractors who have a with USDA/NFC and Treasury/HR need for the record in the performance Connect will be phased in over 18 CATEGORIES OF RECORDS IN THE SYSTEM: of their official duties. All or a portion months. Full implementation is This system of records contains GAO of the records in this system of records scheduled for January 2011. human capital information, which may be disclosed as a routine use Authorized GAO employees access comprises both biographic and pursuant to § 83.4(c) in support of human capital information maintained employment information. Biographic GAO’s human capital management in GAO systems and in systems information includes identifying activities, as follows: maintained by GAO’s shared service information (e.g., name, social security (a) To Federal shared service providers and their contractors. All number, date of birth, gender, race, and providers and their contractors as

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reasonably necessary to provide agreed either is seeking to become or is already Room 1127, 441 G St., NW., upon services to support GAO human licensed, certified, or accredited. Washington, DC 20548, or by e-mail to capital management activities; [email protected]. RETRIEVABILITY: (b) To Federal, State, local, territorial, RECORD ACCESS PROCEDURES: Tribal, or foreign law enforcement Information maintained in the system authorities or other appropriate entities may be retrieved only by employees of See ‘‘Notification Procedure’’ above. GAO who have a need for the where a record, either alone or in CONTESTING RECORD PROCEDURE: conjunction with other information, information in the performance of their indicates a violation, or potential official duties. See ‘‘Notification Procedure’’ above. violation, of law or regulation, and SAFEGUARDS: RECORD SOURCE CATEGORIES: where such entities are responsible for Information maintained in the system Information in this system of records investigating or prosecuting such is safeguarded under 4 CFR 83.7(i), and originates from individuals whose violation or enforcing or implementing GAO information systems security personal information is maintained in such law or regulation; policies and procedures. Strict controls this system of records, agency records, (c) To Federal, State, local, or are imposed to minimize the risk of financial institutions, employee and international agencies in connection compromising the information professional organizations, previous with an individual’s hiring, maintained in this system of records employers, consumer reporting employment, related benefits, and any of its supporting information agencies, debt collection agencies, suitability, or security investigation, or systems. Furthermore, GAO human courts, and other government agencies. security clearance; or in connection capital information maintained by with the letting of a contract, or the GAO’s Federal shared service providers EXEMPTIONS CLAIMED FOR THE SYSTEM: issuance of a grant or other benefit to and their contractors are subject to Certain records contained in this the extent that GAO determines the privacy and security laws applicable to system of records are exempt from information is relevant and necessary to executive branch agencies (e.g., the access, amendment, and other an agency or organization’s decision; Privacy Act, FISMA, the E–Government procedural requirements pursuant to 4 (d) To Federal agencies to verify or Act), and related regulations, standards, CFR 83.21. determine the citizenship or and guidance. immigration status of any individual Catherine Teti, seeking employment with GAO or as RETENTION AND DISPOSAL: Chief Agency Privacy Officer, Government required by law; All GAO human capital information Accountability Office. (e) To agencies, entities, and persons will be retained in accordance with the [FR Doc. E9–19445 Filed 8–12–09; 8:45 am] when: (1) GAO suspects or has following schedule: BILLING CODE 1610–02–P confirmed that the security or (a) Time and attendance records are confidentiality of information in this destroyed 7 years after the end of the system of records has been fiscal year in which they are created. DEPARTMENT OF HEALTH AND compromised; (2) GAO has determined (b) Individual employee payroll HUMAN SERVICES that as a result of the suspected or records are destroyed 7 years after the confirmed compromise there is a risk of end of the fiscal year in which they are Health Resources and Services harm to economic or property interests, created. Administration (c) An individual’s Official Personnel identity theft or fraud, or harm to the Agency Information Collection security or integrity of this system or Folder (OPF) is retained for 65 years after separation. Activities: Proposed Collection: other systems or programs (whether Comment Request maintained by GAO or another agency Compelling legal or policy purposes or entity) that rely upon the (e.g., ongoing or potential litigation) In compliance with the requirement compromised information; and (3) the may require retention of certain records for opportunity for public comment on disclosure made to such agencies, beyond the retention periods identified proposed data collection projects entities, and persons is reasonably above. (section 3506(c)(2)(A) of Title 44, United necessary to assist in connection with SYSTEM MANAGER AND ADDRESS: States Code, as amended by the GAO’s efforts to respond to a suspected The GAO official responsible for this Paperwork Reduction Act of 1995, Pub. or confirmed compromise and prevent, system of records is the Chief Human L. 104–13), the Health Resources and minimize, or remedy such harm; Capital Officer (CHCO), Human Capital Services Administration (HRSA) (f) To an agency, organization, or Office, U.S. Government Accountability publishes periodic summaries of individual for the purposes of Office, Room 1157, 441 G St., NW., proposed projects being developed for performing audit or oversight operations Washington, DC, 20548. submission to the Office of Management as authorized by law, but only such and Budget (OMB) under the Paperwork information as is necessary and relevant NOTIFICATION PROCEDURE: Reduction Act of 1995. To request more to such audit or oversight function; and As provided under 4 CFR 83.12–18 information on the proposed project or (g) To a public or professional and Appendix I to Part 83— to obtain a copy of the data collection licensing, certification, or accreditation Memorandum of Understanding, GAO plans and draft instruments, e-mail organization to confirm the claimed employees, former employees, or [email protected] or call the HRSA credentials of a GAO applicant or applicants to GAO interested in Reports Clearance Officer on (301) 443– employee, or when information knowing whether this system of records 1129. indicates, either by itself or in contains information about them, how Comments are invited on: (a) The combination with other information, a to obtain access to such information, or proposed collection of information for violation or potential violation of how to contest any element of such the proper performance of the functions professional standards, or reflects on the information may submit a request in of the agency; (b) the accuracy of the moral, educational, or professional writing to the Chief Privacy Officer, U.S. agency’s estimate of the burden of the qualifications of an individual who Government Accountability Office, proposed collection of information; (c)

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ways to enhance the quality, utility, and the Nurse Traineeship Database for the access point to submit their grant clarity of the information to be two nursing traineeship programs. The applications including the tables. collected; and (d) ways to minimize the AENT and NAT tables are used Applications are submitted in two burden of the collection of information annually by grant applicants that are phases: Grants.gov (Phase 1) and the on respondents, including through the applying for AENT and NAT funding. HRSA Electronic Handbooks (Phase 2). use of automated collection techniques The funds appropriated for the AENT These tables will be available or other forms of information and NAT programs are distributed electronically through the HRSA technology. among eligible institutions based on a Electronic Handbooks (Phase 2) for formula. Award amounts are based on applicants to submit their AENT and/or Proposed Project: Advanced Education enrollment and graduate data reported NAT grant application(s). The tables are Nursing Traineeship (AENT) and Nurse on the tables and two funding factors also used in the Nurse Traineeship Anesthetist Traineeship (NAT) (OMB (Statutory Funding Preference and Database which is used by Division of No. 0915–0305): Revision Statutory Special Consideration). Nursing staff and not the applicants. The Health Resources and Services The AENT and NAT tables include Data from the tables will be used in Administration (HRSA) provides information on program participants the award determination and validation training grants to educational such as the number of enrollees, process. Additionally, the data will be institutions to increase the numbers of projected data on enrollees and used to ensure programmatic advanced education nurses through the graduates for the following academic compliance, report to Congress and Advanced Education Nursing year, number of trainees supported, policymakers on the program Traineeship (AENT) program and the number of graduates, number of accomplishments, and formulate and Nurse Anesthetist Traineeship (NAT) graduates supported and the types of justify future budgets for these activities program. programs they are enrolling into and/or submitted to OMB and Congress. HRSA developed the AENT and NAT from which they are graduating. AENT The burden estimate for this project is tables for the application guidances and and NAT applicants will have a single as follows:

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

AENT ...... 500 1 500 1.5 750 NAT ...... 100 1 100 1 100

Total ...... 600 ...... 600 ...... 850

E-mail comments to OMB for review, e-mail generate a Medicaid rebate. Further, [email protected] or mail to the [email protected] or call the HRSA section 340B(a)(5)(B) prohibits a HRSA Reports Clearance Officer, Room Reports Clearance Office on (301) 443– covered entity from reselling or 10–33, Parklawn Building, 5600 Fishers 1129. otherwise transferring a discounted drug Lane, Rockville, MD 20857. Written The following request has been to a person who is not a patient of the comments should be received within 60 submitted to the Office of Management entity. days of this notice. and Budget for review under the In response to the statutory mandate Dated: August 5, 2009. Paperwork Reduction Act of 1995: of section 340B(a)(9) to notify manufacturers of the identities of Alexandra Huttinger, Proposed Project: Enrollment and Re- covered entities and the mandate of Director, Division of Policy Review and Certification of Entities in the 340B section 340B(a)(5)(A)(ii) to establish a Coordination. Drug Pricing Program [NEW] mechanism to ensure against duplicate [FR Doc. E9–19393 Filed 8–12–09; 8:45 am] Section 602 of Public Law 102–585, discounts and the ongoing BILLING CODE 4165–15–P the Veterans Health Care Act of 1992, responsibility to administer the 340B enacted section 340B of the Public Drug Pricing Program while maintaining Health Service Act (PHS Act) DEPARTMENT OF HEALTH AND efficiency, transparency and integrity, ‘‘Limitation on Prices of Drugs HUMAN SERVICES the HRSA Office of Pharmacy Affairs Purchased by Covered Entities.’’ Section (OPA) developed a process of Health Resources and Services 340B provides that a manufacturer who registration of covered entities to enable Administration sells covered outpatient drugs to eligible it to address those mandates. entities must sign a pharmaceutical Enrollment/Registration Agency Information Collection pricing agreement with the Secretary of Activities: Submission for OMB Health and Human Services in which To enroll and certify the eligible Review; Comment Request the manufacturer agrees to charge a federally funded grantees and other price for covered outpatient drugs that safety net health care providers, OPA Periodically, the Health Resources will not exceed an amount determined requires entities to submit and Services Administration (HRSA) under a statutory formula. administrative information (e.g., publishes abstracts of information Covered entities which choose to shipping and billing arrangements, collection requests under review by the participate in the section 340B Drug Medicaid participation), certifying Office of Management and Budget Pricing Program must comply with the information and signatures from (OMB), in compliance with the requirements of 340B(a)(5) of the PHS appropriate grantee level or entity level Paperwork Reduction Act of 1995 (44 Act. Section 340B(a)(5)(A) prohibits a authorizing officials and State/local U.S.C. Chapter 35). To request a copy of covered entity from accepting a government representatives. The the clearance requests submitted to discount for a drug that would also purpose of this registration information

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is to determine eligibility for the 340B entities to submit modifications to any arrangements, covered entities that elect program. This information is received administrative information that they to utilize a contract pharmacy are and verified according to 340B submitted when initially enrolling into required to submit to OPA a self- requirements and entered into the 340B the program. The burden requirement certification form similar to the database. Accurate records are critical to for these processes is minimal. registration form that they have signed implementation of the 340B legislation Contract Pharmacy Self-Certification an agreement with the contract especially to prevent diversion and pharmacy. In order to ensure that drug duplicate discounts. To maintain manufacturers and drug wholesalers The Estimates of annualized burden accurate records, the OPA requests recognize contract pharmacy are as follows:

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

DSH & Children’s Hospital Enrollment, Additions & Recertifications

340B Program Registrations & Certifications for Dis- proportionate Share Hospitals ...... 70 1 70 .25 17 .5 340B Program Registrations & Certifications for Chil- dren’s Hospitals ...... 80 1 80 .25 20 Certifications to Enroll DSH & Children’s Hospitals Out- patient facilities to 340B Program ...... 180 1 180 .083 14 .94 DSH & Children’s Hospitals’ Annual Recertification ...... 937 1 937 .5 468.5

Registration for Entities Other Than Hospitals & Recertifications

340B Registration Form (Family Planning, STD, TB, and others) ...... 170 1 170 .083 14 .11 Family Planning Annual Recertification ...... 85 47 3995 .083 331.59 STD & TB Annual Recertification ...... 111 11 1221 .083 101.34 Other Entity Annual Recertification for entities other than DSHs, FP, STD or TB entities ...... 400 10 4000 .083 332 Submission of Administrative Changes for any entity ..... 460 1 460 .083 38 .18

Contracted Pharmacy Services Registration & Recertifications

Contracted Pharmacy Services Registration ...... 2000 1 2000 .083 166 Total ...... * 4493 ...... 13,313 ...... 1504 .16 * The total number of respondents may be overestimated since we are unable to avoid duplication of respondents who submit information to the OPA over the course of participation in the 340B Drug Pricing Program, via the initial registration process to any updates/modifications and enrolling contract pharmacies, if applicable, to the recertification process.

Written comments and DEPARTMENT OF HEALTH AND forth in section 552b(c)(4) and (6), Title 5 recommendations concerning the HUMAN SERVICES U.S.C., and the Determination of the Director, proposed information collection should Management Analysis and Services Office, CDC, pursuant to Public Law 92–463. be sent within 30 days of this notice to Centers for Disease Control and Prevention Matters To Be Discussed: The meeting will the desk officer for HRSA, either by e- include the review, discussion, and _ mail to OIRA [email protected] Disease, Disability, and Injury evaluation of the application received in or by fax to 202–395–6974. Please direct response to ‘‘Health Promotion and Disease Prevention and Control Special Prevention Research Centers, Special Interest all correspondence to the ‘‘attention of Emphasis Panel (SEP): Health the desk officer for HRSA.’’ Project Competitive Supplements (SIPS) (U48 Promotion and Disease Prevention Panels N, O and P), RFA–DP09–101SUPP09, Dated: August 5, 2009. Research Centers, Special Interest initial review.’’ Alexandra Huttinger, Project Competitive Supplements Contact Person for More Information: (SIPS) (U48 Panels N, O and P), RFA– Brenda Colley-Gilbert, Ph.D., Director, Director, Division of Policy Review and DP09–101SUPP09, Initial Review Extramural Research Program Office, CCH, Coordination. 47770 Buford Highway, MS K–92, Atlanta, [FR Doc. E9–19381 Filed 8–12–09; 8:45 am] In accordance with section 10(a)(2) of GA 30341, Telephone (770) 488–8390. BILLING CODE 4165–15–P the Federal Advisory Committee Act The Director, Management Analysis and (Pub. L. 92–463), the Centers for Disease Services Office, has been delegated the Control and Prevention (CDC) authority to sign Federal Register notices pertaining to announcements of meetings and announces the aforementioned meeting. other committee management activities, for Time and Dates: both CDC and the Agency for Toxic 9 a.m.–5 p.m., August 5, 2009 (closed). Substances and Disease Registry. 9 a.m.–5 p.m., August 6, 2009 (closed). Elaine L. Baker, 9 a.m.–5 p.m., August 7, 2009 (closed). Director, Management Analysis and Services Place: Westin Hotel, 3377 Peachtree Road, Office, Centers for Disease Control and NE., Atlanta, GA, 30326, Telephone (678) Prevention. 500–3100. Status: The meeting will be closed to the [FR Doc. E9–19293 Filed 8–12–09; 8:45 am] public in accordance with provisions set BILLING CODE 4163–18–P

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DEPARTMENT OF HEALTH AND 93.701, ARRA Related Biomedical Research Integrated Review Group. Auditory System HUMAN SERVICES and Research Support Awards, National Study Section. Institutes of Health, HHS) Date: September 30–October 1, 2009. National Institutes of Health Time: 8 a.m. to 5 p.m. Dated: August 6, 2009. Agenda: To review and evaluate grant National Institute on Alcohol Abuse Jennifer Spaeth, applications. Place: Hotel Monaco, 501 Geary Street, San Director, Office of Federal Advisory and Alcoholism; Notice of Meeting Francisco, CA 94102. Committee Policy. Contact Person: Lynn E. Luethke, PhD, Pursuant to section 10(d) of the [FR Doc. E9–19425 Filed 8–12–09; 8:45 am] Federal Advisory Committee Act, as Scientific Review Officer, Center for BILLING CODE 4140–01–M Scientific Review, National Institutes of amended (5 U.S.C. App.), notice is Health, 6701 Rockledge Drive, Room 5166, hereby given of a meeting of the Board MSC 7844, Bethesda, MD 20892, (301) 435– of Scientific Counselors, NIAAA. DEPARTMENT OF HEALTH AND 1018, [email protected]. The meeting will be open to the HUMAN SERVICES Name of Committee: Endocrinology, public as indicated below, with Metabolism, Nutrition and Reproductive attendance limited to space available. National Institutes of Health Sciences Integrated Review Group. Individuals who plan to attend and Pregnancy and Neonatology Study Section. need special assistance, such as sign Center for Scientific Review; Notice of Date: October 1–2, 2009. language interpretation or other Closed Meetings Time: 8 a.m. to 5 p.m. reasonable accommodations, should Agenda: To review and evaluate grant applications. notify the Contact Person listed below Pursuant to section 10(d) of the Federal Advisory Committee Act, as Place: InterContinental Harbor Court in advance of the meeting. Baltimore, 550 Light Street, Baltimore, MD The meeting will be closed to the amended (5 U.S.C. App.), notice is 21202. public as indicated below in accordance hereby given of the following meetings. Contact Person: Michael Knecht, PhD, with the provisions set forth in section The meetings will be closed to the Scientific Review Officer, Center for 552b(c)(6), Title 5 U.S.C., as amended public in accordance with the Scientific Review, National Institutes of for the review, discussion, and provisions set forth in sections Health, 6701 Rockledge Drive, Room 6176, evaluation of individual intramural 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., MSC 7892, Bethesda, MD 20892, (301) 435– 1046, [email protected]. programs and projects conducted by the as amended. The grant applications and National Institute on Alcohol Abuse and the discussions could disclose Name of Committee: Integrative, confidential trade secrets or commercial Functional and Cognitive Neuroscience Alcoholism, including consideration of Integrated Review Group. Neurobiology of personnel qualifications and property such as patentable material, Learning and Memory Study Section. performance, and the competence of and personal information concerning Date: October 1–2, 2009. individual investigators, the disclosure individuals associated with the grant Time: 8 a.m. to 5 p.m. of which would constitute a clearly applications, the disclosure of which Agenda: To review and evaluate grant unwarranted invasion of personal would constitute a clearly unwarranted applications. privacy. invasion of personal privacy. Place: Four Points by Sheraton Washington DC Downtown, 1201 K Street, NW., Name of Committee: Board of Scientific Name of Committee: Brain Disorders and Washington, DC 20005. Counselors, NIAAA. Clinical Neuroscience Integrated Review Contact Person: Bernard F. Driscoll, PhD, Date: September 23–24, 2009. Group. Anterior Eye Disease Study Section. Scientific Review Officer, Center for Open: September 23, 2009, 8:15 a.m. to Date: September 21–22, 2009. Scientific Review, National Institutes of 8:30 a.m. Time: 8 a.m. to 5 p.m. Health, 6701 Rockledge Drive, Room 5184, Agenda: Program reports and Agenda: To review and evaluate grant MSC 7844, Bethesda, MD 20892. (301) 435– presentations. applications. 1242. [email protected]. Place: National Institutes of Health, 5635 Place: Embassy Suites Washington DC, Name of Committee: Cardiovascular and Fishers Lane, Bethesda, MD 20892. 1250 22nd Street, NW., Washington, DC Respiratory Sciences Integrated Review 20037. Closed: September 23, 2009, 8:30 a.m. to 6 Group. Lung Injury, Repair, and Remodeling Contact Person: Jerry L. Taylor, PhD, p.m. Study Section. Scientific Review Officer, Center for Agenda: To review and evaluate the Date: October 1–2, 2009. Scientific Review, National Institutes of Laboratory of Membrane Biochemistry and Time: 8 a.m. to 5 p.m. Health, 6701 Rockledge Drive, Room 5202, Biophysics (LMBB). Agenda: To review and evaluate grant Place: National Institutes of Health, 5635 MSC 7846, Bethesda, MD 20892, 301–435– applications. Fishers Lane, Bethesda, MD 20892. 1175, [email protected]. Place: Hyatt Regency Bethesda, One Closed: September 24, 2009, 8:30 a.m. to Name of Committee: Integrative, Bethesda Metro Center, 7400 Wisconsin 4:30 p.m. Functional and Cognitive Neuroscience Avenue, Bethesda, MD 20814. Agenda: To review and evaluate the Integrated Review Group. Neurobiology of Contact Person: Ghenima Dirami, PhD, Laboratory of Molecular Signaling and Motivated Behavior Study Section. Scientific Review Officer, Center for Metabolic Control. Date: September 30–October 1, 2009. Scientific Review, National Institutes of Place: National Institutes of Health, 5635 Time: 8 a.m. to 5 p.m. Health, 6701 Rockledge Drive, Room 4112, Fishers Lane, Bethesda, MD 20892. Agenda: To review and evaluate grant MSC 7814, Bethesda, MD 20892. 301–594– Contact Person: Trish Scullion, Chief of applications. 1321. [email protected]. Administrative Branch, National Institute of Place: One Washington Circle Hotel, One Name of Committee: Center for Scientific Health, National Institute on Alcohol Abuse, Washington Circle, NW., Washington, DC Review Special Emphasis Panel. Small and Alcoholism, 5635 Fishers Lane, Room 20037. Business. 3061, Rockville, MD 20852. 301–443–6076. Contact Person: Edwin C. Clayton, PhD, Date: October 1–2, 2009. (Catalogue of Federal Domestic Assistance Scientific Review Officer, Center for Time: 8 a.m. to 2 p.m. Program Nos. 93.271, Alcohol Research Scientific Review, National Institutes of Agenda: To review and evaluate grant Career Development Awards for Scientists Health, 6701 Rockledge Drive, Room 5095C, applications. and Clinicians; 93.272, Alcohol National MSC 7844, Bethesda, MD 20892, (301) 402– Place: Bethesda Marriott, 5151 Pooks Hill Research Service Awards for Research 1304, [email protected]. Road, Bethesda, MD 20814. Training; 93.273, Alcohol Research Programs; Name of Committee: Integrative, Contact Person: Bill Bunnag, PhD, 93.891, Alcohol Research Center Grants; Functional and Cognitive Neuroscience Scientific Review Officer, Center for

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Scientific Review, National Institutes of Dated: August 6, 2009. action to mitigate any human health Health, 6701 Rockledge Drive, Room 3156, Jennifer Spaeth, risks associated with these outbreaks. MSC 7770, Bethesda, MD 20892. (301) 435– Director, Office of Federal Advisory DATE: 1177. [email protected]. The decision is effective Committee Policy. September 14, 2009. Name of Committee: Cardiovascular and [FR Doc. E9–19447 Filed 8–12–09; 8:45 am] Respiratory Sciences Integrated Review FOR FURTHER INFORMATION CONTACT: Dr. BILLING CODE 4140–01–P Group. Myocardial Ischemia and Metabolism Robert Mullan, Division of Global Study Section. Migration and Quarantine, National Date: October 1–2, 2009. Center for Preparedness, Detection, and DEPARTMENT OF HEALTH AND Time: 8 a.m. to 5 p.m. Control of Infectious Diseases, Centers HUMAN SERVICES Agenda: To review and evaluate grant for Disease Control and Prevention, applications. 1600 Clifton Road, NE., MS E–03, Place: St. Gregory Hotel, 2033 M Street, Centers for Disease Control and Prevention Atlanta, Georgia 30333; telephone 404– NW., Washington, DC 20036. 498–1600. Contact Person: Joseph Thomas Peterson, PhD, Scientific Review Officer, Center for Rescission of February 4, 2004, Order SUPPLEMENTARY INFORMATION: and Subsequent Amendments Scientific Review, National Institutes of Background Health, 6701 Rockledge Drive, Room 4118, Prohibiting the Importation of Birds MSC 7814, Bethesda, MD 20892. 301–443– and Bird Products From Specified Since late 2003, highly pathogenic 8130. [email protected]. Countries avian influenza (HPAI) has become Name of Committee: Brain Disorders and established as a veterinary and human Clinical Neuroscience Integrated Review AGENCY: Centers for Disease Control and health threat throughout the world. As Group. Acute Neural Injury and Epilepsy Prevention (CDC), Department of Health of April 1, 2009 HPAI has been Study Section. and Human Services (HHS). confirmed by the World Organization Date: October 1–2, 2009. ACTION: Final Notice. for Animal Health (OIE) in birds from Time: 8 a.m. to 5 p.m. over 60 countries in Asia, Europe, and Agenda: To review and evaluate grant applications. SUMMARY: On January 21, 2009, CDC Africa. In addition, as of March 30, Place: Embassy Suites Washington DC, published a notice in the Federal 2009, 413 human cases, including 256 1250 22nd Street, NW., Washington, DC Register (74 FR 3608) announcing its deaths, have been confirmed by the 20037. intent to rescind its February 4, 2004 World Health Organization (WHO). Contact Person: Seetha Bhagavan, PhD, order and subsequent amendments Birds imported into the United States Scientific Review Officer, Center for prohibiting the importation of birds and from countries with HPAI could pose a Scientific Review, National Institutes of bird products from specified countries risk for human infection or spread of Health, 6701 Rockledge Drive, Room 5194, virus to U.S. birds. MSC 7846, Bethesda, MD 20892. (301) 435– based on the threat that imports from 1121. [email protected]. such countries increases the risk that USDA Actions Name of Committee: Healthcare Delivery highly pathogenic avian influenza (HPAI) may be introduced into the To protect the U.S. commercial and Methodologies. Community-Level Health poultry industry, USDA/APHIS has Promotion Study Section. United States. The U.S. Department of Agriculture (USDA) Animal and Plant taken specific actions to reduce the Date: October 1–2, 2009. threat of importing birds or products Time: 9 a.m. to 5 p.m. Health Inspection Service (APHIS) has Agenda: To review and evaluate grant implemented and continues to enforce with HPAI. • applications. regulations to prohibit or restrict the USDA’s authority for these actions Place: Hotel Palomar, 2121 P Street, NW., importation of birds, poultry, and is found at 9 CFR Parts 93, 94, and 95. • Washington, DC 20037. unprocessed birds and poultry products USDA/APHIS issued an interim Contact Person: William N. Elwood, PhD, from regions that have reported the final rule on February 4, 2004, and a Scientific Review Officer, Center for presence of highly pathogenic avian final rule on July 20, 2005, providing Scientific Review, National Institutes of influenza H5N1 in poultry. While restrictions on the importation of birds Health, 6701 Rockledge Drive, Room 3162, USDA/APHIS actions are based and unprocessed bird products from MSC 7770, Bethesda, MD 20892. 301/435– countries confirmed to have HPAI in 1503. [email protected]. primarily on protecting the U.S. commercial poultry industry from the commercial birds. Name of Committee: Healthcare Delivery • To date, USDA has placed import and Methodologies. Biomedical Computing introduction of highly pathogenic avian influenza H5N1, these actions have the restrictions on 46 countries. and Health Informatics Study Section. • Date: October 2, 2009. added benefit of mitigating the risk of Import restrictions allow US-origin Time: 3 p.m. to 6 p.m. human exposure to the virus. Because pet birds and performing birds to return Agenda: To review and evaluate grant the USDA/APHIS import restrictions to the United States following a 30-day applications. adequately address risks to human quarantine at a USDA facility. Place: Bethesda Marriott, 5151 Pooks Hill health, HHS/CDC is announcing, in this Importations of processed bird products Road, Bethesda, MD 20814. Notice, its decision to lift its embargo that have been rendered noninfectious Contact Person: Bill Bunnag, PhD, against imports of birds and are also allowed provided such products Scientific Review Officer, Center for unprocessed bird products from those are accompanied by a USDA Veterinary Scientific Review, National Institutes of same countries. All of the bird Services (VS) permit and a government Health, 6701 Rockledge Drive, Room 5124, certification confirming that the MSC 7854, Bethesda, MD 20892. (301) 435– embargoes that are currently in force 1177. [email protected]. under USDA regulations remain in products were treated according to effect. HHS/CDC will work closely with USDA requirements. (Catalogue of Federal Domestic Assistance • Program Nos. 93.306, Comparative Medicine; USDA/APHIS to monitor the Bird products that are potentially 93.333, Clinical Research; 93.306, 93.333, international situation regarding HPAI infectious may be imported for science 93.337, 93.393–93.396, 93.837–93.844, H5N1 outbreaks and if human health and education purposes under a USDA/ 93.846–93.878, 93.892, 93.893, National risks are not adequately contained by APHIS permit process, provided that the Institutes of Health, HHS) USDA regulatory actions, CDC will take product can be safely transported.

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CDC Actions prohibiting the importation of birds and 1. To enforce USDA’s importation bird products from specified countries. embargo, CDC staff at the 20 U.S. On February 4, 2004, HHS/CDC Quarantine Stations will continue Public Comments Received and CDC issued an order to immediately ban the working closely with other federal Responses import of all birds (Class: Aves) from agencies at ports of entry, such as specified countries, subject to limited CDC received three comments from USDA, the Department of Homeland exemptions for returning pet birds of US the public in response to its January 21, Security (DHS), and the U.S. Fish and origin and certain processed bird- 2009 Notice. Two commenters opposed Wildlife Service (FWS) of the derived products. HHS/CDC took this CDC’s proposal to rescind its bird Department of the Interior (DoI). action because birds from these embargo and one commenter 2. CDC staff will closely follow the countries can potentially infect humans commended CDC on its recognition that international situation regarding HPAI with HPAI. Countries affected by the USDA’s ban also protects human health. outbreaks and spread through review of February 4, 2004, order included Public Comment #1: The first information from its internal Cambodia, Indonesia, Japan, Laos, comment opposing the plan for CDC to surveillance systems, World Health People’s Republic of China (including rescind its bird embargo cited three Organization Influenza Collaborating Hong Kong Special Administrative concerns, as follows: Centers, CDC’s USDA liaison officer, the Region [SAR]), South Korea, Thailand, 1. The USDA and CDC prohibitions United Nations Food and Agriculture and Vietnam. This order was further have been part of a well-coordinated Organization, and the World amended on March 10, 2004, to lift the federal response to the avian influenza Organization for Animal Health. embargo of birds and bird products from threat, and there is no need to change 3. CDC staff will continue to monitor the Hong Kong SAR because of the these practices. the World Organizations for Animal documented control of the outbreak 2. The USDA does not have the Health (OIE) and USDA/APHIS actions there and the absence of HPAI cases in mandate to protect human health from toward countries in which HPAI has Hong Kong’s domestic bird populations. the introduction of pathogens into the been established in commercial birds to Following the documentation of HPAI United States, and CDC does. ascertain that they are consistent and in commercial birds in additional make an assessment if actions taken 3. Rescinding the CDC prohibitions countries, HHS/CDC amended the mitigate the human health risk to the might have the undesirable effect of February 4, 2004, order to add these United States. If the review process reducing the public’s understanding of countries to its embargo: Malaysia on identifies human health risks that are human health concerns, including avian September 28, 2004; Kazakhstan, not adequately contained by USDA/ influenza, associated with the Romania, Russia, Turkey, and Ukraine APHIS actions, HHS/CDC will on December 29, 2005; Nigeria on importation of birds and bird products implement additional importation February 8, 2006; India on February 22, into the United States. restrictions for birds and unprocessed 2006; Egypt on February 27, 2006; Niger CDC Response: While the USDA/ bird products. For example, if human on March 2, 2006; Albania, Azerbaijan, APHIS rule is based primarily on cases of HPAI were reported in a Cameroon, and Burma (Myanmar) on protecting the U.S. commercial poultry country with no official confirmation of March 15, 2006; Israel on March 20, industry from introduction of HPAI avian cases (that would normally trigger 2006; Afghanistan on March 21, 2006; H5N1, it has the added benefit of a USDA ban), HHS/CDC could Jordan on March 29, 2006; Burkina Faso mitigating the risk of human exposure to implement restrictions on an emergency on April 10, 2006; Pakistan on April 10, the virus. Through contacts with basis. 2006; Gaza, the West Bank, and Ivory international veterinary authorities and 4. CDC staff will post a link to all Coast (Coˆte d’Ivoire) on April 28, 2006; trade relationships with countries of USDA/APHIS restrictions on its Web Sudan on May 16, 2006; Djibouti on concern, USDA/APHIS is able to site (http://www.cdc.gov/flu/avian/ June 2, 2006; and Kuwait on February quickly assess import risk and outbreaks/embargo.htm). 28, 2007. subsequently implement importation 5. CDC and USDA will continue to restrictions on affected countries. By HHS/CDC has experienced practical collaborate on guidelines and protocols working in close collaboration with and operational issues since the to ensure a timely and coordinated USDA/APHIS, CDC is confident that implementation of these orders. The response to an HPAI outbreak should it their actions before issuing new bird orders occur in the United States. In 2005– import orders are sufficient to protect 2006 the agencies worked together with • Duplicate the USDA/APHIS rule public health. other federal agencies on the USDA and thus do not provide any additional As the nation’s lead agency for human Playbook for Avian Influenza, a protocol protection of the public’s health; health, HHS/CDC will ensure mitigation • that defines each agency’s roles and Cause confusion at ports of entry of the human health risks from HPAI responsibilities in response to H5N1 in regarding which agency has primary and other animal influenza viruses that the United States. authority to respond; pose a risk to human health while also 6. CDC staff will closely monitor • Give the appearance of a lack of demonstrating a coordinated and human cases of HPAI and human coordinated action by the U.S. efficient federal approach to managing infections with other novel influenza government, and risks from imported birds and strains in other countries. If the review • May interfere with the importation unprocessed bird products. HHS/CDC process identifies clearly that risks to of products for laboratory evaluation, will also take action if future USDA/ human health could be further mitigated epidemiologic assessment, and vaccine APHIS restrictions do not adequately by an importation ban on birds and bird distribution and research. address the public health risk from products coming from a particular Thus, on January 21, 2009, CDC HPAI or other influenza viruses in country, HHS/CDC will implement published a notice with a 30-day animals. additional importation restrictions for comment period in the Federal Register HHS/CDC will take the following birds and unprocessed bird products. (74 FR 3608) in which it announced its steps to ensure the human health threat For example, if human illnesses and/or intention to rescind the February 4, of HPAI H5N1 continues to be deaths from infection with a novel 2004, order and all subsequent orders prevented: strain of influenza also shown to be

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circulating in birds were reported in a Dated: August 5, 2009. VIII. Federal Agency Programs country with no official confirmation of James Seligman, Committee. avian cases (that would normally trigger Chief Information Officer, Centers for Disease A. Recovery Act Update. a USDA ban), HHS/CDC could Control and Prevention. B. Trans Alaska Pipeline Exemption. implement restrictions on an emergency [FR Doc. E9–19453 Filed 8–12–09; 8:45 am] C. Section 106 Case Updates. basis. BILLING CODE P IX. Communications, Education, and Outreach Committee. Public Comment #2: The second A. Service Learning Initiative. comment was not specific for HPAI, but ADVISORY COUNCIL ON HISTORIC . Chairman’s Report. addressed general concerns about A. ACHP Alumni Foundation. PRESERVATION potentially zoonotic diseases associated B. Transition. with wild birds. The commenter urged Notice of Meeting C. FY 2011 Budget. CDC to reconsider rescinding this order XI. Executive Director’s Report. with respect to live birds and to review AGENCY: Advisory Council on Historic A. Staff Changes and Recruitment. the disease risks created by these bird Preservation. XII. New Business. imports to protect people from ACTION: Notice of meeting. XIII. Adjourn. dangerous infectious diseases. Note: The meetings of the ACHP are open SUMMARY: Notice is hereby given that to the public. CDC Response: The current embargo the Advisory Council on Historic on birds and bird products from Preservation (ACHP) will meet If you need special accommodations countries that have had HPAI identified Wednesday, August 19, 2009. The due to a disability, please contact the in poultry is very specific and does not meeting will be held in the Caucus Advisory Council on Historic cover all potentially zoonotic diseases Room of the Cannon House Office Preservation, 1100 Pennsylvania from imported wild birds. Therefore, Building, Independence Avenue, and Avenue, NW., Room 803, Washington, rescinding the current order would have 1st Street, SE., Washington, DC at 9 a.m. DC, 202–606–8503, at least seven (7) neither an adverse nor a positive affect The ACHP was established by the days prior to the meeting. on the zoonotic risks of importing wild National Historic Preservation Act of FOR FURTHER INFORMATION CONTACT: birds. 1966 (16 U.S.C. 470 et seq.) to advise the Additional information concerning the meeting is available from the Executive Public Comment #3: The third President and Congress on national historic preservation policy and to Director, Advisory Council on Historic comment was in support of CDC’s Preservation, 1100 Pennsylvania rescission of its bird embargo. comment upon Federal, federally assisted, and federally licensed Avenue, NW., #803, Washington, DC CDC Response: As stated above, CDC undertakings having an effect upon 20004. will continue to work closely with properties listed in or eligible for Dated: August 6, 2009. USDA and other human and animal inclusion in the National Register of John Fowler, health partners to monitor the situation Historic Places. The ACHP’s members Executive Director. with HPAI in both birds and people to are the Architect of the Capitol; the [FR Doc. E9–19282 Filed 8–12–09; 8:45 am] protect both animal and human health Secretaries of the Interior, Agriculture, in the United States. Defense, Housing and Urban BILLING CODE 4310–K6–M In summary, HHS/CDC believes that Development, Commerce, Education, the actions taken to date by USDA/ Veterans Affairs, and Transportation; the Administrator of the General DEPARTMENT OF HOMELAND APHIS adequately mitigate the human SECURITY health risks of HPAI associated with Services Administration; the Chairman of the National Trust for Historic birds and unprocessed bird products U.S. Customs and Border Protection Preservation; the President of the imported from the countries of concern. National Conference of State Historic HHS/CDC plans to mitigate any future Agency Information Collection Preservation Officers; a Governor; a Activities: Protest human health risks that are not Mayor; a Native American; and eight adequately addressed by USDA/APHIS non-Federal members appointed by the AGENCY: U.S. Customs and Border regulations, thus ensuring a strong President. Protection, Department of Homeland coordinated federal response. Therefore, The agenda for the meeting includes Security. the HHS/CDC order of February 4, 2004, the following: ACTION: 30-Day notice and request for and its subsequent amendments are no Call to Order—9 a.m.: comments; Revision of an existing longer needed. I. Chairman’s Welcome. information collection: 1651–0017. II. Preserve America and Chairman’s Action Award Presentation. SUMMARY: U.S. Customs and Border Protection (CBP) of the Department of Therefore, effective September 14, III. Native American Activities. Homeland Security has submitted the 2009, HHS/CDC is rescinding its A. Native American Advisory Group. following information collection request February 4, 2004, order and all B. Native American Program Report. IV. Engaging Youth in Historic to the Office of Management and Budget amendments from the following dates: Preservation. (OMB) for review and approval in March 10, 2004; September 28, 2004; V. Preserve America Program accordance with the Paperwork December 29, 2005; February 8, 2006; Implementation. Reduction Act: Protest (Form 19). This February 22, 2006; February 27, 2006; VI. Department of Interior’s Treasured is a proposed revision and extension of March 2, 2006; March 15, 2006; March Landscapes Initiative. an information collection that was 20, 2006; March 21, 2006; March 29, VII. Preservation Initiatives Committee. previously approved. CBP is proposing 2006; April 10, 2006; April 28, 2006; A. Administration Urban Policy that this information collection be May 16, 2006; June 2, 2006; and Initiative. extended with a change to the burden February 28, 2007. B. Legislative Update. hours. This document is published to

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obtain comments from the public and Current Actions: This submission is Prevention Branch, U.S. Coast Guard, affected agencies. This proposed being made to extend the expiration telephone 504–671–2153. If you have information collection was previously date with a change to the burden hours. questions on viewing or submitting published in the Federal Register (74 Type of Review: Extension (with material to the docket, call Renee V. FR 16227) on April 9, 2009, allowing for change). Wright, Program Manager, Docket a 60-day comment period. This notice Affected Public: Businesses. Operations, telephone 202–366–9826. allows for an additional 30 days for Estimated Number of Respondents: SUPPLEMENTARY INFORMATION: public comments. This process is 3,750. conducted in accordance with 5 CFR Estimated Number of Annual Background and Purpose 1320.10. Responses per Respondent: 12. The offshore supply vessel CALLAIS Estimated Number of Total Annual DATES: Written comments should be NAVIGATOR will be used for offshore Responses: 45,000. received on or before September 14, supply operations. The Certificate of Estimated Time per Respondent: 60 2009. Alternative Compliance allows for the minutes. horizontal distance between the forward ADDRESSES: Interested persons are Estimated Total Annual Burden and aft masthead lights to be 20′ 85⁄8″. invited to submit written comments on Hours: 45,000. Placing the aft masthead light at the the proposed information collection to If additional information is required horizontal distance from the forward the Office of Information and Regulatory contact: Tracey Denning, U.S. Customs masthead light as required by Annex I, Affairs, Office of Management and and Border Protection, Office of paragraph 3(a) of the 72 COLREGS, and Budget. Comments should be addressed Regulations and Rulings, 799 9th Street, Annex I, section 84.05(a) of the Inland to the OMB Desk Officer for Customs NW., 7th Floor, Washington, DC 20229– Rules Act, would result in an aft and Border Protection, Department of 1177, at 202–325–0265. masthead light location directly over the Homeland Security, and sent via Dated: August 7, 2009. cargo deck, where it would interfere electronic mail to _ Tracey Denning, with loading and unloading operations. oira [email protected] or faxed The offset from centerline of the RAM/ to (202) 395–5806. Agency Clearance Officer, Customs and Border Protection. NUC lights may be 3’. Offsetting the SUPPLEMENTARY INFORMATION: U.S. RAM/NUC lights 2 meters from the Customs and Border Protection (CBP) [FR Doc. E9–19438 Filed 8–12–09; 8:45 am] BILLING CODE 9111–14–P centerline as required by Annex I encourages the general public and paragraph 3(c) and Annex I, section affected Federal agencies to submit 84.05(c) would place them in an written comments and suggestions on DEPARTMENT OF HOMELAND exposed position beyond the width of proposed and/or continuing information SECURITY the aft end of the pilothouse. collection requests pursuant to the The Certificate of Alternative Paperwork Reduction Act (Pub. L. 104– Coast Guard Compliance allows for the horizontal 13). Your comments should address one [Docket No. USCG–2009–0680] separation of the forward and aft of the following four points: masthead lights to deviate from the (1) Evaluate whether the proposed Certificate of Alternative Compliance requirements of Annex I, paragraph 3(a) collection of information is necessary for the Offshore Supply Vessel of 72 COLREGS, and Annex I, section for the proper performance of the CALLAIS NAVIGATOR 84.05(a) of the Inland Rules Act, as well functions of the agency/component, as the offset of the RAM/NUC lights to including whether the information will AGENCY: Coast Guard, DHS. deviate from the requirements of Annex have practical utility; ACTION: Notice. I, paragraph 3(c) of 72 COLREGS and (2) Evaluate the accuracy of the Annex I, section 84.05(c) of the Inland agency’s/component’s estimate of the SUMMARY: The Coast Guard announces Rules Act. burden of the proposed collection of that a Certificate of Alternative This notice is issued under authority information, including the validity of Compliance was issued for the offshore of 33 U.S.C. 1605(c), and 33 CFR 81.18. the methodology and assumptions used; supply vessel CALLAIS NAVIGATOR as (3) Enhance the quality, utility, and required by 33 U.S.C. 1605(c) and 33 Dated: July 27, 2009. clarity of the information to be CFR 81.18. J.W. Johnson, Commander, U.S. Coast Guard, Chief, collected; and DATES: The Certificate of Alternative (4) Minimize the burden of the Inspections and Investigations Branch, By Compliance was issued on July 14, Direction of the Commander, Eighth Coast collections of information on those who 2009. are to respond, including the use of Guard District. appropriate automated, electronic, ADDRESSES: The docket for this notice is [FR Doc. E9–19403 Filed 8–12–09; 8:45 am] mechanical, or other technological available for inspection or copying at BILLING CODE 4910–15–P techniques or other forms of the Docket Management Facility (M–30), information. U.S. Department of Transportation, Abstract: Protest (Form 19) is used by West Building Ground Floor, Room DEPARTMENT OF HOMELAND an importer, filer, or any party at W12–140, 1200 New Jersey Avenue, SE., SECURITY interest to petition CBP, or protest any Washington, DC 20590, between 9 a.m. Coast Guard action made by the port director on or and 5 p.m., Monday through Friday, against any imported merchandise. The except Federal holidays. You may also [Docket No. USCG–2009–0681] burden hours were adjusted for this find this docket on the Internet by going information collection due to revised to http://www.regulations.gov, inserting Certificate of Alternative Compliance estimates by CBP which included USCG–2009–0680 in the ’’Keyword’’ for the Offshore Supply Vessel HOS increasing the estimated time per box, and then clicking ’’Search.’’ SWEET WATER response from 30 minutes to 60 FOR FURTHER INFORMATION CONTACT: If AGENCY: Coast Guard, DHS. minutes. No substantive revisions were you have questions on this notice, call ACTION: Notice. made to Form 19. CWO2 David Mauldin, District Eight,

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SUMMARY: The Coast Guard announces DEPARTMENT OF HOMELAND This notice is issued under authority that a Certificate of Alternative SECURITY of 33 U.S.C. 1605(c), and 33 CFR 81.18. Compliance was issued for the offshore Dated: July 27, 2009. Coast Guard supply vessel HOS SWEET WATER as J.W. Johnson, required by 33 U.S.C. 1605(c) and 33 [Docket No. USCG–2009–0704] Commander, U.S. Coast Guard, Chief, CFR 81.18. Inspections and Investigations Branch, By DATES: The Certificate of Alternative Certificate of Alternative Compliance Direction of the Commander Eighth Coast Compliance was issued on July 6, 2009. for the Oceanographic Research Guard District. Vessel FAIRFIELD CHALLENGER [FR Doc. E9–19401 Filed 8–12–09; 8:45 am] ADDRESSES: The docket for this notice is available for inspection or copying at AGENCY: Coast Guard, DHS. BILLING CODE 4910–15–P the Docket Management Facility (M–30), ACTION: Notice. U.S. Department of Transportation, DEPARTMENT OF HOMELAND West Building Ground Floor, Room SUMMARY: The Coast Guard announces SECURITY W12–140, 1200 New Jersey Avenue, SE., that a Certificate of Alternative Washington, DC 20590, between 9 a.m. Compliance was issued for the Coast Guard and 5 p.m., Monday through Friday, oceanographic research vessel except Federal holidays. You may also FAIRFIELD CHALLENGER as required [Docket No. USCG–2009–0705] find this docket on the Internet by going by 33 U.S.C. 1605(c) and 33 CFR 81.18. Certificate of Alternative Compliance to http://www.regulations.gov, inserting DATES: The Certificate of Alternative for the Offshore Supply Vessel BJ USCG–2009–0681 in the ‘‘Keyword’’ Compliance was issued on June 2, 2009. BLUE DOLPHIN box, and then clicking ‘‘Search.’’ ADDRESSES: The docket for this notice is FOR FURTHER INFORMATION CONTACT: If available for inspection or copying at AGENCY: Coast Guard, DHS. you have questions on this notice, call the Docket Management Facility (M–30), ACTION: Notice. CWO2 David Mauldin, District Eight, U.S. Department of Transportation, SUMMARY: The Coast Guard announces Prevention Branch, U.S. Coast Guard, West Building Ground Floor, Room that a Certificate of Alternative telephone 504–671–2153. If you have W12–140, 1200 New Jersey Avenue, SE., Compliance was issued for the offshore questions on viewing or submitting Washington, DC 20590, between 9 a.m. supply vessel BJ BLUE DOLPHIN as material to the docket, call Renee V. and 5 p.m., Monday through Friday, required by 33 U.S.C. 1605(c) and 33 Wright, Program Manager, Docket except Federal holidays. You may also CFR 81.18. Operations, telephone 202–366–9826. find this docket on the Internet by going to http://www.regulations.gov, inserting DATES: The Certificate of Alternative SUPPLEMENTARY INFORMATION: USCG–2009–0704 in the ‘‘Keyword’’ Compliance was issued on May 18, Background and Purpose box, and then clicking ‘‘Search.’’ 2009. ADDRESSES: The offshore supply vessel HOS FOR FURTHER INFORMATION CONTACT: If The docket for this notice is SWEET WATER will be used for you have questions on this notice, call available for inspection or copying at offshore supply operations. The CWO2 David Mauldin, District Eight, the Docket Management Facility (M–30), Certificate of Alternative Compliance Prevention Branch, U.S. Coast Guard, U.S. Department of Transportation, allows for the horizontal distance telephone 504–671–2153. If you have West Building Ground Floor, Room between the forward and aft masthead questions on viewing or submitting W12–140, 1200 New Jersey Avenue, SE., lights to be 21′11″. Placing the aft material to the docket, call Renee V. Washington, DC 20590, between 9 a.m. masthead light at the horizontal Wright, Program Manager, Docket and 5 p.m., Monday through Friday, distance from the forward masthead Operations, telephone 202–366–9826. except Federal holidays. You may also light as required by Annex I, paragraph SUPPLEMENTARY INFORMATION: find this docket on the Internet by going to http://www.regulations.gov, inserting 3(a) of the 72 COLREGS, and Annex I, Background and Purpose Section 84.05(a) of the Inland Rules Act, USCG–2009–0705 in the ‘‘Keyword’’ would result in an aft masthead light The oceanographic research vessel box, and then clicking ‘‘Search.’’ location directly over the cargo deck FAIRFIELD CHALLENGER will be used FOR FURTHER INFORMATION CONTACT: If where it would interfere with loading for oceanographic operations. The you have questions on this notice, call and unloading operations. Certificate of Alternative Compliance CWO2 David Mauldin, District Eight, The Certificate of Alternative allows for the horizontal distance Prevention Branch, U.S. Coast Guard, Compliance allows for the horizontal between the forward and aft masthead telephone 504–671–2153. If you have ′3 ″ separation of the forward and aft lights to be 50 ⁄4 . Placing the aft questions on viewing or submitting masthead lights to deviate from the masthead light at the horizontal material to the docket, call Renee V. requirements of Annex I, paragraph 3(a) distance from the forward masthead Wright, Program Manager, Docket of 72 COLREGS, and Annex I, Section light as required by Annex I, paragraph Operations, telephone 202–366–9826. 84.05(a) of the Inland Rules Act. 3(a) of the 72 COLREGS, and Annex I, SUPPLEMENTARY INFORMATION: Section 84.05(a) of the Inland Rules Act, This notice is issued under authority would result in an aft masthead light Background and Purpose of 33 U.S.C. 1605(c), and 33 CFR 81.18. location that would interfere with crane The offshore supply vessel BJ BLUE Dated: July 27, 2009. operations. DOLPHIN will be used for offshore J.W. Johnson, The Certificate of Alternative supply operations. The Certificate of Commander, U.S. Coast Guard, Chief, Compliance allows for the horizontal Alternative Compliance allows for the Inspections and Investigations Branch, by separation of the forward and aft horizontal distance between the forward Direction of the Commander Eighth Coast masthead lights to deviate from the and aft masthead lights to be 21′10″. Guard District. requirements of Annex I, paragraph 3(a) Placing the aft masthead light at the [FR Doc. E9–19402 Filed 8–12–09; 8:45 am] of 72 COLREGS, and Annex I, Section horizontal distance from the forward BILLING CODE 4910–15–P 84.05(a) of the Inland Rules Act. masthead light as required by Annex I,

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paragraph 3(a) of the 72 COLREGS, and Wright, Program Manager, Docket except Federal holidays. You may also Annex I, Section 84.05(a) of the Inland Operations, telephone 202–366–9826. find this docket on the Internet by going Rules Act, would result in an aft SUPPLEMENTARY INFORMATION: to http://www.regulations.gov, inserting masthead light location directly over the USCG–2009–0654 in the ‘‘Keyword’’ cargo deck where it would interfere Background and Purpose box, and then clicking ‘‘Search.’’ with loading and unloading operations. The offshore supply vessel PAO DE FOR FURTHER INFORMATION CONTACT: If The Certificate of Alternative ACUCAR will be used for offshore you have questions on this notice, call Compliance allows for the horizontal supply operations. The Certificate of CWO2 David Mauldin, District Eight, separation of the forward and aft Alternative Compliance allows for the Prevention Branch, U.S. Coast Guard, masthead lights to deviate from the horizontal distance between the forward telephone 504–671–2153. If you have requirements of Annex I, paragraph 3(a) and aft masthead lights to be 21′ 10″. questions on viewing or submitting of 72 COLREGS, and Annex I, Section Placing the aft masthead light at the material to the docket, call Renee V. 84.05(a) of the Inland Rules Act. horizontal distance from the forward Wright, Program Manager, Docket This notice is issued under authority masthead light as required by Annex I, Operations, telephone 202–366–9826. of 33 U.S.C. 1605(c), and 33 CFR 81.18. paragraph 3(a) of the 72 COLREGS, and SUPPLEMENTARY INFORMATION: Annex I, Section 84.05(a) of the Inland Dated: July 27, 2009. Background and Purpose J.W. Johnson, Rules Act, would result in an aft masthead light location directly over the The offshore supply vessel HOS Commander, U.S. Coast Guard, Chief, SILVER ARROW will be used for Inspections and Investigations Branch, By cargo deck, where it would interfere Direction of the Commander Eighth Coast with loading and unloading operations. offshore supply operations. The Guard District. The Certificate of Alternative Certificate of Alternative Compliance [FR Doc. E9–19400 Filed 8–12–09; 8:45 am] Compliance allows for the horizontal allows for the horizontal distance between the forward and aft masthead BILLING CODE 4910–15–P separation of the forward and aft masthead lights to deviate from the lights to be 21′ 11″. Placing the aft requirements of Annex I, paragraph 3(a) masthead light at the horizontal DEPARTMENT OF HOMELAND of 72 COLREGS, and Annex I, Section distance from the forward masthead SECURITY 84.05(a) of the Inland Rules Act. light as required by Annex I, paragraph This notice is issued under authority 3(a) of the 72 COLREGS, and Annex I, Coast Guard of 33 U.S.C. 1605(c) and 33 CFR 81.18. Section 84.05(a) of the Inland Rules Act, Dated: July 27, 2009. would result in an aft masthead light [Docket No. USCG–2009–0706] location directly over the cargo deck, J.W. Johnson, where it would interfere with loading Certificate of Alternative Compliance Commander, U.S. Coast Guard, Chief, and unloading operations. for the Offshore Supply Vessel PAO Inspections and Investigations Branch, By The Certificate of Alternative Direction of the Commander Eighth Coast DE ACUCAR Guard District. Compliance allows for the horizontal separation of the forward and aft AGENCY: [FR Doc. E9–19399 Filed 8–12–09; 8:45 am] Coast Guard, DHS. masthead lights to deviate from the ACTION: Notice. BILLING CODE 4910–15–P requirements of Annex I, paragraph 3(a) of 72 COLREGS, and Annex I, Section SUMMARY: The Coast Guard announces 84.05(a) of the Inland Rules Act. that a Certificate of Alternative DEPARTMENT OF HOMELAND SECURITY This notice is issued under authority Compliance was issued for the offshore of 33 U.S.C. 1605(c), and 33 CFR 81.18. supply vessel PAO DE ACUCAR as required by 33 U.S.C. 1605(c) and 33 Coast Guard Dated: July 27, 2009. CFR 81.18. [Docket No. USCG–2009–0654] J.W. Johnson, DATES: The Certificate of Alternative Commander, U.S. Coast Guard, Chief, Compliance was issued on May 18, Certificate of Alternative Compliance Inspections and Investigations Branch, By Direction of the Commander Eighth Coast 2009. for the Offshore Supply Vessel HOS SILVER ARROW Guard District. ADDRESSES: The docket for this notice is [FR Doc. E9–19398 Filed 8–12–09; 8:45 am] available for inspection or copying at AGENCY: Coast Guard, DHS. BILLING CODE 4910–15–P the Docket Management Facility (M–30), ACTION: Notice. U.S. Department of Transportation, West Building Ground Floor, Room SUMMARY: The Coast Guard announces DEPARTMENT OF HOMELAND W12–140, 1200 New Jersey Avenue, SE., that a Certificate of Alternative SECURITY Washington, DC 20590, between 9 a.m. Compliance was issued for the offshore and 5 p.m., Monday through Friday, supply vessel HOS SILVER ARROW as Coast Guard except Federal holidays. You may also required by 33 U.S.C. 1605(c) and 33 [Docket No. USCG–2009–0580] find this docket on the Internet by going CFR 81.18. to http://www.regulations.gov, inserting DATES: The Certificate of Alternative Certificate of Alternative Compliance USCG–2009–0706 in the ‘‘Keyword’’ Compliance was issued on July 2, 2009. for the Lift Boat CAITLIN box, and then clicking ‘‘Search.’’ ADDRESSES: The docket for this notice is AGENCY: Coast Guard, DHS. FOR FURTHER INFORMATION CONTACT: If available for inspection or copying at ACTION: Notice. you have questions on this notice, call the Docket Management Facility (M–30), CWO2 David Mauldin, District Eight, U.S. Department of Transportation, SUMMARY: The Coast Guard announces Prevention Branch, U.S. Coast Guard, West Building Ground Floor, Room that a Certificate of Alternative telephone 504–671–2153. If you have W12–140, 1200 New Jersey Avenue, SE., Compliance was issued for the lift boat questions on viewing or submitting Washington, DC 20590, between 9 a.m. CAITLIN as required by 33 U.S.C. material to the docket, call Renee V. and 5 p.m., Monday through Friday, 1605(c) and 33 CFR 81.18.

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DATES: The Certificate of Alternate Dated: July 27, 2009. may be located on the outermost edges Compliance was issued on June 22, J.W. Johnson, of the top of the pilothouse, 7′ 6″ from 2009. Commander, U.S. Coast Guard, Chief, the centerline. Placing the sidelights in Inspections and Investigations Branch, By the locations required by Annex I, ADDRESSES: The docket for this notice is Direction of the Commander Eighth Coast paragraph 3(b) of 72 COLREGS, and available for inspection or copying at Guard District. Annex I, paragraph 84.05(b) of the the Docket Management Facility (M–30), [FR Doc. E9–19397 Filed 8–12–09; 8:45 am] Inland Rules Act would expose the U.S. Department of Transportation, BILLING CODE 4910–15–P sidelights to probable damage from the West Building Ground Floor, Room working machinery around the forward W12–140, 1200 New Jersey Avenue, SE., legs of the vessel. Washington, DC 20590, between 9 a.m. DEPARTMENT OF HOMELAND The Certificate of Alternative and 5 p.m., Monday through Friday, SECURITY Compliance allows for the horizontal except Federal holidays. You may also separation of the masthead light from find this docket on the Internet by going Coast Guard the stem of the vessel to deviate from to http://www.regulations.gov, inserting [Docket No. USCG–2009–0581] the requirements of Annex I, paragraph USCG–2009–0580 in the ‘‘Keyword’’ 3(d) of 72 COLREGS, and Annex I, box, and then clicking ‘‘Search.’’ Certificate of Alternative Compliance Section 84.05(d) of the Inland Rules Act. FOR FURTHER INFORMATION CONTACT: If for the Lift Boat PAUL In addition, this Certificate of Alternative Compliance allows for the you have questions on this notice, call AGENCY: Coast Guard, DHS. CWO2 David Mauldin, District Eight, placement of the side lights to deviate ACTION: Notice. Prevention Branch, U.S. Coast Guard, from requirements set forth in Annex I, telephone 504–671–2153. If you have SUMMARY: The Coast Guard announces paragraph 3(b) of 72 COLREGS, and questions on viewing or submitting that a Certificate of Alternative Annex I, paragraph 84.05(b) of the material to the docket, call Renee V. Compliance was issued for the lift boat Inland Rules Act. Wright, Program Manager, Docket PAUL as required by 33 U.S.C. 1605(c) This notice is issued under authority Operations, telephone 202–366–9826. and 33 CFR 81.18. of 33 U.S.C. 1605(c) and 33 CFR 81.18. SUPPLEMENTARY INFORMATION: DATES: The Certificate of Alternate Dated: July 27, 2009. Compliance was issued on June 12, J.W. Johnson, Background and Purpose 2009. Commander, U.S. Coast Guard, Chief, Inspections and Investigations Branch, By The lift boat CAITLIN will be used for ADDRESSES: The docket for this notice is oil exploration. The horizontal distance Direction of the Commander Eighth Coast available for inspection or copying at Guard District. between the stem of the vessel and the Docket Management Facility (M–30), masthead light is permitted to be 108′. [FR Doc. E9–19394 Filed 8–12–09; 8:45 am] U.S. Department of Transportation, BILLING CODE 4910–15–P Placing the masthead light at the West Building Ground Floor, Room horizontal distance from the stem of the W12–140, 1200 New Jersey Avenue, SE., vessel as required by Annex I, paragraph Washington, DC 20590, between 9 a.m. DEPARTMENT OF HOMELAND 3(d) of the 72 COLREGS, and Annex I, and 5 p.m., Monday through Friday, SECURITY Section 84.05(d) of the Inland Rules Act, except Federal holidays. You may also would result in a masthead light find this docket on the Internet by going U.S. Customs and Border Protection location that would interfere with crane to http://www.regulations.gov, inserting operations. In addition, the sidelights USCG–2009–0581 in the ‘‘Keyword’’ Accreditation and Approval of Oiltest, may be located on the outermost edges box, and then clicking ‘‘Search.’’ Inc., as a Commercial Gauger and of the top of the pilothouse, 7′ 6″ from FOR FURTHER INFORMATION CONTACT: If Laboratory the centerline. Placing the sidelights in you have questions on this notice, call the locations required by Annex I, AGENCY: U.S. Customs and Border CWO2 David Mauldin, District Eight, Protection, Department of Homeland paragraph 3(b) of 72 COLREGS, and Prevention Branch, U.S. Coast Guard, Annex I, paragraph 84.05(b) of the Security. telephone 504–671–2153. If you have ACTION: Notice of accreditation and Inland Rules Act would expose the questions on viewing or submitting sidelights to probable damage from the approval of Oiltest, Inc., as a material to the docket, call Renee V. commercial gauger and laboratory. working machinery around the forward Wright, Program Manager, Docket legs of the vessel. Operations, telephone 202–366–9826. SUMMARY: Notice is hereby given that, The Certificate of Alternative SUPPLEMENTARY INFORMATION: pursuant to 19 CFR 151.12 and 19 CFR Compliance allows for the horizontal 151.13, Oiltest, Inc., 100 Grove Road, separation of the masthead light from Background and Purpose Paulsboro, NJ 08066, has been approved the stem of the vessel to deviate from The lift boat PAUL will be used for oil to gauge and accredited to test the requirements of Annex I, paragraph exploration. The Certificate of petroleum and petroleum products, 3(d) of 72 COLREGS, and Annex I, Alternative Compliance allows for the organic chemicals and vegetable oils for Section 84.05(d) of the Inland Rules Act. horizontal distance between the stem of customs purposes, in accordance with In addition, this Certificate of the vessel and masthead light to be 108′. the provisions of 19 CFR 151.12 and 19 Alternative Compliance allows for the Placing the masthead light at the CFR 151.13. Anyone wishing to employ placement of the sidelights to deviate horizontal distance from the stem of the this entity to conduct laboratory from requirements set forth in Annex I, vessel as required by Annex I, paragraph analyses and gauger services should paragraph 3(b) of 72 COLREGS, and 3(d) of the 72 COLREGS, and Annex I, request and receive written assurances Annex I, paragraph 84.05(b) of the Section 84.05(d) of the Inland Rules Act, from the entity that it is accredited or Inland Rules Act. would result in a masthead light approved by the U.S. Customs and This notice is issued under authority location that would interfere with crane Border Protection to conduct the of 33 U.S.C. 1605(c) and 33 CFR 81.18. operations. In addition, the sidelights specific test or gauger service requested.

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Alternatively, inquiries regarding the to the U.S. Customs and Border The inquiry may also be sent to specific test or gauger service this entity Protection by calling (202) 344–1060. [email protected]. Please reference the is accredited or approved to perform The inquiry may also be sent to Web site listed below for a complete may be directed to the U.S. Customs and [email protected]. Please reference the listing of CBP approved gaugers and Border Protection by calling (202) 344– Web site listed below for a complete accredited laboratories. http://cbp.gov/ 1060. The inquiry may also be sent to listing of CBP approved gaugers and xp/cgov/import/operations_support/ [email protected]. Please reference the accredited laboratories. http://cbp.gov/ labs_scientific_svcs/ Web site listed below for a complete xp/cgov/import/operations_support/ commercial_gaugers/. listing of CBP approved gaugers and labs_scientific_svcs/ DATES: The accreditation and approval accredited laboratories. http://cbp.gov/ commercial_gaugers/. of Intertek USA, Inc., as commercial xp/cgov/import/operations_support/ DATES: The accreditation and approval gauger and laboratory became effective labs_scientific_svcs/ of SGS North America, Inc., as on June 03, 2009. The next triennial commercial_gaugers/. commercial gauger and laboratory inspection date will be scheduled for DATES: The accreditation and approval became effective on April 21, 2009. The June 2012. of Oiltest, Inc., as commercial gauger next triennial inspection date will be FOR FURTHER INFORMATION CONTACT: and laboratory became effective on June scheduled for April 2012. Anthony Malana, Laboratories and 9, 2009. The next triennial inspection FOR FURTHER INFORMATION CONTACT: Scientific Services, U.S. Customs and date will be scheduled for June 2012. Anthony Malana, Laboratories and Border Protection, 1300 Pennsylvania FOR FURTHER INFORMATION CONTACT: Scientific Services, U.S. Customs and Avenue, NW., Suite 1500N, Anthony Malana, Laboratories and Border Protection, 1300 Pennsylvania Washington, DC 20229, 202–344–1060. Scientific Services, U.S. Customs and Avenue, NW., Suite 1500N, Dated: August 4, 2009. Border Protection, 1300 Pennsylvania Washington, DC 20229, 202–344–1060. Ira S. Reese, Avenue, NW., Suite 1500N, Dated: August 4, 2009. Executive Director, Laboratories and Washington, DC 20229, 202–344–1060. Ira S. Reese, Scientific Services. Dated: August 4, 2009. Executive Director, Laboratories and [FR Doc. E9–19385 Filed 8–12–09; 8:45 am] Ira S. Reese, Scientific Services. BILLING CODE 9111–14–P Executive Director, Laboratories and [FR Doc. E9–19384 Filed 8–12–09; 8:45 am] Scientific Services. BILLING CODE 9111–14–P [FR Doc. E9–19382 Filed 8–12–09; 8:45 am] DEPARTMENT OF HOMELAND BILLING CODE 9111–14–P SECURITY DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection Accreditation and Approval of Inspectorate America Corporation, as a U.S. Customs and Border Protection Accreditation and Approval of Intertek Commercial Gauger and Laboratory USA, Inc., as a Commercial Gauger AGENCY: Accreditation and Approval of SGS and Laboratory U.S. Customs and Border North America, Inc., as a Commercial Protection, Department of Homeland AGENCY: Gauger and Laboratory U.S. Customs and Border Security. Protection, Department of Homeland ACTION: Notice of accreditation and AGENCY: U.S. Customs and Border Security. approval of Inspectorate America Protection, Department of Homeland ACTION: Notice of accreditation and Corporation, as a commercial gauger Security. approval of Intertek USA, Inc., as a and laboratory. ACTION: Notice of accreditation and commercial gauger and laboratory. approval of SGS North America, Inc., as SUMMARY: Notice is hereby given that, a commercial gauger and laboratory. SUMMARY: Notice is hereby given that, pursuant to 19 CFR 151.12 and 19 CFR pursuant to 19 CFR 151.12 and 19 CFR 151.13, Inspectorate America SUMMARY: Notice is hereby given that, 151.13, Intertek USA, Inc., 4951A East Corporation, 2947 Duttons Mill Road, pursuant to 19 CFR 151.12 and 19 CFR Adamo Drive, Suite 130, Tampa, FL Suite A–1, Aston, PA 19014, has been 151.13, SGS North America, Inc., 151 33605, has been approved to gauge and approved to gauge and accredited to test James Drive West, St. Rose, LA 70087, accredited to test petroleum and petroleum and petroleum products, has been approved to gauge and petroleum products, organic chemicals organic chemicals and vegetable oils for accredited to test petroleum and and vegetable oils for customs purposes, customs purposes, in accordance with petroleum products, organic chemicals in accordance with the provisions of 19 the provisions of 19 CFR 151.12 and 19 and vegetable oils for customs purposes, CFR 151.12 and 19 CFR 151.13. Anyone CFR 151.13. Anyone wishing to employ in accordance with the provisions of 19 wishing to employ this entity to conduct this entity to conduct laboratory CFR 151.12 and 19 CFR 151.13. Anyone laboratory analyses and gauger services analyses and gauger services should wishing to employ this entity to conduct should request and receive written request and receive written assurances laboratory analyses and gauger services assurances from the entity that it is from the entity that it is accredited or should request and receive written accredited or approved by the U.S. approved by the U.S. Customs and assurances from the entity that it is Customs and Border Protection to Border Protection to conduct the accredited or approved by the U.S. conduct the specific test or gauger specific test or gauger service requested. Customs and Border Protection to service requested. Alternatively, Alternatively, inquires regarding the conduct the specific test or gauger inquires regarding the specific test or specific test or gauger service this entity service requested. Alternatively, gauger service this entity is accredited is accredited or approved to perform inquires regarding the specific test or or approved to perform may be directed may be directed to the U.S. Customs and gauger service this entity is accredited to the U.S. Customs and Border Border Protection by calling (202) 344– or approved to perform may be directed Protection by calling (202) 344–1060. 1060. The inquiry may also be sent to

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[email protected]. Please reference the accredited laboratories. http://cbp.gov/ DATES: The accreditation and approval Web site listed below for a complete xp/cgov/import/operations_support/ of Saybolt LP, as commercial gauger and listing of CBP approved gaugers and labs_scientific_svcs/ laboratory became effective on March accredited laboratories. http://cbp.gov/ commercial_gaugers. 24, 2009. The next triennial inspection _ xp/cgov/import/operations support/ DATES: The accreditation and approval date will be scheduled for March 2012. labs_scientific_svcs/ FOR FURTHER INFORMATION CONTACT: _ of Saybolt LP, as commercial gauger and commercial gaugers/. laboratory became effective on April 09, Anthony Malana, Laboratories and DATES: The accreditation and approval 2009. The next triennial inspection date Scientific Services, U.S. Customs and of Inspectorate America Corporation, as will be scheduled for April 2012. Border Protection, 1300 Pennsylvania commercial gauger and laboratory FOR FURTHER INFORMATION CONTACT: Avenue, NW., Suite 1500N, became effective on June 11, 2009. The Anthony Malana, Laboratories and Washington, DC 20229, 202–344–1060. next triennial inspection date will be Scientific Services, U.S. Customs and Dated: August 4, 2009. scheduled for June 2012. Border Protection, 1300 Pennsylvania Ira S. Reese, FOR FURTHER INFORMATION CONTACT: Avenue, NW., Suite 1500N, Executive Director, Laboratories and Anthony Malana, Laboratories and Washington, DC 20229, 202–344–1060. Scientific Services. Scientific Services, U.S. Customs and Dated: August 4, 2009. [FR Doc. E9–19386 Filed 8–12–09; 8:45 am] Border Protection, 1300 Pennsylvania BILLING CODE 9111–14–P Avenue, NW., Suite 1500N, Ira S. Reese, Washington, DC 20229, 202–344–1060. Executive Director, Laboratories and Scientific Services. DEPARTMENT OF HOMELAND Dated: August 4, 2009. [FR Doc. E9–19391 Filed 8–12–09; 8:45 am] Ira S. Reese, SECURITY BILLING CODE 9111–14–P Executive Director, Laboratories and Scientific Services. U.S. Customs and Border Protection [FR Doc. E9–19387 Filed 8–12–09; 8:45 am] DEPARTMENT OF HOMELAND Approval of Marine Technical BILLING CODE 9111–14–P SECURITY Surveyors, Inc., as a Commercial Gauger U.S. Customs and Border Protection DEPARTMENT OF HOMELAND AGENCY: U.S. Customs and Border SECURITY Accreditation and Approval of Saybolt Protection, Department of Homeland LP, as a Commercial Gauger and Security. U.S. Customs and Border Protection Laboratory ACTION: Notice of approval of Marine Accreditation and Approval of Saybolt AGENCY: U.S. Customs and Border Technical Surveyors, Inc., as a LP, as a Commercial Gauger and Protection, Department of Homeland commercial gauger. Security. Laboratory SUMMARY: Notice is hereby given that, ACTION: Notice of accreditation and AGENCY: U.S. Customs and Border pursuant to 19 CFR 151.13, Marine approval of Saybolt LP, as a commercial Technical Surveyors, Inc., 2382 Protection, Department of Homeland gauger and laboratory. Security. Highway 1 South, Donaldsonville, LA 70346, has been approved to gauge ACTION: Notice of accreditation and SUMMARY: Notice is hereby given that, petroleum, petroleum products, organic approval of Saybolt LP, as a commercial pursuant to 19 CFR 151.12 and 19 CFR chemicals and vegetable oils for gauger and laboratory. 151.13, Saybolt LP, 710 Loop 197 North, Texas City, TX 77590, has been customs purposes, in accordance with SUMMARY: Notice is hereby given that, approved to gauge and accredited to test the provisions of 19 CFR 151.13. pursuant to 19 CFR 151.12 and 19 CFR petroleum and petroleum products, Anyone wishing to employ this entity to 151.13, Saybolt LP, 235 Marginal St. organic chemicals and vegetable oils for conduct gauger services should request Suite 3, Chelsea, MA 02150, has been customs purposes, in accordance with and receive written assurances from the approved to gauge and accredited to test the provisions of 19 CFR 151.12 and 19 entity that it is approved by the U.S. petroleum and petroleum products, CFR 151.13. Anyone wishing to employ Customs and Border Protection to organic chemicals and vegetable oils for this entity to conduct laboratory conduct the specific gauger service customs purposes, in accordance with analyses and gauger services should requested. Alternatively, inquires the provisions of 19 CFR 151.12 and 19 request and receive written assurances regarding the specific gauger service this CFR 151.13. Anyone wishing to employ from the entity that it is accredited or entity is approved to perform may be this entity to conduct laboratory approved by the U.S. Customs and directed to the U.S. Customs and Border analyses and gauger services should Border Protection to conduct the Protection by calling (202) 344–1060. request and receive written assurances specific test or gauger service requested. The inquiry may also be sent to from the entity that it is accredited or Alternatively, inquires regarding the [email protected]. Please reference the approved by the U.S. Customs and specific test or gauger service this entity Web site listed below for a complete Border Protection to conduct the is accredited or approved to perform listing of CBP approved gaugers and specific test or gauger service requested. may be directed to the U.S. Customs and accredited laboratories. http://cbp.gov/ Alternatively, inquiries regarding the Border Protection by calling (202) 344– xp/cgov/import/operations_support/ specific test or gauger service this entity 1060. The inquiry may also be sent to labs_scientific_svcs/ is accredited or approved to perform [email protected]. Please reference the commercial_gaugers/. may be directed to the U.S. Customs and Web site listed below for a complete DATES: The approval of Marine Border Protection by calling (202) 344– listing of CBP approved gaugers and Technical Surveyors, Inc., as 1060. The inquiry may also be sent to accredited laboratories. http://cbp.gov/ commercial gauger became effective on [email protected]. Please reference the xp/cgov/import/operations_support/ March 19, 2009. The next triennial Web site listed below for a complete labs_scientific_svcs/ inspection date will be scheduled for listing of CBP approved gaugers and commercial_gaugers/. March 2012.

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FOR FURTHER INFORMATION CONTACT: Dated: August 4, 2009. DEPARTMENT OF HOMELAND Anthony Malana, Laboratories and Ira S. Reese, SECURITY Scientific Services, U.S. Customs and Executive Director, Laboratories and Border Protection, 1300 Pennsylvania Scientific Services. U.S. Customs and Border Protection Avenue, NW., Suite 1500N, [FR Doc. E9–19389 Filed 8–12–09; 8:45 am] Approval of Petrospect, Inc., as a Washington, DC 20229, 202–344–1060. BILLING CODE 9111–14–P Dated: August 4, 2009. Commercial Gauger Ira S. Reese, DEPARTMENT OF HOMELAND AGENCY: U.S. Customs and Border Executive Director, Laboratories and Protection, Department of Homeland Scientific Services. SECURITY Security. [FR Doc. E9–19383 Filed 8–12–09; 8:45 am] U.S. Customs and Border Protection BILLING CODE 9111–14–P ACTION: Notice of approval of Petrospect, Approval of Intertek USA, Inc., as a Inc., as a commercial gauger. Commercial Gauger SUMMARY: Notice is hereby given that, DEPARTMENT OF HOMELAND AGENCY: U.S. Customs and Border pursuant to 19 CFR 151.13, Petrospect, SECURITY Protection, Department of Homeland Inc., 499 N. Nimitz Pier 21, Honolulu, Security. HI 96817, has been approved to gauge U.S. Customs and Border Protection petroleum, petroleum products, organic ACTION: Notice of approval of Intertek chemicals and vegetable oils for Approval of Intertek USA, Inc., as a USA, Inc., as a commercial gauger. Commercial Gauger customs purposes, in accordance with the provisions of 19 CFR 151.13. SUMMARY: Notice is hereby given that, AGENCY: U.S. Customs and Border pursuant to 19 CFR 151.13, Intertek Anyone wishing to employ this entity to Protection, Department of Homeland USA, Inc., 91–110 Hanua Street #204, conduct gauger services should request Security. Kapolei, HI 96707, has been approved to and receive written assurances from the ACTION: Notice of approval of Intertek gauge petroleum, petroleum products, entity that it is approved by the U.S. USA, Inc., as a commercial gauger. organic chemicals and vegetable oils for Customs and Border Protection to customs purposes, in accordance with conduct the specific gauger service SUMMARY: Notice is hereby given that, the provisions of 19 CFR 151.13. requested. Alternatively, inquires pursuant to 19 CFR 151.13, Intertek Anyone wishing to employ this entity to regarding the specific gauger service this USA, Inc., 354 Fairbanks Street, Valdez, conduct gauger services should request entity is approved to perform may be AK 99686, has been approved to gauge and receive written assurances from the directed to the U.S. Customs and Border petroleum, petroleum products, organic entity that it is approved by the U.S. Protection by calling (202) 344–1060. chemicals and vegetable oils for Customs and Border Protection to The inquiry may also be sent to customs purposes, in accordance with conduct the specific gauger service [email protected]. Please reference the the provisions of 19 CFR 151.13. requested. Alternatively, inquires Web site listed below for a complete Anyone wishing to employ this entity to regarding the specific gauger service this listing of CBP approved gaugers and conduct gauger services should request entity is approved to perform may be accredited laboratories. http://cbp.gov/ and receive written assurances from the directed to the U.S. Customs and Border xp/cgov/import/operations_support/ entity that it is approved by the U.S. Protection by calling (202) 344–1060. labs_scientific_svcs/ Customs and Border Protection to The inquiry may also be sent to commercial_gaugers/. conduct the specific gauger service [email protected]. Please reference the requested. Alternatively, inquires Web site listed below for a complete DATES: The approval of Petrospect, Inc., regarding the specific gauger service this listing of CBP approved gaugers and as commercial gauger became effective entity is approved to perform may be accredited laboratories. http://cbp.gov/ on May 21, 2009. The next triennial directed to the U.S. Customs and Border xp/cgov/import/operations_support/ inspection date will be scheduled for Protection by calling (202) 344–1060. labs_scientific_svcs/ May 2012. The inquiry may also be sent to commercial_gaugers/. FOR FURTHER INFORMATION CONTACT: [email protected]. Please reference the DATES: Web site listed below for a complete The approval of Intertek USA, Anthony Malana, Laboratories and listing of CBP approved gaugers and Inc., as commercial gauger became Scientific Services, U.S. Customs and accredited laboratories. http://cbp.gov/ effective on May 20, 2009. The next Border Protection, 1300 Pennsylvania xp/cgov/import/operations_support/ triennial inspection date will be Avenue, NW., Suite 1500N, labs_scientific_svcs/ scheduled for May 2012. Washington, DC 20229, 202–344–1060. commercial_gaugers/. FOR FURTHER INFORMATION CONTACT: Dated: August 4, 2009. DATES: The approval of Intertek USA, Anthony Malana, Laboratories and Ira S. Reese, Inc., as commercial gauger became Scientific Services, U.S. Customs and Executive Director, Laboratories and effective on May 28, 2009. The next Border Protection, 1300 Pennsylvania Scientific Services. triennial inspection date will be Avenue, NW., Suite 1500N, [FR Doc. E9–19388 Filed 8–12–09; 8:45 am] Washington, DC 20229, 202–344–1060. scheduled for May 2012. BILLING CODE 9111–14–P Dated: August 4, 2009. FOR FURTHER INFORMATION CONTACT: Anthony Malana, Laboratories and Ira S. Reese, Scientific Services, U.S. Customs and Executive Director, Laboratories and Border Protection, 1300 Pennsylvania Scientific Services. Avenue, NW., Suite 1500N, [FR Doc. E9–19390 Filed 8–12–09; 8:45 am] Washington, DC 20229, 202–344–1060. BILLING CODE 9111–14–P

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DEPARTMENT OF HOMELAND Labour Organization (ILO) in February Dated: August 7, 2009. SECURITY 2006. It sets out seafarers’ rights to J.G. Lantz, decent conditions of work and helps to Director of Commercial, Regulations and Coast Guard create conditions of fair competition for Standards. [Docket No. USCG–2009–0693] shipowners. The MLC, 2006, has been [FR Doc. E9–19395 Filed 8–12–09; 8:45 am] designed to become the ‘‘fourth pillar’’ BILLING CODE 4910–15–P Maritime Labour Convention, 2006; of the international regulatory regime Informational Meeting for quality shipping complementing the key conventions of the International DEPARTMENT OF THE INTERIOR AGENCY: Coast Guard, DHS. Maritime Organization (IMO), such as ACTION: Notice of informational meeting. the International Convention for the Office of Surface Mining Reclamation Safety of Life at Sea, 1974, as amended and Enforcement SUMMARY: The Coast Guard and the (SOLAS), the International Convention Maritime Administration will host an on Standards of Training, Certification Notice of Proposed Information informational meeting to discuss the and Watchkeeping, 1978, as amended Collection for 1029–0098 content of the Maritime Labour (STCW), and the International Convention, 2006 (MLC, 2006). The AGENCY: Office of Surface Mining Convention for the Prevention of purpose of this meeting is to provide the Reclamation and Enforcement. Pollution from Ships, 73/78 (MARPOL). industry with an overview of the MLC, The MLC, 2006, contains a ACTION: Notice and request for 2006, and to help clarify areas that may comprehensive set of global standards, comments. require additional interpretation. This based on those that are already found in meeting is strictly informational and it SUMMARY: In compliance with the 68 maritime labour instruments adopted is not meant to discuss the merits of Paperwork Reduction Act of 1995, the by the ILO since 1920. ratification of the MLC, 2006. The Office of Surface Mining Reclamation meeting will be on Monday, August 24, Meeting Agenda: The purpose of this and Enforcement (OSM) is announcing 2009, and open to the public. meeting is to provide the industry with its intention to request approval to an overview of the MLC, 2006, and to DATES: The public meeting will be on continue the collection of information Monday, August 24, 2009, from 9 a.m. help clarify areas that may require under 30 CFR Part 769—Petition to 11:50 a.m., at the Department of additional interpretation. This meeting process for designation of Federal lands Transportation, Conference Center, is strictly informational and it is not as unsuitable for all or certain types of Rooms 8–9–10, 1200 New Jersey meant to discuss the merits of surface coal mining operations and for Avenue, SE., Washington, DC 20590, ratification of the MLC, 2006. The termination of previous designations. telephone 202–366–4000. Please note tentative agenda of the meeting is: This information collection activity was this meeting may close early if all • Introduction to the MLC, 2006; previously approved by the Office of business is finished. • Seafarer’s perspective; Management and Budget (OMB), and assigned clearance number 1029–0098. ADDRESSES: This notice is available on • Shipowner’s perspective; DATES: Comments on the proposed the Internet at www.regulations.gov • Overview of the MLC, 2006; under the docket number USCG–2009– information collection activity must be • 0693. The MLC, 2006, is available on United States Process for received by October 13, 2009, to be the Internet at http://www.ilo.org/ ratification. assured of consideration. global/What_we_do/ Procedural FOR FURTHER INFORMATION CONTACT: To InternationalLabourStandards/ receive a copy of the information MaritimeLabourConvention/lang—en/ The meeting is open to the public. collection request, or to comment on the index.htm. Please note that the meeting may close information collection activity, contact early if all business is finished. At the John A. Trelease, Office of Surface FOR FURTHER INFORMATION CONTACT: If meeting facilitator’s discretion, you have questions on this notice Mining Reclamation and Enforcement, members of the public may make contact Mr. Anthony D. Morris, U.S. 1951 Constitution Ave, NW., Room 202– presentations and ask questions in Coast Guard Headquarters, CG–5221, SIB, Washington, DC 20240. You may response to information provided at the Room 1210, 2100 Second Street SW., contact Mr. Trelease or submit meeting. The meeting will not be Stop 7126, Washington, DC 20593– comments electronically at recorded and the Coast Guard and the 7126; telephone 202–372–1408, fax [email protected]. Maritime Administration do not intend 202–372–1926, or e-mail at Anthony D. SUPPLEMENTARY INFORMATION: OMB to provide response to presentations. [email protected]. regulations at 5 CFR 1320, which However, a summary of the information implement provisions of the Paperwork SUPPLEMENTARY INFORMATION: presented by the Coast Guard and the Reduction Act of 1995 (Pub. L. 104–13), Maritime Administration will be made Information on Services for Individuals require that interested members of the available after the meeting on the With Disabilities public and affected agencies have an Internet at http://homeport.uscg.mil. For information on facilities or opportunity to comment on information services for individuals with disabilities A government-issued photo collection and recordkeeping activities or to request special assistance at the identification (for example, a driver’s [see 5 CFR 1320.8(d)] This notice meeting, contact Mr. Anthony D. Morris license) will be required for entrance at identifies an information collection that at the telephone number or e-mail the meeting location. We encourage OSM will be submitting to OMB for address indicated under the FOR individuals planning on attending to renewed approval. This collection is FURTHER INFORMATION CONTACT section of arrive early in order to allow sufficient contained in 30 CFR Part 769—Petition this notice as soon as possible. time before the meeting to clear process for designation of Federal lands Background and Purpose: The MLC, security. as unsuitable for all or certain types of 2006, was adopted by the International This notice is issued under authority surface coal mining operations and for Labour Conference of the International of 5 U.S.C. 552. termination of previous designations.

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OSM will request a 3-year term of Dated: August 7, 2009. implementing the Migratory Bird Treaty approval for this information collection John R. Craynon, Act (MBTA) (16 U.S.C. 703 et seq.). activity. Chief, Division of Regulatory Support. Under the MBTA, it is unlawful to take, Comments are invited On: (1) The [FR Doc. E9–19426 Filed 8–12–09; 8:45 am] possess, import, export, transport, sell, need for the collection of information BILLING CODE 4310–05–M purchase, barter, or offer for sale, for the performance of the functions of purchase, or barter, migratory birds or the agency; (2) the accuracy of the their parts, nests, or eggs, except as agency’s burden estimates; (3) ways to DEPARTMENT OF THE INTERIOR authorized by regulations implementing enhance the quality, utility and clarity the MBTA. of the information collection; and (4) Fish and Wildlife Service The regulations at 50 CFR 21.47 ways to minimize the information [FWS-R9-MB-2009-N169] [91200-1231-9BPP- (Aquaculture Depredation Order) collection burden on respondents, such L2] authorize aquaculture producers in 13 as use of automated means of collection States to take double-crested cormorants of the information. A summary of the Proposed Information Collection; OMB when the birds are found committing or public comments will accompany Control Number 1018-0121; about to commit depredations on OSM’s submission of the information Depredation Orders for Double- commercial freshwater aquaculture collection request to OMB. Crested Cormorants stocks. The regulations at 50 CFR 21.48 Before including your address, phone AGENCY: Fish and Wildlife Service, (Public Resource Depredation Order) number, e-mail address, or other Interior. authorize State fish and wildlife personal identifying information in your agencies, the U.S. Department of ACTION: Notice; request for comments. comment, you should be aware that Agriculture (APHIS-Wildlife Services), your entire comment, including your SUMMARY: We (Fish and Wildlife and federally recognized tribes in 24 personal identifying information, may Service) will ask the Office of States to take double-crested cormorants be made publicly available at any time. Management and Budget (OMB) to to prevent depredations on the public While you can ask us in your comment approve the information collection (IC) resources of fish, wildlife, plants, and to withhold your personal identifying described below. As required by the their habitats. information from public review, we Paperwork Reduction Act of 1995 and Both 50 CFR 21.47 and 21.48 impose cannot guarantee that we will be able to as part of our continuing efforts to reporting and recordkeeping do so. reduce paperwork and respondent requirements on those operating under This notice provides the public with burden, we invite the general public and the depredation orders. We use the 60 days in which to comment on the other Federal agencies to take this information collected to: following information collection opportunity to comment on this IC. This (1) Help assess the impact of the activity: IC is scheduled to expire on December depredation orders on double-crested Title: 30 CFR Part 769—Petition 31, 2009. We may not conduct or cormorant populations. process for designation of Federal lands sponsor and a person is not required to (2) Protect nontarget migratory birds as unsuitable for all or certain types of respond to a collection of information or other species. surface coal mining operations and for unless it displays a currently valid OMB (3) Ensure that agencies and termination of previous designations. control number. individuals are conforming to the terms, OMB Control Number: 1029–0098. DATES: To ensure that we are able to conditions, and purpose of the orders. Summary: This part establishes the consider your comments on this IC, we (4) Help gauge the effectiveness of the minimum procedures and standards for must receive them by October 13, 2009. orders at mitigating cormorant-related designating Federal lands unsuitable for ADDRESSES: Send your comments on the damages. certain types of surface mining IC to Hope Grey, Information Collection II. Data operations and for terminating Clearance Officer, Fish and Wildlife designations pursuant to a petition. The Service, MS 222–ARLSQ, 4401 North OMB Control Number: 1018-0121. information requested will aid the Fairfax Drive, Arlington, VA 22203 Title: Depredation Orders for Double- regulatory authority in the (mail); or [email protected] (e-mail). Crested Cormorants, 50 CFR 21.47 and decisionmaking process to approve or FOR FURTHER INFORMATION CONTACT: To 21.48. disapprove a request. request additional information about Service Form Number(s): None. Bureau Form Number: None. this IC, contact Hope Grey by mail or e- Type of Request: Extension of a Frequency of Collection: Once. mail (see ADDRESSES) or by telephone currently approved collection. Description of Respondents: People at (703) 358–2482. Affected Public: Aquaculture who may be adversely affected by SUPPLEMENTARY INFORMATION: producers, States, and tribes. surface mining on Federal lands. Respondent’s Obligation: Required to Total Annual Responses: 1. I. Abstract obtain or retain a benefit. Total Annual Burden Hours: 1,000 This information collection is Frequency of Collection: Annually for hours. associated with regulations reports; ongoing for recordkeeping.

Number of annual Number of annual Completion time Annual burden Activity respondents responses per response hours

Report take of migratory bird species other than double- 1 1 1 hour...... 1 crested cormorants (21.47(d)(7); 21.48(d)(7)). Report take of species protected under Endangered Species 1 1 1 hour...... 1 Act (21.47(d)(8); 21.48(d)(8)). Written notice of intent to conduct control activities 12 12 3 hours...... 36 (21.48(d)(9)). Report of control activities (21.48(d)(10) and (11)) ...... 12 12 20 hours ...... 240 Report effects of management activities (21.48(d)(12)) ...... 9 9 100 hours ...... 900

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Number of annual Number of annual Completion time Annual burden Activity respondents responses per response hours

Recordkeeping (21.47(d)(9)) ...... 500 500 7 hours ...... 3,500

Totals ...... 535 535 ...... 4,678

III. Request for Comments described below. As required by the • Maintain records of the importation We invite comments concerning this Paperwork Reduction Act of 1995 and and exportation of these commodities. IC on: as part of our continuing efforts to Additionally, we use information (1) Whether or not the collection of reduce paperwork and respondent from FWS Forms 3-177 and 3-177A to information is necessary, including burden, we invite the general public and compile an annual report that we whether or not the information will other Federal agencies to take this provide to the CITES Secretariat in have practical utility; opportunity to comment on this IC. This Geneva, Switzerland. This annual report (2) The accuracy of our estimate of the IC is scheduled to expire on January 31, on the number and types of imports and burden for this collection of 2010. We may not conduct or sponsor exports of fish, wildlife, and wildlife information; and a person is not required to respond products is one of our treaty obligations (3) Ways to enhance the quality, to a collection of information unless it under CITES. The report does not utility, and clarity of the information to displays a currently valid OMB control contain any personally identifying be collected; and number. information. (4) Ways to minimize the burden of DATES: To ensure that we are able to We also use the information obtained the collection of information on consider your comments on this IC, we from FWS Form 3-177 as an respondents. must receive them by October 13, 2009. enforcement tool and management aid Comments that you submit in ADDRESSES: Send your comments on the to monitor the international wildlife response to this notice are a matter of IC to Hope Grey, Information Collection market and detect trends and changes in public record. We will include or Clearance Officer, Fish and Wildlife the commercial trade of fish, wildlife, summarize each comment in our request Service, MS 222–ARLSQ, 4401 North and wildlife products. Our Division of to OMB to approve this IC. Before Fairfax Drive, Arlington, VA 22203 Scientific Authority and Division of including your address, phone number, (mail); or [email protected] (e-mail). Management Authority use this e-mail address, or other personal FOR FURTHER INFORMATION CONTACT: To information to assess the need for identifying information in your request additional information about additional protection for native species. comment, you should be aware that this IC, contact Hope Grey by mail or e- The information we collect is part of your entire comment, including your mail (see ADDRESSES) or by telephone a system of records covered by the personal identifying information, may at (703) 358–2482. Privacy Act (5 U.S.C. 552(a)). Businesses or individuals must file be made publicly available at any time. SUPPLEMENTARY INFORMATION: While you can ask us in your comment FWS Forms 3-177 and 3-177a with us at to withhold your personal identifying I. Abstract the time and port where they request information from public review, we The Endangered Species Act (16 clearance of the import or export of cannot guarantee that we will be able to U.S.C. 1531 et seq.) makes it unlawful wildlife or wildlife products. Our do so. to import or export fish, wildlife, or regulations allow for certain species of wildlife to be imported or exported Dated: August 6, 2009 plants without filing a declaration or report deemed necessary for enforcing between the United States and Canada Hope Grey, or Mexico at U.S. Customs and Border Information Collection Clearance Officer, the Act or upholding the Convention on International Trade in Endangered Protection ports, even though our Fish and Wildlife Service. wildlife inspectors may not be present. FR Doc. E9–19405 Filed 8–12–09; 8:45 am Species (CITES) (see 16 U.S.C. 1538(e)). With a few exceptions, businesses or In these instances, importers and BILLING CODE 4310–55–S individuals importing into or exporting exporters may file the forms with U.S. from the United States any fish, Customs and Border Protection. We collect the following information: DEPARTMENT OF THE INTERIOR wildlife, or wildlife product must complete and submit to the Service an (1) Name of the importer or exporter Fish and Wildlife Service FWS Form 3-177 (Declaration for and broker. Importation or Exportation of Fish or (2) Scientific and common name of [FWS-R9-LE-2009-N168] [99011-1224-0000- Wildlife). This form as well as FWS the fish or wildlife. 9B] Form 3-177a (Continuation Sheet) and (3) Permit numbers (if permits are required). Proposed Information Collection; OMB instructions for completion are available (4) Description, quantity, and value of Control Number 1018-0012; for electronic submission at https:// the fish or wildlife. Declaration for Importation or edecs.fws.gov. These forms are also (5) Natural country of origin of the Exportation of Fish or Wildlife available in hard copy at http:// www.fws.gov/forms/. fish or wildlife. AGENCY: Fish and Wildlife Service, The information that we collect is In addition, certain information, such Interior. unique to each wildlife shipment and as the airway bill or bill of lading ACTION: Notice; request for comments. enables us to: number, the location of the fish or • Accurately inspect the contents of wildlife for inspection, and the number SUMMARY: We (Fish and Wildlife the shipment; of cartons containing fish or wildlife, Service, Service) will ask the Office of • Enforce any regulations that pertain assists our wildlife inspectors if a Management and Budget (OMB) to to the fish, wildlife, or wildlife products physical examination of the shipment is approve the information collection (IC) contained in the shipment; and necessary.

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II. Data Type of Request: Extension of a government agencies that import or currently approved collection. export fish or wildlife specimens for OMB Control Number: 1018-0012. Affected Public: Businesses or various purposes. Title: Declaration for Importation or individuals that import or export fish, Respondent’s Obligation: Required to Exportation of Fish or Wildlife. wildlife, or wildlife products; scientific obtain or retain a benefit. Service Form Number(s): 3-177 and 3- institutions that import or export fish or 177a. wildlife scientific specimens; Frequency of Collection: On occasion.

Number of annual Number of annual Completion time Annual burden Activity respondents responses per response hours

3-177 - Hard Copy Submission ...... 4,200 37,000 15 minutes ...... 9,250 3-177 -Electronic Submission ...... 16,500 145,000 10 minutes ...... 24,167 Totals ...... 20,700 182,000 ...... 33,417

III. Request for Comments ACTION: Notice of availability of the made available our draft CCP and We invite comments concerning this revised comprehensive conservation Environmental Assessment (EA) and IC on: plan and finding of no significant requested comments in a notice of • Whether or not the collection of impact for environmental assessment. availability in the Federal Register (73 information is necessary, including FR 58259; October 6, 2008). The draft SUMMARY: We, the Fish and Wildlife CCP and EA evaluated two alternatives whether or not the information will Service (Service, USFWS), announce the for managing the Refuges for the next 15 have practical utility; availability of our revised • years. The accuracy of our estimate of the comprehensive conservation plan (CCP) Established in 1980 by the Alaska burden for this collection of and finding of no significant impact National Interest Lands Conservation information; (FONSI) for the Koyukuk, Northern Unit • Act (ANILCA: 16 U.S.C. 410hh et seq., Ways to enhance the quality, utility, Innoko, and Nowitna National Wildlife 43 U.S.C. 1602 et seq.), Koyukuk, and clarity of the information to be Refuges (Refuges). In this revised CCP, Northern Unit Innoko, and Nowitna collected; and we describe how we will manage the • Refuges encompass approximately 6 Ways to minimize the burden of the Refuges for the next 15 years. million acres under Service jurisdiction. collection of information on ADDRESSES: You may view or obtain The purposes for which the Refuges respondents. copies of the revised CCP and FONSI by were established include: (i) To Comments that you submit in any of the following methods. You may conserve fish and wildlife populations response to this notice are a matter of request a paper copy, a summary, or a and habitats in their natural diversity; public record. We will include or CD–ROM containing both. (ii) to fulfill international treaty summarize each comment in our request Agency Web Site: Download a copy of obligations of the United States with to OMB to approve this IC. Before the documents at http://alaska.fws.gov/ respect to fish and wildlife and their including your address, phone number, nwr/planning/plans.htm. habitats; (iii) to provide the opportunity _ e-mail address, or other personal E-mail: fw7 Koyukuk for continued subsistence use by local _ identifying information in your Nowitna [email protected]. Please residents; and (iv) to ensure water comment, you should be aware that include ‘‘Revised CCP’’ in the subject quality and necessary water quantity your entire comment, including your line of the message. within the Refuge. The Draft CCP and personal identifying information, may Mail: Mikel R. Haase, Natural EA for the Refuges was developed be made publicly available at any time. Resource Planner, U.S. Fish and consistent with Section 304(g) of While you can ask us in your comment Wildlife Service, 1011 E. Tudor Road, ANILCA and the Refuge Administration to withhold your personal identifying MS–231, Anchorage, AK 99503–6199, or Act as amended by the Refuge information from public review, we Refuge Manager, Koyukuk/Nowitna Improvement Act (16 U.S.C. 668dd et cannot guarantee that we will be able to NWRs, P.O. Box 287, Galena, AK 99741. seq.). do so. In-Person Viewing or Pickup: Call CCPs were originally prepared for the Dated: August 6, 2009 (907) 786–3357 to make an appointment Refuges in 1987. The revised plan Hope Grey, during regular business hours at the includes management direction updated USFWS Regional Office, 1011 E. Tudor Information Collection Clearance Officer, by changes to policy since completion Fish and Wildlife Service. Road, Anchorage AK 99053, or call of the 1987 plans. It also includes a (907) 656–1231 to make an appointment FR Doc. E9–19404 Filed 8–12–09; 8:45 am vision statement, goals, and objectives during business hours at the Koyukuk/ BILLING CODE 4310–55–S for management of the Refuge. Nowitna Refuges’ office in Galena, AK. Management of the Refuges would FOR FURTHER INFORMATION CONTACT: generally continue to follow DEPARTMENT OF THE INTERIOR Mikel Haase, (907) 786–3402 (phone); management direction described in the _ (907) 786–3965 (fax); or fw7 1987 CCPs and records of decisions as _ Fish and Wildlife Service KoyukukNowitna [email protected] (e- modified by subsequent program- mail). specific plans (e.g., fisheries, cultural [FWS–R7–R–2009–N0105; 70133–1265– SUPPLEMENTARY INFORMATION: resources, and fire management plans). 0000–S3] With this notice, we finalize the As required by ANILCA, areas of the Koyukuk/Nowitna National Wildlife revised CCP for Koyukuk, Northern Unit Refuges were designated in the 1987 Refuges, Galena, AK Innoko, and Nowitna National Wildlife CCPs according to their respective Refuges. We started this process through resources. Under the original CCPs and AGENCY: Fish and Wildlife Service, a notice of intent in the Federal Register the revised CCP, 91 percent of the Interior. (72 FR 57343; October 9, 2007). We Refuge is Minimal management, 7

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percent is designated Wilderness, and 2 DEPARTMENT OF THE INTERIOR reasonable accommodations, should percent is Wild River management. The contact the BLM as provided below. Bureau of Land Management revised plan would continue to protect Renee Johnson, and maintain existing wildlife values, Assistant Field Manager, Renewable natural diversity, and ecological [LLMTB07900 09 L10100000.PH0000 Resources. LXAMANMS0000] diversity of the Refuge. Human [FR Doc. E9–19441 Filed 8–12–09; 8:45 am] disturbances to fish and wildlife BILLING CODE 4310–$$–P habitats and populations would be Notice of Public Meeting, Western minimal. Private and commercial uses Montana Resource Advisory Council of the Refuges would not change, and Meeting DEPARTMENT OF THE INTERIOR public uses employing existing access methods would continue to be allowed. AGENCY: Bureau of Land Management, Bureau of Land Management Opportunities to pursue traditional Interior. subsistence activities, and recreational ACTION: Notice of Public Meeting. [LLID100000–L10200000–PH0000] hunting, fishing, and other wildlife- Notice of Public Meeting, Idaho Falls dependent activities, would be SUMMARY: In accordance with the District Resource Advisory Council maintained. Opportunities to pursue Federal Land Policy and Management Meeting research would be maintained. Act (FLPMA) and the Federal Advisory We selected Alternative B, the Committee Act of 1972 (FACA), the U.S. AGENCY: Bureau of Land Management, preferred alternative, because it Department of the Interior, Bureau of Interior. provides a realistic balance between Land Management (BLM), the Western ACTION: Notice of Public Meetings. public use of the Refuges and the Montana Resource Advisory Council conservation needs of the Refuges. will meet as indicated below. SUMMARY: In accordance with the Alternative B best accomplishes the DATES: The Western Montana RAC will Federal Land Policy and Management Refuges’ purposes, best helps achieve meet Sept. 3, 2009 at 9 a.m. The public Act (FLPMA) and the Federal Advisory the missions of the National Wildlife comment period for the meeting will Committee Act of 1972 (FACA), the U.S. Refuge System and the Service, and best begin at 11:30 a.m. and the meeting is Department of the Interior, Bureau of meets the vision and goals identified in expected to adjourn at approximately 3 Land Management (BLM) Idaho Falls the plan. It provides long-term p.m. District Resource Advisory Council protection of fish and wildlife (RAC) Sub-Committee, will meet as populations and their habitats while ADDRESSES: The meeting will be held at indicated below. allowing for appropriate levels of fish the Dillon Field Office, 1005 Selway DATES: The RAC Sub-Committee will be and wildlife-dependent recreation, Drive, Dillon, Montana. having a meeting on September 21, 2009 interpretation and environmental FOR FURTHER INFORMATION CONTACT: from 1 p.m. to 4:30 p.m. at the Pocatello education, subsistence, and other public David Abrams, Western Montana Field Office, 4350 Cliffs Drive, uses. Objectives identified in the plan Resource Advisory Council Coordinator, Pocatello, Idaho 83204. All meetings are address the effects of climate change on Butte Field Office, 106 North Parkmont, open to the public. the Refuges now and in the future. Butte, Montana 59701, telephone 406– SUPPLEMENTARY INFORMATION: The 15- We are furnishing this notice to 533–7617. member Council advises the Secretary advise other agencies and the public of SUPPLEMENTARY INFORMATION: The 15- of the Interior, through the Bureau of the availability of the final CCP and member Council advises the Secretary Land Management, on a variety of FONSI. Based on the review and of the Interior, through the Bureau of planning and management issues evaluation of the information contained Land Management, on a variety of associated with public land in the draft CCP and EA, we have planning and management issues management in the BLM Idaho Falls determined that implementation of the associated with public land District (IFD), which covers eastern final CCP does not constitute a major management in western Montana. At the Idaho. Federal action that would significantly September meeting, topics we plan to All meetings are open to the public. affect the quality of the human discuss include: Abandoned Mines The public may present written environment within the meaning of Reclamation, trapping on public lands, comments to the Council. Each formal Section 102(2)(c) of the National Economic Stimulus Package Project Council meeting will also have time Environmental Policy Act (NEPA). Updates, public access issues, travel allocated for hearing public comments. Therefore, an Environmental Impact management implementation, and a Depending on the number of persons Statement will not be prepared. Future review of Forest Service fee proposals. wishing to comment and time available, site-specific proposals discussed in the the time for individual oral comments final CCP requiring additional NEPA All meetings are open to the public. may be limited. Individuals who plan to compliance will be addressed in The public may present written attend and need special assistance, such separate planning efforts with full comments to the Council. Each formal as sign language interpretation, tour public involvement. Council meeting will also have time transportation or other reasonable allocated for hearing public comments. accommodations, should contact the Dated: August 7, 2009. Depending on the number of persons BLM as provided below. Gary Edwards, wishing to comment and time available, FOR FURTHER INFORMATION CONTACT: Acting Regional Director, U.S. Fish and the time for individual oral comments Joanna Wilson, RAC Coordinator, Idaho Wildlife Service, Anchorage, Alaska. may be limited. Individuals who plan to [FR Doc. E9–19444 Filed 8–12–09; 8:45 am] Falls District, 1405 Hollipark Dr., Idaho attend and need special assistance, such Falls, ID 83401. Telephone: (208) 524– BILLING CODE 4310–55–P as sign language interpretation, or other 7550. E-mail: [email protected].

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Dated: August 4, 2009. include in the administrative record for II. Discussion of the Proposed Joanna Wilson, the supplemental rule, comments that Supplementary Rules RAC Coordinator, Public Affairs Specialist. the BLM receives after the close of the These proposed supplementary rules [FR Doc. E9–19439 Filed 8–12–09; 8:45 am] comment period (see DATES), unless would apply to undeveloped public BILLING CODE 4310–GG–P they are postmarked or electronically lands administered by the BLM within dated before the deadline, or comments the States of Montana, North Dakota, delivered to an address other than the and South Dakota. They would DEPARTMENT OF THE INTERIOR address listed above (See ADDRESSES). supersede all existing camping stay The BLM will make your comments, limits and occupancy on undeveloped Bureau of Land Management including your name and address, public land administered by the BLM in [LLMT924000 L12200000.PM0000] available for public review at the Montana, North Dakota, and South Montana State Office address listed in Dakota published previously. These Proposed Supplementary Rules for ‘‘ADDRESSES’’ above during regular proposed supplementary rules would Camping on Undeveloped Public business hours (8 a.m. to 4:30 p.m., allow camping at a particular location Lands in Montana, North Dakota, and Monday through Friday, except Federal for 16 days, either cumulatively or South Dakota holidays). Before including your consecutively, during any 30-day address, phone number, e-mail address, interval. Any camp relocation within AGENCY: Bureau of Land Management, or other personal identifying Interior. that 30-day period would not be information in your comment, you allowed within a one-half mile radius ACTION: Proposed supplementary rules. should be aware that your entire from the original site. These SUMMARY: The Bureau of Land comment—including your personal supplemental rules are consistent with Management (BLM) is proposing identifying information—may be made existing recreation sections and supplementary rules regarding time publicly available at any time. While management for camping in resource limits for camping and the storage of you can ask us in your comment to management plans in each district property on undeveloped public lands withhold your personal identifying office. These rules are not contradictory managed by the BLM in Montana, North information from public review, we to campsite selections stated in the Dakota, and South Dakota. These cannot guarantee that we will be able to Montana, North Dakota and South proposed supplementary rules do so. Dakota June 2003 Record of Decision and Environmental Impact Statement consolidate existing rules for camping Clarity of the Proposed Supplementary for Off-Highway Vehicles. This notice on undeveloped BLM-administered Rules public lands throughout Montana, North does not affect more restrictive camping Dakota, and South Dakota. These Executive Order 12866 requires each limits that may already be in place for proposed supplementary rules will agency to write regulations that are certain areas. Future exceptions to the supersede prior published rules. simple and easy to understand. We 16-day camping limit for any field office will be considered and analyzed DATES: You should submit your invite your comments on how to make through their respective land use plan comments by September 14, 2009. In these proposed supplementary rules revisions. developing final rules, BLM will not easier to understand, including answers These proposed supplementary rules accept written comments postmarked or to questions such as the following: would not apply to locations that received in person or by electronic mail (1) Are the requirements in the contain structures or capital after this deadline. proposed supplementary rules clearly improvements (such as boat launch stated? ADDRESSES: You may mail or deliver sites, picnic areas, and interpretive comments on the proposed (2) Do the proposed supplementary centers) and that are used primarily by supplementary rules to Christina Miller, rules contain technical language or the public for recreational purposes. Outdoor Recreation Planner, Bureau of jargon that interferes with its clarity? Examples of such locations include Land Management, Montana State (3) Does the format of the proposed developed campgrounds, designated Office, 5001 Southgate Drive, Billings, supplementary rules (grouping and recreation areas, and special recreation Montana 59101–4669. You may also order of sections, use of headings, management areas. The BLM regulates comment by e-mail at the following the use and occupancy at such _ _ paragraphing, etc.) aid or reduce its address: MT Billings [email protected]. clarity? developed locations in accordance with FOR FURTHER INFORMATION CONTACT: (4) Would the proposed 43 CFR 8365.1–2. In addition, site- Christina Miller, Outdoor Recreation supplementary rules be easier to specific rules for these locations remain Planner, BLM Montana State Office, understand if they were divided into in effect and are posted at each site. 5001 Southgate Drive, Billings, Montana more (but shorter) sections? These proposed supplementary rules 59101–4669, (406) 896–5038. would supersede rules previously SUPPLEMENTARY INFORMATION: (5) Is the description of the proposed published at 72 FR 19958 (April 20, supplementary rules in the 2007). The rules in the 2007 notice I. Public Comment Procedures ‘‘SUPPLEMENTARY INFORMATION’’ section required camps to be moved a minimum Written comments on the proposed of this preamble helpful in of 5 miles every 14 days. These supplementary rules should be specific, understanding these proposed proposed supplementary rules would be confined to issues pertinent to the supplementary rules? How could this allow camping at a particular location proposed supplementary rules, and description be more helpful in making for 16 days, either cumulatively or explain the reason for any the proposed supplementary rules easier consecutively, during any 30-day recommended change. Where possible, to understand? interval. The placing or leaving of comments should reference the specific Please send any comments you have unattended motor vehicles, trailers, or section or paragraph of the proposal on the clarity of the proposed other personal property for the purpose which the comment is addressing. The supplementary rules to the address of reserving a camping site is considered BLM is not obligated to consider or specified in the ‘‘ADDRESSES’’ section. camping for the purpose of these

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supplementary rules. Thus, overnight Regulatory Flexibility Act implications under this Executive occupation is not necessarily the only Congress enacted the Regulatory Order. criterion for determining whether or not Flexibility Act (RFA) of 1980, as Executive Order 13132, Federalism the 16-day limit has been met. amended, 5 U.S.C. 601–612, to ensure Once campers have met the 16-day that Government regulations do not These proposed supplementary rules limit, they would be prohibited from unnecessarily or disproportionately do not have a substantial direct effect on camping at the original location for at burden small entities. The RFA requires the States, on the relationship between least 30 days, and any camp relocation a regulatory flexibility analysis if a rule the national government and the States, within that 30-day period would not be would have a significant economic or on the distribution of power and allowed within a one-half mile radius impact, either detrimental or beneficial, responsibilities among the various from the original site. These changes are on a substantial number of small levels of government. These being proposed to better allow the entities. These supplementary rules do supplementary rules will have little or public to remain in the general area in not pertain specifically to commercial or no effect on State or local government. which they wish to recreate while still governmental entities of any size, but to Therefore, in accordance with E.O. achieving the BLM’s goal of protecting public recreational use of specific 13132, the BLM has determined that public lands and natural resources by public lands. Therefore, the BLM has these proposed supplementary rules do prohibiting long-term camps in a single determined under the RFA that these not have sufficient Federalism location. proposed supplementary rules would implications to warrant preparation of a not have a significant economic impact Federalism Assessment. III. Procedural Matters on a substantial number of small Executive Order 12988, Civil Justice Executive Order 12866, Regulatory entities. Reform Planning and Review Small Business Regulatory Enforcement Fairness Act Under E.O. 12988, the BLM has These proposed supplementary rules determined that these proposed are not a significant regulatory action These proposed supplementary rules supplementary rules would not unduly and are not subject to review by Office do not constitute a ‘‘major rule’’ as burden the judicial system and that they of Management and Budget under E.O. defined at 5 U.S.C. 804(2). Again, these meet the requirements of sections 3(a) 12866. These proposed supplementary proposed supplementary rules merely and 3(b)(2) of the Executive Order. rules will not have an effect of $100 establish limits for recreational use of million or more on the economy. These certain public lands. These proposed Paperwork Reduction Act supplementary rules have no effect on proposed supplementary rules will not These proposed supplementary rules business—commercial or industrial— adversely affect in a material way the do not directly provide for any use of the public lands. economy, productivity, competition, information collection that the Office of jobs, the environment, public health or Unfunded Mandates Reform Act Management and Budget must approve safety, or State, local, or tribal These proposed supplementary rules under the Paperwork Reduction Act, 44 governments or communities. These U.S.C. 3501 et seq. Any information proposed supplementary rules will not do not impose an unfunded mandate on State, local or tribal governments, or the collection that may result from Federal create a serious inconsistency or criminal investigations or prosecutions otherwise interfere with an action taken private sector of more than $100 million per year; nor do these proposed conducted in enforcing these proposed or planned by another agency. These supplementary rules is exempt from the proposed supplementary rules do not supplementary rules have a significant or unique effect on State, local, or tribal provisions of the Paperwork Reduction alter the budgetary effects of Act of 1995, 44 U.S.C. 3518(c)(1). entitlements, grants, user fees, or loan governments, or the private sector. Executive Order 13175, Consultation programs or the right or obligations of These proposed supplementary rules do and Coordination with Indian Tribal their recipients; nor do these proposed not require anything of State, local, or Governments In accordance with supplementary rules raise novel legal or tribal governments. Therefore, the BLM is not required to prepare a statement Executive Order 13175, the BLM has policy issues. They establish limits for containing the information required by found that these supplementary rules do public recreational use of undeveloped the Unfunded Mandates Reform Act (2 not include policies that have tribal public lands in Montana, North Dakota, U.S.C. 1531 et seq.). implications. These supplementary and South Dakota to protect public rules provide for enforcement of lands and natural resources. Executive Order 12630, Governmental decisions adopted in the Record of Actions and Interference With National Environmental Policy Act decision and thoroughly analyzed in the Constitutionally Protected Property EIS prepared for the resource The BLM prepared an environmental Rights (Takings) management plans (RMP) of each impact statement (EIS) as part of the These proposed supplementary rules district office. During preparation of the development of the resource do not represent a government action EIS, government-to government management plan (RMP) for each capable of interfering with consultation was conducted with the district office. During that National constitutionally protected property tribal governments with interests in the Environmental Policy Act (NEPA) rights. These proposed supplementary affected area. None of these tribal process, many proposed decisions were rules do not address property rights in governments expressed concerns fully analyzed, including the substance any form and do not cause the regarding the decisions these of these supplementary rules. The impairment of anybody’s property supplementary rules are designed to pertinent analysis can be found in rights. Therefore, the Department of the enforce. Therefore, in accordance with Chapter 4, Alternatives, of the RMP for Interior has determined that these Executive Order 13175, the BLM has each district office. These proposed supplementary rules would found that these supplementary rules do supplementary rules provide for not cause a taking of private property or not include polices that have tribal enforcement of plan decisions. require further discussion of takings implications.

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Supplementary Rules for Undeveloped members of any organized rescue or fire- DEPARTMENT OF THE INTERIOR BLM-Administered Lands in the States fighting force in performance of an of Montana, North Dakota, and South official duty; and any person whose Bureau of Land Management Dakota activities are authorized in writing by [WY–D04–1430–; WYW–167587] Definitions the Bureau of Land Management. Notice of Realty Action: Recreation Camping: The erecting of a tent or Penalties and Public Purposes Act Classification shelter of natural or synthetic material, The rules we are proposing here of Public Lands in Sweetwater County, preparing a sleeping bag or other Wyoming bedding material for use, parking of a provide for penalties that may depend motor vehicle, motor home, or trailer, or on the location where a violation AGENCY: Bureau of Land Management, mooring of a vessel for the apparent occurs. The primary statutory authority Interior. purpose of overnight occupancy. The for proposing these supplementary rules ACTION: Notice of Realty Action. placing or leaving of unattended motor is the Federal Land Policy and vehicles, trailers, or other personal Management Act (FLPMA). Section 310 SUMMARY: The Bureau of Land property for the purpose of reserving a of FLPMA (43 U.S.C. 1740) authorizes Management (BLM) has examined and camping site is considered camping for us to issue rules and regulations to carry found suitable for classification for lease the purpose of these supplementary out the purposes of FLPMA and other and/or conveyance to the Sweetwater rules. laws applicable to the public lands. County Fire District #1 under the You must follow these rules: Under section 303(a) of the Federal provisions of the Recreation and Public These supplementary rules apply, Land Policy and Management Act, 43 Purposes (R&PP) Act, as amended, 20 acres of public land in Sweetwater except as specifically exempted, to all U.S.C. 1733(a), and 43 CFR 8360.0–7, County, Wyoming. The Sweetwater camping on undeveloped public lands any person who violates any of these County Fire District #1 proposes to use managed by the Montana State Office of supplementary rules on any public the land for a training facility and fire the Bureau of Land Management within lands may be tried before a United the states of Montana, South Dakota, station. States Magistrate and fined no more and North Dakota. These supplementary DATES: Interested parties may submit than $1,000 or imprisoned for no more rules are in effect on a year-round basis written comments until September 28, than 12 months, or both. Also, such and will remain in effect until modified 2009. violations may be subject to the by the BLM. ADDRESSES: Mail written comments to 1. You must not camp longer than 16 enhanced fines provided for by 18 U.S.C. 3571. Under the Taylor Grazing the Field Manager, Bureau of Land consecutive days at any one location. Management, Rock Springs Field Office, 2. No person or group may camp Act, any person who violates any of 280 Highway 191 North, Rock Springs, within a single location on public lands these supplementary rules on public Wyoming 82901. more than 16 days within any period of lands within grazing districts (see 43 30 consecutive days. The 16-day limit U.S.C. 315a), or on public lands subject FOR FURTHER INFORMATION CONTACT: may be reached either by compiling to a grazing lease (see 43 U.S.C. 315m), Carol Montgomery, Realty Specialist, individual visits during a 30-day may be tried before a United States Bureau of Land Management, Rock interval, or by occupying a location Magistrate and fined no more than Springs Field Office, at (307) 352–0344. continuously for 16 days during a 30- $500.00. Such violations may also be SUPPLEMENTARY INFORMATION: The day interval. A 16-day interval begins subject to the enhanced fines provided following described public land in when a person initially camps or leaves for by 18 U.S.C. 3571. Sweetwater County, Wyoming, has been vehicles or property at a site on public examined and found suitable for lands. Any person who violates any of these classification for lease and/or 3. After 16 days of camping in a single supplementary rules on public lands conveyance under the provisions of the location, you must not camp at that managed in accordance with the Sikes R&PP Act, as amended, (43 U.S.C. 869 location until at least 30 days have Act may be tried before a United States et seq.): Magistrate and fined no more than $500 passed, and any camp relocation within Sixth Principal Meridian that 30-day period shall not be within or imprisoned for no more than 6 T. 19 N., R. 105 W., a one-half mile radius from the original months, or both. Such violations may Sec. 4, S1⁄2NW1⁄4SE1⁄4. site. Under special circumstances and also be subject to the enhanced fines provided for by 18 U.S.C. 3571. The area described contains 20 acres, more upon request, the BLM may issue a or less, in Sweetwater County. written permit for extension of the 16- In accordance with 43 CFR 8365.1–7, In accordance with the R&PP Act, the day limit. State or local officials may also impose Sweetwater County Fire District #1 has 4. You must not leave any personal penalties for violations of Montana, property or refuse after vacating the filed an R&PP application and plan of North Dakota, or South Dakota law. campsite. This includes any property development in which it proposes to left for the purposes of use by another Gene R. Terland, develop the above described land to camper or occupant. Montana/Dakotas State Director, Bureau of construct a proposed training facility 5. The time such property is left Land Management. and fire station for the purpose of unattended at a site will be counted [FR Doc. E9–19412 Filed 8–12–09; 8:45 am] meeting the fire protection needs for the towards the 16-day camping limit. community of Rock Springs. The (Unattended property is still subject to BILLING CODE 4310–DN–P proposed project will include a parking the time limits found in 43 CFR 8365.1– lot, training tower, and fire station. 2(b)). Additional detailed information 6. The following persons are exempt pertaining to this application, plan of from these supplementary rules: Any development, and site plan is in case Federal, State, or local officer or file WYW167587, located in the Bureau employee in the scope of their duties; of Land Management (BLM) Rock

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Springs Field Office at the above directly related to the suitability of the Miles City, Montana 59301. Comments address. The land is not needed for any land for a fire facility. received in electronic form, such as Federal purpose. Lease and/or Confidentiality of Comments: Before e-mail or facsimile, will not be conveyance is consistent with the BLM including your address, phone number, considered. Green River Resource Management Plan e-mail address, or other personal FOR FURTHER INFORMATION CONTACT: dated August 8, 1997, and would be in identifying information in your Information regarding the proposed land the public interest. The Sweetwater comment, you should be aware that use lease amendment and proposed County Fire District #1 has not applied your entire comment—including your land use may be reviewed at the BLM for more than the 640-acre limitation for personal identifying information—may Miles City Field Office address listed in non-recreation public uses in a year and be made publicly available at any time. ADDRESSES above during regular has submitted an application in While you can ask us in your comment business hours, 7:45 a.m. to 4:30 p.m., compliance with the regulations at 43 to withhold your personal identifying Monday through Friday, except Federal CFR 2741.4(b). The patent or lease, if information from public review, we holidays. For this and additional issued, will be subject to the provisions cannot guarantee that we will be able to information contact Pam Wall, BLM of the R&PP Act and applicable do so. Only written comments Miles City Field Office, Miles City, regulations of the Secretary of the submitted by postal service or overnight Montana 59301, telephone 406–233– Interior, and will contain the following mail to the Field Manager—BLM Rock 2846. terms, conditions, and reservations: Springs Field Office will be considered SUPPLEMENTARY INFORMATION: The 1. Provisions of the R&PP Act, properly filed. Electronic mail, facsimile following described land, associated or telephone comments will not be including, by not limited to, the terms with the proposed amendment, has been considered. required by 43 CFR 2741.9. examined and identified as suitable for Any adverse comments will be 2. A right-of-way thereon for ditches leasing under section 302 of the Federal or canals constructed by the authority of reviewed by the BLM State Director, Land Policy and Management Act (43 the United States, Act of August 30, who may sustain, vacate or modify this U.S.C. 1732) at not less than fair market 1890 (43 U.S.C. 945). realty action. In the absence of any value: 3. All minerals, together with the right adverse comments, the classification of to prospect for, mine, and remove the the land described in this notice will Principal Meridian, Montana minerals under applicable laws and become effective October 13, 2009. T. 8 S., R. 39 E., regulations established by the Secretary Sec. 35, NE1⁄4NE1⁄4, SE1⁄4NE1⁄4, Authority: 43 CFR 2740. 1 1 1 1 1 1 1 of the Interior shall be reserved to the E ⁄2NW ⁄4NE ⁄4, E ⁄2W ⁄2NW ⁄4NE ⁄4, Lance Porter, NW1⁄4NW1⁄4NW1⁄4NE1⁄4, United States. 1 1 1 1 1 1 1 Field Manager. NE ⁄4SW ⁄4NE ⁄4, NE ⁄4SE ⁄4SW ⁄4NE ⁄4, 4. Lease and/or patent of the lands E1⁄2NE1⁄4SE1⁄4, E1⁄2NW1⁄4NE1⁄4SE1⁄4, and shall be subject to all valid existing [FR Doc. E9–19417 Filed 8–12–09; 8:45 am] NE1⁄4SE1⁄4SE1⁄4. rights of record documented on the BILLING CODE 4310–22–P T. 9 S., R. 40 E., official public land records at the time Sec. 6, lot 5. of lease/patent issuance. The area described contains 197.12 acres, 5. Any other reservations that the DEPARTMENT OF THE INTERIOR more or less, in Big Horn County. authorized officer deems appropriate. Bureau of Land Management The BLM is hereby notifying any 6. An appropriate indemnification interested parties of the proposal to clause protecting the United States from [LLMTC02200–L14300000–EQ0000; MTM– amend land use lease MTM–74913 and claims arising out of the lease/patentee’s 74913] is accepting comments on the proposed use, occupancy, or operations on the land use lease amendment. property. Notice of Realty Action; Proposed Spring Creek Coal Company’s existing Upon publication of this notice in the Amendment to Noncompetitive Land land use lease MTM–74913, which was Federal Register, the lands will be Use Lease; Montana issued under the authority of section segregated from all other forms of AGENCY: Bureau of Land Management, 302 of the Federal Land Policy and appropriation under the public land Interior. Management Act (43 U.S.C. 1732), may laws, including the general mining laws, be amended to authorize the surface use ACTION: Notice of Realty Action and except for lease and/or conveyance of 197.12 acres of public land for coal request for public comment. under the R&PP Act. mine layback, a flood control structure, Classification Comments: Interested SUMMARY: On March 6, 2009, the Bureau topsoil and overburden stockpiles, and parties may submit comments involving of Land Management (BLM) received a transportation and utility line corridors the suitability of the land for a fire proposal from Spring Creek Coal in order to facilitate the full recovery of facility. Comments on the classification Company to amend their existing land coal reserves from their adjoining are restricted to whether the land is use lease, MTM–74913. The BLM is Federal Coal Lease MTM–94378, physically suited for the proposal, hereby notifying any interested parties Montana State Coal Lease C–1088–05, whether the use will maximize the of the proposal to amend land use lease and for Spring Creek’s pending Coal future use or uses of the land, whether MTM–74913 and is accepting comments Lease Modification MTM–069782. The the use is consistent with local planning on the proposed land use lease layback is a critical component in coal and zoning, or if the use is consistent amendment. strip mine recovery which consists of a with State and Federal programs. series of benches cut into the mine Application Comments: Interested DATES: Interested parties may submit highwall to stabilize the wall as mining parties may submit comments regarding comments on or before September 28, progresses into an area. The lands the specific use proposed in the 2009. adjacent to a coal lease need to be application and plan of development, ADDRESSES: Written comments should disturbed during normal mining whether the BLM followed proper be sent to the Field Manager, Miles City operations to completely and safely administrative procedures in reaching Field Office, Bureau of Land remove the coal within the lease the decision or any other factor not Management, 111 Garryowen Road, boundary. The flood control structure

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consists of a reservoir sized at application must include a reference to INTERNATIONAL TRADE approximately 159 acre feet, to contain this notice and a complete description COMMISSION a 100-year, 24-hour flood event of the proposed project. An [Inv. No. 337–TA–660] associated with the Pearson Creek environmental analysis will be drainage. This reservoir is needed to completed addressing this proposed Notice of Commission Determination prevent saturation and potential failure land use lease amendment, along with Not To Review an Initial Determination of the highwall and/or flooding into the the proposed coal lease modification, Terminating the Investigation Based pit which would not only slow or stop after publication of this notice and on a Settlement Agreement and coal production but expose mine comment period. A National Withdrawal of the Complaint; Request personnel to a health and safety hazard. Environmental Policy Act analysis will for Briefing on Bonding and the Public The topsoil stripped from the coal leases be completed prior to any decision by Interest; In the Matter of Certain Active would be stockpiled on the subject the BLM to approve the proposed Comfort Footwear lands to be used in reclamation after application for a land use lease mining. The overburden removed from amendment and coal lease modification. AGENCY: U.S. International Trade the pit would also be stockpiled on the Commission. Public Comment Procedures: Please subject lands to be used in post-mining ACTION: Notice. topography construction. An electric submit your comments on issues related line and distribution station would be to the proposed action, in writing, SUMMARY: Notice is hereby given that located within the use area to keep it according to the ADDRESSES section the U.S. International Trade safely away from the pit and grading above. Comments on the proposed Commission has determined not to activity and buffered by the access/haul action should be specific, should be review an initial determination (‘‘ID’’) roads which will be used in the mining confined to issues pertinent to the (Order No. 12) of the presiding process and to service the stockpiles. proposed action, and should explain the administrative law judge (‘‘ALJ’’) The proposed land use lease reason for any recommended change. granting motions for termination of the amendment consists of 160 acres in the Where possible, your comments should investigation; based on a settlement E1⁄2 of section 35, T. 8 S., R. 39 E., and reference the specific section or agreement and withdrawal of the 37.12 acres in lot 5 of section 6, T. 9 S., paragraph of the proposal that you are complaint. The Commission has also R. 40 E. The total disturbed area in addressing. The BLM may not requested briefing on remedy, bonding, section 35 is estimated to be 108.90 necessarily consider or include in the and the public interest in connection acres with the remaining 51.10 acres Administrative Record comments that with issuing a default limited exclusion receiving a 10 percent usage. The total the BLM receives after the close of the order. disturbed area in section 6 is estimated comment period (see DATES) or FOR FURTHER INFORMATION CONTACT: to be 21.20 acres with the remaining comments delivered to an address other Mark B. Rees, Esq., Office of the General 15.92 acres receiving a 10 percent usage. than those listed above (see ADDRESSES). Counsel, U.S. International Trade The subject land could be offered Commission, 500 E Street, SW., noncompetitively to Spring Creek Coal Comments, including names and Washington, DC 20436, telephone 202– Company as an amendment to their street addresses of respondents, will be 205–3116. Copies of the ID and all other existing Land Use Lease MTM–74913 available for public review at the BLM nonconfidential documents filed in for stockpiling of topsoil and Miles City Field Office address listed in connection with this investigation are or overburden, construction of a haul road, ADDRESSES above during regular will be available for inspection during and for drainage control, for their business hours, 7:45 a.m. to 4:30 p.m., current coal mining operation. The Monday through Friday, except Federal official business hours (8:45 a.m. to 5:15 proposed land use lease amendment, holidays. Before including your address, p.m.) in the Office of the Secretary, U.S. which would be authorized under the phone number, e-mail address, or other International Trade Commission, 500 E authority of section 302 of the Federal personal identifying information in your Street, SW., Washington, DC 20436, Land Policy and Management Act (43 comments, be advised that your entire telephone 202–205–2000. Hearing- U.S.C. 1732) and pursuant to regulations comment—including your personal impaired persons are advised that found at 43 CFR 2920, would provide identifying information—may be made information on this matter can be authorized surface use only of the publicly available at any time. While obtained by contacting the public land and would be subject to the you can ask us in your comment to Commission’s TDD terminal on 202– terms and conditions of the existing withhold your personal identifying 205–1810. General information lease. No mineral use would be information from public review, we concerning the Commission may also be authorized under this land use lease cannot guarantee that we will be able to obtained by accessing its Internet server amendment, however Spring Creek Coal do so. (http://www.usitc.gov). The public record for this investigation may be Company has applied for a modification Any adverse comments will be of coal lease MTM–069782 which is viewed on the Commission’s electronic evaluated by the BLM Montana State docket (EDIS) at http://edis.usitc.gov. being processed concurrently (under Director, who may sustain, vacate or SUPPLEMENTARY INFORMATION: The regulations found at 43 CFR 3432) with modify this realty action. In the absence the land use lease amendment. Commission instituted this investigation of timely filed objections, this realty The application will be accepted for on November 25, 2008, based on the this land use lease amendment at the action will become the final complaint of Masai Marketing & Trading address listed above at the end of the 45 determination of the Department of the AG of Romanshorn, Switzerland and day comment period for this notice. The Interior. Masai USA Corp. of Haley, Idaho application will be subject to Authority: 43 CFR 2920.4(c). (‘‘Complainants’’). 73 FR 73884 (Nov. reimbursement of costs in accordance 25, 2008). The complaint, as with the provisions of 43 CFR 2920.6. M. Elaine Raper, supplemented, alleges violations of The land would be leased at fair market Field Office Manager. section 337 of the Tariff Act of 1930 (19 value as determined by appraisal and as [FR Doc. E9–19415 Filed 8–12–09; 8:45 am] U.S.C. 1337) in the importation into the provided for at 43 CFR 2920.8. The BILLING CODE 4310–DN–P United States, the sale for importation,

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and the sale within the United States USITC Pub. 2843 (Dec. 1994) (Comm’n Secretary of the Commission and must after importation of certain active Op.). include a full statement of the reasons comfort footwear that infringes certain If the Commission contemplates some why the Commission should grant such claims of U.S. Patent No. 6,341,432. form of remedy, it must consider the treatment. See 19 CFR 210.6. Documents Complainants named as respondents effects of that remedy upon the public for which confidential treatment by the RYN Korea Co., Ltd. of Seoul, Korea interest. The factors the Commission Commission is sought will be treated (RYN); Main d/b/a will consider include the effect that an accordingly. All nonconfidential written WalkingShoesPlus.com of Los Angeles, exclusion order and/or cease and desist submissions will be available for public California (‘‘WalkingShoesPlus’’); and orders would have on (1) The public inspection at the Office of the Secretary. Feet First Inc. of Boca Raton, Florida health and welfare, (2) competitive The authority for the Commission’s (‘‘Feet First’’). The Tannery of conditions in the U.S. economy, (3) U.S. determination is contained in section Cambridge, Massachusetts and A Better production of articles that are like or 337 of the Tariff Act of 1930, as Way to Health of West Melbourne, directly competitive with those that are amended (19 U.S.C. 1337), and in Florida were subsequently added as subject to investigation, and (4) U.S. section 210.16 and 210.42–46 of the respondents in the investigation by an consumers. The Commission is Commission’s Rules of Practice and unreviewed ID. 74 FR 11378 (Mar. 17, therefore interested in receiving written Procedure (19 CFR 210.16; 210.42–46). submissions that address the 2009). By order of the Commission. On May 21, 2009, the Commission aforementioned public interest factors in the context of this investigation. Issued: August 5, 2009. determined not to review an ID (Order Marilyn R. Abbott, No. 6) finding WalkingShoesPlus and If the Commission orders some form Secretary to the Commission. Feet First in default for failure to of remedy, the U.S. Trade respond to the complaint and notice of Representative, as delegated by the [FR Doc. E9–19413 Filed 8–12–09; 8:45 am] investigation. President, has 60 days to approve or BILLING CODE 7020–02–P disapprove the Commission’s action. On July 13, 2009, the ALJ issued the See Presidential Memorandum of July subject ID (Order 12), terminating the 21, 2005. 70 FR 43251 (July 26, 2005). INTERNATIONAL TRADE investigation based on a settlement During this period, the subject articles COMMISSION agreement as to RYN and withdrawal of would be entitled to enter the United the complaint as to the remaining [Inv. No. 337–TA–649] States under bond, in an amount respondents. No party petitioned for determined by the Commission and review of the subject ID. Notice of Commission Determination prescribed by the Secretary of the Not To Review an Initial Determination The Commission has determined not Treasury. The Commission is therefore to review the ID. Granting Complainant’s Motion To interested in receiving submissions Terminate the Investigation; Section 337(g)(1), 19 U.S.C. 1337(g)(1) concerning the amount of the bond that and Commission Rule 210.16(c), 19 Termination of Investigation; In the should be imposed if a remedy is Matter of Certain Semiconductor Chips U.S.C. 210.16(c) authorize the ordered. Commission to order relief against With Minimized Chip Package Size and Written Submissions: Parties to the Products Containing Same (IV) respondents found in default unless, investigation, interested government after consideration of the public agencies, and any other interested AGENCY: U.S. International Trade interest, it finds that such relief should parties are encouraged to file written Commission. not issue. Complainants did not file a submissions on the issues of the public ACTION: Notice. declaration stating that they were interest, and bonding. Complainants seeking a general exclusion order as and the Commission investigative SUMMARY: Notice is hereby given that provided in Commission Rule 210.16(c). attorney are also requested to submit the U.S. International Trade In conjunction with the final proposed remedial orders for the Commission has determined not to disposition of this investigation, Commission’s consideration. review an initial determination (‘‘ID’’) therefore, the Commission may: (1) Complainants are also requested to state (Order No. 25) of the presiding Issue an order that could result in the the HTSUS numbers under which the administrative law judge (‘‘ALJ’’) exclusion of articles manufactured or accused products are imported and the granting complainant Tessera, Inc.’s imported by the defaulting respondents; date on which the patent at issue motion to terminate the investigation. and/or (2) issue a cease and desist order expires. Main written submissions must FOR FURTHER INFORMATION CONTACT: that could result in the defaulting be filed no later than close of business Michael Liberman, Esq., Office of the respondents being required to cease and on August 24, 2009. Reply submissions General Counsel, U.S. International desist from engaging in unfair acts in must be filed no later than the close of Trade Commission, 500 E Street, SW., the importation and sale of such business on August 31, 2009. No further Washington, DC 20436, telephone 202– articles. Accordingly, the Commission is submissions on any of these issues will 205–3152. Copies of the ID and all other interested in receiving written be permitted unless otherwise ordered nonconfidential documents filed in submissions that address the remedy, if by the Commission. connection with this investigation are or any, that should be ordered. If a party Persons filing written submissions will be available for inspection during seeks exclusion of an article from entry must file the original document and 12 official business hours (8:45 a.m. to 5:15 into the United States for purposes other true copies thereof on or before the p.m.) in the Office of the Secretary, U.S. than for consumption, they should so deadlines stated above with the Office International Trade Commission, 500 E indicate and provide information of the Secretary. Any person desiring to Street, SW., Washington, DC 20436, establishing that activities involving submit a document to the Commission telephone 202–205–2000. Hearing- other types of entry either are adversely in confidence must request confidential impaired persons are advised that affecting it or likely to do so. For treatment unless the information has information on this matter can be background, see In the Matter of Certain already been granted such treatment obtained by contacting the Devices for Connecting Computers via during the proceedings. All such Commission’s TDD terminal on 202– Telephone Lines, Inv. No. 337–TA–360, requests should be directed to the 205–1810. General information

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concerning the Commission may also be the Tariff Act of 1930 (19 U.S.C. Issued: August 7, 2009. obtained by accessing its Internet server 1675(c)(5)) to determine whether Marilyn R. Abbott, (http://www.usitc.gov). The public revocation of the antidumping duty Secretary to the Commission. record for this investigation may be finding on pressure sensitive plastic [FR Doc. E9–19410 Filed 8–12–09; 8:45 am] viewed on the Commission’s electronic tape from Italy would be likely to lead BILLING CODE 7020–06–P docket (EDIS) at http://edis.usitc.gov. to continuation or recurrence of material SUPPLEMENTARY INFORMATION: On May injury within a reasonably foreseeable 28, 2008, the Commission instituted an time. A schedule for the review will be INTERNATIONAL TRADE investigation under section 337 of the established and announced at a later COMMISSION Tariff Act of 1930, 19 U.S.C. 1337, based date. For further information concerning [Investigation No. 332–345] on a complaint filed by Tessera, Inc. of the conduct of this review and rules of San Jose, California (‘‘Tessera’’), alleging general application, consult the Shifts in U.S. Merchandise Trade 2008 a violation of section 337 in the Commission’s Rules of Practice and importation, sale for importation, and Procedure, part 201, subparts A through AGENCY: United States International sale within the United States after E (19 CFR part 201), and part 207, Trade Commission. importation of certain semiconductor subparts A, D, E, and F (19 CFR part ACTION: Availability on Commission’s chips with minimized chip package size 207). Web site of 2009 report on shifts in and products containing same that merchandise trade during 2008; infringe certain claims of U.S. Patents DATES: Effective Date: August 4, 2009. opportunity to submit written Nos. 5,852,326; 6,433,419; and comments relating to the 2009 report FOR FURTHER INFORMATION CONTACT: 5,679,977. 73 FR 30628 (May 28, 2008). and possible content of the 2010 report. The complaint named numerous entities Edward Petronzio (202–205–3176), as respondents. Subsequently, the Office of Investigations, U.S. SUMMARY: The 2009 report can now be complaint and Notice of Investigation International Trade Commission, 500 E accessed and downloaded from the were amended to add U.S. Patent No. Street, SW., Washington, DC 20436. Commission’s Web site at http:// 5,663,106, and the target date for Hearing-impaired persons can obtain www.usitc.gov/research_and_analysis/ completion of this investigation was information on this matter by contacting trade_shifts.htm. The format used by the extended. the Commission’s TDD terminal on 202– Commission since 2004 includes links On March 12, 2009, complainant 205–1810. Persons with mobility to Commission research and other Tessera moved to terminate the impairments who will need special resources including data, as well as investigation based on withdrawal of assistance in gaining access to the links to other organizations with related the complaint. On July 17, 2009, the ALJ Commission should contact the Office information. User feedback on the issued Order No. 25 granting the of the Secretary at 202–205–2000. revised format is encouraged by motion. No petitions for review were General information concerning the providing access to the ITC online filed. The Commission has determined Commission may also be obtained by Reader Satisfaction Survey (http:// not to review the ID. accessing its Internet server (http:// reportweb.usitc.gov/reader_survey/ The authority for the Commission’s www.usitc.gov). The public record for readersurvey.html). A CD–ROM version determination is contained in section this review may be viewed on the of the 2008 report may be requested by 337 of the Tariff Act of 1930, as Commission’s electronic docket (EDIS) contacting the Office of the Secretary at amended (19 U.S.C. 1337), and in at http://edis.usitc.gov. 202–205–2000 or by fax at 202–205– section 210.42(h) of the Commission’s 2104. Readers of the report may also SUPPLEMENTARY INFORMATION: Rules of Practice and Procedure (19 CFR On August provide comments by downloading the 210.42(h)). 4, 2009, the Commission determined survey form and business reply mailer that it should proceed to a full review By order of the Commission. for this publication from the in the subject five-year review pursuant Commission’s Web site. Issued: August 7, 2009. to section 751(c)(5) of the Act. The ADDRESSES: Marilyn R. Abbott, Commission found that the domestic All Commission offices, including the Commission’s hearing Secretary to the Commission. interested party group response to its rooms, are located in the United States [FR Doc. E9–19411 Filed 8–12–09; 8:45 am] notice of institution (74 FR 20340, May International Trade Commission BILLING CODE 7020–02–P 1, 2009) was adequate but that the Building, 500 E Street, SW., respondent interested group response Washington, DC 20436. All written was inadequate. The Commission also submissions should be addressed to the INTERNATIONAL TRADE found that other circumstances Secretary, United States International COMMISSION warranted conducting a full review.1 A Trade Commission, 500 E Street, SW., record of the Commissioners’ votes, the Investigation No. AA1921–167 (Third Washington, DC 20436. The public Commission’s statement on adequacy, Review); Pressure Sensitive Plastic record for this investigation may be Tape From Italy and any individual Commissioner’s viewed on the Commission’s electronic statements will be available from the docket (EDIS) at http://www.usitc.gov/ AGENCY: International Trade Office of the Secretary and at the secretary/edis.htm. Commission. Commission’s Web site. FOR FURTHER INFORMATION CONTACT: ACTION: Notice of Commission Authority: This review is being conducted Project leader, Jeremy Wise, Office of determination to conduct a full five-year under authority of title VII of the Tariff Act review concerning the antidumping Industries (202–205–3190 or of 1930; this notice is published pursuant to [email protected]) or deputy project finding on pressure sensitive plastic section 207.62 of the Commission’s rules. tape from Italy. leader Brendan Lynch (202–205–3313 or By order of the Commission. [email protected]). For SUMMARY: The Commission hereby gives information on the legal aspects, please notice that it will proceed with a full 1 Commissioners Irving A. Williamson and Dean contact William Gearhart, Office of review pursuant to section 751(c)(5) of A. Pinkert dissenting. General Counsel (202–205–3091 or

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[email protected]). The media to the Secretary of Commerce on or EPA Region I, Robert F. Kennedy should contact Margaret O’Laughlin, before August 24, 2009; Commissioners’ Federal Building, Boston, Massachusetts Public Affairs Officer (202–205–1819 or opinions are currently scheduled to be 02203–2211. During the public [email protected]). Hearing transmitted to the Secretary of comment period, the Consent Decree impaired individuals are advised that Commerce on or before August 31, may also be examined on the following information on this matter can be 2009.) Department of Justice Web site: http:// obtained by contacting the TDD 5. Outstanding action jackets: none. www.usdoj.gov/enrd/ terminal on 202–205–2648. In accordance with Commission Consent_Decrees.html. A copy of the Background: The Commission has policy, subject matter listed above, not Consent Decree may also be obtained by prepared and published annual reports disposed of at the scheduled meeting, mail from the Consent Decree Library, on U.S. trade shifts in selected may be carried over to the agenda of the P.O. Box 7611, U.S. Department of industries/commodity areas under following meeting. Earlier Justice, Washington, DC 20044–7611, or investigation No. 332–345 since 1993. announcement of this meeting was not by faxing or e-mailing a request to Tonia Beginning in 2004, the Commission possible. Fleetwood ([email protected]) converted the report to an exclusively Issued: August 11, 2009. fax number (202) 514–0097, phone web-based format (with added focus on By order of the Commission. confirmation number (202) 514–1547. In sectoral issues) that can be accessed William R. Bishop, requesting a copy from the Consent electronically. The initial notice of Hearings and Meetings Coordinator. Decree Library, please enclose a check institution of this investigation was in the amount of $8.00 (25 cents per published in the Federal Register of [FR Doc. E9–19554 Filed 8–11–09; 4:15 pm] BILLING CODE 7020–02–P page reproduction cost) payable to the September 8, 1993 (58 FR 47287). The U.S. Treasury, or, if by e-mail or fax, Commission expanded the scope of this forward a check in that amount to the investigation to cover services trade in Consent Decree Library at the stated a separate report, which it announced in DEPARTMENT OF JUSTICE address. a notice published in the Federal Notice of Lodging of Consent Decree Register of December 28, 1994 (59 FR Maureen Katz, 66974). The merchandise trade report Under the Clean Air Act and Resource Conservation and Recovery Act Assistant Section Chief, Environmental has been published in the current series Enforcement Section, Environment and under investigation No. 332–345 Under 28 CFR 50.7, notice is hereby Natural Resources Division. annually since September 1993. given that on August 7, 2009, a [FR Doc. E9–19421 Filed 8–12–09; 8:45 am] This year’s Web-based format proposed Consent Decree (‘‘Consent BILLING CODE 4410–15–P identifies the key trends affecting Decree’’) in the matter of United States principal foreign markets and 10 major v. Bradford Industries, Civil Action No. U.S. sectors. 1:09–cv–09–11333, was lodged with the DEPARTMENT OF JUSTICE By order of the Commission. United States District Court for the Issued: August 6, 2009. District of Massachusetts. Membership of the Senior Executive Marilyn R. Abbott, In the complaint in this matter, the Service Standing Performance Review Secretary to the Commission. United States sought injunctive relief Boards [FR Doc. E9–19378 Filed 8–12–09; 8:45 am] and civil penalties against Bradford Industries, Inc. (‘‘Bradford’’) for claims AGENCY: Department of Justice. BILLING CODE 7020–02–P arising under the Clean Air Act and the ACTION: Notice of Department of Resource Conservation and Recovery Justice’s standing members of the Senior INTERNATIONAL TRADE Act, in connection with the operation of Executive Service Performance Review the Bradford’s operation of its facility COMMISSION Boards. located at 75 Rogers Street in Lowell, [USITC SE–09–024] MA. Under the Consent Decree, SUMMARY: Bradford will hire an independent Pursuant to the requirements Government in the Sunshine Act auditor to conduct two environmental of 5 U.S.C. 4314(c)(4), the Department of Meeting Notice compliance audits, and pay a civil Justice announces the membership of its penalty of $75,000. 2009 Senior Executive Service (SES) AGENCY HOLDING THE MEETING: United Standing Performance Review Boards States International Trade Commission. The Department of Justice will receive for a period of thirty (30) days from the (PRBs). The purpose of a PRB is to TIME AND DATE: August 21, 2009 at date of this publication comments provide fair and impartial review of SES 2 p.m. relating to the Consent Decree. performance appraisals, bonus PLACE: Room 101, 500 E Street SW., Comments should be addressed to the recommendations and pay adjustments. Washington, DC 20436, Telephone: Assistant Attorney General, The PRBs will make recommendations (202) 205–2000. Environment and Natural Resources regarding the final performance ratings STATUS: Open to the public. Division, and either e-mailed to to be assigned, SES bonuses and/or pay MATTERS TO BE CONSIDERED: [email protected] or adjustments to be awarded. 1. Agenda for future meetings: None. mailed to P.O. Box 7611, U.S. FOR FURTHER INFORMATION CONTACT: Rod 2. Minutes. Department of Justice, Washington, DC Markham, Director, Human Resources, 3. Ratification List. 20044–7611, and should refer to United Justice Management Division, 4. Inv. Nos. 701–TA–467 and 731– States v. Bradford Industries, Inc., D.J. Department of Justice, Washington, DC TA–1164–1165 (Preliminary) (Narrow Ref. No. 90–5–2–1–09314. 20530; (202) 514–4350. Woven Ribbons with Woven Selvedge The Consent Decree may be examined from China and Taiwan)—briefing and at the Office of the United States Lee J. Lofthus, vote. (The Commission is currently Attorney, 1 Courthouse Way, John Assistant Attorney General for scheduled to transmit its determinations Joseph Moakley Courthouse, and at U.S. Administration.

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Name Position title

Office of the Attorney General—AG

RICHARDSON, MARGARET ...... COUNSELOR TO THE ATTORNEY GENERAL FOR EXECUTIVE BRANCH RELATIONS. BIES, JOHN E ...... COUNSELOR TO THE ATTORNEY GENERAL. GARLAND, JAMES ...... DEPUTY CHIEF OF STAFF AND COUNSELOR. OLSEN, MATTHEW G ...... EXECUTIVE DIRECTOR. JEFFRESS, DOROTHY, AMES ...... COUNSELOR TO THE ATTORNEY GENERAL.

Office of the Deputy Attorney General—DAG

MACBRIDE, NEIL H ...... ASSOCIATE DEPUTY ATTORNEY GENERAL. LIBIN, NANCY ...... CHIEF PRIVACY AND CIVIL LIBERTIES OFFICER. DELERY, STUART F ...... CHIEF OF STAFF AND COUNSELOR. RUEMMLER, KATHYREN H ...... PRINCIPAL ASSOCIATE DEPUTY ATTORNEY GENERAL. MARGOLIS, DAVID ...... ASSOCIATE DEPUTY ATTORNEY GENERAL. SCHOOLS, SCOTT N ...... ASSOCIATE DEPUTY ATTORNEY GENERAL. VERRILLI, DONALD B ...... ASSOCIATE DEPUTY ATTORNEY GENERAL. BURROWS, CHARLOTTE ...... ASSOCIATE DEPUTY ATTORNEY GENERAL.

Office of the Associate Attorney General—OASG

GUERRA, JOSEPH R ...... PRINCIPAL DEPUTY ASSOCIATE ATTORNEY GENERAL. MASON, KAROL V ...... DEPUTY ASSOCIATE ATTORNEY GENERAL. GREENFELD, HELAINE ANN ...... DEPUTY ASSOCIATE ATTORNEY GENERAL. HIRSCH, SAMUEL ...... DEPUTY ASSOCIATE ATTORNEY GENERAL. CHUN, A. MARISA ...... DEPUTY ASSOCIATE ATTORNEY GENERAL.

Office of the Solicitor General—OSG

KATYAL, NEAL K ...... PRINCIPAL DEPUTY SOLICITOR GENERAL. STEWART, MALCOLM L ...... DEPUTY SOLICITOR GENERAL. DREEBEN, MICHAEL R ...... DEPUTY SOLICITOR GENERAL. KNEEDLER, EDWIN S ...... DEPUTY SOLICITOR GENERAL.

Antitrust Division—ATR

SOVEN, JOSHUA H ...... CHIEF LITIGATION I SECTION. O’SULLIVAN, CATHERINE G ...... CHIEF, APPELLATE SECTION. HAND, EDWARD T ...... CHIEF, FOREIGN COMMERCE SECTION. KRAMER II, J. ROBERT ...... DIRECTOR OF OPERATIONS. WATSON, SCOTT M ...... CHIEF, CLEVELAND FIELD OFFICE. PRICE JR, MARVIN N ...... CHIEF, CHICAGO FIELD OFFICE. WARREN, PHILLIP H ...... CHIEF SAN FRANCISCO FIELD OFFICE. CONNOLLY, ROBERT E ...... CHIEF, PHILADELPHIA FIELD OFFICE. DAVIS, NEZIDA S ...... CHIEF, ATLANTA FIELD OFFICE. CAVANAUGH, WILLIAM F ...... DEPUTY ASSISTANT ATTORNEY GENERAL. HAMMOND, SCOTT D ...... DEPUTY ASSISTANT ATTORNEY GENERAL. GIORDANO, RALPH T ...... CHIEF, NEW YORK FIELD OFFICE. POTTER, ROBERT A ...... CHIEF, LEGAL POLICY SECTION. FAMILANT, NORMAN ...... CHIEF, ECONOMIC LITIGATION SECTION. HEYER, KENNETH ...... DIRECTOR OF ECONOMICS. BOAST, MARY H ...... DEPUTY ASSISTANT ATTORNEY GENERAL. PETRIZZI, MARIBETH ...... CHIEF, LITIGATION II SECTION. KING, THOMAS D ...... EXECUTIVE OFFICER. GOODMAN, NANCY M ...... CHIEF, TELECOMMUNICATIONS AND MEDIA SECTION. PHELAN, LISA M ...... CHIEF, NATIONAL CRIMINAL ENFORCEMENT SECTION. KURSH, GAIL ...... DEPUTY CHIEF, LEGAL POLICY SECTION. TIERNEY, JAMES J ...... CHIEF, NETWORKS AND TECHNOLOGY ENFORCEMENT SECTION.

Antitrust Division—ATR

READ, JOHN R ...... CHIEF, LITIGATION III SECTION. MAJURE, WILLIAM ROBERT ...... CHIEF, COMPETITION POLICY SECTION. CURRIE, DUNCAN S ...... CHIEF, DALLAS FIELD OFFICE.

Bureau of Alcohol, Tobacco, Firearms, and Explosives—ATF

CHAIT, MARK R ...... DEPUTY ASSISTANT DIRECTOR, FIELD OPERATIONS—CENTRAL.

Bureau of Alcohol, Tobacco, Firearms, and Explosives—ATF

CARROLL, CARSON W ...... ASSISTANT DIRECTOR, ENFORCEMENT PROGRAM AND SERVICES. STUCKO, AUDREY M ...... DEPUTY ASSISTANT DIRECTOR, ENFORCEMENT PROGRAM AND SERVICES. GODDARD, VALERIE J ...... DEPUTY ASSISTANT DIRECTOR, TRAINING AND PROFESSIONAL DEVELOPMENT. LOGAN, MARK ...... ASSISTANT DIRECTOR, TRAINING AND PROFESSIONAL DEVELOPMENT.

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Name Position title

CRENSHAW, KELVIN N ...... ASSISTANT DIRECTOR, OFFICE OF PROFESSIONAL RESPONSIBILITY AND SECURITY OPERATIONS. MICHALIC, VIVIAN B ...... DEPUTY ASSISTANT DIRECTOR, MANAGEMENT. STINNETT, MELANIE S ...... ASSISTANT DIRECTOR, MANAGEMENT AND CHIEF FINANCIAL OFFICER. BELL, WILLIAM L ...... DEPUTY ASSISTANT DIRECTOR, SCIENCE AND TECHNOLOGY. ETHRIDGE, MICHAEL W ...... DIRECTOR, LABORATORY SERVICES. FICARETTA, TERESA G ...... DEPUTY CHIEF COUNSEL. LOOS, ELEANER R ...... ASSOCIATE CHIEF COUNSEL, ADMINISTRATION AND ETHICS. MCMAHON JR, WILLIAM G ...... DEPUTY ASSISTANT DIRECTOR, FIELD OPERATIONS—WEST. TORRES, JOHN A ...... SPECIAL AGENT IN CHARGE, LOS ANGELES. DOMENECH, EDGAR A ...... SPECIAL AGENT IN CHARGE, WASHINGTON D.C. WEBB, JAMES D ...... SPECIAL AGENT IN CHARGE, HOUSTON. TORRES, JULIE ...... DEPUTY ASSISTANT DIRECTOR, FIELD OPERATIONS—EAST. RUBENSTEIN, STEPHEN R ...... CHIEF COUNSEL. MASSEY, KENNETH ...... DEPUTY ASSISTANT DIRECTOR, OFFICE OF PROFESSIONAL RESPONSIBILTY AND SE- CURITY OPERATIONS. ZAMMILLO SR, JAMES A ...... DEPUTY ASSISTANT DIRECTOR, INDUSTRY OPERATIONS. CAVANAUGH, JAMES M ...... SPECIAL AGENT IN CHARGE, NASHVILLE. FORD, WILFRED L ...... ASSISTANT DIRECTOR, OFFICE OF PUBLIC AND GOVERNMENTAL AFFAIRS. MARTIN, STEPHEN K ...... DEPUTY ASSISTANT DIRECTOR, OFFICE OF STRATEGIC INTELLIGENCE AND INFOR- MATION. MCDERMOND, JAMES E ...... ASSISTANT DIRECTOR, OFFICE OF STRATEGIC INTELLIGENCE AND INFORMATION. COLUCCI, NICHOLAS V ...... DEPUTY ASSISTANT DIRECTOR, OFFICE OF PUBLIC AND GOVERNMENTAL AFFAIRS. GANT, GREGORY K ...... SPECIAL AGENT IN CHARGE, ATLANTA. ANDERSON, GLENN N ...... SPECIAL AGENT IN CHARGE, BOSTON. TRAVER, ANDREW L ...... SPECIAL AGENT IN CHARGE, CHICAGO. BOXLER, MICHAEL B ...... SPECIAL AGENT IN CHARGE, KANSAS CITY. POTTER, MARK W ...... SPECIAL AGENT IN CHARGE, PHILADELPHIA. NEWELL, WILLIAM D ...... SPECIAL AGENT IN CHARGE, PHOENIX. HERKINS, STEPHEN C ...... SPECIAL AGENT IN CHARGE, SAN FRANCISCO. BARRERA, HUGO J ...... SPECIAL AGENT IN CHARGE, MIAMI. GRAHAM, ZEBEDEE T ...... SPECIAL AGENT IN CHARGE, CHARLOTTE. BRANDON, THOMAS E ...... SPECIAL AGENT IN CHARGE, DETROIT. VIDO, PAUL J ...... SPECIAL AGENT IN CHARGE, LOUISVILLE. O’BRIEN, VIRGINIA T ...... SPECIAL AGENT IN CHARGE, TAMPA. ZAPOR, BERNARD J ...... SPECIAL AGENT IN CHARGE, ST PAUL. HARPER, DAVID G ...... SPECIAL AGENT IN CHARGE, NEW ORLEANS. SADOWSKI, CHRISTOPHER P ...... SPECIAL AGENT IN CHARGE, COLUMBUS. STOOP, THERESA R ...... SPECIAL AGENT IN CHARGE, BALTIMORE. HOOVER, WILLIAM J ...... ASSISTANT DIRECTOR, FIELD OPERATIONS. CARTER, RONNIE A ...... SPECIAL AGENT IN CHARGE, DALLAS. HORACE, MATTHEW W ...... SPECIAL AGENT IN CHARGE, NEWARK. CHASE, RICHARD E ...... SPECIAL AGENT IN CHARGE, DENVER. MELSON, KENNETH E ...... SENIOR POLICY ADVISOR.

Bureau of Prisons—BOP

LAPPIN, HARLEY G ...... DIRECTOR. DALIUS, WILLIAM F. JR ...... ASSISTANT DIRECTOR FOR ADMINISTRATION. CONLEY, JOYCE K ...... ASSISTANT DIRECTOR CORRECTIONAL PROGRAMS DIVISION. KENNEY, KATHLEEN M ...... ASSISTANT DIRECTOR, OFFICE OF GENERAL COUNSEL. DODRILL, D. SCOTT ...... REGIONAL DIRECTOR, NORTHEAST REGION. HOLT, RAYMOND E ...... REGIONAL DIRECTOR, SOUTHEAST REGION. NALLEY, MICHAEL K ...... REGIONAL DIRECTOR, NORTH CENTRAL REGION. MCFADDEN, ROBERT E ...... REGIONAL DIRECTOR, WESTERN REGION. MALDONADO JR, GERARDO ...... REGIONAL DIRECTOR, SOUTH CENTRAL REGION. GRAYER, LOREN A ...... WARDEN, USP, ATLANTA, GA. CHESTER, CLAUDE ...... WARDEN, USP, LEAVENWORTH, . BLEDSOE, BRYAN A ...... WARDEN, USP, LEWISBURG, PA. SANDERS, LINDA L ...... WARDEN, FCC, LOMPOC, CA. ANDERSON, MARTY C ...... WARDEN, USMCFP, SPRINGFIELD, MO. DEWALT, STEPHEN M ...... WARDEN, FMC, LEXINGTON, KY. HOLLINGSWORTH, LISA W ...... WARDEN, USP, MARION, IL. LAIRD, PAUL A ...... ASSISTANT DIRECTOR, INDUSTRIES, EDUCATION AND VOCATIONAL TRAINING DIVI- SION. MARBERRY, HELEN J ...... WARDEN, FCC TERRE HAUTE, IN. THIGPEN SR, MORRIS L ...... DIRECTOR NATIONAL INSTITUTE OF CORRECTIONS. REVELL, SARA M ...... WARDEN, FCC, BUTNER, NC. EICHENLAUB, LOUIS C ...... WARDEN, FCI MARIANNA, FL. LE BLANC JR, WHITNEY I ...... ASSISTANT DIRECTOR FOR HUMAN RESOURCES MANAGEMENT. SAMUELS, CHARLES E. JR ...... SENIOR DEPUTY ASSISTANT DIRECTOR OF CORRECTIONAL PROGRAMS DIVISION. CHAVEZ, RICARDO E ...... WARDEN, FCI, PHOENIX, AZ. JETT, BRIAN R ...... WARDEN, FMC, ROCHESTER, MN. WHITE, KIM M ...... REGIONAL DIRECTOR, MIDDLE ATLANTIC REGION.

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Name Position title

KANE, THOMAS R ...... ASSISTANT DIRECTOR, INFORMATION, POLICY, AND PUBLIC AFFAIRS DIVISION. REESE, CONSTANCE N ...... WARDEN, FCI, TALLADEGA, AL. GRONDOLSKY, JEFF F ...... WARDEN, FCI, FORT DIX, NJ. DAVIS, BLAKE R ...... WARDEN, USP, HIGH, FLORENCE, CO. WILEY, RONNIE ...... WARDEN, FCC, FLORENCE, CO. YOUNG JR, JOSEPH P ...... WARDEN, FCC, OAKDALE, LA. CHAPMAN, W. ELANIE ...... WARDEN, FMC, CARSWELL, TX. MARTINEZ, RICARDO ...... WARDEN, FCC, ALLENWOOD, PA. KASTNER, PAUL A ...... WARDEN, FTC, OKLAHOMA CITY, OK. RATHMAN, JOHN T ...... WARDEN, FDC, MIAMI, FL. SCHULTZ, PAUL M ...... WARDEN, FCI, FAIRTON, NJ. ADAMS, VANESSA P ...... SENIOR DEPUTY ASSISTANT DIRECTOR PROGRAM REVIEW DIVISION. MITCHELL, MARY M ...... WARDEN, FCI, EDGEFIELD, SC. SABOL, CAROLYN ANN ...... WARDEN, FMC, DEVENS, MA. BENOV, MICHAEL L ...... WARDEN, MDC, LOS ANGELES, CA. FOX, JOHN B ...... WARDEN, FCC, BEAUMONT, TX. HASTINGS, SUZANNE R ...... SENIOR DEPUTY ASSISTANT DIRECTOR, CORRECTIONAL PROGRAMS DIVISION. BEUSSE, ROBIN LITMAN ...... SENIOR DEPUTY ASSISTANT DIRECTOR FOR ADMINISTRATION. LINDSAY, CAMERON K ...... WARDEN, MDC, BROOKLYN, NY. KEFFER, JOSEPH E ...... WARDEN, USP, POLLUCK, LA. BERKEBILE, DAVID W ...... WARDEN, FCI, BECKLEY, WV. HICKEY, DEBORAH A ...... WARDEN, FCI, JESUP, GA. KILLIAN, JANICE M ...... WARDEN, FCI, OTISVILLE, NY. TERRELL, DUDLEY J ...... WARDEN, MCC, NEW YORK, NY. RIOS JR., HECTOR ...... WARDEN, USP, ATWATER, CA. DREW, DARRYL ...... WARDEN, FCC, COLEMAN, FL.

Bureau of Prisons—BOP

O’BRIEN, TERENCE T ...... WARDEN, USP, LEE, VA. KENDALL, PAUL F ...... SENIOR COUNSEL. STANSBERRY, PATRICIA R ...... WARDEN, FCC, PETERSBURG, VA. ZUERCHER, JEROME C ...... WARDEN, USP, BIG SANDY, KY. NORWOOD, JOSEPH L ...... WARDEN, FCC, VICTORVILLE, CA. WILSON, ERIC D ...... WARDEN, USP, MCCREARY, KY. CROSS JR, JAMES ...... WARDEN, USP, HAZELTON, WV. PEARSON, BRUCE A ...... WARDEN, FCC, YAZOO CITY, MS. HOLT, RONNIE R ...... WARDEN, USP, CANAAN, PA. OUTLAW, TIMOTHY C ...... WARDEN, FCC, FORREST CITY, AR. JOHNS, TRACY W ...... WARDEN, FCI, MEDIUM–I, BUTNER, NC. MIDDLEBROOKS, SCOTT A ...... WARDEN, USP, COLEMAN–I, COLEMAN, FL. APKER JR, LIONEL C ...... WARDEN, USP, TUCSON, AZ. WHITEHEAD, JIMMY D ...... WARDEN, FCI, CUMBERLAND, MD. RIVERA, MILDRED ...... WARDEN, FCI, ESTILL, SC. SHERROD, WILLIAM A ...... WARDEN, FCI, GREENVILLE, IL. QUINTANA, FRANCISCO J ...... WARDEN, FCI, MCKEAN, PA. HOLINKA–WURDEMAN, CAROL J ...... WARDEN, FCI, OXFORD, WI. SMITH, DENNIS R ...... WARDEN, FCI, PEKIN, IL. SNIEZEK, THOMAS R ...... WARDEN, FCI, SCHUYLKILL, PA. JOSLIN, DANIEL M ...... WARDEN, FCI, THREE RIVERS, TX. HAYES, ANTHONY ...... WARDEN, MDC, GUAYNABO, PUERTO RICO. CASTILLO, JUAN D ...... WARDEN, FCI, MEMPHIS, TN. THOMAS, JEFFREY E ...... WARDEN, FCI, SHERIDAN, OR. DEBOO, KUMA J ...... WARDEN, FCI, GILMER, WV. HOGSTEN, KAREN F ...... WARDEN, FCI, MANCHESTER, KY. DREW, DARLENE ...... WARDEN, FCI, BENNETTSVILLE, SC. LEDEZMA, HECTOR A ...... WARDEN, FCI, EL RENO, OK. OWEN, JOHN R ...... WARDEN, FCI, WILLIAMSBURG, SC. SCHULT, DEBORAH G ...... WARDEN, FCI, RAY BROOK, NY. IVES, RICHARD B ...... WARDEN, FCI, HERLONG, CA.

Civil Division—CIV

COPPOLINO, ANTHONY J ...... SPECIAL LITIGATION COUNSEL. RIVERA, JENNIFER D ...... BRANCH DIRECTOR. KOPP, ROBERT E ...... DIRECTOR, APPELLATE STAFF. DAVIDSON, JEANNE E ...... DIRECTOR, COMMERCIAL LITIGATION BRANCH. HUNT, JOSEPH H ...... BRANCH DIRECTOR. BRANDA, JOYCE R ...... DIRECTOR, COMMERCIAL LITIGATION BRANCH. KOHN, J. CHRISTOPHER ...... DIRECTOR, COMMERCIAL LITIGATION BRANCH. PYLES, PHYLLIS J ...... DIRECTOR, FEDERAL TORT CLAIMS ACT SECTION. FARGO, JOHN J ...... DIRECTOR, COMMERCIAL LITIGATION BRANCH. GARREN, TIMOTHY PATRICK ...... DIRECTOR, CONSTITUTIONAL AND SPECIALIZED TORT LITIGATION SECTION. FROST, PETER F ...... DIRECTOR, AVIATION AND ADMIRALTY SECTION.

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Name Position title

BAXTER, FELIX V ...... BRANCH DIRECTOR. HOLLIS, ROBERT MARK ...... DIRECTOR, COMMERCIAL LITIGATION BRANCH. O’MALLEY, BARBARA B ...... SPECIAL LITIGATION COUNSEL, AVIATION AND ADMIRALTY SECTION. SHAPIRO, ELIZABETH J ...... DEPUTY BRANCH DIRECTOR. HERTZ, MICHAEL F ...... DEPUTY ASSISTANT ATTORNEY GENERAL. RAVEL, ANN MILLER ...... DEPUTY ASSISTANT ATTORNEY GENERAL. BRUEN JR, JAMES G ...... SPECIAL LITIGATION COUNSEL. HUSSEY, THOMAS W ...... DIRECTOR, APPELLATE LITIGATION. GLYNN, JOHN PATRICK ...... DIRECTOR, ENVIRONMENTAL TORT LITIGATION SECTION. KIRSCHMAN JR., ROBERT E ...... DEPUTY DIRECTOR, COMMERCIAL LITIGATION BRANCH. GARVEY, VINCENT MORGAN ...... DEPUTY BRANCH DIRECTOR. ZWICK, KENNETH L ...... DIRECTOR, OFFICE OF MANAGEMENT PROGRAMS.

Civil Division—CIV

GRANSTON, MICHAEL D ...... DEPUTY DIRECTOR, COMMERCIAL LITIGATION BRANCH. LIEBER, SHEILA M ...... DEPUTY BRANCH DIRECTOR. THIROLF, EUGENE M ...... DIRECTOR, OFFICE OF CONSUMER LITIGATION. LETTER, DOUGLAS N ...... APPELLATE LITIGATION COUNSEL. STERN, MARK B ...... APPELLATE LITIGATION COUNSEL. GERSHENGORN, IAN H ...... DEPUTY ASSISTANT ATTORNEY GENERAL. SNEE, BRYANT G ...... DEPUTY DIRECTOR, COMMERCIAL LITIGATION BRANCH. KANTER, WILLIAM G ...... DEPUTY DIRECTOR, APPELLATE STAFF. MCCONNELL, DAVID M ...... DEPUTY DIRECTOR, APPELLATE SECTION. BRINKMANN, BETH S ...... DEPUTY ASSISTANT ATTORNEY GENERAL. KLINE, DAVID J ...... DIRECTOR, FEDERAL DISTRICT COURT SECTION. ANDERSON, DANIEL R ...... DEPUTY DIRECTOR, COMMERCIAL LITIGATION BRANCH.

Civil Rights Division—CRT

GADZICHOWSKI, JOHN M ...... CHIEF, EMPLOYMENT LITIGATION SECTION. FLYNN, DIANA KATHERINE ...... CHIEF, APPELLATE SECTION. KAPPELHOFF, MARK JOHN ...... CHIEF, CRIMINAL SECTION. ROSENBAUM, STEVEN H ...... CHIEF, HOUSING AND CIVIL ENFORCEMENT SECTION. COATES, HARRY CHRISTOPHER ...... CHIEF, VOTING SECTION. GLASSMAN, JEREMIAH ...... CHIEF, EDUCATIONAL OPPORTUNITIES SECTION. BROWN–CUTLAR, SHANETTA Y ...... CHIEF, SPECIAL LITIGATION SECTION. WODATCH, JOHN L ...... CHIEF, DISABILITY RIGHTS SECTION. KING, LORETTA ...... DEPUTY ASSISTANT ATTORNEY GENERAL. SAMUELS, JOCELYN ...... COUNSELOR TO THE ASSISTANT ATTORNEY GENERAL. FRIEDLANDER, MERRILY A ...... CHIEF, COORDINATION AND REVIEW SECTION. GREENE, IRVA D ...... EXECUTIVE OFFICER. BALDWIN, KATHERINE A ...... DEPUTY SPECIAL COUNSEL FOR IMMIGRATION–RELATED UNFAIR EMPLOYMENT PRACTICES. GINSBURG, JESSICA A ...... COUNSEL TO THE ASSISTANT ATTORNEY GENERAL.

Criminal Division—CRM

ROGERS, RICHARD M ...... SENIOR COUNSEL. NASH, STUART G ...... DIRECTOR, ORGANIZED CRIME, DRUG ENFORCEMENT TASK FORCE. OHR, BRUCE G ...... CHIEF, ORGANIZED CRIME AND RACKETEERING SECTION. STEMLER, PATTY MERKAMP ...... CHIEF, APPELLATE SECTION. WELCH II, WILLIAM M ...... CHIEF, PUBLIC INTEGRITY SECTION. O’BRIEN, PAUL M ...... CHIEF, NARCOTIC AND DANGEROUS DRUG SECTION. WEINSTEIN, JASON ...... DEPUTY ASSISTANT ATTORNEY GENERAL. KEENEY, JOHN C ...... DEPUTY ASSISTANT ATTORNEY GENERAL. SWARTZ, BRUCE CARLTON ...... DEPUTY ASSISTANT ATTORNEY GENERAL. WARLOW, MARY ELLEN ...... DIRECTOR, OFFICE OF INTERNATIONAL AFFAIRS. PELLETIER, PAUL E ...... DEPUTY CHIEF FOR LITIGATION. WEBER, RICHARD M ...... CHIEF, ASSET FORFEITURE AND MONEY LAUNDERING SECTION. MORRIS, BRENDA K ...... DEPUTY CHIEF, PUBLIC INTEGRITY SECTION. GRINDLER, GARY G ...... DEPUTY ASSISTANT ATTORNEY GENERAL. GLAZER, SIDNEY ...... SENIOR APPELLATE COUNSEL. PARENT, STEVEN J ...... EXECUTIVE OFFICER. KILLION, MAUREEN H ...... DIRECTOR, OFFICE OF ENFORCEMENT OPERATIONS. ROBINSON, STEWART C ...... DEPUTY DIRECTOR, OFFICE OF INTERNATIONAL AFFAIRS. BLANCO, KENNETH A ...... DEPUTY ASSISTANT ATTORNEY GENERAL. WROBLEWSKI, JONATHAN J ...... DIRECTOR, OFFICE OF POLICY AND LEGISLATION. AINSWORTH, PETER J ...... SENIOR DEPUTY CHIEF, PUBLIC INTEGRITY SECTION. OOSTERBAAN, ANDREW ...... CHIEF, CHILD EXPLOITATION AND OBSCENITY SECTION. ROSENBAUM, ELI M ...... DIRECTOR, OFFICE OF SPECIAL INVESTIGATIONS. PAINTER, CHRISTOPHER M ...... DEPUTY CHIEF, COMPUTER CRIME AND INTELLECTUAL PROPERTY SECTION.

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Name Position title

Criminal Division—CRM

TREVILLIAN IV, ROBERT C ...... DIRECTOR, INTERNATIONAL CRIMINAL INVESTIGATIVE TRAINING ASSISTANCE PRO- GRAM. REYNOLDS, JAMES S ...... SENIOR COUNSEL. RAABE, WAYNE C ...... DEPUTY CHIEF, NARCOTIC AND DANGEROUS DRUG SECTION. ALEXANDRE, CARL ...... DIRECTOR, OPDAT. DUBOSE, MICHAEL M ...... CHIEF, COMPUTER CRIME, AND INTELLECTUAL PROPERTY SECTION. MCHENRY, TERESA L ...... CHIEF, DOMESTIC SECURITY SECTION. FAGELL, STEVEN E ...... COUNSELOR TO THE ASSISTANT ATTORNEY GENERAL. TYRRELL, STEVEN A ...... CHIEF, FRAUD SECTION. JOSEPH, LESTER M ...... DEPUTY CHIEF, ASSET FORFEITURE AND MONEY LAUNDERING SECTION. CARWILE, P. KEVIN ...... CHIEF, GANG SQUAD. PADDEN, THOMAS WILLIAM ...... DEPUTY DIRECTOR, ORGANIZED CRIME, DRUG ENFORCEMENT TASK FORCE.

Environmental and Natural Resources Division—ENRD

RANDALL, GARY B ...... DEPUTY CHIEF, NATURAL RESOURCES SECTION. HAUGRUD, K. JACK ...... CHIEF, NATURAL RESOURCES SECTION. BUTLER, VIRGINIA P ...... CHIEF, LAND ACQUISITION SECTION. KILBOURNE, JAMES C ...... CHIEF, APPELLATE SECTION. ALEXANDER, S. CRAIG ...... CHIEF, INDIAN RESOURCES SECTION. GRISHAW, LETITIA J ...... CHIEF, ENVIRONMENTAL DEFENSE SECTION. DISHEROON, FRED R ...... SENIOR LITIGATION COUNSEL ATTORNEY EXAMINER. MILIUS, PAULINE H ...... CHIEF, LAW AND POLICY SECTION. CRUDEN, JOHN C ...... DEPUTY ASSISTANT ATTORNEY GENERAL. WILLIAMS, JEAN E ...... CHIEF, WILDLIFE AND MARINE RESOURCES. FISHEROW, W. BENJAMIN ...... DEPUTY CHIEF, ENVIRONMENTAL ENFORCEMENT SECTION. MITCHELL, STACEY H ...... CHIEF, ENVIRONMENTAL CRIMES SECTION. GELBER, BRUCE S ...... CHIEF, ENVIRONMENTAL ENFORCEMENT SECTION. STEWART, HOWARD P ...... SENIOR LITIGATION COUNSEL. SOBECK, EILEEN ...... DEPUTY ASSISTANT ATTORNEY GENERAL. BRUFFY, ROBERT L ...... EXECUTIVE OFFICER. MAHAN, ELLEN M ...... DEPUTY CHIEF, ENVIRONMENTAL ENFORCEMENT SECTION. CLARK II, TOM C ...... DEPUTY CHIEF, NATURAL RESOURCES SECTION. VADEN, CHRISTOPHER S ...... DEPUTY CHIEF, ENVIRONMENTAL DEFENSE SECTION.

Executive Office for Immigration Review—EOIR

OSUNA, JUAN P ...... CHAIRMAN, BOARD OF IMMIGRATION APPEALS. NASCA, PAULA N ...... ASSOCIATE DIRECTOR. CREPPY, MICHAEL J ...... CHIEF ADMINISTRATIVE HEARING OFFICER. O’LEARY, BRIAN M ...... CHIEF IMMIGRATION JUDGE. NEAL, DAVID ...... VICE CHAIRMAN, BOARD OF IMMIGRATION APPEALS.

Executive Office for U.S. Attorneys—EOUSA

BAILIE, MICHAEL W ...... DIRECTOR, OFFICE OF LEGAL EDUCATION. BEVELS, LISA A ...... DEPUTY DIRECTOR FINANCIAL MANAGEMENT. FLESHMAN, JAMES MARK ...... CHIEF INFORMATION OFFICER. WONG, NORMAN Y ...... COUNSELOR TO THE DIRECTOR. JARRETT, HOWARD MARSHALL ...... DIRECTOR. MACKLIN, JAMES ...... GENERAL COUNSEL. VILLEGAS, DANIEL A ...... COUNSEL, LEGAL PROGAMS AND POLICY.

Executive Office for U.S. Trustees—EOUST

WHITE III, CLIFFORD J ...... DIRECTOR. REDMILES, MARK A ...... PRINCIPAL DEPUTY DIRECTOR. MILLER, JEFFREY M ...... ASSOCIATE DIRECTOR.

Justice Management Division—JMD

OLSON, ERIC R ...... DEPUTY, CHIEF INFORMATION OFFICER FOR E–GOVERNMENT SERVICES STAFF. MURRAY, JOHN W ...... DIRECTOR, ENTERPRISE SOLUTIONS STAFF. DEELEY, KEVIN ...... DEPUTY CHIEF INFORMATION OFFICER FOR IT SECURITY.

Justice Management Division—JMD

BEASLEY, ROGER ...... DIRECTOR, OPERATION SERVICES STAFF. HOLTGREWE, KENT L ...... DIRECTOR, IT POLICY AND PLANNING STAFF. ALLEN, MICHAEL H ...... DEPUTY ASSISTANT ATTORNEY GENERAL FOR POLICY, MANAGEMENT, AND PLAN- NING, AND CHIEF OF STAFF. MARKHAM, ROD E ...... DIRECTOR, HUMAN RESOURCES. DUNLAP, JAMES L ...... DIRECTOR, SECURITY AND EMERGENCY PLANNING STAFF.

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Name Position title

MORGAN, MELINDA B ...... DIRECTOR, FINANCE STAFF. LAURIA–SULLENS, JOLENE A ...... DEPUTY ASSISTANT ATTORNEY GENERAL/CONTROLLER. SANTANGELO, MARI BARR ...... DEPUTY ASSISTANT ATTORNEY GENERAL FOR HUMAN RESOURCES AND ADMINIS- TRATION (CHCO). DESSY, BLANE K ...... DIRECTOR, LIBRARY STAFF. HAMILTON, EDWARD A ...... DIRECTOR, FACILITIES AND ADMINISTRATIVE SERVICES STAFF. OLDS, CANDACE A ...... DIRECTOR, ASSET FORFEITURE MANAGEMENT STAFF. DEFALAISE, LOUIS ...... DIRECTOR, OFFICE OF ATTORNEY RECRUITMENT AND MANAGEMENT. ORR, DAVID MARSHALL ...... DIRECTOR, MANAGEMENT AND PLANNING STAFF. O’LEARY, KARIN ...... DIRECTOR, BUDGET STAFF. HITCH, VANCE E ...... DEPUTY ASSISTANT ATTORNEY GENERAL/CHIEF INFORMATION OFFICER. JOHNSTON, JAMES W ...... DIRECTOR, PROCUREMENT SERVICES STAFF. FRISCH, STUART ...... GENERAL COUNSEL. FROST–TUCKER, VONTELL D ...... DIRECTOR, EQUAL EMPLOYMENT OPPORTUNITY STAFF. SCHULTZ JR, WALTER H ...... DEPUTY DIRECTOR, BUDGET STAFF, OPERATIONS AND FUNDS CONTROL. ATSATT, MARILYNN B ...... DEPUTY DIRECTOR, BUDGET STAFF, PROGRAMS AND PERFORMANCE. ALVAREZ, CHRISTOPHER C ...... DEPUTY DIRECTOR (AUDITING), FINANCE STAFF. NORRIS, J. TREVOR ...... DEPUTY DIRECTOR, HUMAN RESOURCES. RODGERS, JANICE M ...... DIRECTOR, DEPARTMENTAL ETHICS OFFICE.

National Drug Intelligence Center—NDIC

WALTHER, MICHAEL F ...... DIRECTOR, NATIONAL DRUG INTELLIGENCE CENTER.

National Security Division—NSD

DION, JOHN J ...... CHIEF, COUNTERESPIONAGE SECTION. BRADLEY, MARK A ...... SPECIAL COUNSEL FOR OVERSIGHT SECTION. KEEGAN, MICHAEL ...... DEPUTY CHIEF, COUNTERTERRORISM SECTION. HINNEN, TODD ...... DEPUTY ASSISTANT ATTORNEY GENERAL. WALTER, SHERYL L ...... EXECUTIVE OFFICER. MULLANEY, MICHAEL J ...... CHIEF, COUNTERTERRORISM SECTION. GAUHAR, TASHINA ...... CHIEF, OPERATIONS SECTION. KENNEDY, J. LIONEL ...... SPECIAL COUNSEL FOR NATIONAL SECURITY. PELAK, STEVEN W ...... DEPUTY CHIEF, COUNTERESPIONAGE SECTION. STEELE, CHARLES M ...... SPECIAL COUNSEL TO THE AAG.

Office of Information and Privacy—OIP

PUSTAY, MELANIE ANN ...... DIRECTOR.

Office of Inspector General—OIG

ROBINSON, GAIL A ...... GENERAL COUNSEL. GULLEDGE, MICHAEL D ...... ASSISTANT INSPECTOR GENERAL EVALUATION AND INSPECTIONS. BEAUDET, RAYMOND J ...... ASSISTANT INSPECTOR GENERAL FOR AUDIT. MCLAUGHLIN, THOMAS F ...... ASSISTANT INSPECTOR GENERAL FOR INVESTIGATIONS. PETERS, GREGORY T ...... ASSISTANT INSPECTOR GENERAL FOR MANAGEMENT & PLANNING. MARTIN, PAUL K ...... DEPUTY INSPECTOR GENERAL. FORTINE OCHOA, CAROL A ...... ASSISTANT INSPECTOR GENERAL FOR OVERSIGHT & REVIEW.

Office of Inspector General—OIG

MARSKE, CARYN A ...... DEPUTY ASSISTANT INSPECTOR GENERAL FOR AUDIT. DORSETT, GEORGE L ...... DEPUTY ASSISTANT INSPECTOR GENERAL FOR INVESTIGATIONS.

Office of Intergovernmental and Public Liaison—OIPL

ROBERSON, PORTIA L ...... DIRECTOR.

Office of Justice Programs—OJP

IWANOW, WALTER ...... CHIEF INFORMATION OFFICER. GARRY, EILEEN M ...... DEPUTY DIRECTOR FOR PROGRAMS, BUREAU OF JUSTICE ASSISTANCE. SINCLAIR, MICHAEL D ...... DEPUTY DIRECTOR, BUREAU OF JUSTICE STATISTICS. FEUCHT, THOMAS E ...... EXECUTIVE SCIENCE ADVISOR, NATIONAL INSTITUTE OF JUSTICE. MERKLE, PHILLIP ...... DIRECTOR, OFFICE OF ADMINISTRATION. MADAN, RAFAEL A ...... GENERAL COUNSEL. PAULL, MARCIA K ...... CHIEF FINANCIAL OFFICER. BURCH II, JAMES H ...... DEPUTY DIRECTOR, POLICY AND MANAGEMENT, BUREAU OF JUSTICE PROGRAMS. ROBINSON, LAUREL ...... PRINCIPAL DEPUTY ASSISTANT ATTORNEY GENERAL. ROBERTS, MARILYN M ...... DEPUTY ADMINISTRATOR, OJJDP. AYERS, NANCY LYNN ...... DEPUTY ADMINISTRATOR FOR POLICY, OJJDP. GREENHOUSE, DENNIS E ...... DIRECTOR, COMMUNITY CAPACITY DEVELOPMENT OFFICE.

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Name Position title

MORGAN, JOHN S ...... ASSISTANT DIRECTOR, NATIONAL INSTITUTE OF JUSTICE, OFFICE OF SCIENCE AND TECHNOLOGY. GREENFELD, LAWRENCE A ...... DEPUTY DIRECTOR, PLANNING, BUREAU OF JUSTICE ASSISTANCE. MCGARRY, BETH ...... DEPUTY ASSISTANT ATTORNEY GENERAL, OPERATIONS MANAGEMENT. BALDWIN, LINDA ...... SMART COORDINATOR. BENDA, BONNIE LEIGH ...... DEPUTY, CHIEF FINANCIAL OFFICER. HENNEBERG, MAUREEN A ...... DIRECTOR, OFFICE OF AUDIT, ASSESSMENT, AND MANAGEMENT.

Office of Legal Counsel—OLC

RHEE, JEANNIE S ...... DEPUTY ASSISTANT ATTORNEY GENERAL. KOFFSKY, DANIEL L ...... DEPUTY ASSISTANT ATTORNEY GENERAL. LEDERMAN, MARTIN ...... DEPUTY ASSISTANT ATTORNEY GENERAL. HART, ROSEMARY A ...... SPECIAL COUNSEL. COLBORN, PAUL P ...... SPECIAL COUNSEL. BARRON, DAVID ...... PRINCIPAL DEPUTY ASSISTANT ATTORNEY GENERAL. CEDARBAUM, JONATHAN ...... DEPUTY ASSISTANT ATTORNEY GENERAL.

Office of Legal Policy—OLP

JONES, KEVIN ROBERT ...... DEPUTY ASSISTANT ATTORNEY GENERAL. THIEMANN, ROBYN L ...... DEPUTY ASSISTANT ATTORNEY GENERAL. OVERTON, SPENCER ...... PRINCIPAL DEPUTY ASSISTANT ATTORNEY GENERAL. DE, RAJESH ...... DEPUTY ASSISTANT ATTORNEY GENERAL. MEYER, JONATHAN E ...... DEPUTY ASSISTANT ATTORNEY GENERAL.

Office of Legislative Affairs—OLA

AGRAST, MARK D ...... DEPUTY ASSISTANT ATTORNEY GENERAL. BURTON, M. FAITH ...... SPECIAL COUNSEL. APPELBAUM, JUDITH C ...... DEPUTY ASSISTANT ATTORNEY GENERAL.

Office of Professional Responsibility—OPR

WISH, JUDITH B ...... DEPUTY COUNSEL ON PROF RESPONSIBILITY.

Office of Public Affairs—PAO

MILLER, MATTHEW A ...... DIRECTOR.

Office of the Federal Detention Trustee—OFDT

HYLTON, STACIA A ...... FEDERAL DETENTION TRUSTEE.

Office of the Pardon Attorney—OPA

RODGERS, RONALD L ...... PARDON ATTORNEY.

Professional Responsibility Advisory Office—PRAO

DUNSTON, JERRI U ...... DIRECTOR.

Tax Division—TAX

ROTHENBERG, GILBERT S ...... CHIEF, APPELLATE SECTION. FRAHM, STEVEN L ...... CHIEF, CLAIMS COURT SECTION. HEALD, SETH G ...... CHIEF, CIVIL TRIAL SECTION, CENTRAL REGION.

Tax Division—TAX

MULLARKEY, DANIEL P ...... CHIEF, CIVIL TRIAL SECTION, NORTHERN REGION. KEARNS, MICHAEL J ...... CHIEF, CIVIL TRIAL SECTION, SOUTHERN REGION. WARD, RICHARD ...... CHIEF, CIVIL TRIAL SECTION, WESTERN REGION. SHATZ, EILEEN M ...... SPECIAL LITIGATION COUNSEL. DONOHUE, DENNIS M ...... SENIOR LITIGATION COUNSEL. SALAD, BRUCE M ...... CHIEF, CRIMINAL ENFORCEMENT SECTION, SOUTHERN REGION. PAGUNI, ROSEMARY E ...... CHIEF, CRIMINAL ENFORCEMENT SECTION, NORTHERN REGION. DICICCO, JOHN ...... DEPUTY ASSISTANT ATTORNEY GENERAL. CIMINO, RONALD ALLEN ...... CHIEF, CRIMINAL ENFORCEMENT SECTION, WESTERN REGION. MELAND, DEBORAH ...... CHIEF, OFFICE OF REVIEW. HYTKEN, LOUISE P ...... CHIEF, CIVIL TRIAL SECTION, SOUTHWESTERN REGION. HUBBERT, DAVID A ...... CHIEF, CIVIL TRIAL SECTION, EASTERN REGION. YOUNG, JOSEPH E ...... EXECUTIVE OFFICER. HECHTKOPF, ALAN ...... CHIEF, CRIMINAL APPEALS AND TAX ENFORCEMENT POLICY SECTION.

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Name Position title

U.S. Marshals Service—USMS

DOLAN, EDWARD ...... SPECIAL ASSISTANT FOR FINANCIAL SYSTEMS. CALLAGHAN, DARLA KAY ...... ASSISTANT DIRECTOR, HUMAN RESOURCES. JONES, SYLVESTER E ...... ASSISTANT DIRECTOR, WITNESS SECURITY. DONOVAN, DONALD S ...... ASSISTANT DIRECTOR, MANAGEMENT SUPPORT. PEARSON, MICHAEL A ...... ASSISTANT DIRECTOR, ASSET FORFEITURE. SYMONDS, CANDRA S ...... ASSISTANT DIRECTOR, PRISONER OPERATIONS. EARP, THOMAS M ...... ASSISTANT DIRECTOR, INVESTIGATIVE OPERATIONS. PROUT, MICHAEL J ...... ASSISTANT DIRECTOR, JUDICIAL SECURITY. FARMER, MARC A ...... ASSISTANT DIRECTOR, TRAINING. AUERBACH, GERALD ...... GENERAL COUNSEL. ROLSTAD, SCOTT C ...... ASSISTANT DIRECTOR FOR JUSTICE PRISONER AND ALIEN TRANSPORTATION SYS- TEM (JPATS). DAVIS, LISA M ...... ASSISTANT DIRECTOR, INFORMATION TECHNOLOGY. FINAN II, ROBERT J ...... ASSOCIATE DIRECTOR, OPERATIONS. DUDLEY, CHARLES C ...... ASSOCIATE DIRECTOR, ADMINISTRATION. SNELSON, WILLIAM D ...... ASSISTANT DIRECTOR, TACTICAL OPERATIONS.

[FR Doc. E9–19460 Filed 8–12–09; 8:45 am] correspondence. The NRC requires Because your comments will not be BILLING CODE 4410–AR–P certain licensees to use tamper- edited to remove any identifying or indicating devices (TIDs) for material contact information, the NRC cautions control and accounting (MC&A) and for you against including any information NUCLEAR REGULATORY physical security of special nuclear in your submission that you do not want COMMISSION material (SNM). Title 10, part 70, to be publicly disclosed. ‘‘Domestic Licensing of Special Nuclear The NRC requests that any party [NRC–2009–0353] Material,’’ of the Code of Federal soliciting or aggregating comments Draft Regulatory Guide: Issuance, Regulations (10 CFR part 70) requires, in received from other persons for Availability part, that no person subject to the submission to the NRC inform those regulations in 10 CFR part 70 may persons that the NRC will not edit their AGENCY: Nuclear Regulatory receive title to, own, acquire, deliver, comments to remove any identifying or Commission. receive, possess, use, or transfer SNM, contact information, and therefore, they ACTION: Notice of Issuance and except as authorized in a license issued should not include any information in Availability of Draft Regulatory Guide, by the NRC. their comments that they do not want DG–5029, ‘‘Pressure-Sensitive and This regulatory guide (RG) replaces publicly disclosed. You may submit Tamper-Indicating Device Seals for the existing RG 5.10, ‘‘Selection and Use comments by any of the following Material Control and Accounting Use.’’ of Pressure-Sensitive Seals on methods: Containers for Onsite Storage of Special 1. Mail comments to: Rulemaking and FOR FURTHER INFORMATION CONTACT: Nuclear Material,’’ issued July 1973 and Directives Branch, Mail Stop: TWB–05– Steven Ward, U.S. Nuclear Regulatory the existing RG 5.15, ‘‘Tamper- B01M, Office of Administration, U.S. Commission, Washington, DC 20555– Indicating Seals for the Protection and Nuclear Regulatory Commission, 0001, telephone: (301) 492–3426 or e- Control of Special Nuclear Material,’’ Washington, DC 20555–0001. mail to [email protected]. issued March 1997, with a new title, 2. Federal e-Rulemaking Portal: Go to SUPPLEMENTARY INFORMATION: ‘‘Pressure-Sensitive and Tamper- http://www.regulations.gov and search Indicating Device Seals for MC&A Use.’’ for documents filed under Docket ID I. Introduction RG 5.10 refers to a pressure-sensitive [NRC–2009–0353]. Address questions The U.S. Nuclear Regulatory () seal that is no longer in general use about NRC dockets to Carol Gallagher, Commission (NRC) is issuing for public and may no longer be commercially 301–492–3668; e-mail comment a draft guide in the agency’s available. RG 5.15 refers to tamper- [email protected]. ‘‘Regulatory Guide’’ series. This series indicating devices (TID) including PS 3. Fax comments to: Rulemaking and was developed to describe and make seals. As a replacement, this guide Directives Branch, Office of available to the public such information describes a number of improved TIDs Administration, U.S. Nuclear Regulatory as methods that are acceptable to the and PS seals developed in recent years Commission at (301) 492–3446. NRC staff for implementing specific primarily in response to commercial Requests for technical information parts of the NRC’s regulations, interests outside the nuclear industry. about DG–5029 may be directed to the techniques that the staff uses in NRC contact, Steven Ward at (301) 492– evaluating specific problems or II. Further Information 3426 or e-mail to [email protected]. postulated accidents, and data that the The NRC staff is soliciting comments Comments would be most helpful if staff needs in its review of applications on DG–5029. Comments may be received by October 13, 2009. for permits and licenses. accompanied by relevant information or Comments received after that date will The draft regulatory guide (DG), supporting data and should mention be considered if it is practical to do so, entitled, ‘‘Pressure-Sensitive and DG–5029 in the subject line. Comments but the NRC is able to ensure Tamper-Indicating Device Seals for submitted in writing or in electronic consideration only for comments Material Control and Accounting Use,’’ form will be made available to the received on or before this date. is temporarily identified by its task public in their entirety through the Although a time limit is given, number, DG–5029, which should be NRC’s Agencywide Documents Access comments and suggestions in mentioned in all related and Management System (ADAMS). connection with items for inclusion in

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guides currently being developed or I. Introduction To comply with the procedural improvements in all published guides requirements of E-Filing, at least ten are encouraged at any time. By letters dated November 6, 2008, (10) days prior to the filing deadline, the Electronic copies of DG–5029 are and July 8, 2009, the U.S. Army petitioner/requestor should contact the available through the NRC’s public Web Installation Command submitted a Office of the Secretary by e-mail at site under Draft Regulatory Guides in Source Material License application to [email protected], or by the ‘‘Regulatory Guides’’ collection of the Nuclear Regulatory Commission calling (301) 415–1677, to request: (1) A the NRC’s Electronic Reading Room at (NRC), for the Schofield Barracks and digital ID certificate, which allows the http://www.nrc.gov/reading-rm/doc- Pohakuloa Training Area (PTA) sites in participant (or its counsel or collections/. Electronic copies are also Oahu and the Island of Hawaii, Hawaii. representative) to digitally sign available in ADAMS (http:// This license application is for documents and access the E-Submittal www.nrc.gov/reading-rm/adams.html), possession of depleted uranium (DU) server for any proceeding in which it is under Accession No. ML091670070. due to the potential for residual DU to participating; and/or (2) creation of an In addition, regulatory guides are be at various Army Installations where electronic docket for the proceeding available for inspection at the NRC’s testing of the M101 Spotting Round has (even in instances in which the Public Document Room (PDR) located at occurred. petitioner/requestor (or its counsel or 11555 Rockville Pike, Rockville, An NRC administrative review, representative) already holds an NRC- Maryland. The PDR’s mailing address is documented in a letter to the U.S. Army issued digital ID certificate). Each USNRC PDR, Washington, DC 20555– Installation Command dated August 3, petitioner/requestor will need to 0001. The PDR can also be reached by 2009, found the generic and site specific download the Workplace Forms telephone at (301) 415–4737 or (800) security and environmental radiation ViewerTM to access the Electronic 397–4205, by fax at (301) 415–3548, and monitoring plans submitted by the Information Exchange (EIE), a by e-mail to [email protected]. applicant acceptable to begin a technical component of the E-Filing system. The Regulatory guides are not and environmental review. Before Workplace Forms ViewerTM is free and copyrighted, and Commission approval approving the license application, the is available at http://www.nrc.gov/site- is not required to reproduce them. NRC will need to make the findings help/e-submittals/install-viewer.html. required by the Atomic Energy Act of Information about applying for a digital Dated at Rockville, Maryland, this 6th day ID certificate is available on NRC’s of August, 2009. 1954, as amended, and the NRC’s regulations. These findings will be public Web site at http://www.nrc.gov/ For the Nuclear Regulatory Commission. site-help/e-submittals/apply- John N. Ridgely, documented in a Safety Evaluation Report (SER) and a site-specific certificates.html. Acting Chief, Regulatory Guide Development Once a petitioner/requestor has Branch, Division of Engineering, Office of Environmental Review consistent with the provisions of 10 CFR Part 51. obtained a digital ID certificate, had a Nuclear Regulatory Research. docket created, and downloaded the EIE [FR Doc. E9–19458 Filed 8–12–09; 8:45 am] II. Opportunity To Request a Hearing viewer, it can then submit a request for BILLING CODE 7590–01–P hearing or petition for leave to The NRC hereby provides notice that intervene. Submissions should be in this is a proceeding on an application Portable Document Format (PDF) in NUCLEAR REGULATORY for a source material license submitted accordance with NRC guidance COMMISSION by the U.S. Army Installation Command available on the NRC public Web site at to possess depleted uranium at the http://www.nrc.gov/site-help/e- [NRC–2009–0352; Docket No. 40–9083] Schofield Barracks and PTA sites in submittals.html. A filing is considered Oahu and the Island of Hawaii, Hawaii. complete at the time the filer submits its Notice of License Application Request Any person whose interest may be documents through EIE. To be timely, of U.S. Army Installation Command for affected by this proceeding and who an electronic filing must be submitted to Schofield Barracks, Oahu, HI, and desires to participate as a party must file the EIE system no later than 11:59 p.m. Pohakuloa Training Area, Island of a request for a hearing and a Eastern Time on the due date. Upon Hawaii, HI; and Notice of Opportunity specification of the contentions which receipt of a transmission, the E-Filing for Hearing the person seeks to have litigated in the system time-stamps the document and hearing in accordance with the NRC E- AGENCY: Nuclear Regulatory sends the submitter an e-mail notice Filing rule, which the NRC promulgated Commission. confirming receipt of the document. The on August 28, 2007 (72 FR 49139). All EIE system also distributes an e-mail ACTION: Notice of license application documents filed in NRC adjudicatory notice that provides access to the and opportunity to request a hearing. proceedings, including documents filed document to the NRC Office of the by interested governmental entities General Counsel and any others who DATES: A request for a hearing must be participating under 10 CFR 2.315(c) and filed by October 13, 2009. have advised the Office of the Secretary any motion or other document filed in that they wish to participate in the FOR FURTHER INFORMATION CONTACT: John the proceeding prior to the submission proceeding, so that the filer need not Hayes, Senior Project Manager, of a request for hearing or petition to serve the documents on those Materials Decommissioning Branch, intervene, must be filed in accordance participants separately. Therefore, Division of Waste Management and with the E-Filing rule. The E-Filing rule applicants and other participants (or Environmental Protection, Office of requires participants to submit and their counsel or representative) must Federal and State Materials and serve all adjudicatory documents over apply for and receive a digital ID Environmental Management Programs, the Internet or, in some cases, to mail certificate before a hearing request/ U.S. Nuclear Regulatory Commission, copies on electronic storage media. petition to intervene is filed so that they Washington, DC 20555. Telephone: Participants may not submit paper can obtain access to the document via (301) 415–5928; fax number: (301) 415– copies of their filings unless they seek the E-Filing system. 5369; e-mail: [email protected]. a waiver in accordance with the A person filing electronically using SUPPLEMENTARY INFORMATION: procedures described below. the agency’s adjudicatory e-filing system

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may seek assistance through the The formal requirements for supporting reasons for the requester’s/ ‘‘Contact Us’’ link located on the NRC documents contained in 10 CFR petitioner’s belief. Web site at http://www.nrc.gov/site- 2.304(c)–(e) must be met. If the NRC In addition, in accordance with 10 help/e-submittals.html or by calling the grants an electronic document CFR 2.309(f)(2), contentions must be NRC Meta-System Help Desk, which is exemption in accordance with 10 CFR based on documents or other available between 8 a.m. and 8 p.m., 2.302(g)(3), then the requirements for information available at the time the Eastern Time, Monday through Friday, paper documents, set forth in 10 CFR petition is to be filed, such as the excluding government holidays. The 2.304(b) must be met. application or other supporting Meta-System Help Desk can be In accordance with 10 CFR 2.309(b), document filed by an applicant or contacted by telephone at 1–866–672– a request for a hearing must be filed by licensee, or otherwise available to the 7640 or by e-mail at October 13, 2009. petitioner. The requester/petitioner may [email protected]. In addition to meeting other amend those contentions or file new Participants who believe that they applicable requirements of 10 CFR contentions if there are data or have a good cause for not submitting 2.309, a request for a hearing filed by a conclusions in the NRC documents that documents electronically must, in person other than an applicant must differ significantly from the data or accordance with 10 CFR 2.302(g), file an state: conclusions in the applicant’s exemption request with their initial 1. The name, address, and telephone documents. Otherwise, contentions may paper filing requesting authorization to number of the requester; be amended or new contentions filed continue to submit documents in paper 2. The nature of the requester’s right after the initial filing only with leave of format. Such filings must be submitted under the Act to be made a party to the the presiding officer. by: (1) first class mail addressed to the proceeding; Requesters/petitioners should, when possible, consult with each other in Office of the Secretary of the 3. The nature and extent of the preparing contentions and combine Commission, U.S. Nuclear Regulatory requester’s property, financial or other similar subject matter concerns into a Commission, Washington, DC 20555– interest in the proceeding; joint contention, for which one of the 0001, Attention: Rulemaking and 4. The possible effect of any decision co-sponsoring requesters/petitioners is Adjudications Staff; or (2) courier, or order that may be issued in the designated the lead representative. express mail, or expedited delivery proceeding on the requester’s interest; Further, in accordance with 10 CFR service to the Office of the Secretary, and 2.309(f)(3), any requester/petitioner that Sixteenth Floor, One White Flint North, 5. The circumstances establishing that wishes to adopt a contention proposed 11555 Rockville Pike, Rockville, the request for a hearing is timely in by another requester/petitioner must do Maryland 20852, Attention: Rulemaking accordance with 10 CFR 2.309(b). so, in accordance with the E–Filing rule, and Adjudications Staff. Participants In accordance with 10 CFR 2.309(f)(1), within ten days of the date the filing a document in this manner are a request for hearing or petition for contention is filed, and designate a responsible for serving the document on leave to intervene must set forth with representative who shall have the all other participants. Filing is particularity the contentions sought to authority to act for the requester/ considered complete by first-class mail be raised. For each contention, the petitioner. as of the time of deposit in the mail, or request or petition must: In accordance with 10 CFR 2.309(g), by courier, express mail, or expedited 1. Provide a specific statement of the a request for hearing and/or petition for delivery service upon depositing the issue of law or fact to be raised or leave to intervene may also address the document with the provider of the controverted; selection of the hearing procedures, service. 2. Provide a brief explanation of the taking into account the provisions of 10 Non-timely requests and/or petitions basis for the contention; CFR 2.310. and contentions will not be entertained 3. Demonstrate that the issue raised in absent a determination by the the contention is within the scope of the III. Further Information Commission, the presiding officer, or proceeding; Documents related to this action, the Atomic Safety and Licensing Board 4. Demonstrate that the issue raised in including the November 6, 2008, and that the petition and/or request should the contention is material to the July 8, 2009 application and the be granted and/or the contentions findings that the NRC must make to supporting documentation (i.e., should be admitted based on a support the action that is involved in Environmental Radiation Plan and balancing of the factors specified in 10 the proceeding; Security Plan), are available CFR 2.309(c)(1)(i)–(viii). 5. Provide a concise statement of the electronically at the NRC’s Electronic Documents submitted in adjudicatory alleged facts or expert opinions which Reading Room at http://www.nrc.gov/ proceedings will appear in NRC’s support the requester’s/petitioner’s reading-rm/adams.html. From this site, electronic hearing docket which is position on the issue and on which the you can access the NRC’s Agencywide available to the public at http:// requester/petitioner intends to rely to Document Access and Management ehd.nrc.gov/EHD_Proceeding/home.asp, support its position on the issue; and System (ADAMS), which provides text unless excluded pursuant to an order of 6. Provide sufficient information to and image files of NRC’s public the Commission, an Atomic Safety and show that a genuine dispute exists with documents. The ADAMS accession Licensing Board, or a Presiding Officer. the applicant on a material issue of law numbers for the documents related to Participants are requested not to include or fact. This information must include this notice are: ML090070095, ‘‘US social security numbers in their filings. references to specific portions of the Department of Army Installations With respect to copyrighted works, application that the requester/petitioner Application for Materials License;’’ except for limited excerpts that serve disputes and the supporting reasons for ML091950280, ‘‘Memorandum on the purpose of the adjudicatory filings each dispute, or, if the requester/ Security and Environmental Radiation and would constitute a Fair Use petitioner believes the application fails Monitoring Plans;’’ and ML092150316, application, participants are requested to contain information on a relevant ‘‘Acknowledgement of Receipt of not to include copyrighted materials in matter as required by law, the Generic and Site Specific Security and their submission. identification of each failure and the Environmental Radiation Monitoring

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Plans.’’ If you do not have access to lack of current and accurate information (‘‘SEC’’ or ‘‘Commission’’) the proposed ADAMS or if there are problems in concerning the securities of Verex rule change as described in Items I and accessing the documents located in Laboratories, Inc. because it has not II below, which Items have been ADAMS, contact the NRC Public filed any periodic reports since the prepared by the Exchange. Phlx has Document Room (PDR) Reference staff period ended March 31, 2002. designated the proposed rule change as at 1–800–397–4209, 301–415–4737 or It appears to the Securities and constituting a non-controversial rule by e-mail to [email protected] Exchange Commission that there is a change under Rule 19b–4(f)(6) under the These documents may also be viewed lack of current and accurate information Act,3 which renders the proposal electronically on the public computers concerning the securities of Vibro-Tech effective upon filing with the located at the NRC’s Public Document Industries, Inc. because it has not filed Commission. The Commission is Room (PDR), O 1 F21, One White Flint any periodic reports since it filed a publishing this notice to solicit North, 11555 Rockville Pike, Rockville, Form 10–SB on January 5, 2000. comments on the proposed rule change MD 20852. The PDR reproduction It appears to the Securities and from interested persons. contractor will copy documents for a Exchange Commission that there is a fee. lack of current and accurate information I. Self-Regulatory Organization’s Dated at Rockville, Maryland, this 5th day concerning the securities of Video City, of August, 2009. Inc. because it has not filed any periodic Statement of the Terms of Substance of the Proposed Rule Change For the Nuclear Regulatory Commission. reports since the period ended July 31, Keith McConnell, 2003. The Exchange proposes to amend It appears to the Securities and Deputy Director, Phlx Rule 506 (Allocation Application) Exchange Commission that there is a regarding automatic allocation of Decommissioning and Uranium Recovery, lack of current and accurate information options on related securities. Licensing Directorate, Division of Waste Management and Environmental Protection, concerning the securities of Vidikron The text of the proposed rule change Office of Federal and State Materials and Technologies Group, Inc. because it has is available on the Exchange’s Web site Environmental Management Programs. not filed any periodic reports since the at http:// [FR Doc. E9–19449 Filed 8–12–09; 8:45 am] period ended March 31, 1999. nasdaqomxphlx.cchwallstreet.com/ NASDAQOMXPHLX/Filings/, at the BILLING CODE 7590–01–P The Commission is of the opinion that the public interest and the protection of principal office of the Exchange, and at investors require a suspension of trading the Commission’s Public Reference Room. SECURITIES AND EXCHANGE in the securities of the above-listed COMMISSION companies. II. Self-Regulatory Organization’s Therefore, it is ordered, pursuant to Statement of the Purpose of, and [File No. 500–1] Section 12(k) of the Securities Exchange Statutory Basis for, the Proposed Rule Act of 1934, that trading in the Change In the Matter of V–Twin Holdings, Inc. securities of the above-listed companies (n/k/a Tobacco One, Inc.), Valley Media, is suspended for the period from 9:30 In its filing with the Commission, the Inc., Venturequest Group, Inc. (n/k/a a.m. EDT on August 11, 2009, through Exchange included statements Dex-Ray Resources, Inc.), Verex 11:59 p.m. EDT on August 24, 2009. concerning the purpose of and basis for Laboratories, Inc., Vibro-Tech the proposed rule change and discussed Industries, Inc., Video City, Inc., and By the Commission. any comments it received on the Vidikron Technologies Group, Inc.; Jill M. Peterson, proposed rule change. The text of these Order of Suspension of Trading Assistant Secretary. statements may be examined at the [FR Doc. E9–19486 Filed 8–11–09; 8:45 am] places specified in Item IV below. The August 11, 2009. BILLING CODE 8010–01–P Exchange has prepared summaries, set It appears to the Securities and forth in sections A, B, and C below, of Exchange Commission that there is a the most significant aspects of such lack of current and accurate information SECURITIES AND EXCHANGE statements. concerning the securities of V–Twin COMMISSION Holdings, Inc. (n/k/a Tobacco One, Inc.) A. Self-Regulatory Organization’s because it has not filed any periodic [Release No. 34–60455; File No. SR–Phlx– Statement of the Purpose of, and 2009–62] reports since the period ended March Statutory Basis for, the Proposed Rule Change 31, 2001. Self-Regulatory Organizations; It appears to the Securities and NASDAQ OMX PHLX, Inc.; Notice of 1. Purpose Exchange Commission that there is a Filing and Immediate Effectiveness of The amendments proposed to Phlx lack of current and accurate information a Proposed Rule Change Relating to Rule 506 are based on and similar to concerning the securities of Valley Automatic Allocations of Options on Commentary .05 to AMEX Rule 27.4 Media, Inc. because it has not filed any Related Securities The purpose of the proposed rule periodic reports since the period ended change is to amend Rule 506 to indicate September 29, 2001. August 6, 2009. It appears to the Securities and Pursuant to Section 19(b)(1) of the 3 17 CFR 240.19b–4(f)(6). Exchange Commission that there is a Securities Exchange Act of 1934 4 See Securities Exchange Act Release No. 45260 lack of current and accurate information (‘‘Act’’) 1 and Rule 19b–4 2 thereunder, (January 9, 2002), 67 FR 2255 (January 16, 2002) concerning the securities of (SR–AMEX–2001–19) (approval order regarding notice is hereby given that on July 31, AMEX Rules 26 and 27). See also Securities Venturequest Group, Inc. (n/k/a Dex- 2009, NASDAQ OMX PHLX, Inc. Exchange Act Release No. 44972 (October 23, 2001), Ray Resources, Inc.), because it has not (‘‘Phlx’’ or ‘‘Exchange’’) filed with the 66 FR 55031 (October 31, 2001)(SR–AMEX–2001– filed any periodic reports since the Securities and Exchange Commission 19) (notice of filing regarding, among other things, Commentary .05 to AMEX Rule 27). The American period ended September 30, 2001. Stock Exchange LLC was purchased in 2008 by It appears to the Securities and 1 15 U.S.C. 78s(b)(1). NYSE Euronext and is now known as NYSE Amex Exchange Commission that there is a 2 17 CFR 240.19b–4. LLC (AMEX).

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that new options that are related to proceeding (‘‘Allocation Preclusion’’).10 trading allocated related options if the currently allocated options (‘‘Related The current Allocation Rules do not Exchange determines that the trading Options’’) shall be automatically contain guidelines regarding allocation characteristics of the Related Options to allocated to the specialist unit that is of Related Options. be allocated are similar to the already already the current specialist in This filing would amend Rule 506 to allocated options.13 option(s) on the underlying security(ies) clarify that Related Options will be The following example illustrates (‘‘Current Specialist’’).5 If the Related automatically allocated, under how the proposed allocation process Options are not automatically allocated, conditions set forth in new would work. In 2008, Wachovia the Exchange may, nonetheless, allocate Supplementary Material .02, to the Corporation (WB) was acquired by the Related Options to the Current Current Specialist that is already Wells Fargo & Company (WFC), with Specialist if the Exchange determines allocated options overlying securities WFC being the surviving company (the that the trading characteristics of the that are related to securities that the ‘‘merger’’). At the time of the merger, Related Options to be allocated are new options overly. which was effective December 31, 2008, similar to the options already allocated In particular, Supplementary Material options on the surviving company WFC to the Current Specialist. 6 .02 in subsection (a) defines the term were already listed and being traded by The allocation and re-allocation ‘‘Related Securities’’ 11 underlying one specialist (the ‘‘WFC Specialist’’) process for classes of options to options to mean, but not be limited to: and options on WB were listed and • specialist units and individual Securities of a partially or wholly being traded on the Exchange by specialists on the Exchange is found in owned subsidiary; another specialist (the ‘‘WB Specialist’’). • Rules 500–599 (the ‘‘Allocation Rules’’), Securities that are convertible into Under the current allocation structure, which rules are administered by the the securities of the issuer; the WB Specialist would have to 7 • exchange. The Allocation Rules also Warrants on securities of the issuer; continue to act as a specialist vis a vis • Securities issued in connection deal with, among other things: WB options for the purpose of trading with a name change; application for becoming and the adjusted WB option series until all • Securities issued in a reverse stock appointment of specialists; application open interest traded out or expired. The split; for becoming and approval of Streaming WFC Specialist would, at the same time, Quote Traders (‘‘SQTs’’) 8 and Remote • Contingent value rights; • trade the WFC options. Under the Streaming Quote Traders (‘‘RSQTs’’) 9 ‘‘Tracking’’ securities designed to track the performance of the underlying automatic allocation process proposed and assignment of options to them; and in this filing, in that WFC and WB specialist, SQT, and RSQT performance security or corporate affiliate thereof; • would be Related Securities, WFC evaluations. The Allocation Rules also Securities created in connection with the merger or acquisition of one or options would be Currently Allocated indicate under what circumstances new Options, the WFC Specialist would be allocations may not be made. more companies; • the Current Specialist, and the adjusted Supplementary Material .01 to Rule 506, Securities created in connection with a ‘‘spin-off’’ transaction; WB options series would be new as an example, states that a specialist • Related Options, by operation of may not apply for a new allocation for Convertible on non-convertible Supplementary Material .02, the Related a period of six months after an option senior securities; and • Options would be automatically allocation was taken away from the Securities into which a listed allocated to the Current Specialist. As specialist in a disciplinary proceeding security is convertible. such, the WFC Specialist would assume or an involuntary reallocation Where such Related Securities emanate from or are related to securities specialist privileges in the WFC options and the adjusted WB option series, 5 Exchange specialists are allocated classes of underlying options that are currently options by the Exchange in relation to assisting in allocated to a specialist on the Exchange therefore becoming the specialist for all the maintenance, insofar as reasonably practicable, (‘‘Currently Allocated Options’’). options related to the merger of WFC of a fair and orderly market in such options. See Subsection (b) to Supplementary and WB.14 Rule 1020. The Exchange believes that the 6 Related Options, Related Securities, and Current Material .02 goes on to state that while Specialist are defined in proposed Supplementary unallocated new Related Options shall automatic allocation of Related Options Material .02 to Rule 506. be automatically allocated to the to Current Specialists as proposed 7 See Rule 500. See also Securities Exchange Act Current Specialist, no automatic herein should increase the efficiency Release No. 59924 (May 14, 2009), 74 FR 23759 allocation can occur if the Current and speed of the allocation of options (May 20, 2009)(SR–Phlx–2009–23). that are logically related to each other, 8 An SQT is an Exchange Registered Options Specialist is subject, pursuant to Trader (‘‘ROT’’) who has received permission from Supplementary Material .01, to an to the benefit of Exchange members and the Exchange to generate and submit option Allocation Preclusion because of a traders and the public.15 quotations electronically in eligible options to disciplinary proceeding or involuntary which such SQT is assigned. An SQT may only 2. Statutory Basis 12 submit such quotations while such SQT is reallocation proceeding. Where there physically present on the floor of the Exchange. See is no automatic allocation the Exchange The Exchange believes that its Rule 1014(b)(ii)(A). See also Securities Exchange may decide to allocate Related Options proposal is consistent with Section 6(b) Act Release No. 59995 (May 28, 2009), 74 FR 26750 to the Current Specialist that is already of the Act 16 in general, and furthers the (June 3, 2009)(approval order regarding enhancements to opening, linkage and routing, quoting, and order management processes in the 10 See Rule 960 et seq. for disciplinary procedures 13 An ETF (only) specialist will not be eligible to Exchange’s electronic options order entry, trading, and Allocation Rules for reallocation procedures. receive automatic allocations for the duration of the and execution system PHLX XL II.) [sic] 11 For purposes of Supplementary Material .02, Allocation Preclusion applicable to him or her. 9 An RSQT is an ROT that is a member or member Related Securities does not mean Exchange Traded 14 It is assumed, for purposes of this example, that organization with no physical trading floor Funds. the Current Specialist is not subject to an Allocation presence who has received permission from the 12 Although automatic allocation of New Options Preclusion as defined in Supplementary Material Exchange to generate and submit option quotations pursuant to Supplementary Material .02 will not .01. electronically in eligible options to which such require the Exchange to make an allocation 15 The Exchange has made conforming, technical RSQT has been assigned. An RSQT may only determination as it would with regular option changes to proposed Rule 506 to integrate the submit such quotations electronically from off the allocations, the Exchange will continue to perform proposed language into its current rules and to floor of the Exchange. See Exchange Rule other allocation-related duties such as, for example, correct a typographical error. 1014(b)(ii)(B). written notification. See Rule 506. 16 15 U.S.C. 78f(b).

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objectives of Section 6(b)(5) of the Act 17 Electronic Comments SECURITIES AND EXCHANGE in particular, in that it is designed to • COMMISSION promote just and equitable principles of Use the Commission’s Internet comment form (http://www.sec.gov/ [Release No. 34–60454; File No. SR–CBOE– trade, to remove impediments to and 2009–054] perfect the mechanism of a free and rules/sro.shtml); or open market and a national market • Send an e-mail to rule- Self-Regulatory Organizations; system, and, in general to protect [email protected]. Please include File Chicago Board Options Exchange, investors and the public interest, by Number SR–Phlx–2009–62 on the Incorporated; Notice of Filing and providing for automatic allocation to an subject line. Immediate Effectiveness of Proposed Exchange specialist of options that are Rule Change To Amend the Marketing related to each other. Paper Comments Fee Program • B. Self-Regulatory Organization’s Send paper comments in triplicate August 6, 2009. Statement on Burden on Competition to Elizabeth M. Murphy, Secretary, Pursuant to Section 19(b)(1) of the Securities and Exchange Commission, The Exchange does not believe that Securities Exchange Act of 1934 the proposed rule change will impose 100 F Street, NE., Washington, DC (‘‘Act’’),1 and Rule 19b–4 thereunder,2 any burden on competition not 20549–1090. notice is hereby given that on July 31, necessary or appropriate in furtherance All submissions should refer to File 2009, the Chicago Board Options of the purposes of the Act. Number SR–Phlx–2009–62. This file Exchange, Incorporated (‘‘CBOE’’ or the number should be included on the ‘‘Exchange’’) filed with the Securities C. Self-Regulatory Organization’s and Exchange Commission subject line if e-mail is used. To help the Statement on Comments on the (‘‘Commission’’) the proposed rule Commission process and review your Proposed Rule Change Received From change as described in Items I, II, and Members, Participants or Others comments more efficiently, please use III below, which Items have been only one method. The Commission will prepared by the CBOE. CBOE has No written comments were either post all comments on the Commission’s solicited or received. designated this proposal as one Internet Web site (http://www.sec.gov/ establishing or changing a due, fee, or III. Date of Effectiveness of the rules/sro.shtml). Copies of the other charge applicable only to a Proposed Rule Change and Timing for submission, all subsequent member under Section 19(b)(3)(A)(ii) of Commission Action amendments, all written statements the Act 3 and Rule 19b–4(f)(2) with respect to the proposed rule 4 Because the foregoing proposed rule thereunder, which renders the proposal change that are filed with the change does not: (i) Significantly affect effective upon filing with the Commission, and all written the protection of investors or the public Commission. The Commission is interest; (ii) impose any significant communications relating to the publishing this notice to solicit burden on competition; and (iii) become proposed rule change between the comments on the proposed rule change operative for 30 days from the date on Commission and any person, other than from interested parties. which it was filed, or such shorter time those that may be withheld from the I. Self-Regulatory Organization’s as the Commission may designate, it has public in accordance with the Statement of the Terms of Substance of become effective pursuant to Section provisions of 5 U.S.C. 552, will be the Proposed Rule Change 19(b)(3)(A) of the Act 18 and Rule 19b– available for inspection and copying in CBOE proposes to amend its 4(f)(6) thereunder.19 the Commission’s Public Reference Room, 100 F Street, NE., Washington, Marketing Fee Program. The text of the At any time within 60 days of the proposed rule change is available on the DC 20549, on official business days filing of the proposed rule change, the Exchange’s Web site (http:// between the hours of 10 a.m. and 3 p.m. Commission may summarily abrogate www.cboe.org/Legal/), at the Exchange’s Copies of such filing also will be such rule change if it appears to the Office of the Secretary, and at the Commission that such action is available for inspection and copying at Commission. necessary or appropriate in the public the principal office of the Exchange. All interest, for the protection of investors, comments received will be posted II. Self-Regulatory Organization’s or otherwise in furtherance of the without change; the Commission does Statement of the Purpose of, and purposes of the Act. not edit personal identifying Statutory Basis for, the Proposed Rule Change IV. Solicitation of Comments information from submissions. You should submit only information that In its filing with the Commission, Interested persons are invited to you wish to make publicly available. All CBOE included statements concerning submit written data, views, and submissions should refer to File the purpose of and basis for the arguments concerning the foregoing, Number SR–Phlx–2009–62 and should proposed rule change and discussed any including whether the proposed rule be submitted on or before September 3, comments it received on the proposed change is consistent with the Act. 2009. rule change. The text of these statements Comments may be submitted by any of may be examined at the places specified the following methods: For the Commission, by the Division of in Item IV below. The CBOE has Trading and Markets, pursuant to delegated prepared summaries, set forth in authority.20 17 15 U.S.C. 78f(b)(5). sections (A), (B), and (C) below, of the 18 15 U.S.C. 78s(b)(3)(A). Florence E. Harmon, most significant aspects of such 19 17 CFR 240.19b–4(f)(6). In addition, Rule 19b– Deputy Secretary. statements. 4(f)(6) requires a self-regulatory organization to give [FR Doc. E9–19374 Filed 8–12–09; 8:45 am] the Commission written notice of its intent to file 1 the proposed rule change at least five business days BILLING CODE 8010–01–P 15 U.S.C. 78s(b)(1). prior to the date of filing of the proposed rule 2 17 CFR 240.19b–4. change, or such shorter time as designated by the 3 15 U.S.C. 78s(b)(3)(A)(ii). Commission. Phlx has satisfied this requirement. 20 17 CFR 200.30–3(a)(12). 4 17 CFR 240.19b–4(f)(2).

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A. Self-Regulatory Organization’s the same trading privileges.) Today, as other charges among persons using its Statement of the Purpose of, and Rule 8.3(c)(i) makes clear, Market- facilities. Statutory Basis for, the Proposed Rule Makers create customized class B. Self-Regulatory Organization’s Change appointments, called ‘‘virtual trading Statement on Burden on Competition crowd’’ appointments, which allow (a) Purpose Market-Makers to quote electronically CBOE does not believe that the Currently, CBOE’s marketing fee is into various option classes irrespective proposed rule change will impose any assessed only on transactions of Market- of their geographic location on CBOE’s burden on competition that is not Makers, e-DPMs, and DPMs, resulting trading floor. Additionally, as Rule necessary or appropriate in furtherance from (i) orders for less than 1,000 8.3(c)(ii) states, Market-Makers have an of [sic] purposes of the Act. contracts from payment accepting firms, appointment to trade in open outcry in C. Self-Regulatory Organization’s or (ii) customer orders for less than all Hybrid classes traded on CBOE, Statement on Comments on the 1,000 contracts that have designated a meaning that they are free to go from Proposed Rule Change Received From ‘‘Preferred Market-Maker’’ under CBOE trading crowd to trading crowd to trade Members, Participants, or Others Rule 8.13. CBOE proposes to amend its in open outcry in any Hybrid option marketing fee program such that the fee class. Market-Makers are not required to No written comments were solicited will be assessed on transactions of be on the trading floor to submit or received with respect to the proposed Market-Makers, e-DPMs, and DPMs electronic quotations into their rule change. resulting from customer orders for less appointed classes (see Rule 8.3(c)(v)) III. Date of Effectiveness of the than 1,000 contracts from payment and also are permitted to enter orders accepting firms. CBOE believes that Proposed Rule Change and Timing for electronically in non-appointed option Commission Action limiting the collection of the fee to classes (see Rule 8.7(b)(iii)B). Also, transactions resulting from customer CBOE has established Off-Floor DPMs, Because the foregoing rule change orders for less than 1,000 contracts from and the option classes formerly located establishes or changes a due, fee, or payment accepting firms is appropriate at one trading station can be relocated other charge imposed by the Exchange, and will continue to allow its DPMs to among various trading stations—even it has become effective pursuant to compete for order flow.5 though the same DPM organization Section 19(b)(3)(A) of the Act 8 and CBOE will continue to assess the fee continues to function now as the Off- subparagraph (f)(2) of Rule 19b–4 9 on transactions resulting from customer Floor DPM. As a result of all of these thereunder. At any time within 60 days orders for less than 1,000 contracts that changes, this limitation has become of the filing of the proposed rule change, have designated a ‘‘Preferred Market- unnecessary. the Commission may summarily Maker’’ under CBOE Rule 8.13. CBOE For an example of this proposed abrogate such rule change if it appears proposes to implement this change to change, assume the same DPM operated to the Commission that such action is the marketing fee program beginning on at two different trading stations on necessary or appropriate in the public August 1, 2009. CBOE’s trading floor: Station 1 and interest, for the protection of investors, Additionally, CBOE proposes to Station 5. If $10,000 was generated from or otherwise in furtherance of the amend the marketing fee program to the marketing fee in a given month from purposes of the Act. eliminate a limitation pertaining to the transactions in option classes located at IV. Solicitation of Comments manner in which DPMs use the funds Station 1 and $15,000 from Station 5, made available to them to attract order under CBOE’s proposed change a total Interested persons are invited to flow to CBOE. Currently, the funds of $25,000 would be made available to submit written data, views, and made available to DPMs can only be the DPM for the month, and the DPM arguments concerning the foregoing, used to attract orders in the option could use the funds to attract order flow including whether the proposed rule classes at the trading station where the in the option classes located at Stations change is consistent with the Act. fee is assessed. CBOE imposed this 1 and 5. (This example assumes none of Comments may be submitted by any of limitation at a time when CBOE Market- these funds were made available to the following methods: Makers’ appointments consisted of Preferred Market-Makers.) CBOE those option classes located at a Electronic Comments believes that this is fair and reasonable particular trading station. Market- • in light of the manner in which Market- Use the Commission’s Internet Makers were required by rule to be Makers function today on CBOE as comment form (http://www.sec.gov/ physically present in the trading station rules/sro.shtml); or described above. • in order to quote electronically into the Finally, CBOE proposes to delete Send an e-mail to rule- classes at that station. As a result (and reference in footnote 6 to two option [email protected]. Please include File as discussed in CBOE’s rule filing SR– classes it no longer trades: BXO and Number SR–CBOE–2009–054 on the CBOE–2004–58; Rel. No. 34–51429), RUH. subject line. Market-Makers effectively had a ‘‘one- CBOE is not amending its marketing Paper Comments station’’ appointment. fee program in any other respects. CBOE subsequently amended its rules • Send paper comments in triplicate to provide the same flexibility to its on- (b) Statutory Basis to Elizabeth M. Murphy, Secretary, floor Market-Makers that its former The Exchange believes that the Securities and Exchange Commission, Remote Market-Makers (‘‘RMM’’) had. proposed rule change is consistent with 100 F Street, NE., Washington, DC (CBOE eliminated its RMM program a Section 6(b) of the Act 6 in general, and 20549–1090. couple years ago and all former RMMs furthers the objectives of Section 6(b)(4) All submissions should refer to File were designated as Market-Makers with of the Act 7 in particular, in that it is Number SR–CBOE–2009–054. This file designed to provide for the equitable number should be included on the 5 CBOE notes that in the past, its marketing fee allocation of reasonable dues, fees, and subject line if e-mail is used. To help the was assessed on transactions resulting from customer orders. See Securities Exchange Act Rel. No. 34–50736 (11/24/04), 69 FR 69966 (12/1/04) 6 15 U.S.C. 78f(b). 8 15 U.S.C. 78s(b)(3)(A). (SR–CBOE–2004–68). 7 15 U.S.C. 78f(b)(4). 9 17 CFR 240.19b–4(f)(2).

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Commission process and review your III below, which Items have been and other charges among its members comments more efficiently, please use prepared by the Exchange. The and other market participants that use only one method. The Commission will Exchange filed the proposed rule change the trading facilities of NYSE Amex post all comments on the Commission’s pursuant to Section 19(b)(3)(A) of the Options. Under this proposal, all Internet Web site (http://www.sec.gov/ Act 4 and Rule 19b–4(f)(2) thereunder,5 similarly situated members and other rules/sro.shtml). Copies of the which renders the proposal effective Exchange participants of NYSE Amex submission, all subsequent upon filing with the Commission. The Options will be charged the same amendments, all written statements Commission is publishing this notice to reasonable dues, fees and other charges. with respect to the proposed rule solicit comments on the proposed rule change that are filed with the change from interested persons. B. Self-Regulatory Organization’s Commission, and all written Statement on Burden on Competition I. Self-Regulatory Organization’s communications relating to the The Exchange does not believe that Statement of the Terms of Substance of proposed rule change between the the proposed rule change will impose the Proposed Rule Change Commission and any person, other than any burden on competition that is not those that may be withheld from the The Exchange proposes to amend its necessary or appropriate in furtherance public in accordance with the Schedule of Fees and Charges for of the purposes of the Act. provisions of 5 U.S.C. 552, will be Exchange Services (‘‘Schedule’’) by available for inspection and copying in waiving the Cancellation Fee until C. Self-Regulatory Organization’s the Commission’s Public Reference November 1, 2009. The Schedule is Statement on Comments on the Room on official business days between attached as Exhibit 5 to the 19b–4 form. Proposed Rule Change Received From the hours of 10 a.m. and 3 p.m. Copies A copy of this filing is available on the Members, Participants, or Others of such filing also will be available for Exchange’s Web site at http:// No written comments were solicited inspection and copying at the principal www.nyse.com, at the Exchange’s or received with respect to the proposed office of CBOE. All comments received principal office and at the Commission’s rule change. will be posted without change; the Public Reference Room. III. Date of Effectiveness of the Commission does not edit personal II. Self-Regulatory Organization’s identifying information from Proposed Rule Change and Timing for Statement of the Purpose of, and Commission Action submissions. You should submit only Statutory Basis for, the Proposed Rule information that you wish to make Change The foregoing rule change is effective available publicly. All submissions upon filing pursuant to Section should refer to File Number SR–CBOE– In its filing with the Commission, the 19(b)(3)(A) 6 of the Act and 2009–054 and should be submitted on self-regulatory organization included subparagraph (f)(2) of Rule 19b–4 7 or before September 3, 2009. statements concerning the purpose of, thereunder, because it establishes a due, and basis for, the proposed rule change fee, or other charge imposed by the For the Commission, by the Division of and discussed any comments it received Trading and Markets, pursuant to delegated NYSE Amex. authority.10 on the proposed rule change. The text At any time within 60 days of the of those statements may be examined at Florence E. Harmon, filing of the proposed rule change, the the places specified in Item IV below. Deputy Secretary. Commission may summarily abrogate The Exchange has prepared summaries, such rule change if it appears to the [FR Doc. E9–19376 Filed 8–12–09; 8:45 am] set forth in sections A, B, and C below, BILLING CODE 8010–01–P Commission that such action is of the most significant parts of such necessary or appropriate in the public statements. interest, for the protection of investors, SECURITIES AND EXCHANGE A. Self-Regulatory Organization’s or otherwise in furtherance of the COMMISSION Statement of the Purpose of, and the purposes of the Act. Statutory Basis for, the Proposed Rule [Release No. 34–60452; File No. SR– IV. Solicitation of Comments Change NYSEAmex–2009–54] Interested persons are invited to 1. Purpose Self-Regulatory Organizations; NYSE submit written data, views, and Amex LLC; Notice of Filing and The Exchange proposes to waive the arguments concerning the foregoing, Immediate Effectiveness of Proposed Cancellation Fee until November 1, including whether the proposed rule Rule Change Implementing Its 2009. The Cancellation Fee was change is consistent with the Act. Schedule of Fees and Charges for scheduled to take effect on August 1, Comments may be submitted by any of Exchange Services 2009, however, the required the following methods: development to Exchange billing Electronic Comments August 5, 2009. systems has not been completed. Those Pursuant to Section 19(b)(1) 1 of the system enhancements are scheduled to • Use the Commission’s Internet Securities Exchange Act of 1934 (the be implemented for the November comment form (http://www.sec.gov/ ‘‘Act’’) 2 and Rule 19b–4 thereunder,3 billing cycle that begins on November 1, rules/sro.shtml); or notice is hereby given that, on July 31, 2009. • Send an e-mail to rule- 2009, NYSE Amex LLC (‘‘NYSE Amex’’ [email protected]. Please include File 2. Statutory Basis or the ‘‘Exchange’’) filed with the Number SR–NYSEAmex–2009–54 on Securities and Exchange Commission The Exchange believes that the the subject line. proposal is consistent with Section 6(b) (the ‘‘Commission’’) the proposed rule Paper Comments change as described in Items I, II, and of the Act, in general, and Section 6(b)(4), in particular, in that it provides • Send paper comments in triplicate 10 17 CFR 200.30–3(a)(12). for the equitable allocation of dues, fees to Elizabeth M. Murphy, Secretary, 1 15 U.S.C. 78s(b)(1). 2 15 U.S.C. 78a. 4 15 U.S.C. 78s(b)(3)(A). 6 15 U.S.C. 78s(b)(3)(A). 3 17 CFR 240.19b–4. 5 17 CFR 240.19b–4(f)(2). 7 17 CFR 240.19b–4(f)(2).

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Securities and Exchange Commission, (‘‘Act’’) 1 and Rule 19b–4 thereunder,2 A Sponsored Participant is a non- 100 F Street, NE., Washington, DC notice is hereby given that on July 29, member of the Exchange, such as an 20549–1090. 2009, NASDAQ OMX PHLX, Inc. institutional investor, that gains access All submissions should refer to File (‘‘Phlx’’ or ‘‘Exchange’’) filed with the to the Exchange and trades under a Number SR–NYSEAmex–2009–54. This Securities and Exchange Commission Sponsoring Member’s execution and file number should be included on the (‘‘Commission’’) the proposed rule clearing identity pursuant to a subject line if e-mail is used. To help the change as described in Items I and II sponsorship arrangement between such Commission process and review your below, which Items have been prepared non-member and a member comments more efficiently, please use by the Exchange. The Commission is organization. Specifically, the Exchange only one method. The Commission will publishing this notice to solicit proposes to permit Sponsored post all comments on the Commission’s comments on the proposed rule change Participants to be sponsored by Internet Web site (http://www.sec.gov/ from interested persons. Sponsoring Member Organizations, and thereby access the Exchange, subject to rules/sro.shtml). Copies of the I. Self-Regulatory Organization’s certain requirements. These submission, all subsequent Statement of the Terms of Substance of requirements are intended to confirm amendments, all written statements the Proposed Rule Change with respect to the proposed rule that the Sponsored Participant is change that are filed with the The Exchange proposes to renew its required to and had procedures in place Commission, and all written sponsored access rule for a pilot period to comply with Exchange rules, and that communications relating to the ending on October 29, 2009. The the Sponsoring Member Organization 3 proposed rule change between the program expires on July 29, 2009. The takes responsibility for the Sponsored Commission and any person, other than text of the proposed rule change is Participant’s activity on the Exchange. those that may be withheld from the available on the Exchange’s Web site at First, the Sponsored Participant and public in accordance with the http://www.nasdaqtrader.com/ its Sponsoring Member Organization provisions of 5 U.S.C. 552, will be micro.aspx?id=PHLXRulefilings, at the must have entered into and maintained available for inspection and copying in principal office of the Exchange, and at an Access Agreement with the the Commission’s Public Reference the Commission’s Public Reference Exchange. The Sponsoring Member Room, 100 F Street, NE., Washington, Room. Organization must designate the DC 20549, on official business days II. Self-Regulatory Organization’s Sponsored Participant by name in an between the hours of 10 a.m. and 3 p.m. Statement of the Purpose of, and addendum to the Access Agreement. Copies of the filing also will be available Statutory Basis for, the Proposed Rule Second, there must be a Sponsored for inspection and copying at the Change Participant Agreement between the Sponsoring Member Organization and principal office of the Exchange. All In its filing with the Commission, the comments received will be posted the Sponsored Participant that contains self-regulatory organization included the following sponsorship provisions, without change; the Commission does statements concerning the purpose of, not edit personal identifying enumerated in full in Rule 1094(b)(ii): and basis for, the proposed rule change (i) The orders of the Sponsored information from submissions. You and discussed any comments it received should submit only information that Participant are binding in all respects on on the proposed rule change. The text the Sponsoring Member Organization; you wish to make available publicly. All of those statements may be examined at submissions should refer to File (ii) The Sponsoring Member the places specified in Item IV below. Organization is responsible for the Number SR–NYSEAmex–2009–54 and The Exchange has prepared summaries, should be submitted on or before actions of the Sponsored Participant; set forth in sections A, B, and C below, (iii) In addition to the Sponsoring September 3, 2009. of the most significant aspects of such Member Organization being required to For the Commission, by the Division of statements. comply with the Exchange Certificate of Trading and Markets, pursuant to delegated Incorporation, By-laws, Rules and authority.8 A. Self-Regulatory Organization’s Statement of the Purpose of, and procedures of the Exchange, the Florence E. Harmon, Sponsored Participant shall do so as if Deputy Secretary. Statutory Basis for, the Proposed Rule Change such Sponsored Participant were an [FR Doc. E9–19375 Filed 8–12–09; 8:45 am] Exchange member organization; BILLING CODE 8010–01–P 1. Purpose (iv) The Sponsored Participant shall The purpose of the proposed rule maintain, keep current and provide to change is to attract additional business the Sponsoring Member Organization a SECURITIES AND EXCHANGE by renewing its sponsored access rule, list of individuals authorized to obtain COMMISSION which is similar to that of other access to the Exchange on behalf of the [Release No. 34–60456; File No. SR–Phlx– exchanges. During the previous pilot Sponsored Participant; 2009–63] program, no member organizations (v) The Sponsored Participant shall availed themselves of the program, but familiarize its authorized individuals Self-Regulatory Organizations; the Exchange seeks to make another with all of the Sponsored Participant’s NASDAQ OMX PHLX, Inc.; Notice of attempt to institute the program, for a obligations under this Rule and will Filing and Immediate Effectiveness of pilot period expiring October 29, 2009. assure that they receive appropriate a Proposed Rule Change Relating to The Exchange will evaluate whether to training prior to any use or access to the Extension of Sponsored Access Pilot continue the sponsored access program Exchange; Program or not. (vi) The Sponsored Participant may not permit anyone other than authorized August 7, 2009. 1 15 U.S.C. 78s(b)(1). individuals to use or obtain access to Pursuant to Section 19(b)(1) of the 4 2 17 CFR 240.19b–4. the Exchange; Securities Exchange Act of 1934 3 See Securities Exchange Release No. 59362 (February 5, 2009), 74 FR 6931 (February 11, 2009) 4 If the Exchange determines that an authorized 8 17 CFR 200.30–3(a)(12). (SR–Phlx–2009–10). individual has caused a Member Organization to

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(vii) The Sponsored Participant shall C. Self-Regulatory Organization’s or otherwise in furtherance of the take reasonable security precautions to Statement on Comments on the purposes of the Act. prevent unauthorized use or access to Proposed Rule Change Received From the Exchange, including unauthorized Members, Participants, or Others IV. Solicitation of Comments entry of information into the Exchange, No written comments were either Interested persons are invited to and agrees that it is responsible for any solicited or received. submit written data, views and and all orders, trades and other arguments concerning the foregoing, messages and instructions entered, III. Date of Effectiveness of the Proposed Rule Change and Timing for including whether the proposed rule transmitted or received under change is consistent with the Act. identifiers, passwords and security Commission Action Comments may be submitted by any of codes of authorized individuals, and for Because the foregoing rule change the following methods: the trading and other consequences does not: (1) Significantly affect the thereof; protection of investors or the public Electronic Comments interest; (2) impose any significant (viii) The Sponsored Participant • Use the Commission’s Internet acknowledges its responsibility to burden on competition; and (3) become comment form (http://www.sec.gov/ establish adequate procedures and operative for 30 days after the date of this filing, or such shorter time as the rules/sro.shtml); or controls that permit it to effectively Commission may designate, it has monitor its employees’, agents’ and • Send an e-mail to rule- become effective pursuant to Section Participants’ use and access to the [email protected]. Please include File 19(b)(3)(A) of the Act 7 and Rule 19b– Exchange for compliance with the terms 8 Number SR–Phlx–2009–63 on the 4(f)(6) thereunder. subject line. of this agreement; A proposed rule change filed under (ix) The Sponsored Participant shall 19b–4(f)(6) normally may not become Paper Comments pay when due all amounts, if any, operative prior to 30 days after the date payable to Sponsoring Member of filing.9 However, Rule 19b– • Send paper comments in triplicate Organization, the Exchange, or any 4(f)(6)(iii) 10 permits the Commission to to Elizabeth M. Murphy, Secretary, other third parties that arise from the designate a shorter time if such action Securities and Exchange Commission, Sponsored Participant’s access to and is consistent with the protection of 100 F Street, NE., Washington, DC use of the Exchange. Such amounts investors and the public interest. The 20549–1090. include, but are not limited to Exchange has requested that the All submissions should refer to File applicable exchange and regulatory fees. Commission waive the 30-day operative Number SR–Phlx–2009–63. This file Third, the Sponsoring Member delay so that the proposal may become operative upon filing. The Commission number should be included on the Organization must provide the believes that waiving the 30-day subject line if e-mail is used. To help the Exchange with a Sponsored Participant operative delay is consistent with the Commission process and review your Addendum to its Access Agreement protection of investors and the public comments more efficiently, please use acknowledging its responsibility for the interest because such waiver would only one method. The Commission will orders, executions and actions of its allow the pilot program to continue post all comments on the Commission’s Sponsored Participant at issue. uninterrupted. The Commission notes Internet Web site (http://www.sec.gov/ 2. Statutory Basis that the proposal is substantially similar rules/sro.shtml). Copies of the to the rules of other national securities submission, all subsequent The Exchange believes that its exchanges.11 Accordingly, the amendments, all written statements proposal is consistent with Section 6(b) Commission hereby grants the with respect to the proposed rule 5 of the Act in general, and furthers the Exchange’s request and designates the change that are filed with the 6 objectives of Section 6(b)(5) of the Act proposal operative upon filing.12 Commission, and all written in particular, in that it is designed to At any time within 60 days of the communications relating to the filing of such proposed rule change the promote just and equitable principles of proposed rule change between the trade, to remove impediments to and Commission may summarily abrogate Commission and any person, other than perfect the mechanism of a free and such rule change if it appears to the those that may be withheld from the open market and a national market Commission that such action is public in accordance with the system, and, in general to protect necessary or appropriate in the public investors and the public interest by interest, for the protection of investors provisions of 5 U.S.C. 552, will be helping market participants seeking available for inspection and copying in access to a marketplace. 7 15 U.S.C. 78s(b)(3)(A). the Commission’s Public Reference 8 17 CFR 240.19b–4(f)(6). Room, on official business days between B. Self-Regulatory Organization’s 9 17 CFR 240.19b–4(f)(6)(iii). In addition, Rule the hours of 10 a.m. and 3 p.m. Copies Statement on Burden on Competition 19b–4(f)(6)(iii) requires that a self-regulatory of the filing also will be available for organization submit to the Commission written inspection and copying at the principal The Exchange does not believe that notice of its intent to file the proposed rule change, along with a brief description and text of the the proposed rule change will impose office of the Exchange. All comments proposed rule change, at least five business days received will be posted without change; any burden on competition not prior to the date of filing of the proposed rule necessary or appropriate in furtherance change, or such shorter time as designated by the the Commission does not edit personal of the purposes of the Act. Commission. The Exchange has satisfied the five- identifying information from day pre-filing notice requirement. submissions. You should submit only 10 Id. information that you wish to make violate the Exchange’s Rules, the Exchange could 11 See, e.g., International Securities Exchange, direct the Member Organization to suspend or LLC Rule 706 and NYSE Arca, Inc. Rule 7.29. available publicly. All submissions withdraw the person’s status as an authorized 12 For the purposes only of waiving the 30-day should refer to File Number SR–Phlx– individual. operative delay, the Commission has considered the 2009–63 and should be submitted on or 5 15 U.S.C. 78f(b). proposed rule’s impact on efficiency, competition, 6 15 U.S.C. 78f(b)(5). and capital formation. See 15 U.S.C. 78c(f). before September 3, 2009.

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For the Commission, by the Division of General Counsel and Chair of the modifications would be desirable to Trading and Markets, pursuant to delegated Section 301 Committee, (202) 395–3150, obtain a satisfactory solution with authority.13 for questions concerning procedures respect to the EC’s ban on U.S. beef. Florence E. Harmon, under Section 301. Accordingly, the Trade Representative Deputy Secretary. SUPPLEMENTARY INFORMATION: has decided to delay the effective date [FR Doc. E9–19407 Filed 8–12–09; 8:45 am] of the additional duties imposed under A. Background BILLING CODE 8010–01–P the January 15 modifications from On January 15, 2009, the Trade August 15, 2009 to September 19, 2009. Representative announced The actions to be delayed are: (i) The OFFICE OF THE UNITED STATES modifications (‘‘January 15 imposition of increased duties on TRADE REPRESENTATIVE modifications’’) to the action taken in additional products, (ii) the application July 1999 in connection with the World to products of additional EC member [Docket No. USTR–2009–0022] Trade Organization (‘‘WTO’’) States of the increased duties on authorization of the United States in the currently covered products, and (iii) the Implementation of the U.S.-EC Beef EC–Beef Hormones dispute to suspend increase in the level of duties on one of Hormones Memorandum of concessions and related obligations with the products that is being maintained on Understanding respect to the European Communities the product list. These are the same AGENCY: Office of the United States (‘‘EC’’). See 74 FR 4265 (Jan. 23, 2009). actions that were previously delayed Trade Representative. The January 15 modifications initially until August 15, 2009. ACTION: Notice, delay of action, and had an effective date of March 23, 2009. The increased duties under the request for comments. The Trade Representative subsequently January 15 modifications are set out in delayed the effective date of the Annex II of the notice published at 74 SUMMARY: On May 13, 2009, the United additional duties imposed under the FR 12402 (March 24, 2009), as modified States and the European Communities January 15 modifications to April 23, by the notice published at 74 FR 19263 (‘‘EC’’) announced the signing of a 2009; to May 9, 2009; and then to (April 28, 2009). In order to delay the Memorandum of Understanding (MOU) August 15, 2009. The effective date of effective date of the increased duties in the Beef Hormones dispute. Under the removal of duties under the January until September 19, 2009, the Trade the first phase of the agreement, the EC 15 modifications remained March 23, Representative has decided that the is obligated to open a new beef tariff- 2009. See 74 FR 11613 (March 18, modifications to the Harmonized Tariff rate quota (TRQ) in the amount of 2009); 74 FR 12402 (March 24, 2009); 74 Schedule of the United States that are 20,000 metric tons at zero rate of duty. FR 19263 (April 28, 2009). As a result contained in Parts A and B of Annex II The United States in turn is obligated of removal of duties on March 23, 2009, shall be effective with respect to articles not to increase additional duties above a reduced list of products subject to entered, or withdrawn from warehouse those in effect as of March 23, 2009. The additional duties (at a rate of 100 for consumption, on or after September EC opened the new beef TRQ on August percent ad valorem) has been in place 19, 2009. As explained below, however, 1, 2009. This notice undertakes the since that time. This reduced list is set further steps are contemplated before process necessary to implement U.S. out in the Annex to this notice. Under that time. In addition, any merchandise obligations under the first phase of the the first phase of the MOU, the United covered under Part B of Annex II of the MOU and to pursue additional market States maintains the right to impose notice published at 74 FR 12402 that is access under subsequent phases of the these additional duties, and is obligated admitted to a U.S. foreign-trade zone on MOU. not to impose additional duties on any or after September 19, 2009 must be DATES: Effective Date: A modified list of other products in connection with the admitted in ‘‘privileged foreign status’’ products subject to additional duties in EC–Beef Hormones WTO dispute. as defined in 19 CFR 146.41. Questions connection with the Beef Hormones The first phase of the MOU concludes concerning customs matters may be dispute (announced on January 15, on August 3, 2012. Under a possible directed to Renee Chovanec, 2009) had been scheduled to be effective second phase of the MOU, the EC would International Coordination, Office of with respect to products that are expand the beef TRQ to 45,000 metric International Trade, U.S. Customs and Border Protection, (202) 863–6384. entered, or withdrawn from warehouse, tons, and the United States would suspend all of the additional duties for consumption on or after August 15, C. Opportunity for Public Comments imposed in connection with the EC– 2009. In order to meet U.S. obligations Prior to September 19, 2009, the under the MOU, the United States Trade Beef Hormones WTO dispute. For additional background concerning Trade Representative intends to take Representative (‘‘Trade Representative’’) the EC–Beef Hormones WTO dispute; further steps under the Trade Act to has now changed this effective date to the January 15 modifications; and the implement U.S. obligations under the September 19, 2009. Moreover, as prior delays in the effective date of the first phase of the MOU and to pursue explained below, the Trade modifications, see 73 FR 66066 (Nov. 6, additional market access under Representative will take additional steps 2008); 74 FR 4265 (Jan. 23, 2009), 74 FR subsequent phases of the MOU. The before that time in order to continue to 11613 (March 18, 2009), 74 FR 12402 Section 301 Committee seeks comments implement U.S. obligations under the (March 24, 2009), 74 FR 19263 (April on these matters, including with regard MOU. 28, 2009), and 74 FR 22626 (May 13, to the imposition of 100 percent duties FOR FURTHER INFORMATION CONTACT: 2009). Further information on the May on the products currently subject to Roger Wentzel, Director, Agricultural 13, 2009 U.S.-EC MOU may be found on such duties throughout the remainder of Affairs, (202) 395–6127 or David USTR=s Web site, http://www.ustr.gov. the first phase of the MOU. (The list of Weiner, Director for the European products currently subject to 100 Union, (202) 395–4620 for questions B. Delay of Action percent duties in connection with EC– concerning the EC–Beef Hormones Pursuant to Section 305 of the Trade Beef Hormones WTO dispute is set out dispute; or William Busis, Associate Act of 1974, the Trade Representative in the Annex to this notice.) As noted has determined that a further delay in above, the United States maintains the 13 17 CFR 200.30–3(a)(12). implementation of the January 15 right to impose these additional duties

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during the first phase of the MOU, and attaching the document, it is sufficient and open to public inspection. under a possible second phase, the EC to type ‘‘See attached’’ in the ‘‘General Comments containing business would expand the beef TRQ to 45,000 Comments’’ field. confidential information should not be metric tons and the United States in Interested persons may request a submitted via the http:// turn would suspend all of the additional public hearing on these matters. Any www.regulations.gov Web site. Instead, duties imposed in connection with the request for a public hearing should be persons wishing to submit comments EC–Beef Hormones WTO dispute. made by no later than August 20, 2009. containing business confidential Any comments should be submitted In the event a hearing is to be held, information should contact Sandy by no later than September 12, 2009. To USTR will issue a notice specifying the McKinzy at (202) 395–9483. submit comments via http:// date of the hearing and the procedures Information or advice contained in a www.regulations.gov, enter docket for submitting written testimony. comment submitted, other than business Comments will be placed in the number USTR–2009–0022 on the home confidential information, may be docket and open to public inspection page and click ‘‘go’’. The site will determined by USTR to be confidential pursuant to 15 CFR 2006.13, except provide a search-results page listing all in accordance with section 135(g)(2) of confidential business information documents associated with this docket. the Trade Act of 1974 (19 U.S.C. exempt from public inspection in Find a reference to this notice by 2155(g)(2)). If the submitter believes that accordance with 15 CFR 2006.15 or selecting ‘‘Notice’’ under ‘‘Document information or advice may qualify as information determined by USTR to be such, the submitter— Type’’ on the left side of the search- confidential in accordance with 19 results page, and click on the link U.S.C. 2155(g)(2). Comments may be (1) Must clearly so designate the entitled ‘‘Send a Comment or viewed on the http:// information or advice; Submission.’’ (For further information www.regulations.gov Web site by (2) Must clearly mark the material as on using the http://www.regulations.gov entering docket number USTR–2009– ‘‘SUBMITTED IN CONFIDENCE’’ at the Web site, please consult the resources 0022 in the search field on the home top and bottom of the cover page and provided on the Web site by clicking on page. each succeeding page; and ‘‘How to Use This Site’’ on the left side Persons wishing to submit business (3) Must provide a non-confidential of the home page.) confidential information must certify in summary of the information or advice. The http://www.regulations.gov site writing that such information is The non-confidential summary will provides the option of providing confidential in accordance with 15 CFR be placed in the docket and open to comments by filling in a ‘‘General 2006.15(b), and such information must public inspection. Comments submitted Comments’’ field, or by attaching a be clearly marked ‘‘BUSINESS in confidence should not be submitted document. Given the detailed nature of CONFIDENTIAL’’ at the top and bottom via the http://www.regulations.gov Web the comments sought by the Section 301 of the cover page and each succeeding site. Instead, persons wishing to submit Committee, all comments should be page. Any comment containing business such comments should contact Sandy provided in an attached document. confidential information must be McKinzy at (202) 395–9483. Submissions must state clearly the accompanied by a non-confidential position taken and describe with summary of the confidential William Busis, specificity the supporting rationale and information. The non-confidential Chair, Section 301 Committee. must be written in English. After summary will be placed in the docket BILLING CODE 3190–W9–P

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[FR Doc. E9–19455 Filed 8–12–09; 8:45 am] Reserve is correcting the Affected Public focuses on large internationally active BILLING CODE 3190–W9–C and Estimated Burden sections of Part financial institutions, the proposed III (Paperwork Reduction Act) and the guidance emphasizes supervisory Office of the Comptroller of the expectations for all domestic financial DEPARTMENT OF THE TREASURY Currency, Treasury; Board of Governors institutions including banks, thrifts and of the Federal Reserve System; Federal credit unions. Office of the Comptroller of the Deposit Insurance Corporation; Office of The Federal Reserve is correcting the Currency Thrift Supervision, Treasury; and Affected Public and Estimated Burden [Docket ID OCC–2009–0009] National Credit Union Administration sections of Part III (Paperwork (the agencies) are correcting a footnote Reduction Act) to read: regarding the definition of ‘‘financial FEDERAL RESERVE SYSTEM Affected Public institution.’’ [Docket No. OP–1362] FRB: Bank holding companies, state DATES: Comments must be submitted on member banks, state-licensed branches FEDERAL DEPOSIT INSURANCE or before September 4, 2009. and agencies of foreign banks (other CORPORATION FOR FURTHER INFORMATION CONTACT: than insured branches), and James Embersit, Deputy Associate corporations organized or operating DEPARTMENT OF THE TREASURY Director, Market and Liquidity Risk, under sections 25 or 25A of the Federal 202–452–5249 or Mary Arnett, Reserve Act (Agreement corporations Office of Thrift Supervision Supervisory Financial Analyst, Market and Edge corporations). [Docket ID OTS–2009–0011] and Liquidity Risk, 202–721–4534 or Estimate of Respondent Burden: Brendan Burke, Supervisory Financial FRB: Number of respondents: 6,156 NATIONAL CREDIT UNION Analyst, Supervisory Policy and total (29 large (over $100 billion in ADMINISTRATION Guidance, 202–452–2987. assets); 117 mid-size ($10—$100 SUPPLEMENTARY INFORMATION: In the billion); and 6,010 small (less than $10 Proposed Interagency Guidance— Federal Register issue of July 6, 2009 billion). Funding and Liquidity Risk (74 FR 32035), the agencies, in Burden under Section 14: 720 hours Management conjunction with the Conference of per large respondent, 240 hours per AGENCY: Office of the Comptroller of the State Bank Supervisors (CSBS), mid-size respondent, and 80 hours per Currency, Treasury (OCC); Board of requested comment on the proposed small respondent. Governors of the Federal Reserve guidance on funding and liquidity risk Burden under Section 20: 4 hours per System (Board); Federal Deposit management (proposed Guidance). The month. Insurance Corporation (FDIC); Office of proposed Guidance summarizes the Total estimated annual burden: Thrift Supervision, Treasury (OTS); and principles of sound liquidity risk 825,248 hours. National Credit Union Administration management that the agencies have In addition, the OCC, Board, FDIC, (NCUA). issued in the past and, where OTS, and NCUA are correcting footnote ACTION: Request for public comment; appropriate, brings them into 4 (74 FR 32038) to read: correction. conformance with the ‘‘Principles for Unless otherwise indicated, this Sound Liquidity Risk Management and interagency guidance uses the term SUMMARY: This notice corrects the notice Supervision’’ issued by the Basel ‘‘financial institutions’’ or ‘‘institutions’’ published on July 6, 2009 on the Committee on Banking Supervision to include banks, saving associations, proposed guidance on funding and (BCBS) in September 2008. While the credit unions, affiliated holding liquidity risk management. The Federal BCBS liquidity principles primarily companies, state and federally chartered

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U.S. branches and agencies of foreign DEPARTMENT OF VETERANS information to be collected; and (4) banks, and Edge and agreement AFFAIRS ways to minimize the burden of the collection of information on corporations. Federally insured credit [OMB Control No. 2900–New (0913)] unions (FICUs) do not have holding respondents, including through the use company affiliations and therefore Proposed Information Collection of automated collection techniques or references to holding companies (Applicant Background Survey): the use of other forms of information contained within this guidance are not Comment Request technology. applicable to FICUs. Title: Applicant Background Survey, AGENCY: Human Resources and VA Form 0913. [THIS SIGNATURE PAGE PERTAINS Administration, Department of Veterans OMB Control Number: 2900–New TO THE NOTICE AND REQUEST FOR Affairs. (0913). COMMENT TITLED, ‘‘PROPOSED ACTION: Notice. Type of Review: New Collection. INTERAGENCY GUIDELINES— Abstract: VA Form 0913 will be used FUNDING LIQUIDITY RISK SUMMARY: Human Resources and to collect data needed for the planning MANAGEMENT.’’] Administration (HRA), the Department and assessing affirmative employment of Veterans Affairs (VA), is announcing program initiatives. The data will be By order of the Board of Governors of the an opportunity for public comment on used to report in an aggregated manner Federal Reserve System. the proposed collection of certain to the Equal Employment Opportunity Robert deV. Frierson, information by the agency. Under the Commission and to conduct aggregated Deputy Secretary of the Board. Paperwork Reduction Act (PRA) of adverse impact analysis to ensure VA’s [THIS SIGNATURE PAGE PERTAINS TO 1995, Federal agencies are required to employment and selection decisions are THE NOTICE AND REQUEST FOR publish notice in the Federal Register fair and equitable. COMMENT TITLED, ‘‘PROPOSED concerning each proposed collection of Affected Public: Individuals or INTERAGENCY GUIDELINES—FUNDING information, including each new households. Estimated Annual Burden: 1,250 LIQUIDITY RISK MANAGEMENT.’’] collection, and allow 60 days for public Dated: August 4, 2009. comment in response to the notice. This hours. notice solicits comments for information Estimated Average Burden Per John C. Dugan, needed to survey applicant for Respondent: 5 minutes. Comptroller of the Currency. employment background information. Frequency of Response: Annually. Estimated Number of Respondents: [THIS SIGNATURE PAGE PERTAINS TO DATES: Written comments and 15,000. THE NOTICE AND REQUEST FOR recommendations on the proposed COMMENT TITLED, ‘‘PROPOSED collection of information should be Dated: August 10, 2009. INTERAGENCY GUIDELINES—FUNDING received on or before October 13, 2009. By direction of the Secretary. LIQUIDITY RISK MANAGEMENT.’’] ADDRESSES: Submit written comments Denise McLamb, Dated at Washington, DC, the 3rd day of on the collection of information through Program Analyst, Enterprise Records Service. August, 2009. Federal Docket Management System [FR Doc. E9–19408 Filed 8–12–09; 8:45 am] By order of the Federal Deposit Insurance (FDMS) at http://www.Regulations.gov BILLING CODE 8320–01–P Corporation. or to Thomas Middleton, Human Robert E. Feldman, Resources and Administration (06), Executive Secretary. Department of Veterans Affairs, 810 DEPARTMENT OF VETERANS Vermont Avenue, NW., Washington, DC AFFAIRS [THIS SIGNATURE PAGE PERTAINS TO 20420 or e-mail to THE NOTICE AND REQUEST FOR [email protected]. During the Geriatrics and Gerontology Advisory COMMENT TITLED, ‘‘PROPOSED comment period, comments may be Committee; INTERAGENCY GUIDELINES—FUNDING viewed online through FDMS. LIQUIDITY RISK MANAGEMENT.’’] Notice of Meeting Dated: August 7, 2009. FOR FURTHER INFORMATION CONTACT: The Department of Veterans Affairs By the Office of Thrift Supervision. Thomas Middleton at (202) 461–4036 or (VA) gives notice under Public Law 92– FAX (202) 501–2145. John E. Bowman, 463 (Federal Advisory Committee Act) SUPPLEMENTARY INFORMATION: Under the that a meeting of the Geriatrics and Acting Director. PRA of 1995 (Pub. L. 104–13; 44 U.S.C. Gerontology Advisory Committee will [THIS SIGNATURE PAGE PERTAINS TO 3501–3521), Federal agencies must be held on September 10–11, 2009, in THE NOTICE AND REQUEST FOR obtain approval from the Office of Room 630, Department of Veterans COMMENT TITLED, ‘‘PROPOSED Management and Budget (OMB) for each Affairs, 810 Vermont Avenue, NW., INTERAGENCY GUIDELINES—FUNDING collection of information they conduct Washington, DC. On September 10, the LIQUIDITY RISK MANAGEMENT.’’] or sponsor. This request for comment is session will begin at 8:30 a.m. and end Dated: August 3, 2009. being made pursuant to section at 5 p.m. On September 11, the session By the National Credit Union 3506(c)(2)(A) of the PRA. will begin at 8 a.m. and end at 12 noon. Administration Board. With respect to the following This meeting is open to the public. Mary F. Rupp, collection of information, HRA invites The purpose of the Committee is to comments on: (1) Whether the proposed provide advice to the Secretary of Secretary of the Board. collection of information is necessary Veterans Affairs and the Under [FR Doc. E9–19406 Filed 8–12–09; 8:45 am] for the proper performance of its Secretary for Health on all matters BILLING CODE 6210–01–P functions, including whether the pertaining to geriatrics and gerontology. information will have practical utility; The Committee assesses the capability (2) the accuracy of HRA’s estimate of the of VA health care facilities and burden of the proposed collection of programs to meet the medical, information; (3) ways to enhance the psychological, and social needs of older quality, utility, and clarity of the Veterans and evaluates VA programs

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designated as Geriatric Research, By Direction of the Secretary. in rural areas, and discusses ways to Education, and Clinical Centers. E. Philip Riggin, improve and enhance VA services for The meeting will feature Committee Management Officer. these Veterans. presentations and discussions on VA’s [FR Doc. E9–19462 Filed 8–12–09; 8:45 am] On September 2, the Committee will geriatrics and extended care programs, BILLING CODE P hear from VA officials such as the aging research activities, update on the Director, Office of Rural Health, the VA’s geriatric workforce (to include Chief of Staff, a telehealth professional training, recruitment and retention DEPARTMENT OF VETERANS from the Office of Care Coordination, approaches), Veterans Health AFFAIRS and a member of the Telehealth Administration (VHA) strategic Outreach Clinic staff. Veterans’ Rural Health Advisory planning activities in geriatrics and On September 3, the Committee will Committee; Notice of Meeting extended care, recent VHA efforts hear from VA officials such as the Chief regarding dementia and program The Department of Veterans Affairs Consultant on Telehealth from the advances in palliative care, and (VA) gives notice under Public Law 92– Office of Care Coordination and a performance and oversight of the VA 463 (Federal Advisory Committee Act) representative of the Office of General Geriatric Research, Education, and that the Veterans’ Rural Health Advisory Counsel on the annual ethics review. Clinical Centers. Committee will hold a meeting on Interested parties should express in No time will be allocated at this September 2–3, 2009, in Capitol Room writing their desire to address the meeting for receiving oral presentations B at the Hyatt Regency Washington on Committee not less than 10 days in from the public. Interested parties Capitol Hill, 400 New Jersey Avenue, advance of the meeting to Ms. Kara should provide written comments for NW., Washington, DC. The September 2 Hawthorne, Designated Federal Officer, review by the Committee not less than session will be from 8 a.m. to 4 p.m. and 10A5, Department of Veterans Affairs, 10 days in advance of the meeting to on September 3 the session will be from 810 Vermont Avenue, NW., Mrs. Marcia Holt-Delaney, Office of 8 a.m. to 11:30 a.m. The meeting is open Washington, DC 20420, or by e-mail at Geriatrics and Extended Care (114), to the public. [email protected]. Department of Veterans Affairs, 810 The purpose of the Committee is to Dated: August 10, 2009. Vermont Avenue, NW., Washington, DC advise the Secretary of Veterans Affairs 20420. Individuals who wish to attend on health care issues affecting enrolled By Direction of the Secretary. the meeting should contact Mrs. Holt- Veterans residing in rural areas. The E. Philip Riggin, Delaney, Program Analyst, at (202) 461– Committee examines programs and Committee Management Officer. 6769. policies that impact the provision of VA [FR Doc. E9–19450 Filed 8–12–09; 8:45 am] Dated: August 11, 2009. health care to enrolled Veterans residing BILLING CODE 8320–01–P

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Part II

Department of Health and Human Services Food and Drug Administration

21 CFR Part 312 and 316 Charging for Investigational Drugs Under and Investigational New Drug Application; Expanded Access to Investigational Drugs for Treatment Use; Final Rules

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DEPARTMENT OF HEALTH AND A. Overview of Comments regulation concerning charging patients HUMAN SERVICES B. General Comments for investigational new drugs (former C. General Criteria for Charging § 312.7(d) (21 CFR 312.7(d))) and to add Food and Drug Administration 1. Justification for the Amount To Be new § 312.8 (charging for investigational Charged drugs). Under FDA’s previous 21 CFR Part 312 2. Prior Written Authorization to Charge § 312.7(d), FDA could authorize [Docket No. FDA–2006–N–0237] (formerly 3. Withdrawal of Authorization to Charge charging for an investigational drug Docket No. 2006N–0061) 4. Lack of Timeframe for FDA Response used in a clinical trial under an IND and D. Charging in a Clinical Trial for an investigational drug used in a RIN 0910–AF13 1. General Comments treatment protocol or treatment IND: 2. Charging for the Sponsor’s Own Drug in • Former § 312.7(d)(1) provided that a Charging for Investigational Drugs a Clinical Trial sponsor that wished to charge for an Under an Investigational New Drug 3. Charging for an Approved Drug investigational drug in a clinical trial Application Obtained From Another Entity for Use as needed to provide a full written an Active Control or in Combination AGENCY: Food and Drug Administration, With Another Drug explanation of why charging was HHS. 4. Charging for an Approved Drug necessary for the sponsor to undertake ACTION: Final rule. Obtained From Another Entity in a or continue the clinical trial, e.g., why Clinical Trial of the Drug distribution of the drug to test subjects SUMMARY: The Food and Drug 5. Duration of Charging in a Clinical Trial should not be considered part of the Administration (FDA) is amending its E. Charging for Expanded Access to normal cost of doing business. investigational new drug application Investigational Drugs for Treatment Use • Former § 312.7(d)(2) described (IND) regulation concerning charging 1. General Comments several conditions that needed to be met 2. Increasing Access to charge for an investigational drug patients for investigational new drugs. 3. Ethical Considerations This final rule revises the charging 4. Non-Interference With Drug used under a treatment protocol or regulation to clarify the circumstances treatment IND. Development • in which charging for an investigational Former § 312.7(d)(3) provided that a drug in a clinical trial is appropriate, to 5. Treatment INDs or Treatment Protocols sponsor could not commercialize an set forth criteria for charging for an 6. 1-Year Authorization investigational drug by charging a price investigational drug for the different F. Costs Recoverable When Charging for an larger than that necessary to recover types of expanded access for treatment Investigational Drug costs of manufacture, research, 1. Direct and Indirect Costs development, and handling of the use described in the agency’s final rule 2. Recoverable Costs for Expanded Access on expanded access for treatment use of investigational drug. Uses • Former § 312.7(d)(4) provided that investigational drugs published 3. Supporting Documentation elsewhere in this issue of the Federal 4. Authority to Set Pricing FDA could withdraw authorization to Register, and to clarify what costs can 5. Confidentiality charge if it determined that the be recovered for an investigational drug. 6. Effect on Payment Systems (CMS and conditions underlying the authorization This final rule will permit charging for Insurance) were no longer being met. a broader range of uses than was In the preamble to the proposed rule, 7. Collaboration With CMS and the explicitly permitted previously. we identified three principal reasons for National Cancer Institute revising the previous charging DATES: This rule is effective October 13, G. Miscellaneous Comments regulation (the 1987 charging rule) (52 2009. 1. Promotion FR 19466, May 22, 1987). FOR FURTHER INFORMATION CONTACT: 2. Liability First, the provisions of the 1987 3. Product Labeling For the Center for Drug Evaluation charging rule concerning charging for and Research: Colleen L. Locicero, 4. Analysis of Impact IV. Legal Authority investigational drugs in a clinical trial Center for Drug Evaluation and V. Environmental Impact needed to be revised to take into Research, Food and Drug VI. Analysis of Economic Impacts account circumstances that were not Administration, 10903 New A. Objectives of the Final Rule anticipated when that original rule was Hampshire Ave., Bldg. 22, rm. 4200, B. The Need for the Final Rule adopted in 1987. FDA expected that Silver Spring, MD 20993–0002, C. Why Allow Charging? requests to charge in a clinical trial 301–796–2270. D. Baseline for the Analysis would be limited to requests to charge For the Center for Biologics E. Nature of the Impact 1. Charging in a Clinical Trial for the sponsor’s drug being tested in Evaluation and Research: Stephen the trial. In fact, the agency received few M. Ripley, Center for Biologics 2. Charging for Expanded Access Uses Described Under Final Subpart I such requests. Evaluation and Research (HFM–17), 3. Costs Recoverable When Charging for an Far more common have been requests Food and Drug Administration, Investigational Drug to charge for approved drugs in trials 1401 Rockville Pike, Rockville, MD 4. Summary when the drugs needed to be obtained 20852–1448, 301–827–6210. F. Benefits of the Final Rule from another entity. These approved SUPPLEMENTARY INFORMATION: G. Costs of the Final Rule drugs may have been used in a trial of H. Minimizing the Impact on Small Table of Contents the sponsor’s drug as an active control Entities or in combination with the sponsor’s I. Background drug. Even more common were requests II. Overview of the Final Rule, Including I. Alternatives VII. Paperwork Reduction Act of 1995 to charge for approved drugs used in Changes to the Proposed Rule trials by a third party (not the holder of A. General Requirements for Charging VIII. Federalism the approved application) that were B. Charging in Clinical Trials I. Background C. Charging for Expanded Access to intended to study new uses of the Investigational Drugs for Treatment Use In the Federal Register of December approved drug or to compare two drugs. D. Recoverable Costs 14, 2006 (71 FR 75168) (proposed rule), FDA concluded that requests to charge III. Comments on the Proposed Rule we proposed to amend our IND for investigational drugs in these

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situations may be appropriate, but that • Requirements for charging for drug or be otherwise subject to the the criteria for evaluation of such investigational drugs for treatment use requirements in new § 312.8. requests are different from those that under proposed subpart I (described in B. Charging in Clinical Trials apply when the request to charge is for the proposed rule on expanded access to the sponsor’s own drug being tested in investigational drugs for treatment use Section 312.8(b) of the final rule a clinical trial. Accordingly, the agency (expanded access proposed rule) (71 FR describes specific requirements concluded that the 1987 charging rule 75147, December 14, 2006)), and pertaining to charging for an needed to be revised to provide criteria • Requirements for determining what investigational drug in a clinical trial, for charging for approved drugs used in costs can be recovered when charging including investigational use of the clinical trials. for an investigational drug. sponsor’s approved drug. The cost of an Second, the provisions of the 1987 We received 40 comments on the investigational drug used in a clinical charging rule related to treatment use charging proposed rule, which we trial is an anticipated cost of drug allowed charging patients for address in section III of this document. development and should ordinarily be investigational drugs only when those borne by the sponsor. Therefore, FDA drugs were provided under a treatment II. Overview of the Final Rule, believes that charging should be IND or treatment protocol. Elsewhere in Including Changes to the Proposed Rule permitted only when three this issue of the Federal Register, FDA The final rule revises the charging circumstances are present, as described is publishing a final rule that adds to regulation at § 312.7(d) and adds new in § 312.8(b)(1) and as follows: First, charging should be allowed only part 312 (21 CFR part 312) a new § 312.8 to clarify the circumstances in to facilitate development of a promising subpart I concerning ‘‘Expanded Access which charging for an investigational new drug or indication that might not to Investigational Drugs for Treatment drug in a clinical trial is appropriate, to otherwise be developed, or to obtain Use’’ (referred to in this document as set forth criteria for charging for an important safety information that might the ‘‘expanded access final rule’’ or investigational drug for the different not otherwise be obtained. The ‘‘subpart I’’). The expanded access final categories of expanded access for preamble to the 1987 charging rule rule retains the treatment IND and treatment use described in the expanded made clear that there should be treatment protocol provisions in the access final rule, and to clarify what compelling justification for taking the 1987 charging rule with minor costs can be recovered for an unusual step of allowing charging for modifications, and provides for two investigational drug. This final rule unproven therapy during its additional types of expanded access for specifies the types of investigational development, stating that ‘‘cost recovery treatment use: Expanded access for uses of a drug in a clinical trial under is justified in clinical trials only when individual patients and expanded part 312 that require prior authorization necessary to further the study and access for intermediate-size patient to charge and provides criteria to development of promising drugs that populations. The 1987 charging rule authorize charging for each of the uses might otherwise be lost to the medical needed to be revised to provide described in the expanded access final armamentarium.’’ (52 FR 19466 at authority to charge for investigational rule. 19472). FDA believes that philosophy drugs for these two new categories of A. General Requirements for Charging should continue to apply to charging in expanded access. a clinical trial in this final rule. Third, the 1987 charging rule needed New § 312.8(a) describes the general Accordingly, § 312.8(b)(1)(i) requires to be revised to specify the types of requirements and conditions for that a sponsor wishing to charge for its costs that can be recovered. The charging for investigational new drugs. investigational drug in a clinical trial language of the 1987 charging rule was Except for sponsors charging for a drug provide some evidence of potential not very specific and did not provide obtained from another entity (as clinical benefit that, if demonstrated in sufficient guidance to sponsors on the described below), a sponsor who wishes clinical investigations, would provide a costs that could be recovered. Moreover, to charge for an investigational drug significant advantage over available because of the justifications for charging must do the following: products in the diagnosis, treatment, • in a clinical trial differ from the Comply with the applicable mitigation, or prevention of a disease or justifications for charging for expanded requirements for the type of use for condition. Products that are likely to access use, the agency believed that the which charging is requested (either in a meet this criterion are also likely to be costs appropriate for recovery would clinical trial or for expanded access) eligible for fast track development also differ. (§ 312.8(a)(1)), programs and priority review (see FDA’s The reasons FDA believed the 1987 • Provide justification that the guidance for industry on ‘‘Fast Track charging rule needed to be revised are amount to be charged reflects only those Drug Development Programs— described more fully in the sections II.B, costs that are permitted to be recovered Designation, Development, and C, and D of the preamble to the (§ 312.8(a)(2)), and Application Review’’ (January 2006), proposed rule (71 FR 75168 at 75170 • Obtain prior written authorization including the priority review policies through 75171). from FDA (§ 312.8(a)(3)). for the Centers for Drug Evaluation and Accordingly, we proposed to remove Section 312.8(a)(4) provides that FDA Research and Biologics Evaluation and paragraph (d) of former § 312.7 will withdraw authorization to charge if Research in Appendix 3 of that (paragraph (d) discussed charging for it determines that charging is interfering guidance (available on the Internet at and commercialization of with the development of a drug for http://www.fda.gov/cder/guidance/ investigational drugs). We proposed to marketing approval or that the criteria index.htm)). add new § 312.8 containing the for the authorization are no longer being Second, charging should be permitted following: met. only for a trial that is necessary for the • General requirements for charging In response to comments, the final development of the drug. Therefore, for investigational drugs, rule does not require sponsors who § 312.8(b)(1)(ii) requires that the sponsor • Specific requirements pertaining to must obtain an approved drug from demonstrate that the data to be obtained charging for investigational drugs in a another entity for use in a clinical trial from the clinical trial would be essential clinical trial, to obtain FDA approval to charge for the to establishing that the drug is effective

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or safe for the purpose of obtaining for treatment use than would be patient expanded access submission is initial marketing approval of the drug, possible absent charging. limited to a single patient. Similarly, the or that it would support a significant The agency’s principal concern with authorization to charge under an change in the labeling of the sponsor’s charging patients in expanded access intermediate-size patient population approved drug. For example, the trial settings for investigational drugs is that expanded access submission is limited could be designed to provide data that charging not interfere with the to the number of patients permitted to would support approval of a new development of drugs for commercial receive the drug under that particular indication or generate important marketing. Accordingly, § 312.8(c)(1) intermediate-size patient population comparative safety information. requires a sponsor wishing to charge for expanded access IND or protocol. Third, charging must be necessary to an investigational drug for any of the Section 312.8(c)(4) provides that FDA the conduct of the clinical trial. Under three types of expanded access under will ordinarily authorize charging for § 312.8(b)(1)(iii), a sponsor is required to part 312, subpart I to provide reasonable expanded access for treatment use demonstrate that clinical development assurance that charging will not under part 312, subpart I to continue for of the drug could not be continued interfere with developing the drug for 1 year from the time of FDA without charging because the cost of the marketing approval. authorization and that FDA may drug is extraordinary. The cost of the For the types of expanded access to reauthorize charging for additional drug may be extraordinary because of investigational drugs described in periods upon request. It also provides manufacturing complexity, scarcity of a proposed subpart I, FDA believes it is FDA the discretion to specify a shorter natural resource, the large quantity of less likely that the limited numbers of authorization. The final rule limits the drug needed (e.g., due to the size or patients who might obtain individual authorization to charge to a period of 1 duration of the trial) or some patient expanded access to an year or less to permit the agency to investigational drug (§ 312.310) or combination of these or other periodically assess whether the criteria intermediate-size patient population circumstances. In response to for charging continue to be met. FDA expanded access (§ 312.315) would comments, this extraordinary cost anticipates that it will exercise its impede development of a drug or criterion for charging for the sponsor’s discretion to specify a shorter duration indication. The potential to interfere drug in a clinical trial has been revised when there is a particular concern that with drug development is greatest for to clarify that the resources of an charging could interfere with drug treatment use under a treatment IND or individual sponsor are considered in development. treatment protocol (§ 312.320). determining whether cost is Treatment INDs or treatment protocols D. Recoverable Costs extraordinary. can attract large numbers of patients and Section 312.8(d) describes the kinds Section 312.8(b)(2) provides that the thus have the potential to significantly of costs that are recoverable when authorization to charge for a drug in a affect enrollment in the clinical trials charging for an investigational drug in a clinical trial would ordinarily continue needed to establish safety and clinical trial and for expanded access for for the duration of the clinical trial effectiveness. Accordingly, § 312.8(c)(2) treatment use under part 312, subpart I. because it is unlikely that the need for sets forth specific information that The purpose of permitting charging for charging would change during the would be required to reasonably assure an investigational drug in a clinical trial course of the trial. However, FDA that charging for an investigational is to permit a sponsor to recover the § 312.8(b)(2) gives FDA the discretion to drug under a treatment IND or treatment costs of making a drug available to study specify a duration shorter than the protocol will not interfere with drug subjects when those costs are length of the trial. FDA may specify a development. Sponsors are required to extraordinary. Thus, § 312.8(d)(1) limits shorter duration if, for example, there is provide evidence of sufficient cost recovery to the direct costs of a particular concern that the enrollment in any ongoing clinical trials making the investigational drug authorization to charge has the potential needed for marketing approval to available in these situations. Indirect to delay the development of a drug for reasonably assure FDA that the trials costs can not be recovered. marketing approval. will be completed as planned Section 312.8(d)(1)(i) describes direct C. Charging for Expanded Access to (§ 312.8(c)(2)(i)). Sponsors are also costs as costs incurred by a sponsor that Investigational Drugs for Treatment Use required to provide evidence of can be specifically and exclusively adequate progress in the development of attributed to providing the drug for the Section 312.8(c) sets forth the criteria the drug for marketing approval investigational use for which FDA has for charging for the three types of (§ 312.8(c)(2)(ii)). Such evidence could authorized cost recovery. Direct costs expanded access to investigational include successful meetings with FDA include costs per unit to manufacture drugs for treatment use described in before submission of a new drug the drug (e.g., raw materials, labor, and subpart I of part 312 (the expanded application (NDA), submission of an nonreusable supplies and equipment access final rule). Part 312, subpart I NDA, or completion of other significant used to manufacture the quantity of describes two types of treatment use drug development milestones. Sponsors drug needed for the use for which (expanded access for individual patients are also required to submit information charging is authorized) or costs to and expanded access for intermediate- under their general investigational plans acquire the drug from another size patient populations) not previously (§ 312.23(a)(3)(iv)) specifying the drug manufacturing source, and direct costs described in FDA’s regulations and, development milestones they plan to to ship and handle (e.g., store) the drug. therefore, not specifically contemplated meet in the coming year Indirect costs are costs that are not by the 1987 charging rule. FDA’s goal in (§ 312.8(c)(2)(iii)). attributable solely to making the drug permitting charging for the treatment Section 312.8(c)(3) specifies that the available for the investigational use for uses described in subpart I is to authorization to charge be limited to the which charging is requested (for facilitate access to investigational drugs number of patients authorized to receive example, expenditures for physical in situations in which a sponsor might the drug for treatment use, if there is a plant and equipment that are incurred not be able to provide a drug for such limitation. For example, the primarily for the purpose of producing use absent charging, or to facilitate authorization to charge for an large quantities of the drug for broader access to an investigational drug investigational drug under an individual commercial sale after approval, or for

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making the drug available for a variety received from individuals (persons with obtained from another entity for use in of investigational uses). Indirect costs serious diseases,1 persons with family a trial. An academic medical center was are not appropriate for cost recovery for members with serious diseases, and very supportive of FDA’s efforts to investigational uses because these costs other interested persons), health care clarify the charging requirements would be incurred even if the clinical and consumer advocacy organizations, pertaining to approved drugs used in a trial or expanded access use for which pharmaceutical and biotechnology trial under an IND. As discussed in charging is authorized did not occur. companies, health insurance companies, greater detail in responses to comments Section § 312.8(d)(1)(ii) states that trade organizations, a State government, 27 and 31, FDA has revised the indirect costs include costs incurred an academic medical center, and a proposed rule so that sponsors need not primarily to produce the drug for venture capital company. obtain authorization from FDA to charge commercial sale (e.g., costs for facilities Some comments from individuals for approved drugs obtained from and equipment used to manufacture the were supportive of the charging another entity not affiliated with the supply of investigational drug, but that regulation to the extent that it may make sponsor. are primarily intended to produce large it easier to develop drugs for serious The primary concern of health quantities of the drug for eventual diseases in some cases and make insurance companies and their trade commercial sale) and research and investigational drugs more broadly organization was that the new charging development, administrative, labor, or available for treatment use under regulation may create pressure on third- other costs that would be incurred even expanded access programs. Other party payers to reimburse, or lead to if the clinical trial or treatment use for comments from individuals were legislation requiring them to reimburse, which charging is authorized did not concerned that charging, in the absence for investigational drugs. occur. of reimbursement for investigational Reimbursement issues are discussed in Sponsors who provide investigational drugs by health insurance companies, greater detail in comments 63 through drugs for expanded access for treatment would limit enrollment in clinical trials 65. use for intermediate-size patient and expanded access programs to those A major concern for a small populations and for treatment INDs and who can afford to pay for the drug. biotechnology company, a venture treatment protocols incur costs in Health care and consumer advocacy capital firm, and a State health agency addition to the anticipated and ordinary organizations were generally supportive was the narrowing of the cost recovery costs of drug development. The purpose of the proposed rule. Some stated that provision in the proposed rule to permit of permitting cost recovery for expanded the rule struck the appropriate balance recovery of direct costs only for an access use is to encourage sponsors to between facilitating development of investigational drug used in a clinical make investigational drugs available for costly therapies, including drugs for rare trial, and to specifically exclude treatment use. Thus, § 312.8(d)(2) diseases, and increasing access to recovery of substantial capital permits a sponsor to recover the costs of investigational drugs for treatment use. expenditures incurred for purposes of administering treatment use programs One advocacy organization expressed large-scale manufacturing and general for intermediate-size patient concern about the effects of charging on research and development costs. These populations and for treatment INDs and equitable access across different comments were concerned that this treatment protocols, as well as the direct economic strata, arguing that the ability narrowing would make it more difficult costs of the drug. The final rule does not to enroll in clinical trials and expanded for entities with limited resources to develop expensive new therapies. FDA authorize sponsors to recover access programs may be restricted to continues to believe that these administrative costs associated with wealthier individuals. One organization expenditures are not appropriate for expanded access for individual patients was skeptical of the agency’s assertion cost recovery during the development of because these costs would be so minor. that facilitating charging for a new drug. These concerns are Section 312.8(d)(2) provides that in investigational drugs made available discussed in greater detail in responses addition to the direct costs of the drug under expanded access programs would to comments 1 and 46. described in § 312.8(d)(1), a sponsor increase access. may recover the costs of monitoring the FDA believes this final rule will B. General Comments facilitate development of some costly expanded access use, complying with (Comment 1) Two comments stated therapies that might not have been IND reporting requirements, and other that charging for investigational drugs to developed absent cost recovery and will administrative costs directly associated treat rare diseases or conditions (orphan encourage expanded access programs. with making a drug available for drugs) should be subject to less stringent FDA also acknowledges, however, that treatment use under §§ 312.315 and criteria than charging for drugs to treat the rule has the potential to create 312.320. non-orphan diseases. The comments certain inequities. Issues related to Section 312.8(d)(3) provides that, to maintained that drugs to treat orphan equitable access are discussed in greater support its calculation for cost recovery, diseases are commonly developed by detail in responses to comments 36 a sponsor must provide supporting small companies or not-for-profit through 39. documentation to show that the cost entities that have limited or no ability calculation is consistent with the The major concerns of pharmaceutical and biotechnology companies and their to raise money from capital markets. relevant requirements in § 312.8(d). The Therefore, less restrictive charging proposed rule has been revised to state trade organizations were the requirements pertaining to charging for criteria are needed to permit these that the documentation must be entities to recover their development accompanied by a statement that a approved drugs being evaluated in a clinical trial under an IND. These costs. certified public accountant has (Response) FDA does not believe companies were most concerned with reviewed and approved the calculations. there is justification for different and the requirements pertaining to charging less stringent cost recovery criteria for III. Comments on the Proposed Rule for approved drugs that must be investigational drugs for orphan A. Overview of Comments 1 Unless otherwise indicated, ‘‘serious diseases’’ diseases than non-orphan diseases. As The agency received 40 comments on in this final rule refers to serious or immediately stated in the preamble to the proposed the proposed rule. Comments were life-threatening diseases or conditions. rule, FDA does not believe that charging

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for an investigational drug in clinical development, so the criteria would be trial to enhance or preserve the studies intended to support approval of the same for both groups. We also do commercial value of the drug. the drug is the appropriate mechanism not believe that separate provisions are Therefore, as is the case with a request to recoup research and development needed regarding the amount charged to charge for a new molecular entity, the costs beyond those costs directly because, in both cases, the amount sponsor should be required to overcome associated with making the drug charged would be limited to costs. the presumption that the cost of the available under criteria described in this Based on changes made to the drug is a normal cost of the business of charging rule (71 FR 75168 at 75171) proposed rule, FDA also does not drug development, a cost that should (see response to comment 46 for further believe there is any need to divide the ordinarily be borne by the sponsor of discussion). FDA believes sponsors rule into requirements applicable to the trial. Therefore, FDA believes the intending to develop orphan products charging for new molecular entities and sponsor should be required to obtain should pursue orphan product requirements applicable to charging for prior authorization to charge and should designation from FDA to assist with approved drugs under investigation for meet the same burden for charging for development and recovery of new uses. FDA has revised the proposed the approved drug in a clinical trial as investment (21 CFR part 316). Such rule to eliminate the requirement that a it would be required to meet for designation provides for tax credits for sponsor who obtains an approved drug charging for a new molecular entity. the costs of clinical research associated from another source to use in a trial as That is, the requirements in § 312.8(b)(1) with development of an orphan drug an active control or in a trial intended apply with equal force to charging for and 7 years of marketing exclusivity to obtain additional information about the sponsor’s unapproved drug and after an orphan drug is approved. In the approved drug (e.g., to study a new charging for the sponsor’s approved addition, sponsors that obtain orphan indication, to study a safety endpoint) drug in a trial of a new use or a trial that designation may be eligible to receive must obtain prior authorization to could otherwise result in an important grants from FDA of up to $350,000 per charge for the approved drug when used labeling change. It is beyond the scope year for 4 years to defray directly the for an investigational purpose (see of the regulation and FDA’s authority to costs of clinical research (for more comments 27 and 31). FDA has retained regulate insurance reimbursement with information, see Office of Orphan the requirement that a sponsor obtain respect to clinical trials involving Products Development, http:// permission to charge for its own approved drugs. www.fda.gov/orphan/index.htm). approved drug in a trial of that drug. In Moreover, orphan designation and grant this scenario, FDA believes the same C. General Criteria for Charging funds from FDA often provide criteria as would apply to charging for Proposed § 312.8(a) set forth the incentives for additional investment an unapproved drug should apply. general requirements and conditions for from other sources. This final rule is Therefore, a separate provision is not charging for investigational drugs. A intended only to address the situation in needed. sponsor that wishes to charge for an which the cost of the drug itself is so (Comment 4) One comment stated investigational drug must: high that a sponsor needs to recover that the proposed rule’s restrictions on • Comply with the applicable costs associated with making the drug charging should not apply to approved requirements for the type of use for available to be able to conduct or drugs and that investigators and others which charging is requested (either in a continue the trial. charging for approved drugs should be clinical trial or for expanded access) (Comment 2) One comment permitted to charge their usual amounts (proposed § 312.8(a)(1)), mentioned that it is not clear if the rule and to receive the customary insurance • Provide justification that the applies to both unapproved drugs and reimbursement. The comment also amount to be charged reflects only those approved drugs under investigation for noted that restricting charges for costs that are permitted to be recovered new indications. approved drugs in clinical trials would (proposed § 312.8(a)(2)), and (Response) The rule applies to both be administratively burdensome to • Obtain prior written authorization unapproved drugs and, in certain investigators. from FDA (proposed § 312.8(a)(3)). situations, approved drugs under (Response) FDA agrees in part and investigation for new indications (see disagrees in part. FDA agrees that a 1. Justification for the Amount To Be also response to comment 4). sponsor that is not the marketer of an Charged (Comment 3) One comment suggested approved drug (i.e., is not the entity that (Comment 5) One comment asked that that to improve the readability of the holds the approved application) should the following language be added at the proposed rule, the rule should have not be required to obtain FDA approval end of § 312.8(a)(2) and (c)(1) of the different provisions for company- to charge for the drug when it is used proposed rule: ‘‘Any such charges found sponsored expanded access programs in a clinical trial for any purpose—e.g., to be recoverable costs as determined than for investigator-sponsored used for its approved indication as an under [§ 312.8(d)] shall be minimized expanded access programs. The active control or in a trial of a new and/or terminated to the greatest degree comment also suggested that there indication for the drug (see comments or at the earliest opportunity possible should be different provisions for new 27 and 31 discussing in greater detail consistent with the criteria in this rule. molecular entities than for approved the revision to the final rule to If circumstances supporting charging products being studied for new accommodate this change). Accordingly, under this rule are no longer met, indications. the provisions in the proposed rule charging shall terminate.’’ (Response) FDA does not believe requiring prior authorization to charge (Response) FDA does not believe it is there is a need for separate provisions in these situations have been deleted necessary to insert additional language for expanded access depending on from this final rule. However, FDA concerning how long and how much to whether the sponsor of the IND is a believes a sponsor seeking to charge for charge because the language essentially manufacturer or a noncommercial its own approved drug in a trial of a repeats the requirements that are sponsor such as an individual new use or to obtain important safety already in other parts of the rule. physician. In either case, FDA’s primary information about the drug should be Section 312.8(b)(2) and (c)(4) of the final concern is whether the IND would treated differently. In these situations, rule specify how long it is permissible somehow interfere with drug the sponsor is ordinarily conducting the to charge in a clinical trial and for an

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expanded access use, respectively. FDA also does not believe that this 4. Lack of Timeframe for FDA Response Section 312.8(a)(4) permits FDA to provision will delay access to (Comment 8) Two comments withdraw the authorization to charge at investigational therapies by patients recommended that the final rule include any time if it determines that charging with serious diseases who lack a general timeframe for FDA to decide is interfering with the development of a therapeutic alternatives. When there is a whether to permit charging. One of the drug for marketing approval or that the pressing need for cost recovery to make comments recommended that FDA criteria for the authorization are an investigational therapy available, decide all charging requests within 30 to otherwise no longer being met. Section FDA will ordinarily be able to expedite 60 days. 312.8(d) specifies what costs can be review of a charging request. For a new (Response) FDA does not believe it recovered during whatever time period IND, FDA anticipates that, in most should commit to a specified time charging is authorized. cases, it will be able to make a charging period for review that would apply to 2. Prior Written Authorization to Charge determination at the same time it makes all charging requests. In many cases, a determination on the underlying The requirement in the proposed rule FDA anticipates being able to make a expanded access IND. When the need to determination on a request to charge at to obtain prior written authorization charge becomes evident after an from FDA to charge for any the same time it responds to the expanded access IND is ongoing, FDA underlying IND submission (when the investigational drug is a change from the anticipates that a sponsor would be able requirements under the 1987 charging submissions are made at the same time). to foresee the need to charge sufficiently However, in FDA’s experience, charging rule. Under the 1987 charging rule, a far in advance of that need to be able to sponsor was required to obtain prior requests can present challenging issues make a charging submission and obtain that require some discussion between written authorization to charge for an a timely FDA determination. investigational drug in a clinical trial FDA and the sponsor. Thus, it is (§ 312.7(d)(1)), but a sponsor of a FDA also does not believe it is difficult to estimate reliably a time treatment IND or a treatment protocol necessary to specify that the period for making a charging request under § 312.34 was permitted to authorization to charge ‘‘shall not be determination that would apply commence charging 30 days after unreasonably withheld.’’ The uniformly to all charging requests. For receipt by FDA of an information Administrative Procedure Act provides this reason, FDA is not prepared to amendment concerning charging, unless that an agency decision may be set aside commit to a 30-day timeframe for FDA notified the sponsor to the contrary by the courts if found to be ‘‘arbitrary, making charging request (§ 312.7(d)(2)). capricious an abuse of discretion, or determinations. FDA also does not (Comment 6) One comment requested otherwise not in accordance with law’’ foresee the need for a 60-day maximum that FDA retain the provision in the (5 U.S.C. 706(2)(A)). The agency review time. 1987 charging rule (§ 312.7(d)(2)) that believes this language provides the D. Charging in a Clinical Trial allowed authorization to charge for an appropriate standard for FDA’s decision investigational drug under a treatment of whether to allow charging for an Proposed § 312.8(b) described specific IND or treatment protocol to go into investigational drug. requirements pertaining to charging for an investigational drug in a clinical effect automatically 30 days after receipt 3. Withdrawal of Authorization to trial. This provision described criteria by FDA of the information amendment, Charge unless the sponsor is notified to the for charging for an investigational drug contrary by FDA (§ 312.7(d)(2)), and Proposed § 312.8(a)(4) specified that in three situations: • further, that FDA make this provision FDA will withdraw the authorization to Charging for the sponsor’s own drug applicable to all expanded access uses. charge if it determines that charging is in a clinical trial (§ 312.8(b)(1)), • The comment argued that the interfering with the development of a Charging for an approved drug that requirement for prior authorization drug for marketing approval or that the a sponsor must obtain from another would result in delay in the availability criteria for the authorization are entity for use as an active control or in of investigational drugs for expanded otherwise no longer being met. combination with another drug in a access uses. One comment requested clinical trial designed to evaluate the that FDA add the following language (Comment 7) One comment safety and effectiveness of the sponsor’s after the provision requiring prior recommended that the rule include an investigational drug (§ 312.8(b)(2)), and written authorization to charge for an additional requirement specifying that • Charging for an approved drug that investigational drug: ‘‘Such FDA notify the sponsor of a proposal to must be obtained from another entity in authorization shall not be unreasonably withdraw authorization to charge and a clinical trial designed to evaluate the withheld.’’ Two comments agreed with that FDA provide the sponsor an approved drug (e.g., for another FDA’s decision to require prior written opportunity to respond. indication) (§ 312.8(b)(3)). authorization from FDA to charge for (Response) FDA expects in most cases 1. General Comments drugs obtained through expanded access to provide reasonable notice before programs. withdrawing an authorization to charge (Comment 9) Several comments stated (Response) FDA does not agree that to allow sponsors an opportunity to that permitting charging for the charging for expanded access uses address the agency’s concerns. We are investigational drug in clinical trials should be permitted without prior not amending the proposed rule as would make it even more difficult to written authorization to charge from requested, however, because the agency enroll subjects into clinical trials and, FDA. FDA believes it is important to believes we should have the flexibility, therefore, could increase the time to determine, in advance of any patient when warranted, to withdraw an complete trials and delay bringing new being charged, that the criteria for authorization to charge without drugs to market. Three comments stated charging are met (in particular, the providing advance notice to the that charging could discourage requirement that charging not interfere sponsor. Sponsors can request review of enrollment by patients who lack the with drug development) and that the FDA’s withdrawal of an authorization to resources to pay for the investigational amount to be charged is consistent with charge using dispute resolution drug. One comment stated that charging the cost recovery requirements. processes. for nonreimbursed, investigational

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therapies could discourage physicians charge is part of the normal cost of interests or nonregulatory governmental from recommending enrollment in trials doing business.’’ bodies, but believes such efforts would to their patients who are eligible. (Response) FDA does not believe it is be best administered by private sector (Response) As was the case with the necessary to include the suggested interests or nonregulatory governmental prior charging rule, the provisions language in this final rule. The preamble bodies. concerning charging for the sponsor’s to the proposed rule contained language (Comment 13) One comment investigational drug in this final rule are similar to the language in the preamble recommended that the title of the rule intended to help sponsors develop to the 1987 charging rule, stating that: be changed from ‘‘Charging for important new therapies that would be ‘‘Generally, the costs of conducting a Investigational Drugs’’ to ‘‘Charging for very difficult or impossible to develop clinical trial are costs that the sponsor Drugs Used in Clinical Trials’’ because absent charging. In FDA’s experience, should bear. Conducting a clinical trial the rule also would permit sponsors to sponsors have rarely found it necessary is part of the drug development process, charge for approved drugs, which, the to charge for such therapies in clinical and drug development is an ordinary comment asserts, are not investigational. trials to develop a drug for marketing business expense for a commercial (Response) FDA disagrees. The rule approval. FDA anticipates that charging sponsor’’ (71 FR 75168 at 75170). Thus addresses charging for investigational for the sponsor’s drug in a clinical trial it is clear that FDA intends that the drugs both in clinical trials and in will continue to be an unusual presumption that the cost of an expanded access programs under new circumstance. FDA recognizes that investigational drug should ordinarily subpart I. Because the recommended charging could make it difficult to enroll be borne by the sponsor and charging is title would seem to exclude expanded subjects in clinical trials and may have justified only in exceptional access uses, that title is too narrow. a disproportionate impact on enrollment circumstances be carried forward to this Moreover, the use of an approved drug of patients who cannot afford to pay for rule. That presumption is implicit in the in a trial of a new use is an the investigational drug. FDA expects, stringent criteria in § 312.8(b)(1) for investigational use and thus clearly however, that sponsors will monitor allowing charging for a sponsor’s drug covered by the rule and its title. See clinical trial accrual rates and take in a clinical trial. FDA does not believe response to comment 15 for discussion whatever steps are necessary to ensure it is necessary to state the presumption of a minor change to the section’s title. (Comment 14) Two comments stated that subjects are able to enroll. For in the codified language. (Comment 12) One comment stated that permitting charging for an example, in FDA’s experience, sponsors that FDA should consider working with investigational drug in a clinical trial— who have charged for an investigational pharmaceutical firms to develop better because it might exclude economically drug in a clinical trial have made ways of funding clinical trials of disadvantaged persons from trial provision to enroll subjects unable to investigational drugs. The comment participation—could exacerbate existing pay. recommended that FDA evaluate problems with underrepresentation of (Comment 10) Two comments stated practical ways the pharmaceutical economically disadvantaged and that the financial burden for conducting industry can fund patient expenses for minorities in such trials, and thus may clinical trials, including supplying the investigational drugs used in clinical limit generalizability of trial results. investigational drug, should be carried studies and that one option would be for (Response) FDA does not believe that by the sponsors, who stand to benefit FDA to evaluate the viability of inability to participate in a clinical trial from the drug if commercialized. establishing a common patient pool because a subject cannot pay for the (Response) FDA agrees that, in most funded by pharmaceutical firms on a drug will have a meaningful effect on circumstances, sponsors should bear the voluntary or required basis. generalizability of trial results. Many costs of making an investigational drug (Response) The agency believes that factors affect participation in clinical available in a clinical trial. The the comment raises a valid concern. trials, including geographic location, preamble to the proposed rule stated: This charging rule is intended to allow ability to qualify for the trial, ‘‘Generally, the costs of conducting a a sponsor to recover its costs associated demographic representation at trial clinical trial are costs that the sponsor with making an investigational drug sites, and an insufficient number of slots should bear. Conducting a clinical trial available to clinical trial subjects when for all who might like to participate. The is part of the drug development process, the cost of the drug is so high that the effects of charging on the nature of the and drug development is an ordinary study could not be conducted without trial population would probably be of business expense for a commercial charging. The rule is not intended to limited significance relative to other sponsor’’ (71 FR 75168 at 75170). The help defray other costs associated with factors that could affect generalizability. preamble to the proposed rule also the conduct of a trial. However, in In addition, in FDA’s experience, clarified that the philosophy underlying FDA’s experience, the drug cost is sponsors that charge subjects for the 1987 charging rule—that charging usually not the largest expense investigational drug in a clinical trial for an investigational drug in a clinical associated with clinical trials. Typically, typically make provision for subjects trial should be an exceptional the costs of administering and who are unable to pay for the drug, thus circumstance and justified only when monitoring a clinical trial are much mitigating any potential effect on necessary to further the study of a greater than the cost of the drug. At generalizability due to promising drug that might otherwise not present, FDA is focusing its underrepresentation of individuals from be developed—was intended to apply to collaborative efforts with industry on lower economic strata. this charging rule (71 FR 75168 at improving the efficiency of the clinical (Comment 15) Two comments 75170). trial process through various Critical recommended that the rule include a (Comment 11) One comment stated Path programs (e.g., Clinical Trial provision stating that the rule does not that FDA should include in the codified Transformation Initiative, http:// apply to clinical trials that are exempt portion of the rule the language from the www.fda.gov/oc/initiatives/criticalpath/ from the requirement to have an IND. preamble of the 1987 charging rule that: clinicaltrials.html). FDA encourages (Response) FDA did not intend that ‘‘FDA * * * [presumes] that supplying efforts to develop alternative the charging regulation apply to clinical investigational drugs to subjects mechanisms to finance important trials that are exempt from the IND participating in clinical trials without clinical research by private sector requirements under § 312.2(b). To make

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this clearer, FDA has changed the title be considered essential to establishing comment stated that the significant of § 312.8 to ‘‘Charging for that the drug is effective and safe). advantage standard would be likely to investigational drugs under an IND.’’ prevent a sponsor from charging for its 2. Charging for the Sponsor’s Own Drug own drug because the standard (Comment 16) Two comments stated in a Clinical Trial that permitting charging for unapproved presumes that comparative studies have drugs in clinical trials has the potential Proposed § 312.8(b)(1) set forth three been conducted against all the other to adversely affect FDA resources. criteria, in addition to the general products. (Response) As discussed in greater criteria in § 312.8(a), that needed to be (Response) The amount and type of detail in section I of this document, met to permit a sponsor to charge for its data needed to demonstrate a potential FDA believes it is important to provide own investigational drug in a clinical clinical benefit that would be a an option to charge for investigational trial. significant advantage over existing drugs in certain circumstances and, a. Significant advantage over therapy will vary with the stage of also, that is it is important for FDA to available therapy. Section 312.8(b)(1)(i) development. For a request to charge for of the proposed rule provided that a regulate charging to prevent a large phase 3 trial, ordinarily the sponsor who wishes to charge for its commercialization of unapproved drugs clinical data developed in phase 2 will investigational drug, including and unapproved indications. In FDA’s need to confirm or be consistent with a investigational use of its approved drug, years of experience reviewing charging potential significant advantage to satisfy must provide evidence that the drug has requests under the 1987 charging rule, this criterion. For a request to charge for a potential clinical benefit that, if such requests have been infrequent and a trial in an earlier phase of demonstrated in the clinical the resources required to conduct such development, more preliminary data investigations, would provide a reviews did not have a negative effect consistent with a potential significant significant advantage over available on FDA’s mission to ensure the safety advantage will suffice. FDA does not products in the diagnosis, treatment, agree that comparative data will always and effectiveness of new drugs. The mitigation, or prevention of a disease or proposed rule expanded the scope of be necessary to demonstrate a potential condition. significant advantage over existing INDs for which sponsors may seek cost (Comment 18) One comment stated recovery to include the three types of therapy. The agency believes that the that this criterion is not meaningful as need to provide comparative data is a expanded access INDs under new it would apply to all drugs that are subpart I. However, in response to matter of judgment. For example, there selected to be developed by may be noncomparative phase 2 data comments, the final rule no longer pharmaceutical and biotechnology requires sponsors that must obtain an and a plausible pharmacologic basis that companies. suggest a significant advantage over approved drug from another entity to (Response) FDA does not agree that existing therapy, and the phase 3 trial obtain FDA authorization to charge for all drugs selected to be developed for for which charging is requested may be that approved drug. Thus, FDA marketing offer a potential significant a comparative design intended to anticipates only a modest increase in advantage over available therapy. demonstrate that advantage. Similarly, the number of requests to charge due to Companies often deliberately develop comparative data are not needed if the this final rule. drugs that offer only modest advantages drug is intended to treat a disease or In addition, the cost calculation was over existing therapy or appear to be subpopulation with a disease, for which perhaps the most time-consuming similar to existing therapy. There may there is no satisfactory existing therapy aspect of preparing and reviewing be good commercial and clinical reasons (see also FDA guidance for industry charging requests under the 1987 to pursue such development. For entitled ‘‘Fast Track Development charging rule. This final rule clarifies example, there is likely to be variation Programs—Designation, Development, and simplifies the scope of recoverable in response to a pharmacologic and Application Review’’ (June 2006), costs. Thus, FDA anticipates that it will intervention, both in desired treatment especially section III.B.2, discussing typically take less time to prepare and effect and incidence of adverse effects, demonstrating a drug’s potential at review a charging submission under the in different individuals. Thus, the various stages of development). new rule than under the 1987 charging availability of similar therapies can FDA also does not agree that charging rule. provide alternatives for those who have for an investigational drug in a clinical (Comment 17) One comment stated inadequate responses to a drug or trial should be permitted on the basis of that the rule should differentiate experience an adverse reaction even if a only a potential advantage over existing between different phases of testing of an significant advantage has not been therapy, without regard to the unapproved drug because the clinically shown for any of the significance of the advantage. FDA justification for allowing recovery and therapies. This criterion is intended to continues to believe that, as was the supporting evidence will vary for distinguish those types of drugs from articulated in the preamble to the different clinical trials in different those for which there are preliminary proposed rule (71 FR 75168 at 75171), phases of drug development. clinical data suggesting a significant the cost of making a drug available to (Response) FDA believes the criteria advantage in the therapy for a given study subjects during development described in § 312.8(b)(1) concerning disease and for which the development should ordinarily be borne by the charging for a sponsor’s drug provide program is geared toward establishing sponsor. Charging for drugs in this sufficient flexibility to evaluate requests that advantage. situation should be reserved for the to charge for a drug in clinical trials in (Comment 19) One comment asked for exceptional circumstance in which it is different phases of drug development clarification about the type and degree necessary to continue development of a (also see response to comment 19 of evidence needed to show a significant drug that offers a potential significant discussing the variable basis for advantage, especially at the beginning of advantage over existing therapy. assessing whether a drug has a potential large phase 3 trials. Another comment b. Essential to safety or effectiveness. clinical benefit that would be a recommended that this criterion Section 312.8(b)(1)(ii) of the proposed significant advantage over available concerning a significant advantage be rule provided that a sponsor that wishes products and response to comment 20 replaced with ‘‘evidence of potential to charge for its investigational drug, discussing when a clinical trial would advantage over available therapy.’’ The including investigational use of its

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approved drug, must demonstrate that effectiveness trials, or aid in the design criterion and replace it with the the data to be obtained from the clinical of those trials. requirement from previous § 312.7(d)(1) trial would be essential to establishing FDA does agree that its determination, requiring a full written explanation of that the drug is safe or effective for the pursuant to a special protocol the reasons charging is necessary for the purpose of obtaining initial approval of assessment, that a phase 3 study design sponsor to undertake or continue the a drug, or would support a significant and protocol are adequate to provide clinical trial or expanded access. One change in the labeling of an approved effectiveness data that would support comment requested that FDA clarify drug (e.g., new indication, inclusion of approval of a marketing application how extraordinary cost is to be comparative safety information). would, in most cases, mean that the determined for a large company with (Comment 20) One comment stated clinical trial is essential to establishing numerous corporate affiliates, each with that the criterion to show that data that the drug is effective or safe for the separate budgets. obtained from the clinical trial are purpose of obtaining initial approval of (Response) In the proposed rule, FDA essential to show safety or effectiveness the drug. attempted to describe the concept of or make a significant labeling change FDA does not agree that this provision extraordinary cost in a way that would would make it unreasonably difficult for is overly broad. FDA acknowledges that make the determination independent of a sponsor to obtain authorization to the trials conducted as part of a clinical the relative resources of a sponsor. FDA charge because it would require a development program typically build on perceived that this approach would be sponsor to show that all other trial one another. However, it is very fairer than an approach based on components of the development unlikely that all such trials would be sponsor resources, arguably making cost program have been identified and considered essential because they recovery equally accessible to all marketing approval could not be provide the data on the endpoints that sponsors. FDA continues to believe that obtained without completion of the trial establish safety and effectiveness, there are potential scenarios in which a for which charging is requested. The essential corroboration for those data, or drug cost would be so great that it comment recommended that, instead, are essential prerequisites to the major would be considered extraordinary for the criterion should be that the study is safety and effectiveness studies (e.g., any sponsor no matter how great a because they enable the design to be a phase 2 or 3 protocol that was not put sponsor’s resources. And FDA believes refined so that the data will support on hold by FDA (§ 312.42) or the trial that the parameters set forth in the final approval). was agreed to by FDA through the rule—that the cost may be extraordinary special protocol assessment process (see c. Extraordinary cost. Section 312.8(b)(1)(iii) of the proposed rule due to manufacturing complexity, FDA guidance for industry entitled scarcity of a natural resource, the large ‘‘Special Protocol Assessment’’ (May provided that a sponsor that wishes to charge for its investigational drug, quantity of drug needed (e.g., due to the 2002)). Another comment stated that size or duration of the trial), or some this criterion is vague and overly broad including investigational use of its combination of these or other because, arguably, all clinical trials approved drug, must demonstrate that extraordinary circumstances—provide a conducted in a drug development the clinical trial could not be conducted functional objective test for whether a program would be essential to show without charging because the cost of the cost is extraordinary. safety and effectiveness. drug is extraordinary. The proposed rule (Response) FDA does not agree that stated that the cost may be extraordinary However, FDA also acknowledges this provision is too restrictive. The due to manufacturing complexity, that, as a practical matter, whether a phrase ‘‘essential to establishing that the scarcity of a natural resource, the large drug cost is extraordinary in any given drug is effective or safe for the purpose quantity of drug needed (e.g., due to the case will often be a function of the of obtaining initial approval of a drug’’ size or duration of the trial), or some resources of a given sponsor. FDA is intended to limit charging—whether combination of these or other believes that the rule should reflect the in comparative trials, trials of a new use extraordinary circumstances. reality that a sponsor seeking cost of an approved drug, or other trials—to (Comment 21) Several comments had recovery for a drug used in a clinical those trials that will generate significant concerns about the trial will more often be a sponsor with effectiveness or safety data on the extraordinary cost criterion. Two relatively fewer resources compared to endpoint or endpoints intended to comments maintained that this the larger, established pharmaceutical establish safety or effectiveness (e.g., provision is too vague and subjective for and biotechnology companies. clinical outcome on the disease of a regulatory requirement. They argued Accordingly, FDA has revised the interest), trials that would provide that whether a cost is extraordinary extraordinary cost criterion in direct corroborative support for such depends to a certain extent on the § 312.8(b)(1)(iii) to clarify that a sponsor trials, and trials that were necessary resources and perspective of the can demonstrate a cost is extraordinary prerequisites to the major safety and sponsor, i.e., what may be an relative to the resources available to that effectiveness trials (e.g., essential to extraordinary cost for a small company sponsor. This revision is also responsive refining the study design). Such trials with limited resources may not be so for to the comments suggesting that we would include later phase (e.g., phase 2 a larger company with more resources. retain the requirement in the previous and 3) controlled clinical trials One of these comments requested regulation that a sponsor provide a evaluating the clinical endpoints that additional guidance, either in the rule or written explanation of why charging is would establish safety and effectiveness in a separate guidance document, on the necessary to conduct the study. The (e.g., trials designed to demonstrate the meaning of extraordinary cost. Two sponsor would be able to provide such drug’s the potential clinical advantage), comments stated that this requirement an explanation to demonstrate that the but could also include important is more stringent than the 1987 charging cost is extraordinary for that sponsor. clinical pharmacology studies (e.g., rule, which requires only that the (Comment 22) One comment stated thorough QT prolongation studies, drug- sponsor provide a written explanation that extraordinary cost is not a drug interaction studies), safety studies, for why charging is necessary for the meaningful distinguishing criterion in and other types of studies that would sponsor to undertake or continue the the current environment as, arguably, provide essential corroboration for the trial. These comments recommended most new therapies have extraordinary data from the major safety and that FDA delete the extraordinary cost costs.

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(Response) FDA does not agree that was not predicted to be profitable (e.g., (Comment 26) One comment the concept of extraordinary drug cost is would not generate enough revenue to maintained that the extraordinary cost meaningless in the current environment. recoup development costs and provide requirement, when applied to charging Extraordinary cost in this rule does not a profit). The intent of the final rule is for the sponsor’s approved drug in a refer to the amount that would to address the situation in which the trial evaluating a new use of that drug, eventually be charged for a marketed very high, near-term cost of making the would discourage manufacturers from drug in a commercial setting. Arguably, drug available to subjects in a clinical developing new uses for approved such costs are often extraordinary trial is a deterrent to development, not products. compared to historical pricing. the drug’s long-term, potential (Response) FDA believes that the Extraordinary cost in this rule refers profitability. Therefore, FDA believes criteria for permitting charging should only to the actual cost of the drug that the appropriate inquiry is whether be the same for charging for the product in the clinical trial. This rule is a trial could not be conducted without sponsor’s investigational drug in trials primarily intended to provide cost charging because the cost of the drug is to support initial marketing approval as recovery in clinical trials in cases in extraordinary. for charging in trials of a sponsor’s which the drug product itself is (Comment 25) One comment stated approved drug for a new indication. In expensive to provide because of that the need to charge could be for each, the cost of the drug is a routine difficulty in manufacturing costs, reasons other than extraordinarily high business expense that would ordinarily scarcity of a natural resource needed to manufacturing costs. The comment be recouped after approval of the drug manufacture the drug, the large quantity maintained that small biotechnology or new indication, and subjects are of clinical supply needed to conduct companies have difficulty obtaining being asked to pay for an unapproved studies, or other extraordinary funding for clinical trials even when the product or unapproved use in a setting circumstances, and therefore represents product is promising and the rule in which charging for the drug is not the a substantial added cost above and should recognize a sponsor’s inability to norm. The agency is aware that there are beyond the routine costs associated with obtain funding as a reason for charging many factors that a sponsor weighs in the conduct of the study. in a clinical trial. determining whether to develop an (Comment 23) Two comments stated (Response) As discussed in the approved drug for a new use. FDA does that FDA lacked the expertise to decide preceding comment response, charging not believe that limiting charging for the whether the cost of a drug is for investigational drugs under this rule sponsor’s approved drug in a clinical extraordinary and would need to review is not intended to provide funding for trial to situations in which the cost of factual analyses about the sponsor’s clinical trials or drug development the drug is extraordinary would, in most costs, comparative costs of other generally. The intent is to address the cases, be the deciding factor in a treatments, and arguments about what situation in which there is a very high sponsor’s decision to develop or not costs are ordinary versus extraordinary. cost associated with making a drug develop a new indication. (Response) FDA does not believe that available to clinical trial subjects and it will be difficult to differentiate drugs that drug cost prevents continued 3. Charging for an Approved Drug that are truly extraordinarily costly by development unless the cost of the drug Obtained From Another Entity for Use objective measures from those that are can be recouped during development. as an Active Control or in Combination not, or that such determinations will Therefore general development costs, With Another Drug require special expertise. FDA believes such as costs associated with Proposed § 312.8(b)(2) described the it has enough accumulated experience conducting and monitoring a clinical criteria for charging for an approved with the vast array of drugs within its trial, should not be incorporated in the drug obtained from another entity for purview to have the ability to make amount charged for the investigational use as an active control or in such determinations about the relative drug and the lack of funding for such combination with another drug. To costs of various drugs. costs is not an independent basis for charge in this situation a sponsor must: (Comment 24) Two comments permitting charging for the study drug • Demonstrate that the clinical trial is expressed concerns with the (but could be a factor in assessing adequately designed to evaluate the requirement in § 312.8(b)(1)(iii) that a whether the cost is extraordinary for a safety and effectiveness of the sponsor’s sponsor ‘‘[d]emonstrate that the trial given sponsor under § 312.8(b)(1)(iii)). drug and could not be conducted without FDA recognizes that in most drug • Demonstrate that the holder of the charging because the cost of the drug is development scenarios, the costs approved application is not providing extraordinary’’ (emphasis added). The associated with the conduct of clinical the drug to the sponsor free of charge. comments stated that the more trials and drug development generally (Comment 27) Many comments appropriate inquiry is whether a are greater than the costs of the expressed concerns with the provisions sponsor would not conduct a trial absent investigational drug product, and the in the proposed rule concerning cost recovery because the cost is development costs may be a deterrent to charging for approved drugs obtained extraordinary, so, presumably, it would continuing development of a drug. from another entity for use as an active not be in the sponsor’s commercial However, FDA does not believe that control or in combination with another interest to conduct the trial. Similarly, incorporating those costs into an drug. Three comments stated that FDA another comment stated that companies amount charged for the investigational approval should not be required to may choose not to develop a drug drug is the appropriate mechanism to charge for approved drugs when the because it would not be lucrative, but address that situation. If a sponsor drugs are used for their approved or that does not mean the drug could not wishes to recover from trial subjects medically accepted indications and at be developed. other costs associated with the conduct approved or medically accepted doses (Response) The charging regulation is of a clinical trial (e.g., the costs of and dose regimens. One comment not intended to provide a mechanism to medical care necessitated by opined that the cost of approved drugs subsidize drug development generally participation in a clinical trial), FDA used in a trial for medically accepted or to provide an incentive to reconsider believes that recovery should occur purposes is not a drug development development of a drug that a sponsor independent of any charge for the drug expense that should be borne by the has elected not to develop because it product. sponsor. Two comments stated that the

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rule should not distinguish between an charging—that the safety and has revised the proposed rule to remove approved drug obtained from another effectiveness of the drug is unproven— the requirement that a sponsor obtain entity and an approved drug that is the is often not present in this situation. prior approval to charge for an approved sponsor’s own drug and charging should Moreover, FDA believes there would drug that the sponsor must obtain from be permitted for both. Another comment almost never be a basis to deny a request another source for use as an active noted that the rationale that trial to charge for an approved drug for use control or in combination with another subjects should not be charged for as active control or in combination with drug, or in a trial evaluating the exposing themselves to the risks of an another drug under the criteria in the approved drug for a new use or to obtain unproven drug does not apply to proposed rule. FDA also acknowledges important safety information. However, approved drugs used for a medically the potential for significant the final rule retains the requirement accepted purpose. One comment stated administrative burdens associated with that a sponsor studying its own that pharmaceutical companies seldom complying with the proposed charging approved drug for a new indication or charge patients for the cost of an requirements if, as the comments stated, to support another type of significant approved drug used in a clinical trial. the current practice in many cases is labeling change must obtain approval to Two comments stated that the simply to have the approved drug charge for the drug in the study. FDA investigator commonly buys approved dispensed from a pharmacy and have does not agree that whether the use of drugs and bills the patient’s health patients or third parties pay the usual the drug is ‘‘medically accepted’’ by a insurance or the investigator writes a cost for the drug. Moreover, FDA does recognized compendium should be a prescription for the patient, who fills not want to impose a regulatory distinguishing criterion for determining the prescription at a pharmacy that bills requirement that might somehow whether the sponsor should be required the patient’s insurance. interfere with the way in which drug to obtain authorization to charge for its Several comments also raised costs are reimbursed by third-party drug in that situation. concerns that the charging regulation payers. Accordingly, in the final rule, (Comment 30) One comment asked might interfere with routine FDA has revised proposed § 312.8(a) how a trial blind could be maintained reimbursement by third-party payers for and deleted proposed § 312.8(a)(2) and if there is charging for a competitor’s approved drugs used for their approved (a)(3), to clarify that a sponsor need not product used as an active control, but indications in clinical trials. Some obtain authorization to charge for an not for the sponsor’s investigational comments stated that, when approved approved drug used for an approved drug. drugs used as comparators are charged indication in a clinical trial done under (Response) We note that the final rule for in a clinical trial, they are ordinarily an IND. removes the requirement of the dispensed through the normal (Comment 28) Three comments stated proposed rule that sponsors seek FDA distribution channel—either an that approved drugs used as active authorization to charge for a inpatient or outpatient pharmacy—and controls or in combination with another competitor’s product used as an active third-party payers routinely reimburse drug are not investigational because control. In general, FDA believes that for such uses. One comment asked FDA they are approved and are not being maintaining the trial blind is the to clarify that the proposed rule does ‘‘investigated’’ in the clinical trial. responsibility of the sponsor. not apply to a situation in which the (Response) FDA disagrees. When an sponsor is not involved in directly approved drug is used as an active 4. Charging for an Approved Drug supplying approved drugs used as control or in combination with another Obtained From Another Entity in a comparators or in combination and does drug (e.g., as standard therapy in a study Clinical Trial of the Drug not incur direct acquisition or handling comparing standard therapy to standard Proposed § 312.8(b)(3) provided that, costs that it then seeks to pass on to trial therapy plus a new investigational for a sponsor to charge for an approved subjects, such as when the drug is therapy), the treatment effect of the drug obtained from another source in a dispensed from a pharmacy. active control or the standard therapy is clinical trial to evaluate that drug, it One comment stated that requiring being measured and compared to the must: sponsors to seek authorization to charge new therapy. Therefore, the approved • Demonstrate that the clinical trial is in cases in which the sponsor is not drug is part of the clinical investigation, adequately designed to evaluate the directly acquiring an approved drug and hence an investigational drug for safety or effectiveness of a new from another entity, such as cases in purposes of part 312. Notwithstanding indication or to provide important which the approved drug is obtained or that such use is subject to part 312, FDA safety information related to an prescribed by investigators and subjects has revised the proposed charging rule approved indication and are billed by the investigator or so that sponsors are no longer required • Demonstrate that the holder of the pharmacy, would dramatically alter to obtain authorization to charge for approved application is not providing existing practice without benefiting trial approved drugs obtained from another the drug to the sponsor free of charge. subjects. The comment stated that a entity for use as active controls or in (Comment 31) Two comments stated large number of clinical studies would combination with another therapy (as that the requirement that a sponsor need to be submitted for FDA review, discussed in the preceding comment seeking to charge for an approved drug dramatically increasing the response). obtained from another source must administrative burden on FDA to review (Comment 29) One comment argued demonstrate that the trial design is charging requests for affected trials and that sponsors should be able to charge adequate to evaluate the effectiveness of on sponsors in making submissions. for approved drugs without FDA the new indication is unnecessary (Response) The agency agrees that authorization when used in clinical because it essentially duplicates what a requiring sponsors to obtain trials for ‘‘medically accepted’’ uses, sponsor is required to demonstrate to be authorization to charge for approved which the comment defined as uses allowed to proceed with the trial under drugs obtained from another entity for supported by a recognized compendium the IND review process. The comments use as active controls or in combination such as U.S. Pharmacopeia Drug argue that the fact that FDA has not with another drug, or for other uses is Information (USP DI). placed the trial on clinical hold not necessary. We recognize that one of (Response) As discussed in the (§ 312.42) should be enough evidence the major rationales for limiting responses to comments 27 and 31, FDA that FDA considers the trial of adequate

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design. One comment stated that organization be required to demonstrate E. Charging for Expanded Access to whether the drug is available without that it sought grant funds for the trial Investigational Drugs for Treatment Use charge does not require FDA review. and any denial of such funds was not Proposed § 312.8(c) set forth criteria One comment asked FDA to clarify what due to lack of merit in the research plan. for charging for the three types of constitutes sufficient evidence that the (Response) FDA does not agree that expanded access to investigational sponsor charging for a drug has not the ability to charge for an approved drugs for treatment use described in received the drug free of charge. drug obtained from another entity new subpart I of part 312—individual Another comment suggested that patient INDs, intermediate-size patient additional criteria be added as a should be limited to nonprofit population INDs, and treatment INDs safeguard to ensure that drug is not organizations. As discussed in the (see the expanded access final rule being made available free of charge, previous response, FDA has removed published elsewhere in this issue of the such as representation by the sponsor from this final rule the proposed Federal Register). FDA’s primary that the manufacturer is not funding or requirement that a sponsor obtain prior concern with charging patients in supporting the trial in any way. approval to charge for an approved drug (Response) FDA acknowledges that obtained from another entity for use in expanded access settings is that charging not interfere with the the proposed criteria for obtaining a trial of the approved drug. Thus, any development of investigational drugs for authorization to charge for an approved type of sponsor can charge for such commercial marketing. Therefore, under drug that the sponsor must obtain from drugs without obtaining authorization proposed § 312.8(c)(1), a sponsor another entity in a trial of a new use of from FDA. that drug, or to obtain important new seeking to charge for expanded access FDA hopes that sponsors that must safety information, do not present a use must provide reasonable assurance significant barrier to obtaining cost obtain a drug from another entity would that charging will not interfere with recovery. FDA intended to present a ordinarily explore all reasonable developing the drug for marketing relatively low barrier to encourage the financing options (e.g., grants from approval. To provide such assurance for kinds of trials that might not be of various sources, funding from the drug a treatment IND or protocol under commercial interest to the drug manufacturer, a drug supply from the § 312.320, a sponsor must include manufacturer or to otherwise encourage drug manufacturer) before seeking to evidence of sufficient enrollment in any trials that would further elucidate the charge trial subjects for the drug. ongoing clinical trial(s) needed for characteristics of approved drugs. FDA However, FDA does not believe that it marketing approval to reasonably assure agrees that, for phase 2 and 3 trials, the is necessary to specify in regulation that FDA that the trials will be successfully fact that the trial has not been placed on a sponsor exhaust all available completed as planned (§ 312.8(c)(2)(i)); clinical hold would ordinarily be alternative financing options before evidence of adequate progress in the sufficient to satisfy the criterion that the charging for the study drug. development of the drug for marketing trial is adequately designed to evaluate approval (§ 312.8(c)(2)(ii)); and the unapproved drug for a new 5. Duration of Charging in a Clinical information submitted under a indication. FDA also acknowledges that Trial sponsor’s general investigational plan specifying the drug development it intended to rely primarily on the (Comment 33) One comment representations of the sponsor for milestones the sponsor plans to meet in interpreted the provision stating that the assurance that the drug was not being the next year (§ 312.8(c)(2)(iii)). authorization to charge for a drug in a made available free of charge. Proposed § 312.8(c)(3) provided that In light of these comments, FDA now clinical trial will usually last for the the authorization to charge for an recognizes that, based on the criteria in duration of the trial, unless FDA expanded access use is limited to the the proposed rule, there would seldom specifies a shorter period, to mean that number of patients authorized to receive be a basis to deny a request to charge for FDA’s approval of the IND (after 30 the drug under the treatment use an approved drug that a sponsor must days) constitutes authorization to charge protocol or IND, if there is a limitation. obtain from another source to study a for an approved drug in a trial of a new Proposed § 312.8(c)(4) provided that new use or to obtain important new indication for the drug as long as the the authorization to charge for expanded safety information. FDA also recognizes protocol states that the sponsor or access may continue for 1 year from the that the cost recovery calculation for investigators may charge for the drug. time of FDA authorization and that this type of use would usually be very (Response) FDA disagrees with this sponsors may request that FDA straightforward—ordinarily, the interpretation. Section 312.8(a)(3), reauthorize charging for additional time sponsor’s acquisition cost if the sponsor which applies to all requests to charge, periods. purchases the drug directly or the cost requires that a sponsor obtain prior 1. General Comments of the drug when dispensed from a written authorization from FDA to pharmacy. Therefore, FDA concludes (Comment 34) One comment objected charge for an investigational drug. A that to require submission of a request to the idea that sponsors could only sponsor must specifically request to to charge for an approved drug obtained charge for expanded access if the cost from another source would often be a charge under the applicable paragraph was extraordinary. needless administrative burden for the in § 312.8 and obtain authorization to (Response) FDA believes this sponsor and FDA. Accordingly, we have charge pursuant to that request before it comment misread the proposed rule. decided not to finalize proposed can charge for a trial drug. No provision The cost of an investigational drug need § 312.8(b)(3) in this final rule. in this final rule should be construed to not be extraordinary for a sponsor to be (Comment 32) One comment stated mean that FDA’s failure to place a able to charge for the drug under an that the ability to charge for an protocol on clinical hold constitutes expanded access IND or protocol in investigational drug obtained from implicit authorization to charge for an subpart I. That extraordinary cost another entity for use in a clinical trial investigational drug, notwithstanding criterion in the proposed of the drug should be limited to that the protocol contains a provision § 312.8(b)(1)(iii) applied only to nonprofit organizations. The comment stating that the sponsor intends to charging for a sponsor’s investigational further recommended that the charge. drug in a clinical trial of that drug under

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proposed § 312.8(b)(1). Moreover, this protocols, we have revised § 312.8(c)(2) investigational drugs under expanded criterion has now been eliminated in the to describe § 312.320 as covering access programs will also make final rule (see comments 21 through 26). treatment INDs and treatment protocols, provision for those who cannot afford (Comment 35) One comment stated rather than merely citing to the section such therapies. that there is a conflict between the as the proposed rules had done. FDA believes that permitting sponsors proposed rule on charging and the to recover all costs associated with proposed rule on expanded access 2. Increasing Access making an investigational drug available because the charging rule would not In the preamble to the proposed rule, and administering an expanded access permit charging for expanded access for FDA identified the costs associated with program provides a reasonable incentive individual patients or intermediate-size making investigational drugs available for sponsors to make investigational patient populations if there were no for treatment use under expanded drugs available for treatment use. As ongoing or planned clinical trial that access programs as a potential obstacle discussed in greater detail in comment would support marketing approval. One to the availability of such drugs (section 46, FDA believes the cost recovery comment asked that charging for II.C of the proposed rule). By facilitating provision, to the extent it allows individual patient expanded access be charging for such use, FDA stated that companies to recover all the direct costs permitted. The comment also stated that it hoped there would be greater access associated with making the drug it was not clear if charging was to investigational drugs (section VI.E of available and administering the permitted for intermediate-size patient the proposed rule). expanded access program, removes a population expanded access. One (Comment 36) Several comments significant obstacle to making drugs comment stated that sponsors should be expressed concerns about the available for treatment use for some permitted to charge for investigational implications of permitting charging for sponsors (e.g., sponsors with limited drugs for all types of expanded access investigational drugs for treatment use resources for expanded access programs, provided that charging will under expanded access programs on programs) while preventing not impede drug development. how such drugs are allocated. Some commercialization of investigational (Response) FDA believes these comments stated that the proposed rule drugs. comments misread the proposed rule. may not increase expanded access (Comment 37) One comment stated Proposed § 312.8(c)(1) stated that a because third-party payers are not likely that FDA should closely monitor sponsor who wishes to charge for an to reimburse for investigational expanded access programs for which it investigational drug for any treatment therapies, thus depriving patients not permits cost recovery to ensure that use under subpart I of part 312 must able to afford such drugs. One comment sponsors honor any commitments to provide reasonable assurance that added that neither patients nor insurers make drugs available to those who charging will not interfere with should pay for investigational drugs or cannot afford them. developing the drug for marketing treatments and that the proposed rule (Response) FDA hopes that sponsors approval. Moreover, the preamble to the will significantly exacerbate the current would, of their own initiative, honor proposed rule specifically stated that problems of access to, and affordability their commitments to make one of the major reasons that FDA was of, health care. Another comment stated investigational drugs available to those revising the 1987 charging rule was to that, although the poor may qualify for who cannot afford them. However, FDA provide authority to charge for company-sponsored assistance to pay cannot require a sponsor to honor a investigational drugs under the two new for investigational drugs, middle-class commitment to provide a drug to those categories of expanded access for patients may not be eligible for such who cannot afford it, or otherwise treatment use—individual patient and programs yet still be unable to afford compel a sponsor to provide expanded intermediate-size population expanded such drugs. Two comments stated that access. FDA also recognizes that access INDs (71 FR 75168 at 75169 permitting charging only for direct costs circumstances may change such that a through 75170). For expanded access may not increase access because it will sponsor is no longer able to honor a under a treatment IND or treatment not provide enough financial incentive commitment to make investigational protocol, the proposed rule stated that for companies to offer access. One drugs available to those who cannot such assurance must also include the comment agreed that permitting afford to pay for them. specific types of evidence in charging for investigational drugs made (Comment 38) One comment stated § 312.8(c)(2), including evidence of available under expanded access that permitting charging for sufficient enrollment in any ongoing programs will result in greater access to investigational drugs for expanded clinical trials needed for marketing investigational drugs. access under subpart I will create a approval. However, the specific types of (Response) FDA recognizes that dichotomy between rich and poor evidence identified apply only to permitting cost recovery for expanded because patients who can afford to pay requests to charge for expanded access access to investigational drugs for for investigational drugs can be use under new § 312.320 (treatment IND treatment use will not remove all guaranteed access under treatment use or treatment protocol) (see § 312.8(c)(2)). barriers to access. The agency shares the protocols, but those who cannot will be Because individual patient INDs (new concerns about equitable access to such forced to enroll in clinical trials with § 312.310) and intermediate-size patient drugs among patients with varying only a chance that they will receive the population INDs can occur earlier in financial resources. FDA’s goal, with investigational drug in question. drug development and typically involve this cost recovery provision, is to enable (Response) FDA does not agree that much smaller numbers of patients, FDA willing sponsors to make a drug this rule will lead to a situation in did not think it would be helpful to available that could not otherwise be which those with fewer resources specify in the rule how to provide made available or to make a drug more disproportionately bear the burdens of reasonable assurance that charging will widely available than would be possible participating in clinical trials. A sponsor not interfere with developing the drug absent cost recovery, thus potentially cannot charge for an investigational for marketing approval for those types of benefiting more individuals than would drug under a treatment IND unless there expanded access program. To clarify have benefited absent charging. FDA has is evidence of sufficient enrollment in that the evidentiary requirements apply no control over reimbursement policy. any ongoing clinical trials needed for only to treatment INDs or treatment FDA hopes that sponsors that charge for marketing approval to provide FDA

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reasonable assurance that the trials will cover investigational drugs. The agency needed for marketing approval. be successfully completed encourages sponsors to include Proposed § 312.8(c)(2)(ii)) required (§ 312.8(c)(2)(i)). FDA anticipates, provisions in their expanded access sponsors to provide evidence of therefore, that in most cases, the programs to assist patients who are adequate progress in the development of majority of subjects needed to be unable to pay for investigational drugs. the drug for marketing approval. Such enrolled in a trial will have been The details of such plans (e.g., the evidence could include successful enrolled before the drug is available percentage of patients eligible to obtain meetings with FDA before submission of under a treatment IND in which the a drug free of charge or the percentage an NDA (e.g., a pre-NDA meeting), sponsor charges for the drug, so the trial of drug supply that will be made submission of an NDA, or completion of will be fully enrolled. In addition, available free of charge) should be other significant drug development access to investigational drugs under an determined based on the circumstances milestones. Sponsors would also be individual patient or intermediate-size of the particular expanded access required to submit information under population expanded access program is program. their general investigational plans usually limited to individuals who are 3. Ethical Considerations (§ 312.23(a)(3)(iv)) specifying the drug ineligible to enroll in controlled clinical development milestones they plan to trials. Section 312.310(a)(2) provides (Comment 40) Two comments stated meet in the coming year (proposed that FDA must determine that a patient that there are ethical concerns with § 312.8(c)(2)(iii)). FDA could then seeking access to a drug under an charging patients for expanded access evaluate actual progress made versus individual patient IND cannot obtain use of investigational drugs that may planned progress to assess the impact, if the drug under another IND or protocol, have no benefit and pose safety any, of charging for an investigational which would include a clinical trial or concerns. drug under a treatment IND. Negative a larger expanded access IND. Section (Response) In determining whether to effects on these criteria would be permit an expanded access use of an 312.315(a)(2) explains that the considered indications of interference investigational drug, FDA assesses intermediate-size patient population with drug development. whether the potential risks are IND for a drug being developed is The proposed rule did not provide intended to address the situation in reasonable in light of the potential benefits, sometimes on the basis of quite specific criteria for individual (new which patients requesting access to a § 312.310) and intermediate-size patient drug are unable to participate in a limited clinical evidence. Therefore, FDA agrees that there is a risk that the population access INDs (new § 312.315). clinical trial of the drug because, for The kinds of situations that present with example, they do not meet enrollment investigational drug will have no benefit and, therefore, that a patient will pay for these types of INDs can vary greatly, criteria, enrollment is closed, or the trial from situations in which there is no site is not geographically accessible. For an investigational drug that provides no drug development to assess, to these reasons, FDA believes this benefit. However, if a drug has a anywhere along the spectrum from very charging rule will not have a significant potential benefit that is reasonable in early in drug development to the last impact on the distribution of light of the risks associated with the stages of drug development. The scope individuals participating in clinical drug, and the sponsor must charge to can range from a single isolated trials and expanded access programs make the drug available, FDA believes incidence of an individual patient based on relative wealth. the public health is best served by (Comment 39) One comment stated making the drug available to patients for treatment use for a use not being that poor and lower- to middle-class a fee, even if the potential benefit is not developed to a late stage intermediate- patients should not be required to pay realized in a given patient. FDA believes size population IND for over 100 any costs associated with an that the ethical concerns expressed in patients. The agency believes the factors investigational drug and that health these comments can be addressed by an that are relevant to such a determination insurance plans should be required to informed consent that accurately will be as varied as the timeframes and cover all costs associated with such reflects the costs, potential risks, and scopes for these types of INDs. drugs. Another comment stated that the potential benefits. Therefore, FDA does not believe it is rule should specify that patients who necessary or helpful to try to describe in 4. Non-Interference With Drug are uninsured, or those whose insurance regulation specific criteria that a Development excludes payment for investigational potential sponsor of an individual drugs, cannot be charged for an (Comment 41) One comment asked patient or intermediate-size population investigational drug. One comment that FDA define what it means to IND must meet to provide reasonable recommended that permission to charge interfere with the development of a drug assurance of non-interference with drug by commercial sponsors be tied to a for marketing approval. development. However, because the requirement that a percentage of drugs (Response) FDA will use several populations are smaller than for a will be provided at no cost to the criteria to determine whether charging treatment IND, the risk of interference uninsured and those whose insurers do for an investigational drug in a with drug development is less than with not cover the costs. Two comments treatment IND will interfere with drug a treatment IND, so FDA does not recommended that the rule specify that development. These criteria were believe it will be difficult to a certain percentage of an described in the proposed rule. demonstrate non-interference with drug investigational drug for which charging Proposed § 312.8(c)(2) described development for most individual patient is permitted be made available free of specific criteria needed to provide FDA and intermediate-size population INDs. charge. reasonable assurance that charging for 5. Treatment INDs or Treatment (Response) The agency cannot require an investigational drug under a Protocols third-party payers to cover the costs of treatment IND or treatment protocol investigational drugs made available (new § 312.320) is not interfering with For treatment INDs or treatment under expanded access programs. We drug development. Proposed protocols (new § 312.320), the proposed also cannot require sponsors to provide § 312.8(c)(2)(i) required sponsors to rule included additional criteria for a drug free of charge to those who lack provide evidence of sufficient charging. Section 312.8(c)(2) of the insurance or whose insurance does not enrollment in any ongoing clinical trials proposed rule provided that for a

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treatment IND or protocol, the sponsor beginning of an expanded access added that the provision could delay must provide: program can be easily recognized and getting drugs to patients if there were a • Evidence of sufficient enrollment in interpreted as related to the availability delay in reauthorizing charging. any ongoing clinical trial(s) needed for of the drug under a treatment IND. For (Response) The agency does not marketing approval to reasonably assure this reason, FDA believes that the believe it is reasonable to place the FDA that the trial(s) will be successfully identified criteria provide a reasonable burden on FDA to investigate whether completed as planned, basis upon which to judge drug the criteria for charging continue to be • Evidence of adequate progress in development progress, both before and met because FDA does not have the development of the drug for after the initiation of a treatment IND, to independent access to the information marketing approval, and determine if progress is adversely needed to make that determination. • Information submitted under the affected. FDA would need to request that the general investigational plan FDA does not believe a 5-percent sponsor provide the necessary (§ 312.23(a)(3)(iv)) specifying the drug decrease in clinical trial accrual from a information. Therefore, FDA believes it development milestones the sponsor planned clinical trial accrual rate would would be more efficient if that sponsor plans to meet in the next year. be a useful benchmark for determining simply provided to FDA the information (Comment 42) One comment stated whether a treatment IND is interfering on an annual basis. We do not agree that that ‘‘evidence of sufficient enrollment with drug development. Typically, requiring that charging be reauthorized in any ongoing clinical trial(s) needed planned accrual rates are crude annually will delay patient access to for marketing approval’’ (§ 312.8(c)(2)(i)) estimates and lack the precision needed investigational drugs provided sponsors and ‘‘evidence of adequate progress in to make a 5-percent deviation make a timely and complete submission the development of the drug for meaningful. In addition, the precision seeking reauthorization to charge. In marketing approval’’ (§ 312.8(2)(ii)) are with which accrual rates can be most cases, FDA believes the too vague and do not provide adequate predicted likely varies for different determination will be straightforward safeguards to ensure that charging for an diseases based on their prevalence and and the review will be completed investigational drug under a treatment other factors. For these reasons, FDA expeditiously. IND will not interfere with a drug’s does not believe that specifying a (Comment 44) Another comment development for marketing. The percentage deviation from expected recommended reducing the time that a comment asked that FDA also require a clinical trial accrual would be useful for sponsor may charge before seeking sponsor to submit a copy of, or cross- evaluating potential interference with reauthorization to charge from 1 year to reference to, its general investigational drug development by a treatment IND. 6 months because charging for plan, including a development timeline FDA also does not agree that investigational drugs always presents a and clinical trial accrual estimates. The determining whether charging for a risk of compromising enrollment in comment stated that when requesting treatment IND is affecting drug clinical trials. reauthorization, a sponsor should be development will require (Response) FDA believes the 1-year required to show that its actual comprehensive analyses of clinical trial anniversary is a reasonable point in time enrollment is no more than 5 percent accrual patterns. FDA anticipates that a to re-evaluate the charging request for less than its original estimates or, if finding that reauthorization is not most authorizations to charge. If FDA lower, provide a satisfactory appropriate because charging is has concerns about charging for a explanation for the deviation from interfering with enrollment in clinical particular treatment IND, for example, planned accrual (e.g., smaller than trials will ordinarily be based on very where there is a concurrent clinical trial anticipated population with the disease strong evidence of a significant effect still enrolling subjects, the rule provides of interest from which to draw subjects). contemporaneous with onset of an FDA the option to specify a shorter One comment stated that determining access program, and not on subtle period in which to re-evaluate whether whether charging is interfering with the deviations from historical accrual the criteria for charging continue to be development of a drug for marketing patterns for clinical trials in the disease met. approval would require FDA to analyze of interest. patterns of enrollment in clinical F. Costs Recoverable When Charging for studies and the causes of insufficiencies 6. 1-Year Authorization an Investigational Drug in enrollment, and assess what delays Section 312.8(c)(4) of the proposed Proposed § 312.8(d) described the are unacceptable. rule provided that charging for any type types of costs that a sponsor can recover (Response) FDA acknowledges that of expanded access to an investigational when charging for an investigational applying the criteria concerning drug drug for treatment use may continue for drug in a clinical trial and for treatment development progress involves 1 year from the time of FDA use under an expanded access IND. judgment, but does not agree that these authorization unless FDA specifies a Proposed § 312.8(d)(1) provided that a criteria are too vague. Modern drug shorter period. It also provided that a sponsor may only recover the direct development involves the progressive sponsor may ask FDA to reauthorize costs of making an investigational drug development of a body of evidence to charging for additional periods. The available. support a marketing application and preamble to the proposed rule stated Proposed § 312.8(d)(1)(i) described generally follows a relatively that FDA will ordinarily authorize direct costs as those incurred by a predictable course. For given diseases, it charging for the drug for a period of 1 sponsor that can be specifically and is possible to predict timeframes for year, unless ‘‘there is a particular exclusively attributed to providing the development generally and specific concern that charging would interfere drug for the investigational use for components of development (e.g., with drug development’’ (71 FR 75168 which FDA has authorized cost individual clinical trials) with some at 75172). recovery. Direct costs include costs per precision. It is also true that initial time (Comment 43) One comment stated unit to manufacture the drug (e.g., raw expectations can be overly optimistic that the 1-year authorization period was materials, labor, and nonreusable and require adjustment. However, FDA unnecessary because FDA can always supplies and equipment used to believes a marked deviation from withdraw authorization if the criteria manufacture the quantity of drug expectations that coincides with the are no longer being met. The comment needed for the use for which charging

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is authorized) or costs to acquire the that the calculation is consistent with The intent of allowing cost recovery drug from another manufacturing the cost recovery provisions in this rule. for expanded access uses is to remove source, and direct costs to ship and (Comment 46) Several comments any financial disincentive for a sponsor handle (e.g., store) the drug. argued that sponsors should be to make a drug available by permitting Proposed § 312.8(d)(1)(ii) described permitted to charge for other types of the sponsor to recover direct costs of indirect costs (those costs that can not costs in addition to those provided for making the drug available plus be recovered when charging for an in the proposed rule. One comment monitoring and administrative costs investigational drug) as costs incurred stated that cost recovery should include directly associated with the expanded primarily to produce the drug for the costs of clinical trials, all related access use. The intent is not to allow a commercial sale (e.g., costs for facilities research and development costs, and sponsor to begin recouping its general and equipment used to manufacture the administrative, labor, and other costs. drug development investment in supply of investigational drug, but that Two comments stated that FDA should advance of marketing approval. FDA are primarily intended to produce large permit some cost recovery for research believes that allowing recovery of those quantities of the drug for eventual and development costs in clinical trials. generalized costs prior to marketing commercial sale) and research and One of the comments requested that approval would be effectively development, administrative, labor, or FDA reconsider its decision to exclude permitting commercialization of an other costs that would be incurred even research and development costs from unapproved drug. if the clinical trial or treatment use for the cost recovery calculation. The The agency also does not agree that which charging is authorized did not comment argued that FDA could the cost recovery provision should occur. provide criteria to better define provide for recovery of capital recoverable research and development investment and fixed manufacturing 1. Direct and Indirect Costs costs, thus avoiding the subjectivity and costs, which are incurred by the sponsor (Comment 45) One comment stated arbitrariness concerning recovery of primarily for the purpose of that FDA lacked the expertise to decide research and development costs in the manufacturing sufficient quantities of whether the price proposed by the 1987 charging rule. One comment asked the drug for commercial sale. These sponsor would only cover direct costs. that cost recovery be permitted for costs also should be recouped during The comment stated that FDA production fixed costs such as capital commercial marketing of the drug. (Comment 47) One comment asked accountants would need to scrutinize investment and fixed manufacturing that FDA revise the proposed rule to each sponsor’s asserted direct costs to expenses. Two comments agreed that permit cost recovery for the cost of drug ensure fairness and consistency in its sponsors should only be permitted to delivery, which includes formulation, handling of the policy and that charge for direct costs. One of the packaging, instrumentation, monitoring, distinguishing between direct and comments agreed with the statement in disposables, setup, nursing, and similar indirect costs is likely to be the proposed rule that provision of costs. complicated. unapproved drugs should ordinarily be (Response) It is not necessary to make (Response) The agency believes that, considered part of the cost of doing the suggested revisions because such when charging for investigational drugs, business and that charging for indirect costs can be recovered without a sponsor of a clinical trial or expanded costs and overall development costs authorization from FDA. Section access program should not be permitted should not be permitted. One comment 312.8(d)(1) is intended to permit a to commercialize (e.g., profit from the stated that the proposed rule’s sponsor to recover its direct costs sale of) the drug. Thus, the proposed description of recoverable costs is incurred in making a drug available rule set forth criteria that permit a subject to varying interpretations by from the onset of manufacturing to the sponsor to recover only costs accounting professionals and would point it arrives at the destination to specifically attributable to making the thus result in inconsistent application of which it was shipped, or acquisition, investigational drug available in the trial the cost recovery provisions. shipping, and handling costs for a drug or expanded access program for which (Response) FDA does not agree that acquired from another source (e.g., cost recovery is authorized (i.e., only the cost recovery provision should where manufacturing is outsourced). those costs that would not have been provide for recovery of research and Subsequent costs incurred at a clinical incurred but for the provision of the development costs incurred to develop trial site (e.g., a hospital or clinic), drug). We believe the direct cost the drug for marketing approval. For a including pharmacy costs (e.g., the cost provision as proposed, by differentiating drug that has not yet been approved for to reformulate a drug for infusion), between direct costs and indirect costs, any purpose, the intent of permitting nursing costs (e.g., costs associated with and not providing for apportionment of charging for that drug in a clinical trial administering a drug and monitoring indirect costs (e.g., overhead and is to provide the opportunity to recoup study subjects), equipment costs (e.g., general research and development costs) the cost of making the drug available intravenous (IV) administration sets), simplifies the cost recovery calculation when the cost of that drug is and costs for study-related procedures to the extent possible and makes clear extraordinary in relation to drug costs (e.g., chemistry labs, radiographic FDA’s objectives concerning what costs generally, or in relation to the resources procedures), are outside the scope of can be recovered. Therefore, FDA does of the sponsor, and therefore, highly this rule. That is, the costs of these not anticipate major controversies burdensome for a sponsor. The intent is items and services can be recovered concerning cost recovery calculations not to subsidize the overall without prior authorization from FDA under this rule, or the need to rely development of the drug. In general, the (also see response to comment 64, heavily on financial experts to costs associated with drug development which includes a link to the Center for adjudicate such calculations. In the are very large, so it is not reasonable to Medicare and Medicaid Services (CMS) event of a significant controversy, FDA expect the relatively small number of policy concerning reimbursement for expects that it will be able to require the patients participating in a clinical trial clinical trial related items and services). sponsor to produce supporting (compared to those who will obtain a (Comments 48) One comment stated documentation prepared by an drug once it is on the market) to be able that there might be substantial independent financial expert attesting to meaningfully subsidize those costs. differences in the amount charged per

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patient for the same drug if the cost sponsor would be able to charge for an costs to produce additional were allocated across a small population approved drug in a clinical trial to cost investigational drugs. clinical trial compared to a large only would have implications for the (Response) The intent of the cost population trial. rebates and discounts that must be made recovery provision is to permit cost (Response) We agree that this result is to eligible entities (private entities recovery for whatever direct costs are possible. For example, if a sponsor is receiving grants under the Public Health attributable to providing the amount of permitted to charge for a drug in a small Service Act, and certain hospitals) drug needed for the clinical trial or clinical trial, and the sponsor then under the Medicaid Rebate and the expanded access use. The rule submits a separate request to charge for 340B Program (section 340B of the purposefully excludes many other costs the drug in a larger subsequent trial of Public Health Service Act (42 U.S.C. (e.g., overhead, depreciation, reusable the same drug, the drug cost may be 256b)). The comment stated that rebates supplies, equipment, manufacturing lower in the larger trial due to and discounts for a drug under these facility) that would be incurred even if economies of scale. FDA believes the programs are based in part on the ‘‘best the amount of drug needed was not higher cost for the smaller population is price’’ to any purchaser during each produced, but a small fraction of which probably unavoidable and is a calendar quarter and was concerned that could be apportioned to the drug supply reasonable outcome for cost recovery if the amount charged under this rule produced under general accounting purposes. were included in the ‘‘best price’’ principles. FDA believes these costs (Comment 49) One comment stated determination, the sponsor could incur would ordinarily be a very small that limiting the amount of cost a large liability for rebates and discounts percentage of the total cost when recovery for an approved drug to to eligible entities. The comment stated apportioned to the amount of drug acquisition and handling costs, instead that such pricing could also be produced for a clinical trial or expanded of permitting investigators and construed to establish most favored access program, so permitting recovery pharmacies to seek normal customer pricing that could be used to for these types of costs would create reimbursement amounts, would create set prices under the Federal Supply needless complexity and administrative serious administrative problems because Schedule contracts with the Federal burdens. For example, FDA would need it would require investigators to Government. to retain personnel with financial establish separate billing and inventory (Response) FDA believes that recovery expertise to assess a relatively small accounting systems for trial drugs. The of drug costs associated with making an number of very complex cost recovery comment added that, to the extent that approved drug available to subjects in a calculations. FDA also believes community pharmacies are furnishing clinical trial is distinct from the permitting cost recovery for a broader drugs in clinical trials, the proposal to commercial sale of drugs. The former array of costs might invite expansive limit what they can charge does not and unwarranted interpretations of seem feasible, because they would not does not involve a commercial sale of allowable costs, which would create even be aware of the customer’s status the drug and is not intended to make a additional administrative burdens. as a clinical trial subject. drug available for use in a clinical (Response) As discussed in comment practice setting. FDA believes that the (Comment 52) Three comments stated 27 and 31, FDA has revised the primary objective of programs for that FDA should allow charging for the proposed rule so that sponsors that must Medicaid and the 340B program (by market value of an approved drug being obtain the study drug or an active which certain federally funded grantees studied for a new indication. One control from another entity (i.e., a and safety net providers may purchase comment stated that when charging for sponsor who is not the applicant who prescription drugs at significantly approved drugs, normal charges holds the approved application for a reduced prices) and of those agencies incurred at the site at which the drug is drug and commercially markets the that administer Federal Supply dispensed (e.g., outpatient or inpatient drug) are not required to obtain Schedules for pharmaceuticals (e.g., the pharmacy) should be permitted. authorization to charge for the drug. Veterans Administration) is to obtain (Response) As discussed in comment FDA believes such sponsors should be fair pricing relative to the prices paid by 31, FDA has revised the proposed rule able to cause the approved drug to be other entities in the commercial to eliminate the requirement for prior distributed to trial subjects through marketplace for drugs used in clinical approval to charge for an approved drug ordinary distribution channels for practice settings (e.g., in a hospital, for being studied for a new indication when approved drugs (e.g., an inpatient or outpatient use), and not relative to the the sponsor must obtain the drug from outpatient pharmacy) pursuant to a amount a sponsor charges in the another entity. In this situation, the physician’s order or prescription and to unusual circumstance in which it seeks sponsor can cause the drug to be cause subjects to be charged the same to recover its drug cost in a clinical trial. distributed to subjects through ordinary amount that would be charged to a However, sponsors who intend to distribution channels for marketed patient who received the drug in the charge for an approved drug in a clinical drugs (e.g., inpatient or outpatient course of clinical practice. As discussed trial should consult with CMS pharmacies). in comment 26, sponsors that conduct concerning the implications of cost However, a sponsor must obtain prior trials of their own approved drug (e.g., recovery on the best price approval to charge, and may recover a drug that the sponsor commercially determination. Sponsors should also only the sponsor’s direct costs for markets) must obtain prior authorization consult with the agencies that making a drug available, in the to charge for the trial drug pursuant to administer Federal Supply Schedule sponsor’s trial of a new indication or the criteria set forth in § 312.8(b)(1) of contracts for pharmaceuticals use of its own approved drug. FDA this final rule. Such sponsors are concerning the implications for prices believes that entities that are marketing permitted to recover only their direct under those contracts. an approved drug should generally not costs for making the trial drug available (Comment 51) One comment asked charge for the drug in such trials. As to subjects as described in § 312.8(d) of that FDA permit cost recovery for direct discussed in comment 26, sponsors that this final rule. manufacturing costs for equipment and also market the approved trial drug (Comment 50) One comment was reusable supplies used to manufacture should not be able to commercialize an concerned that limiting the amount a the investigational drug and marginal unapproved use by charging subjects

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market value for the drug in a trial of the guidance with examples of acceptable requirements, and other administrative unapproved use. cost recovery determinations. costs directly associated with these two (Response) The recoverable costs for types of expanded access. 2. Recoverable Costs for Expanded orphan indications under an expanded Access Uses access program will be the same as for 3. Supporting Documentation Proposed § 312.8(d)(2) provided that other indications: The direct costs of the Proposed § 312.8(d)(3) provided that a when charging for an expanded access drug plus its monitoring, regulatory sponsor must provide supporting use under proposed § 312.315 compliance, and other administrative documentation to show that its cost (intermediate-size patient population costs. FDA believes the rule clearly recovery calculation is consistent with IND or intermediate-size patient reflects this intent and no additional the recoverable costs requirements in population protocol) and § 312.320 criteria or guidance are needed paragraphs (d)(1) and, if applicable, (treatment IND or treatment protocol), a concerning what costs can be recovered (d)(2). sponsor may recover, in addition to the for investigational drugs for orphan (Comment 57) One comment asked direct costs of the investigational drug indications. As discussed in the FDA to clarify that if the sponsor as described in proposed response to comment 48, it is likely that challenges FDA’s calculation or § 312.8(d)(1)(i), the costs of monitoring the unit cost of a drug will increase as authorization of recoverable costs, any the expanded access IND or protocol, the size of the population to be treated affected person, including patients, may complying with IND reporting decreases, but this correlation is be a party to that review. requirements, and other administrative unavoidable and does not require any (Response) If FDA determines that the costs directly associated with the special considerations in the cost amount sought to be charged must be expanded access use. recovery calculation. Although FDA lowered by a specified amount and the (Comment 53) Two comments believes the cost recovery provisions are sponsor formally disputes that recommended that sponsors be allowed sufficiently clear, FDA will evaluate determination, third parties would not to charge a reasonable administrative how the rule is implemented and, if be allowed to be party to the dispute fee, rather than basing charging on an there is confusion concerning resolution without the sponsor’s FDA-reviewed calculation of direct recoverable costs for expanded access consent because the discussion would costs. The comments suggested that the purposes, FDA will consider developing invariably involve commercial fee could be set by the sponsor after guidance to assist implementation. confidential information. A sponsor’s (Comment 55) One comment stated consultation with patient groups or formal dispute of an FDA denial of a that sponsors will continue to be based on a comparison of the cost of charging request would present the reluctant to charge for a product made treatment with other drugs in the class same problem for third parties seeking available for an expanded access use or other therapies. The comments to be a party to the dispute resolution. where the safety and efficacy is further stated that this proposal would Therefore, FDA believes it cannot unproven, for which there is no simplify the administrative burden and reimbursement to help patients pay provide for third-party participation in encourage sponsor participation in such costs, and where the allowable formal disputes concerning charging expanded access programs. charges are limited to the ‘‘direct costs’’ determinations without the consent of (Response) FDA believes its proposed of manufacturing and distributing the the sponsor disputing the FDA approach to determining what costs can proposed product. determination. Moreover, FDA be recovered for making investigational (Response) FDA is not advocating that anticipates that most disputed issues drugs available for expanded access sponsors charge for investigational with a charging request will be resolved uses—permitting a sponsor to recover drugs in expanded access programs. The informally in discussions between FDA its direct drug costs plus costs of purpose of permitting cost recovery for and the sponsor seeking charging, so a monitoring the expanded access IND or expanded access use is to remove any formal dispute will be rare. protocol, regulatory compliance financial disincentive to making a drug (Comment 58) One comment stated associated with the IND or protocol, and available for such use. FDA hopes that that the rule should provide that other direct administrative costs—is sponsors that have the resources to documentation of recoverable costs preferable because it simply permits a make investigational drugs available for follow accepted accounting practices. sponsor to recover all costs it incurs to expanded access use will continue to Another comment stated that it would provide the drug under the expanded make such drugs available free of be difficult for FDA to verify the costs access IND or protocol. An charge. requested, pointing out that the administrative fee approach involving (Comment 56) One comment stated proposed rule stated that if requester’s consultation with affected patient that monitoring or reporting costs for supporting documentation relies on groups and comparisons of treatment expanded access appear to be excluded financial information or accounting costs for similar or related treatment by the rule. methods beyond the expertise of FDA options seems to add needless (Response) The comment reviewers, FDA may request that a complexity and invite arbitrary cost misinterpreted the proposed rule. sponsor provide independent recovery determinations. In addition, Proposed § 312.8(d)(2) specifically certification. this approach would provide FDA no provided that, for expanded access to an (Response) FDA agrees that the tangible criteria by which to assess investigational drug for treatment use documentation provided to support a whether the amount charged represents under proposed §§ 312.315 calculation of recoverable costs for commercialization of an unapproved (intermediate-size patient population) charging purposes should be prepared drug. and 312.320 (treatment IND or treatment by a professional who is competent to (Comment 54) Two comments asked protocol), in addition to the direct costs make the required determinations. FDA FDA to clarify the evidence required to described in proposed paragraph also agrees that it may lack expertise to support the amount to be charged under (d)(1)(i) of § 312.8, a sponsor may verify the costs requested. Accordingly, an expanded access program, especially recover the costs of monitoring the the proposed rule has been revised to for orphan indications. One of the expanded access IND or protocol, state that the documentation must be comments asked that FDA develop complying with IND reporting accompanied by a statement that a

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certified public accountant has 5. Confidentiality (Response) FDA authority to provide reviewed and approved the calculations. for an exception to the general (Comment 62) Three comments (Comment 59) One comment noted prohibition on charging for expressed concern about the that the proposed rule needs to address investigational drugs, and its policies confidentiality of the documentation the tax implications for sponsors of concerning charging, are distinct from used to support cost calculations. Two investigational drug charges. CMS authority to identify the medical comments stated that financial interventions for which it will (Response) It is not within FDA’s information should be considered reimburse. FDA has no authority to expertise to interpret the tax proprietary and should not be available require that CMS reimburse for implications of these charging to the public either before or after investigational drugs for which FDA has regulations. Sponsors and individuals approval. permitted charging. Similarly, FDA has who take advantage of the cost recovery no authority to dictate reimbursement option afforded by these regulations are (Response) FDA will maintain the confidentiality of documentation policy to private health insurers. FDA responsible for determining the tax notes that there is a trend toward consequences of that cost recovery. submitted to support charging requests in a manner consistent with the providing reimbursement for medical 4. Authority to Set Pricing requirements of 21 CFR part 20. The care related to participation in a clinical sponsor is responsible for ensuring that trial, and reimbursing for investigational (Comment 60) Two comments stated the party providing the certification uses of products when there is a certain that FDA has no statutory authority to keeps confidential the information level of evidence to support the use. regulate the price for which medicine is relied on in making that certification. FDA believes these are encouraging sold, whether it is approved or developments and hopes that third- unapproved, and such regulation is 6. Effect on Payment Systems (CMS and party payers will continue to develop outside FDA’s statutory mission to Insurance) policies to provide reimbursement for ensure the safety and effectiveness of investigational therapies in appropriate marketed drug products. (Comment 63) Several comments expressed concern about the circumstances. (Response) The comment relationship between the proposed rule 7. Collaboration With CMS and the misunderstands FDA’s statutory basis and payment systems, specifically National Cancer Institute and goals for regulating charging. FDA systems of CMS and health insurance is not setting a price for a medication for (Comment 64) One comment stated companies. One comment suggested that it would be useful if FDA, CMS, commercial sale. This final rule intends that there should be regulatory changes only to permit recovery of certain costs and the National Cancer Institute were to require Medicare Part D and other to collaborate on the reimbursement associated with making an third-party payers to pay for investigational drug available in a implications of this new rule to ensure investigational drugs used in clinical there are no obstacles to Medicare clinical trial or for an expanded access trials for which FDA has permitted use, not to permit FDA to set the price payment for these investigational drugs. charging. The comment suggested that (Response) FDA discussed the for commercial sale of drugs. In the the proposed rule could also be revised preamble to the proposed rule, FDA implications of the proposed charging to provide that FDA authorization to regulation with CMS prior to publishing discussed its legal authority (71 FR charge for an investigational drug in an 75168 at 75173, citing 52 FR 19466 at the proposed rule so CMS could assess expanded access program constitutes the implications of the rule on its 19472 (May 22, 1987)). FDA concluded approval of the drug so that third-party that permitting a sponsor to charge an reimbursement programs. FDA has also payers such as insurance companies and discussed this final rule with CMS. amount greater than necessary to Medicare Part D would reimburse recover its costs (i.e., to permit a Under current part B policy, CMS does patients. Two comments stated that if not cover the costs of an investigational sponsor to profit) would be considered Medicare covers a drug used in a commercialization. For that reason, FDA drug used in a clinical trial unless the clinical trial under its coverage with drug is otherwise covered outside the stated that sponsors could only recover evidence development policy (see CMS their costs associated with making an clinical trial. However, certain routine ‘‘Coverage with Evidence costs associated with medical care investigational drug available. This final Development,’’ http:// rule merely refines what would be obtained due to clinical trial www.cms.hhs.gov/CoverageGenInfo/ participation may be covered (see considered allowable costs to address 03_CED.asp (FDA has verified the Web some confusion and varied Medicare Clinical Trial Policies, http:// site address, but FDA is not responsible www.cms.hhs.gov/ClinicalTrialPolicies/ interpretations with the 1987 charging for any subsequent changes to the Web rule. (follow link to Current Policy, NCD for site after this document publishes in the Routine Costs in Clinical Trials (Comment 61) One comment asked for Federal Register.)), FDA should permit (310.1))). In Part D, the statute clearly clarification about what would be an charging for the drug. Another comment defines the drugs that may be covered acceptable independent certification for recommended that FDA advise CMS to under the program (and their accepted cost recovery calculations. develop a reimbursement model for indications). (Response) Independent certification drugs being used under expanded (Comment 65) One comment asserted from an outside accountant is likely to access programs because private health that States will create mandated be adequate documentation concerning insurers will then follow suit and there insurance coverage to mirror the the recoverable costs that can be will be more equitable access to proposed rule expansion. The comment incorporated into the unit cost of the investigational drugs. One comment stated that if health insurers are investigational drug. The final rule suggested that FDA should require required to cover the cost of these drugs, states that the documentation must be insurers to agree that investigational they will need to increase premiums accompanied by a statement that an drugs will be listed on a reimbursable and that increasing premiums will cause independent certified public accountant formulary for the indications tested in more people to become uninsured. has reviewed and approved the trials or used in expanded access (Response) Currently, States generally calculations. programs. do not mandate reimbursement for

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investigational medical interventions. product is acceptable. However, nothing investigational drugs available for That States may, at some point in the in this final rule prevents a sponsor treatment use] would not be excessive future, begin to institute policies from designating a clinical supply of and would be justified by the primary mandating coverage of investigational approved drug for use only in a clinical benefit of this proposed rule, making drugs for which FDA has authorized investigation and labeling the product investigational drugs available for charging is speculative, and thus not a in the manner provided by § 312.6(a). treatment use that could not be otherwise made available without basis for modifying current FDA 4. Analysis of Impact policies. In addition, the likelihood that charging’’ (71 FR 75168 at 75175). The this final rule will further reduce access (Comment 69) One comment disputed comment stated that there is little to health insurance because of increased FDA’s conclusion that Executive Order evidence for these claims, arguing that costs associated with reimbursement for 12866 does not apply because the the costs are likely to be very high in investigational therapies seems remote proposed rule is not an economically some cases and relatively low in other even if reimbursement were required, as significant regulatory action. The cases. investigational drugs provided under comment maintained that expanding the (Response) FDA agrees that there will this regulation would constitute only a scope of treatment uses for which be a range of costs for investigational tiny fraction of overall drug use. charging is permitted to include drugs made available for treatment use charging for drugs made available under and subject to charging, and that costs G. Miscellaneous Comments intermediate-size patient populations could be quite high in some cases. 1. Promotion and for individual patients could result However, the differing costs of drugs in a significant financial impact. The across different expanded access (Comment 66) One comment pointed comment also noted that one of the programs does not undermine FDA’s out that FDA regulations at § 312.7 reasons for allowing charging in clinical conclusion that costs of this final rule prohibit promotion of an investigational trials is that the development of the are justified in light of the potential drug and asked that FDA clarify that investigational drug may be benefits associated with broader access this final rule permits an approved drug extraordinarily expensive. The comment to investigational drugs for treatment to be promoted outside of a clinical trial stated that since FDA is predicting that use. That conclusion is not intended to for its approved uses, even if the drug requests for charging in clinical trials, imply that costs and benefits are offset is used in a clinical trial. and hence charging for extraordinarily in each individual case in which there (Response) FDA agrees with the expensive drugs will increase, there is charging for drugs made available for comment. Nothing in this final rule would likely be a significant financial treatment use, so variation in cost across should be construed as a constraint on impact. The comment asked that FDA different expanded access programs a manufacturer’s ability to promote an perform an economic impact analysis or does not undermine the overall approved drug for its approved provide a better reason the Executive conclusion. indications. order does not apply. (Comment 71) One comment (Response) Based on our analysis 2. Liability reviewed claims data on the treatment (incorporating changes made to the of diseases likely to fall under the FDA’s (Comment 67) One comment notes proposed rule), we conclude that the proposed rule changes. The comment that there are potential liability final rule is not economically significant assumed that physicians would request concerns that need to be addressed that as defined under Executive Order access to investigational drugs only may result from subjects experiencing 12866. The comment does not provide when available therapies have failed or serious adverse events when charged for any data or alternative analyses that when conventional therapies do not an investigational drug not approved by would lead the agency to change this exist. The comment also assumed that, FDA. conclusion. Historical data indicate that depending on the circumstances, (Response) When the amount charged only a very small percentage of all INDs investigational drugs will be used as for the investigational drug is merely the submitted to FDA for clinical trials or first-line therapy, second-line therapy, sponsor’s cost, and subjects have given treatment use include requests to charge monotherapy and combined therapy their informed consent to participate in for the drug. FDA expects only a slight with FDA-approved medications. Based a trial in which there is charging for increase in the already limited number on these assumptions, the comment study drug, FDA does not believe there of requests to charge as a result of the estimated the additive cost of the would be a meaningful difference in a final rule. Our analysis of impacts proposed rule as it would apply to sponsor’s product liability exposure predicts only a slight increase in enrollees in commercial/private health when it charges for the drug compared charging for individual patient INDs, plans to be $273,700,000. The comment to when it does not. and a modest increase in charging for expressed the belief that these estimates intermediate-size patient population actually understate the burden to 3. Product Labeling INDs (see section VI.E.2 of this private sector payers, because they (Comment 68) One comment pointed document) (upper bound of less than exclude potential annual costs to out that § 312.6(a) requires that the 800 total patients affected). Because Medicare Advantage plans. immediate package of an investigational provisions for allowing charging in a (Response) Based on our analysis, we new drug bear a label advising that the clinical trial have been in the regulation concluded that the costs of the final rule drug is limited by law to investigational since 1987, and this rule merely clarifies will be small. In response to the use. The comment expressed concern the criteria for allowing such charging, comment, we have included estimates that the proposed rule could be FDA does not anticipate a meaningful of the number of individual patients interpreted as requiring approved drugs increase in charging requests in that charged for investigational drugs under to bear that statement. setting. Thus, we do not believe that the current rules, and the number of (Response) FDA does not interpret final rule will have a significant additional patients we expect may be this final rule as requiring use of the economic or financial impact. charged for investigational drugs under statement required by § 312.6(a) on the (Comment 70) One comment disputed this final rule. FDA’s estimates indicate label of an approved drug product. The FDA’s assertion in the proposed rule that, on average, as many as 12,566 labeling approved for marketing of the that the ‘‘costs [associated with making patients per year may be charged for

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investigational drugs under current enforcement of the act, section 701(a) of economically significant regulatory rules. In addition, we estimate that as the act (21 U.S.C. 371(a)). action under the Executive order. many as 770 additional patients per year Section 505(i) of the act directs the The Regulatory Flexibility Act may be charged for investigational drugs agency to issue regulations exempting requires agencies to analyze regulatory under this final rule. These estimates from the operation of the new drug options that will minimize any are based on assumptions used in our approval requirements drugs intended significant impact of a rule on small analysis of impacts for the proposed solely for investigational use by experts entities. Our economic analysis for the rule that were not substantively qualified by scientific training and proposed rule did not indicate any challenged in any of the comments expertise to investigate the safety and significant new regulatory burden, and received. effectiveness of drugs. It is this authority we did not receive any comments that that underlies FDA’s IND regulations in would cause us to reconsider this The estimate of 67,500 patients part 312. The final rule adds to and determination. Therefore, the agency affected per year in the comment draws clarifies the previous IND regulations by certifies that the final rule will not have no distinction between patients who revising the 1987 charging rule to a significant economic impact on a may be charged for investigational drugs explain the circumstances under which substantial number of small entities. under current rules and those additional charging for an investigational drug is Section 202(a) of the Unfunded patients who may be charged under this appropriate in a clinical trial and to Mandates Reform Act of 1995 requires final rule. In assessing the impact of the clarify what costs can be recovered. that agencies prepare a written final rule, it is the incremental effect, or Section 561 of the act, added by the statement, which includes an additional patients that may be charged Food and Drug Administration assessment of anticipated costs and for investigational drugs, that must be Modernization Act of 1997 (Public Law benefits, before proposing ‘‘any rule that considered. Patients who may be 105–115), provides additional authority includes any Federal mandate that may charged for investigational drugs under for this final rule. One of that section’s result in an expenditure by State, local, current rules are not relevant to an preconditions to providing an and tribal governments, in the aggregate, analysis of impacts for this final rule. investigational drug for treatment use is or by the private sector, of $100,000,000 The comment appears to assume that all that the sponsors submit a protocol or more (adjusted annually for inflation) patients who may be eligible to obtain consistent with regulations issued under in any one year.’’ The current threshold an investigational drug under an section 505(i) of the act (see section after adjustment for inflation is $133 expanded access IND would seek 561(b)(1), (b)(4), and (c) of the act). This million, using the most current (2008) access, and that an appropriate drug rulemaking sets out the circumstances Implicit Price Deflator for the Gross would be available in all cases. In under which charging for an Domestic Product. FDA does not expect addition, the comment appears to investigational drug is appropriate for this final rule to result in any 1-year assume that all patients with access to treatment use in an expanded access expenditure that will meet or exceed investigational drugs will also be program as well as in a clinical trial and this amount. charged for those drugs. Our analysis of clarifies what costs can be recovered. Preparing additional charging historical data indicates that, on Section 701(a) of the act gives FDA requests accounts for the anticipated average, only about 1.1 percent of all the authority to issue regulations for the costs of this final rule. The agency IND submissions per year are associated efficient enforcement of the act. Further estimates that, the cost for a sponsor to with charging requests. discussion of FDA’s legal authority prepare and submit a charging request is The only direct costs that are relevant regarding charging can be found at 52 approximately $2,500, and that these to this final rule are the costs to drug FR 19466 at 19472 (May 22, 1987). costs will be widely dispersed among affected entities. Because such requests sponsors to prepare and submit charging V. Environmental Impact requests to FDA. The comment did not are rare, the incremental number of provide an estimate of these costs. The agency has determined, under 21 requests generated by this final rule, as CFR 25.30(h), that this action is of a well as the total costs of the rule, will IV. Legal Authority type that does not individually or probably be quite small. Permitting cumulatively have a significant effect on charging for a broader range of treatment FDA has the authority under the the human environment. Therefore, uses for investigational drugs will Federal Food, Drug, and Cosmetic Act neither an environmental assessment increase sponsors’ incentives to (the act) to permit charging for an nor an environmental impact statement undertake such activities, thereby investigational new drug under the is required. promoting development of new conditions set forth in this final rule. products, as well as the development of VI. Analysis of Economic Impacts This final rule clarifies and slightly new uses for already approved products. expands the charging scheme that is FDA has examined the impacts of the Due to uncertainty with respect to the already in place. It is based on the final rule under Executive Order 12866 potential magnitude of such benefits, 2 agency’s authority to issue regulations and the Regulatory Flexibility Act (5 and a lack of necessary data, FDA did pertaining to the investigational use of U.S.C. 601–612), and the Unfunded not generate quantitative estimates of drugs, section 505(i) of the act (21 Mandates Reform Act of 1995 (Public expected benefits. U.S.C. 355(i)), its authority pertaining to Law 104–4). Executive Order 12866 expanded access to unapproved drugs directs agencies to assess all costs and A. Objectives of the Final Rule for treatment use, section 561 of the act benefits of available regulatory The objectives of the final rule are to (21 U.S.C. 360bbb), and its general grant alternatives and, when regulation is clarify and expand on 1987 charging of rulemaking authority for the efficient necessary, to select regulatory rule that permits sponsors to charge approaches that maximize net benefits patients for investigational drugs. Under 2 In light of section 903(d) of the act (21 U.S.C. (including potential economic, this 1987 charging rule, FDA could 393(d)), and the Secretary of Health and Human environmental, public health and safety, authorize charging for an investigational Service’s delegations to the Commissioner of Food and Drugs, statutory references to ‘‘the Secretary’’ and other advantages; distributive drug used in a clinical trial or under a in the discussion of legal authority have been impacts; and equity). The agency treatment IND or protocol. The final rule changed to ‘‘FDA’’ or ‘‘the agency.’’ believes that this final rule is not an describes more specifically the types of

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costs that can be recovered when factors. The agency believes that another entity for a study of the charging for an investigational drug. The allowing cost recovery through charging approved drug (e.g., a study of a new final rule also adds provisions that may be appropriate in these instances, use) to obtain authorization to charge for permit charging for investigational but only as a last resort source of the drug and otherwise comply with the drugs for all of the various types of funding to facilitate development of a requirements of § 312.8. Under this final expanded access use described under promising new therapy that could not rule, such sponsors can charge at their final subpart I of part 312. otherwise be developed. own discretion in this circumstance. In some clinical trials, it may be In contrast to clinical trials, granting B. The Need for the Final Rule necessary for a sponsor to obtain an expanded access to investigational The final rule is needed to establish approved drug from another entity. The drugs for treatment use primarily charging provisions for additional types approved drug may be used as an active benefits individual patients and is not of expanded access use other than the control or in combination with the intended typically to generate data treatment IND or protocol. Elsewhere in sponsor’s drug in a clinical trial needed to support marketing approval. this issue of the Federal Register, FDA designed to evaluate the effectiveness or Thus, the costs to sponsors associated is amending part 312 of its regulations safety of the sponsor’s investigational with making a drug available for by adding subpart I concerning drug. In these situations, the trial expanded access are not considered expanded access to investigational subjects typically must receive some typical drug development expenditures. drugs. In addition to the treatment IND therapy for their disease because using For this reason, the agency believes that or protocol previously described in FDA a placebo control will be unethical. In it is generally more appropriate to regulations, the expanded access final addition, the subjects often will be permit sponsors to charge for expanded rule specifically authorizes expanded treated with the approved drug in the access to investigational drugs for access use for individual patients, course of medical practice if they were treatment use. Allowing charging in including in emergencies, and expanded not participating in the clinical trial. expanded access settings may also access use for intermediate-size patient FDA had proposed criteria for charging provide financial incentives for populations. The expanded access final in these situations that presented a sponsors to make investigational drugs rule is intended to improve access to much lower threshold than for charging more widely available in these investigational drugs for patients with for the sponsor’s own investigational situations. serious diseases who have exhausted drug. Based on comments received, FDA D. Baseline for the Analysis other therapeutic options and may has elected not to require sponsors who benefit from such therapies. This final must obtain an approved drug from During the period 1997 through 2005, rule is necessary to establish provisions another entity for use as an active FDA received an average of 2,046.6 that permit charging for investigational control, or in combination with the INDs per year. During this same period, drugs for all of the categories of sponsor’s own drug, to obtain the agency received an annual average expanded access use described under authorization to charge for the drug and of 22.6 requests to charge patients for final subpart I. otherwise fulfill the requirements in investigational drugs. Thus, only about The final rule is also needed to clarify § 312.8. Under this final rule, such 1.1 percent (0.011 = 22.6 / 2,046.6) of all and better explain the types of costs sponsors can charge at their own INDs received by the agency on an sponsors are permitted to recover discretion in this circumstance. annual basis were associated with through charging. The 1987 charging In other situations, an approved drug charging requests. Similarly, FDA rule describing the costs a sponsor can must be obtained by a third party (not received an average of 4.6 treatment IND recover when charging for an the holder of the approved application) or protocol submissions and 1.1 investigational drug has proven difficult to study the drug in a clinical trial for treatment IND or protocol charging to interpret and apply. Some sponsors a new use or to obtain important safety requests per year during this period. have interpreted the language broadly to information about an approved Thus, requests to charge under permit recovery of costs much greater indication. Researchers conducting such treatment INDs or protocols were than those directly attributable to clinical trials are primarily associated with about 0.05 percent providing the investigational drug for noncommercial entities who are not in (0.0005 = 1.1 / 2,046.6) of all INDs the approved treatment use. In addition, the business of drug development. received by the agency, and ambiguities in the 1987 charging rule Typically, these sponsor-investigators approximately 23.9 percent (0.239 = 1.1 may have caused inefficiencies leading conduct relatively small trials at a single / 4.6) of all treatment IND or protocol some drug sponsors to devote more site. Since such sponsors lack the submissions per year. resources than necessary to the resources of commercial sponsors and FDA also received an average of 55 preparation and submission of charging do not conduct the research for other IND submissions and 15.6 other requests. commercial purposes, they will not be charging requests per year during this able to recover the cost of obtaining the period. These requests were to charge C. Why Allow Charging? approved drug by marketing the drug, patients for expanded access to The expense of conducting a clinical for example, for a new indication. The investigational drugs in situations other trial is considered a normal cost of drug agency believes these kinds of trials than individual patient or emergency development that should be recovered should be encouraged because they may INDs, and treatment INDs or protocols. through sales after marketing approval. yield important data about less Such situations generally included However, in some clinical trial settings, commercially viable uses of a drug or requests to charge for expanded access a sponsor may incur extraordinary costs additional drug safety information. FDA in intermediate-size patient populations compared to typical drug development had proposed criteria for charging in and under clinical trials. Because the expenses. Such a cost burden may arise these situations that presented a much intermediate-size patient population because of unusually high lower threshold than for charging for the IND or protocol was not previously manufacturing costs, the quantity of the sponsor’s own investigational drug. established in regulation, a more precise drug required, the number of patients Based on comments received, FDA has distribution of other charging requests involved, the expected duration of elected not to require sponsors who cannot be determined. Nevertheless, treatment, or some combination of these must obtain an approved drug from other charging requests were associated

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with about 0.76 percent (0.0076 = 15.6 Finally, FDA received an average of percent (0.0029 = 5.9 / 2046.6) of all / 2,046.6) of all INDs received by the 659 individual patient or emergency INDs, and approximately 0.9 percent agency, and approximately 28.4 percent IND submissions and 5.9 charging (0.009 = 5.9 / 659) of all single patient (0.284 = 15.6 / 55) of all other IND requests for individual patient or or emergency INDs received by the submissions each year from 1997 emergency INDs per year. Thus, single agency each year. This information is through 2005. patient or emergency IND charging summarized in table 1 of this document. requests are associated with about 0.29

TABLE 1.—BASELINE DATA FOR AVERAGE ANNUAL NUMBER OF IND SUBMISSIONS AND CHARGING REQUESTS BY CATEGORY

All Charging Treatment IND/ Other Charging Individual Patient/ Category Requests Protocol Requests Requests Emergency Requests

Number of charging requests 22.6 1.1 15.6 5.9

Percent of all INDs 1.1% 0.05% 0.76% 0.29%

Average number of submissions 4.6 55 659

Percent of submissions 23.9% 28.4% 0.9%

One comment submitted in response investigational drugs under single an average of 1.1 treatment IND or to the proposed rule provided an patient or emergency INDs. FDA protocol charging requests per year estimate of the number of patients that believes that it is reasonable to assume could affect between 110 and 11,000 might be affected by this final rule. As that a typical intermediate-size patient individuals. Based on this information, part of our response, we have generated population will include between 10 and FDA estimates that between 272 and estimates of the number of patients 100 individuals. Given that FDA 12,566 individuals may currently be receiving investigational drugs and currently receives an average of 15.6 charged for investigational drugs each subject to charging requests under charging requests for such submissions year under rules in place since 1987. current rules, in place since 1987. per year, we estimate that between 156 The wide range of these estimates Based on the information presented in and 1,560 individuals may currently be reflects significant variation in the table 1 of this document, FDA currently receives an average of 5.9 charging charged for investigational drugs under number of patients enrolled in requests for individual patient or intermediate-size patient populations. A intermediate-size patient populations, emergency INDs per year. Thus, treatment IND or protocol can vary and treatment INDs or protocols. These approximately 5.9 individuals per year significantly in size and may include estimates are summarized in table 2 of may currently be charged for between 100 and 10,000 patients. Thus, this document.

TABLE 2.—APPROXIMATE NUMBER OF INDIVIDUALS AFFECTED ANNUALLY BY CHARGING RULES FOR INVESTIGATIONAL DRUGS IN PLACE SINCE 1987

Average Number Number of Minimum Number Maximum Number Category of Requests Patients of Individuals of Individuals

Individual patient or emergency IND 5.9 1 5.9 5.9

Small patient population/other 15.6 10—100 156 1,560

Treatment IND or protocol 1.1 100—10,000 110 11,000

Total 272 12,566

E. Nature of the Impact rule should help to facilitate patient this final rule should also make the access to drugs that could not be process of obtaining authorization to The final rule will affect patients who provided without charging and permit charge more transparent and more lack effective therapeutic alternatives sponsors to study drugs that might efficient. Given the small percentage of for serious diseases; sponsors that otherwise be too costly to develop. all INDs that include charging requests, develop drugs to treat such diseases; FDA believes that the impact of the final and FDA in determining whether to By describing in regulation the full rule will be small. authorize charging for investigational range of treatment use situations in drugs. By clarifying requirements and which charging for an investigational This final rule could also increase establishing the full range of situations drug may be permitted, this final rule treatment expenses for some patients in which it may be appropriate to charge will likely increase the volume of who obtain investigational drugs for for an investigational drug, the final rule charging requests for treatment use which charging is permitted or for third- will improve patient access by somewhat. However, by clarifying the party payers if they choose to reimburse providing a financial incentive for circumstances under which charging patients for some or all of the costs of sponsors to make promising therapies will be permitted and specifying the such drugs. The agency believes that more widely available. Thus, this final types of costs that sponsors can recover, such costs will not be excessive and will

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be justified by the primary benefit of there would not be a substantial impact Similarly, the agency estimates that this final rule, making investigational on the number of charging requests in the expanded access final rule will drugs available for treatment use that clinical trial situations is unchanged in generate between 3 and 27 additional could not otherwise be made available the final rule. intermediate-size patient population without charging. The potential impact IND submissions per year. Information 2. Charging for Expanded Access Uses of specific provisions of the final rule is presented in table 1 of this document Described Under Final Subpart I discussed in greater detail in the indicates that approximately 28.4 following paragraphs. One comment submitted in response percent of all such IND submissions are 1. Charging in a Clinical Trial to the proposed rule provided an associated with charging requests. estimate of the number of patients that Therefore, the agency estimates that this Since 1987, FDA regulations have might be affected by this final rule. As final rule will generate between 0.85 permitted charging for investigational part of our response, we have generated (0.85 = 3 x 0.284) and 7.67 (7.67 = 27 drugs in clinical trials intended to estimates of the number additional x 0.284) additional charging requests for support marketing approval. This final patients that may be charged for intermediate-size patient population rule is intended only to clarify the investigational drugs under this final submissions per year. The agency situations in which charging for a rule. Information presented in tables in believes it is reasonable to assume that sponsor’s investigational drug in such a the analysis of impacts section of the an intermediate-size patient population clinical trial is appropriate. Therefore, expanded access final rule, published will generally include between 10 and FDA does not expect this final rule to elsewhere in this issue of the Federal 100 individual patients. These figures have a substantial effect on the number Register, will be used to generate these imply that approximately 8.5 (8.5 = 0.85 of requests to charge for sponsors’ estimates. x 10) to 767 (767 = 7.67 x 100) investigational drugs in clinical trials to additional patients may be charged for support initial marketing approval. FDA estimates that the expanded investigational drugs under Based on comments received, FDA access final rule will generate between has elected not to require sponsors who 132 and 395 additional single patient or intermediate-size patient populations must obtain an approved drug from emergency IND submissions per year. each year as a result of this final rule. another entity for use as an active Information presented in table 1 of this Because current regulations allowing control or in combination with the document indicates that approximately charging for investigational drugs under sponsor’s drug to obtain authorization to 0.9 percent of all single patient or a treatment IND or protocol are not charge for the drug. In addition, FDA emergency INDs are associated with significantly altered by this final rule, has elected not to require sponsors who charging requests. Thus, the agency the agency does not anticipate that the must obtain an approved drug from estimates that this final rule will final rule will lead to a change in the another entity for a study of the generate between 1.2 (1.2 = 132 x 0.009) number of requests to charge. Therefore, approved drug (e.g., a study of a new and 3.5 (3.5 = 395 x 0.009) additional FDA expects that between 10 (9.7 = 1.2 use) to obtain authorization to charge for charging requests for single patient or + 8.5) and 770 (770.5 = 3.5 + 767) the drug. Under this final rule, such emergency INDs. These figures imply additional patients may be charged for sponsors can charge for investigational that approximately 1.2 to 3.5 additional investigational drugs per year as a result drugs under these circumstances at their patients may be charged each year for of this final rule. The results of these own discretion. Therefore, our original investigational drugs as a result of this calculations are summarized in table 3 conclusion in the proposed rule that final rule. of this document.

TABLE 3.—APPROXIMATE NUMBER OF ADDITIONAL INDIVIDUALS THAT MAY BE CHARGED FOR INVESTIGATIONAL DRUGS UNDER THIS FINAL RULE

Number of Additional Number of Additional Number of Individuals Total Number Category Submissions Charging Requests per Request of Individuals

Individual patient or emergency IND 132—395 1.2—3.5 1 1.2—3.5

Small patient population/other 3—27 0.85—7.67 10—100 8.5—767

Treatment IND or protocol 0 0 100—10,000 0

Total 10—770

3. Costs Recoverable When Charging for In addition, the final rule permits charge for an investigational drug under an Investigational Drug sponsors to recover the costs of a treatment IND or treatment protocol, monitoring an expanded access to be affected because the final rule does Finally, § 312.8(d) of the final rule protocol, complying with IND reporting not significantly change the 1987 clarifies and better explains the types of requirements, and other administrative charging rule. We estimate that final costs sponsors are permitted to recover costs directly associated with expanded provisions allowing charging for single through charging. In particular, access for an intermediate-size patient patient or emergency INDs and sponsors are limited to recovery of the population and for a treatment IND or intermediate-size patient populations direct or marginal costs associated with treatment protocol. will affect between 10 and 770 making an investigational drug available individuals. for the approved treatment use. Direct 4. Summary F. Benefits of the Final Rule costs that are recoverable under the final The agency does not expect the rule include per unit manufacturing number of requests to charge for a Because FDA currently has no data costs and shipping and handling costs. sponsor’s drug in a clinical trial, or to that will allow us to predict the extent

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to which the final amendments to The final rule limits sponsors to investigational drugs for single patients existing regulations will generate direct recovery of the direct or marginal costs or intermediate-size patient populations benefits for consumers, it is not possible associated with making the drug will increase substantially. Finally, to accurately quantify the magnitude of available. Direct costs that are requests to charge are relatively any expected incremental benefits at recoverable under the final rule include infrequent and the expense necessary to this time. We expect the number of per unit manufacturing costs and prepare a charging request will requests to charge for investigational shipping and handling costs. Indirect or ordinarily be small compared to the drugs for expanded access use to fixed costs incurred for joint or common overall cost of preparing the expanded increase somewhat. However, the objectives and physical plant and access submission. number of additional patients who will equipment expenditures for producing The agency estimates that, on average, gain access to investigational drugs as a marketable quantities of the drug are 48 hours will be needed to prepare a result and the extent to which these specifically excluded under the cost request to charge under the final rule. patients will benefit from such access recovery provisions of the final rule. This estimate is based on FDA’s are highly uncertain. Establishing in The agency believes that these cost experience in reviewing charging regulation all of the situations in which recovery provisions will prevent requests under the 1987 charging rule charging is permissible and clearly sponsors from inappropriately shifting and on a projection of the increased specifying the types of costs that are the normal financial risks associated paperwork burden associated with the eligible for recovery will ease the with new drug development onto final rule. administrative burdens associated with patients when they charge for drugs in FDA’s experience implies that 80 obtaining authorization to charge and clinical trial settings. For expanded percent, or about 38 hours, of this will improve patient access to access use, the limitation to direct cost burden will be associated with investigational drugs for treatment use. recovery will also ensure that drug establishing that the amount proposed Private benefits will accrue to development costs that properly belong to be charged is limited to the direct individual patients receiving the drugs, to sponsors are not shifted to patients. costs of making the drug available. The whereas additional social benefits will G. Costs of the Final Rule agency believes that the cost accrue if others in society also value justification portion of the charging Although the final rule largely these individual patient benefits. request will need to be performed by a clarifies current agency practice, some Because the overall impact of the final cost accountant qualified to assess the additional paperwork costs will be rule is expected to be small, the direct costs of charging. Information incurred to the extent that the rule potential for any new regulatory benefits available on the Internet indicates that increases the total number of sponsor is somewhat limited. median total compensation for a Cost requests to charge patients for In formulating the final rule, FDA Accountant IV (senior level) is considered the interests of patients, investigational drugs. The information approximately $117,000 per year in drug sponsors, and the general public. requirements associated with the final 2008 or about $56 per hour ($116,857 / Concerning charging for investigational rule are not expected to impose a 2,080 hours).3 Thus the cost associated drugs in expanded access settings, the significant burden. Drug sponsors who with certifying the amount to be charged agency concluded that seriously ill wish to charge for investigational drugs is expected to be about $2,130 ($56 per patients could often benefit from will need to review the rule to become hour x 38 hours) per charging request. increased access to investigational drugs familiar with its provisions and to that have not yet been approved for gather the evidence and information The remaining burden (20 percent or marketing. On the other hand, greater necessary to support charging requests. about 10 hours) for the preparation of a patient access to investigational drugs Because of the lack of data described charging request will consist of a brief outside of the clinical trial setting could previously in this document, we are demonstration that the criteria for have the potential to delay approvals of unable to generate quantitative charging that are not related to the drugs to treat serious diseases (e.g., by estimates of compliance costs at this amount to be charged have been met. reducing incentives for potential time. The agency expects that any When the request is to charge for a drug subjects to enroll in clinical trials). If incremental cost burdens will likely be used in a clinical trial, this information allowing charging were to adversely small and widely dispersed among will ordinarily be available as part of the affect the drug approval process, the affected entities for a number of reasons. normal drug development process. general population will experience First, regulations covering charging When the request is to charge for a drug diminished social benefits due to the for investigational drugs in clinical for expanded access, the primary reduced or delayed availability of new trials and under treatment INDs or criterion is to show that charging will therapies approved for marketing by treatment protocols have been in place not interfere with development of the FDA. since 1987. As a result, the primary drug for marketing. FDA believes that The final rule addresses this tension incremental impact of the final rule will preparation of this portion of the by allowing sponsors to charge for be limited to the new charging charging request will likely be investigational drugs in expanded provisions for the new types of performed by a mid-level regulatory access settings as long as the sponsor expanded access for treatment use affairs specialist. Information available provides reasonable assurance that described under final subpart I of part on the Internet indicates that the total charging will not interfere with 312. Second, the agency does not expect median compensation for a Regulatory development of the drug for marketing that these final charging provisions will Affairs Specialist II (intermediate level) approval. In this way, the final rule will lead to a large increase in the total is approximately $100,000 or about $48 address the interests of those patient number of charging requests. Because it per hour in 2008 ($99,930/2,080 populations that will benefit from is not usually extraordinarily expensive having greater access to investigational to make an investigational drug 3 See http://swz.salary.com/salarywizard/ drugs and the broader interests of available to a single patient or a limited layoutscripts/swzl_newsearch.asp, last viewed 7/ 10/08. (FDA has verified the Web site address, but society in having safe and effective number of patients, the agency does not FDA is not responsible for any subsequent changes therapies approved for marketing and anticipate that the number of charging to the Web site after this document publishes in the widely available. requests for expanded access to Federal Register.)

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hours).4 Thus, the cost to demonstrate Most single patient INDs are for treatment use and thus permitting that a charging request meets treatment use and are submitted by charging only for treatment INDs and appropriate criteria is about $480 (10 individual physicians, and these entities treatment protocols. However, hours x $48 per hour) per charging will be classified as small entities. elsewhere in this issue of the Federal request. However, for reasons discussed Register, the agency is finalizing its Based on the figures presented previously, we do not anticipate that the regulations concerning the treatment previously in this document, FDA volume of requests to charge for use of investigational drugs to estimates the cost to prepare and submit individual patient expanded access will specifically authorize expanded access a charging request will thus be about increase substantially. Because for individual patients and for $2,610 ($2,130 + $480). The total costs expanded access for intermediate-size intermediate-size patient populations. associated with this final rule will patient populations is not currently The purpose of those regulations is to probably be widely dispersed among tracked by the agency, no data exist that expand access to investigational drugs. affected entities because charging will allow the agency to identify either In some situations, permitting sponsors requests are rare, and thus, a particular the number of sponsors in this category to charge for investigational drugs to be sponsor will be expected to submit such or the number that will qualify as small used by individual patients or by a request very infrequently. entities. FDA believes that requests to intermediate-size patient populations A significant concern with the final charge for investigational drugs in may be the only way that such patients rule relates to the potential effect on clinical trials of a sponsor’s drug will can receive access to these therapies access to investigational therapies for generally be submitted by large because sponsors may not be willing to economically disadvantaged individuals commercial drug sponsors. In sum, the provide the drugs free of charge. Thus, and the uninsured. Allowing sponsors agency believes that some entities consistent with the philosophy of the to charge could impose a significant submitting charging requests will meet expanded access rule, the agency financial burden on many seriously ill SBA small businesses criteria. As decided to permit charging for individuals who lack therapeutic discussed in section VI.E of this investigational drugs in all expanded alternatives and could preclude access document, the agency expects that any access settings to improve access to by some needy patients. However, in the incremental burden associated with the investigational drugs for patients with past, many companies that have final rule will be small and widely serious diseases who lack other provided investigational drugs for dispersed among affected entities. therapeutic options and who may treatment use have often included benefit from such therapies. assistance programs to cover the costs I. Alternatives for those who could not otherwise FDA considered several alternatives VII. Paperwork Reduction Act of 1995 afford them. FDA expects this practice to the final rule. Each is discussed in the This final rule contains information will continue. following paragraphs: • collection requirements that are subject H. Minimizing the Impact on Small Do not revise the 1987 charging to review by the Office of Management Entities rule. and Budget (OMB) under the Paperwork FDA considered and rejected this Reduction Act of 1995 (44 U.S.C. 3501– The agency does not believe that the alternative because the 1987 charging 3520) (the PRA). The title, description, final rule will have a significant rule does not address all of the types of and respondent description of the economic impact on a substantial expanded access to investigational information collection provisions are number of small entities. Nevertheless, drugs for treatment use specified under shown in the following paragraphs with in the proposed rule, we recognized our final subpart I of part 312. Furthermore, an estimate of the annual reporting uncertainty regarding the number and the cost recovery provisions in the 1987 burden. Our estimate includes the time size distribution of affected entities, as charging rule were vague and for reviewing instructions, searching well as the economic impact of the final ambiguous and thus in need of existing data sources, gathering and rule on those entities, and requested clarification. maintaining the data needed, and detailed comment on these important • Retain the proposed requirements completing and reviewing each issues. We received no comments that that would have required sponsors who collection of information. would cause us to change our must obtain an approved drug from determination that the final rule will not another entity for use in the study Title: Charging for Investigational have a significant economic impact on evaluation to obtain authorization from Drugs Under an IND a substantial number of small entities. FDA to charge. Description: The final rule describes According to agency records, the FDA considered this alternative. the types of investigational uses for majority of treatment INDs and However, FDA believes the comments which a sponsor may be able to charge, treatment protocols (approximately 92 made a persuasive case for not requiring including uses for which charging was percent) are submitted by commercial authorization to charge in these settings. not previously expressly permitted, and sponsors and government agencies that The most common requests to charge the criteria for allowing charging for the are not likely to meet Small Business are for approved drugs in trials when identified investigational uses. The rule Administration (SBA) criteria defining a the drugs must be obtained from another authorizes sponsors to request to charge small entity in the relevant industry company. For reasons discussed in for investigational drugs used in clinical sector. Thus, the agency believes that section VI.C of this document, FDA trials and for investigational drugs for the vast majority of requests to charge believes that charging for investigational expanded access for treatment use. The under expanded access submissions drugs in these situations is appropriate rule also describes the types of costs will not be submitted by small entities. without prior authorization from FDA. that can be recovered when charging for • Do not permit charging for an investigational drug. 4 See http://swz.salary.com/salarywizard/ expanded access for individual patients Section 312.8(a)(1) provides that a layoutscripts/swzl_newsearch.asp, last viewed 7/ or for intermediate-size patient sponsor who wishes to charge for an 10/08. (FDA has verified the Web site address, but FDA is not responsible for any subsequent changes populations. investigational drug must meet the to the Web site after this document publishes in the FDA considered not revising the 1987 criteria applicable to the specific Federal Register.) charging rule concerning charging for sections of the proposal relating to

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charging in a clinical trial or charging Section 312.8(d) describes more Economic Impacts,’’ we estimate that we for expanded access. specifically the costs that are potentially will receive a total of approximately 34 Section 312.8(b) describes the recoverable. Section 312.8(d)(1) charging requests annually under the requirements for charging in a clinical provides that a sponsor may recover final rule. This estimate is the sum of trial. only the direct costs of making the the average number of charging requests Section 312.8(b)(1) describes criteria investigational drug available. Section we currently receive annually (i.e., for charging for the sponsor’s own drug 312.8(d)(1)(i) defines direct costs as 22.6), plus the additional charging in a clinical trial. To charge in this costs incurred by a sponsor that can be requests, as described in the analysis of situation, the sponsor must show the specifically and exclusively attributed economic impacts, that we expect to following three things. The sponsor to providing the drug for the receive annually as a result of the must: investigational use for which FDA has • amendments in the final rule (i.e., 3.5 + Provide evidence that the drug has authorized cost recovery. Direct costs a potential clinical benefit that, if 7.67). Concerning the number of include costs per unit to manufacture respondents, our experience has been demonstrated in the clinical the drug (e.g., raw materials, labor, and investigations, would provide a that, in general, a single sponsor does nonreusable supplies and equipment not make multiple requests to charge for significant advantage over available used to manufacture the quantity of investigational drugs in the same year. products in the diagnosis, treatment, drug needed for the use for which However, we anticipate that multiple mitigation, or prevention of a disease or charging is authorized) or costs to condition; requests may increase somewhat if, as • acquire the drug from another Demonstrate that the data to be manufacturing source and direct costs to we expect, the number of individual obtained from the clinical trial would be ship and handle (e.g., store) the drug. patient treatment uses increases. Thus, essential to establishing that the drug is Section 312.8(d)(1)(ii) states that we have assumed that the number of effective or safe for the purpose of indirect costs include costs that are annual respondents will be obtaining initial approval of a drug, or incurred primarily to produce the drug approximately 30. would support a significant change in for commercial sale. Such costs include, The largest portion of the paperwork the labeling of an approved drug (e.g., for example, costs for facilities and burden associated with the final rule is new indication, inclusion of equipment that are used to manufacture to justify the request to charge by comparative safety information); and the supply of investigational drug but • Demonstrate that the clinical trial showing that the amount proposed to be that are primarily intended to produce could not be conducted without charged is limited to the direct costs of large quantities of drug for eventual charging because the cose of the drug is making the drug available extraordinary to the sponsor. commercial sale and research and (§ 312.8(d)(1)). When the sponsor Section 312.8(c) describes criteria for development, administrative, labor, or requests to charge for making the drug charging for an investigational drug in other costs that would be incurred even available for expanded access by an an expanded access setting. The general if the clinical trial or expanded access intermediate-size patient population or criterion to charge for expanded access for which charging is authorized did not through a treatment IND or treatment for treatment use is that the sponsor occur. protocol, the sponsor may also recover provide reasonable assurance that Section 312.8(d)(2) provides that the costs of monitoring the treatment charging will not interfere with when the sponsor is charging for making use protocol, complying with IND developing the drug for marketing the drug available for expanded access reporting requirements, and other for an intermediate-size patient approval. administrative costs directly associated population or for a treatment IND or For treatment use under a treatment with the expanded access protocol under subpart I, the sponsor IND or treatment protocol, the sponsor (§ 312.8(d)(2)). The sponsor also needs may also recover the costs of monitoring must also provide the following: to support its suggested charge for these • the protocol, complying with IND Evidence of sufficient enrollment in expenses. The remaining portion of the reporting requirements, and other any ongoing clinical trial(s) needed for paperwork burden associated with the marketing approval to reasonably assure administrative costs directly associated with the expanded access in addition to final rule is to show that the criteria FDA that the trial(s) will be successfully applicable to the specific type of completed as planned, the sponsor’s direct costs. • Evidence of adequate progress in Description of Respondents: Licensed charging request (i.e., the type of the development of the drug for physicians and manufacturers, clinical trial (§ 312.8(b)) or type of marketing approval, and including small business manufacturers. expanded access (§ 312.8(c))) have been • Information submitted under its Estimates of Reporting Burden: Table met. Thus, we estimate that the average general investigational plan 4 of this document presents the number of hours needed to prepare a (§ 312.23(a)(3)(iv)) specifying the drug estimated annualized reporting burden request to charge for an investigational development milestones the sponsor for the total number of charging requests drug under the final rule is 48. This plans to meet in the next year. we expect to receive under the final estimate is based on our experience in Section 312.8(a)(2) provides that a rule. The estimates in table 4 have been reviewing charging requests in the past sponsor who wishes to charge for an derived in the following manner. Based and, as explained previously, on a investigational drug must justify the on baseline data presented in section VI projection of the increased paperwork amount to be charged. of this document, ‘‘Analysis of burden associated with the final rule.

TABLE 4.—ESTIMATED ANNUAL REPORTING BURDEN1

Number of Number of Responses Total Annual Hours per 21 CFR Section Respondents per Respondent Responses Response Total Hours

312.8 30 1.13 34 48 1,632 1 There are no capital costs or operating and maintenance costs associated with this collection.

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The information collection provisions investigational drug for treatment use interfere with developing the drug for of this final rule have been submitted to under subpart I of this part, except that marketing approval. OMB for review. Prior to the effective sponsors need not fulfill the (2) For expanded access under date of this final rule, FDA will publish requirements in this section to charge § 312.320 (treatment IND or treatment a notice in the Federal Register for an approved drug obtained from protocol), such assurance must include: announcing OMB’s decision to approve, another entity not affiliated with the (i) Evidence of sufficient enrollment modify, or disapprove the information sponsor for use as part of the clinical in any ongoing clinical trial(s) needed collection provisions in this final rule. trial evaluation (e.g., in a clinical trial of for marketing approval to reasonably An agency may not conduct or sponsor, a new use of the approved drug, for use assure FDA that the trial(s) will be and a person is not required to respond of the approved drug as an active successfully completed as planned; to, a collection of information unless it control). (ii) Evidence of adequate progress in displays a currently valid OMB control (2) A sponsor must justify the amount the development of the drug for number. to be charged in accordance with marketing approval; and paragraph (d) of this section. (iii) Information submitted under the VIII. Federalism (3) A sponsor must obtain prior general investigational plan FDA has analyzed this final rule in written authorization from FDA to (§ 312.23(a)(3)(iv)) specifying the drug accordance with the principles set forth charge for an investigational drug. development milestones the sponsor in Executive Order 13132. FDA has (4) FDA will withdraw authorization plans to meet in the next year. determined that the rule does not to charge if it determines that charging (3) The authorization to charge is contain policies that have substantial is interfering with the development of a limited to the number of patients direct effects on the States, on the drug for marketing approval or that the authorized to receive the drug under the relationship between the National criteria for the authorization are no treatment use, if there is a limitation. Government and the States, or on the longer being met. (4) Unless FDA specifies a shorter distribution of power and (b) Charging in a clinical trial—(1) period, charging for expanded access to responsibilities among the various Charging for a sponsor’s drug. A an investigational drug for treatment use levels of government. Accordingly, the sponsor who wishes to charge for its under subpart I of this part may agency has concluded that the rule does investigational drug, including continue for 1 year from the time of not contain policies that have investigational use of its approved drug, FDA authorization. A sponsor may federalism implications as defined in must: request that FDA reauthorize charging the Executive order and, consequently, (i) Provide evidence that the drug has for additional periods. a federalism summary impact statement a potential clinical benefit that, if (d) Costs recoverable when charging is not required. demonstrated in the clinical for an investigational drug. (1) A investigations, would provide a sponsor may recover only the direct List of Subjects in 21 CFR Part 312 significant advantage over available costs of making its investigational drug Drugs, Exports, Imports, products in the diagnosis, treatment, available. Investigations, Labeling, Medical mitigation, or prevention of a disease or (i) Direct costs are costs incurred by research, Reporting and recordkeeping condition; a sponsor that can be specifically and requirements, Safety. (ii) Demonstrate that the data to be exclusively attributed to providing the ■ Therefore, under the Federal Food, obtained from the clinical trial would be drug for the investigational use for Drug, and Cosmetic Act and under essential to establishing that the drug is which FDA has authorized cost authority delegated to the Commissioner effective or safe for the purpose of recovery. Direct costs include costs per of Food and Drugs, 21 CFR part 312 is obtaining initial approval of a drug, or unit to manufacture the drug (e.g., raw amended as follows: would support a significant change in materials, labor, and nonreusable the labeling of an approved drug (e.g., supplies and equipment used to PART 312—INVESTIGATIONAL NEW new indication, inclusion of manufacture the quantity of drug DRUG APPLICATION comparative safety information); and needed for the use for which charging (iii) Demonstrate that the clinical trial is authorized) or costs to acquire the ■ 1. The authority citation for 21 CFR could not be conducted without drug from another manufacturing part 312 continues to read as follows: charging because the cost of the drug is source, and direct costs to ship and Authority: 21 U.S.C. 321, 331, 351, 352, extraordinary to the sponsor. The cost handle (e.g., store) the drug. 353, 355, 356, 371, 381, 382, 383, 393; 42 may be extraordinary due to (ii) Indirect costs include costs U.S.C. 262. manufacturing complexity, scarcity of a incurred primarily to produce the drug ■ 2. Section 312.7 is amended by natural resource, the large quantity of for commercial sale (e.g., costs for removing paragraph (d) and by revising drug needed (e.g., due to the size or facilities and equipment used to the section heading to read as follows: duration of the trial), or some manufacture the supply of § 312.7 Promotion of investigational combination of these or other investigational drug, but that are drugs. extraordinary circumstances (e.g., primarily intended to produce large * * * * * resources available to a sponsor). quantities of drug for eventual ■ 3. Section 312.8 is added to subpart A (2) Duration of charging in a clinical commercial sale) and research and to read as follows: trial. Unless FDA specifies a shorter development, administrative, labor, or period, charging may continue for the other costs that would be incurred even § 312.8 Charging for investigational drugs length of the clinical trial. if the clinical trial or treatment use for under an IND. (c) Charging for expanded access to which charging is authorized did not (a) General criteria for charging. (1) A investigational drug for treatment use. occur. sponsor must meet the applicable (1) A sponsor who wishes to charge for (2) For expanded access to an requirements in paragraph (b) of this expanded access to an investigational investigational drug for treatment use section for charging in a clinical trial or drug for treatment use under subpart I under §§ 312.315 (intermediate-size paragraph (c) of this section for charging of this part must provide reasonable patient populations) and 312.320 for expanded access to an assurance that charging will not (treatment IND or treatment protocol), in

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addition to the direct costs described in Application which clarifies the efforts to expand access to paragraph (d)(1)(i) of this section, a circumstances in which charging for an investigational drugs for treatment use. sponsor may recover the costs of investigational drug in a clinical trial is Before 1987, there was no formal monitoring the expanded access IND or appropriate, sets forth criteria for recognition of treatment use in FDA’s protocol, complying with IND reporting charging for an investigational drug for regulations concerning INDs, but requirements, and other administrative the different types of expanded access investigational drugs were made costs directly associated with the for treatment use described in this final available for treatment use informally. expanded access IND. rule, and clarifies what costs can be In 1987, FDA revised the IND (3) To support its calculation for cost recovered for an investigational drug. regulations in part 312 (21 CFR part recovery, a sponsor must provide DATES: This rule is effective October 13, 312) to explicitly provide for one supporting documentation to show that 2009. specific kind of treatment use of the calculation is consistent with the FOR FURTHER INFORMATION CONTACT: investigational drugs (52 FR 19466, May requirements of paragraphs (d)(1) and, if Colleen L. Locicero, Center for Drug 22, 1987). Section 312.34 authorized applicable, (d)(2) of this section. The Evaluation and Research, Food and access to investigational drugs for a documentation must be accompanied by Drug Administration, 10903 New broad population under a treatment a statement that an independent Hampshire Ave., Bldg. 22, rm. 4200, protocol or treatment IND when certain certified public accountant has Silver Spring, MD 20993–0002, criteria were met. Section 312.35 reviewed and approved the calculations. 301–796–2270; or described the submission requirements Dated: July 20, 2009. Stephen M. Ripley, Center for for such treatment use. The 1987 IND Jeffrey Shuren, Biologics Evaluation and Research regulations also implicitly acknowledged the existence of other Associate Commissioner for Policy and (HFM–17), Food and Drug Planning. Administration, 1401 Rockville kinds of treatment use, notably use in individual patients, by adding a [FR Doc. E9–19004 Filed 8–12–09; 8:45 am] Pike, Rockville, MD 20852, 301– 827–6210. provision for obtaining an BILLING CODE 4160–01–S SUPPLEMENTARY INFORMATION: investigational drug for treatment use in an emergency situation (§ 312.36). Table of Contents DEPARTMENT OF HEALTH AND However, § 312.36 did not describe HUMAN SERVICES I. Background criteria or requirements that must be II. Overview of the Final Rule Including met to authorize individual patient Food and Drug Administration Changes to the Proposed Rule treatment use. A. Overview In response to criticisms that this lack 21 CFR Parts 312 and 316 B. Changes to the Proposed Rule of criteria and submission requirements III. Comments on the Proposed Rule resulted in inconsistent policies, [Docket No. FDA–2006–N–0238] (formerly A. General Comments on the Proposed Docket No. 2006N–0062) Rule inequitable access, and preferential access for certain categories of patients, RIN 0910–AF14 B. Comments Related to Proposed Rule as Congress included in the Food and Drug a Whole Administration Modernization Act of Expanded Access to Investigational C. Comments on Specific Provisions of the 1997 (FDAMA) (Public Law 105–115), Drugs for Treatment Use Proposed Rule which amended the Federal Food, Drug, IV. Legal Authority AGENCY: and Cosmetic Act (the act), specific Food and Drug Administration, V. Environmental Impact HHS. provisions concerning expanded access VI. Analysis of Economic Impacts to investigational drugs for treatment ACTION: Final rule. A. Objectives of the Final Action B. Nature of the Problem Being Addressed use (Expanded Access to Unapproved SUMMARY: The Food and Drug C. Baseline for the Analysis Therapies and Diagnostics, section 561 Administration (FDA) is amending its D. Nature of the Impact of the act (21 U.S.C. 360bbb)). regulations on access to investigational E. Benefits of the Final Rule FDA proposed this rule in December new drugs for the treatment of patients. F. Costs of the Final Rule 2006 to further address the concerns The final rule clarifies existing G. Minimizing the Impact on Small Entities that motivated the FDAMA changes, regulations and adds new types of H. Alternatives including problems of inconsistent expanded access for treatment use. VII. Paperwork Reduction Act of 1995 application of access policies and A. The Final Rule Under the final rule, expanded access to B. Estimates of Reporting Burden programs and inequities in access based investigational drugs for treatment use VIII. Federalism on the relative sophistication of the is available to individual patients, setting in which a patient is treated or including in emergencies; intermediate- I. Background on the patient’s disease or condition. By size patient populations; and larger In the Federal Register of December describing in detail in the final rule the populations under a treatment protocol 14, 2006 (71 FR 75147), FDA proposed criteria, submission requirements, and or treatment investigational new drug to amend its regulations permitting safeguards for the different types of application (IND). The final rule is access to investigational drugs to treat expanded access for treatment use of intended to improve access to patients with serious or immediately investigational drugs, FDA hopes to investigational drugs for patients with life-threatening diseases or conditions increase awareness and knowledge of serious or immediately life-threatening when there is no comparable or expanded access programs and the diseases or conditions who lack other satisfactory alternative therapy to procedures for obtaining investigational therapeutic options and who may diagnose, monitor, or treat the patient’s drugs for treatment use. The agency benefit from such therapies. Elsewhere disease or condition. believes that the final rule appropriately in this issue of the Federal Register, As discussed in greater detail in the authorizes access to promising drugs for FDA is publishing the final rule on preamble to the proposed rule (71 FR treatment use, while protecting patient Charging for Investigational Drugs 75147 at 75148 to 75149), there have safety and avoiding interference with Under an Investigational New Drug been several statutory and regulatory the development of investigational

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drugs for marketing under approved B. Changes to the Proposed Rule insurance companies, hospitals, a trade applications. The final rule has been revised in organization representing hospitals, and In 2007, after the proposed rule on response to comments received on the a professional society representing expanded access was published, proposed rule. The responses are oncologists. Congress passed the Food and Drug discussed in section III of this A. General Comments on the Proposed Administration Amendments Act of document. The final rule: Rule 2007 (FDAAA) (Public Law 110–85). • Revises proposed § 312.300(a) to Most of the comments strongly One provision, codified in 505–1(f)(6) of clarify that subpart I is intended to the act (21 U.S.C. 355–1(f)(6)), requires supported the goal of expanding access apply not only to the use of to investigational drugs for treatment the Secretary of Health of Human investigational new drugs but also to Services (the Secretary) to promulgate use. The vast majority of these approved drugs whose availability is comments expressed strong support for regulations concerning how a physician limited because the drugs are subject to may provide a drug under the the proposed rule as a way to expand a risk evaluation and mitigation strategy access. As a category, the largest volume mechanisms of section 561 when the (REMS) in accordance with section 505– drug is subject to elements to assure safe of comments came from individuals, 1(f)(6) of the act. and the vast majority of those supported use under a risk evaluation and • Also revises proposed § 312.300(a) the proposed rule. Healthcare and mitigation strategy (REMS). The to clarify that subpart I is intended to expanded access mechanisms described consumer advocacy organizations apply to all those with a serious disease provided the next largest volume of in this final rule can be used by a or condition, regardless of whether the patient seeking access to a drug with a comments. Comments from these patient would currently be considered organizations spanned the spectrum REMS in the event that the drug is not seriously ill with that disease or available to the patient under the from strongly supportive to strongly condition. negative. Many healthcare and criteria of the REMS, provided the drug • Revises proposed § 312.300(b) to consumer advocacy organizations and the patient meet the criteria for an include a definition of ‘‘serious disease expanded access program. Therefore, commented that they believe the rule or condition.’’ strikes the appropriate balance between this rule fulfills the FDAAA • Revises proposed § 312.305(c)(5) to requirement. increased access and patient safety clarify that a sponsor should make an without impeding enrollment in clinical This final rule applies both to drug investigator’s brochure available to products that are subject to section 505 trials or otherwise jeopardizing the licensed physicians in an expanded development of new drugs for marketing of the act (21 U.S.C. 355) and biological access program whenever such a products subject to the licensing approval. brochure exists. Healthcare and consumer advocacy provisions of the Public Health Service • Revises proposed § 312.310(a)(2) to organizations who opposed the Act (42 U.S.C. 201 et seq.) and 21 CFR omit the words ‘‘type of.’’ proposed rule had widely divergent part 601. This is consistent with the • Revises proposed § 312.310(c)(2) to views. Some of these commenters previous regulations on treatment use, clarify that the summary of the expressed the view that the rule did not which applied to both drug and expanded access use should include all go far enough in removing the obstacles biological products. adverse effects, not merely unexpected to patient access to investigational drugs II. Overview of the Final Rule Including ones, and that the summary should be for treatment use and argued that, after Changes to the Proposed Rule submitted to FDA. phase 1 safety testing, there should be • Revises proposed § 312.310(d)(2) to largely unfettered access to A. Overview extend the time in which to make investigational drugs for patients with The final rule amends FDA written submissions to 15 working days serious or immediately life-threatening regulations by removing the current after FDA’s authorization of emergency diseases or conditions and no sections on treatment use of use. alternative therapies. One of these investigational drugs (§§ 312.34, 312.35, The agency did not propose to amend organizations urged that the rule be and 312.36), revising § 312.42 on the text of § 316.40. However, because withdrawn and a substantially more clinical holds, and adding subpart I of § 316.40 references the requirements of permissive access policy (one that part 312 on expanded access. Subpart I § 312.34, which is being withdrawn, affords individual patients greater describes the following ways that FDA has revised § 316.40 to remove the autonomy) be developed and expanded access to treatment use of reference to § 312.34. implemented. investigational drugs are available: Some healthcare and consumer III. Comments on the Proposed Rule • Expanded access for individual advocacy organizations expressed the patients, including in emergencies; The agency received 119 comments view that the proposed rule went much • Expanded access for intermediate- on the proposed rule. Comments were too far in making investigational drugs size patient populations (smaller than received from individuals (persons with available to patients for treatment use. those typical of a treatment IND or serious or immediately life-threatening One comment argued that expanded treatment protocol); and diseases or conditions, persons with access as described in the proposed rule • Expanded access treatment IND or family members with such diseases or would eliminate the incentive for treatment protocol (described in conditions, and other interested patients to enroll in clinical trials that previous §§ 312.34 and 312.35). persons), healthcare and consumer provide the evidence necessary to make The final rule provides the following: advocacy organizations, healthcare effective use of new therapies, would be (1) Criteria that must be met to authorize professionals (physicians and harmful to patients exposed to therapies the expanded access use, (2) pharmacists), pharmaceutical and for which there is limited safety and requirements for expanded access biotechnology companies, trade effectiveness information, and raises submissions, and (3) safeguards to organizations representing issues of fairness because of the protect patients and preserve the ability pharmaceutical and biotechnology potential that the supply of the drug to develop meaningful data about companies, health insurance companies, may not be adequate to make it available treatment use. a trade organization representing health to all those seeking access. Some

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comments argued that there should be may not be satisfactory to all; sometimes disseminating information to the lay access only in the very late stages of it is not possible to reconcile the more public or their healthcare providers and clinical development, ideally not until disparate views. FDA has made its best complained that the proposed rule did phase 3 testing had been completed. effort to set forth a regulatory policy that not mention any additional efforts to Comments from pharmaceutical and is consistent with its statutory mandate, disseminate the new policies. biotechnology companies and their taking into account the views of those Several comments recommended that trade organizations were the next largest who commented. FDA believes it has FDA do more to publicize its expanded category of comments. These comments addressed these competing issues in a access regulations, educate and train were generally supportive of the goal of way that affords patients a meaningful physicians, and/or improve expanding access, but expressed and reasonable measure of autonomy communications with patients and concern about the potential for over their own healthcare decisions patient advocacy organizations. One expanded access, as described in the while preserving the integrity of the comment stated that patients are proposed rule, to impede drug drug approval process and protecting sometimes confused about the reasons development and add new patient safety. they are not able to enroll in an administrative burdens or expense for Specific issues raised by the expanded access program or obtain companies. comments and the agency’s responses individual access and urged FDA to FDA’s response to these general follow. consider ways to improve comments is that we believe the final communication to patients about the rule appropriately addresses the B. Comments Related to the Proposed standards for expanded access to competing concerns surrounding Rule as a Whole minimize this confusion. One comment expanded access. As discussed in detail 1. Public Awareness and Physician and recommended that training materials in the preamble to the proposed rule (71 Patient Education Programs and information be made available to FR 75147 at 75160), the key question in the general public in an easily making investigational drugs available (Comment 1) In the preamble to the accessible format and medium, such as for treatment use is how to address the proposed rule (71 FR 75147 at 75149), on FDA’s Web site, so that patients and various interests—individual patients’ FDA stated that the major goals of this patient advocates can obtain the desires to make their own decisions rulemaking are to broaden the scope of instructions for submitting an expanded about their healthcare, including expanded access and to address access request. Another comment from decisions about using experimental concerns about inequities in access to a patient advocacy group recommended therapies in advance of such treatments investigational drugs under expanded that FDA provide guidance on each of being approved for marketing, society’s access programs. FDA explained that by the specific types of expanded access. interest in the efficient development of describing in detail in regulation the The comment stated that not all new therapies to treat serious and criteria, submission requirements, and physicians will have the time or immediately life-threatening diseases or safeguards for the different types of inclination to inform themselves about conditions, and the need to protect expanded access programs, FDA hoped the expanded access mechanisms and vulnerable patients from unnecessary to increase knowledge and awareness of processes and, therefore, it is important and unacceptable risks. FDA recognizes expanded access programs and the that patients and patient advocates be that these issues are complex and can procedures for obtaining investigational informed about expanded access and have life-or-death implications, both for drugs under such programs and, as a FDA’s requirements for expanded access individuals seeking access to result, facilitate wider availability of so that they can inform their physicians. investigational drugs and for large investigational drugs in appropriate (Response) FDA believes that clearly populations of patients with a given circumstances. FDA also explained that specifying in regulations the disease or condition who desire that it wished to address concerns that in the mechanisms and processes for obtaining innovative therapies for their disease or past, access to investigational drugs has investigational drugs for treatment use condition be developed and marketed as been primarily available to patients with is the essential and fundamental quickly as possible. Therefore, it is not certain serious or immediately life- platform on which to build awareness surprising that there are a range of threatening diseases or condition— of, and accessibility to, expanded access perspectives about how best to reconcile particularly cancers, Human programs. FDA agrees, however, that these competing interests and highly Immunodeficiency Virus (HIV) disease, new expanded access regulations alone impassioned defenses of the various and HIV-related conditions—and hoped will not be sufficient to increase perspectives. that the greater awareness and clarity knowledge and awareness about FDA’s perspective in attempting to fostered by this rulemaking would expanded access to an extent that will address and, where possible, reconcile facilitate access to investigational drugs meet FDA’s goals for broader and more these different views, is intended to be for patients with serious or immediately equitable access. Therefore, in consistent with its statutory mandate to life-threatening diseases or conditions conjunction with publication of this ensure that drug therapies developed who may have been underserved in the final rule, FDA intends to develop and and marketed for serious and past. engage in a broad range of publicity and immediately life-threatening diseases or Several comments expressed the view educational efforts in a variety of forums conditions are safe and effective (which that this rulemaking alone would not be and media to increase awareness of the requires substantial evidence from sufficient to accomplish these goals. mechanisms for obtaining clinical trials) and that individuals One comment argued that promulgating investigational drugs for treatment use. exposed to investigational therapies expanded access regulations is an (Comment 2) Some comments stated under an IND, whether in a clinical trial ineffective vehicle to increase that additional steps would be needed or for an expanded access use, are not knowledge and awareness of expanded to address complaints that access to subject to unnecessary and unacceptable access programs because FDA investigational drugs was biased toward risks. FDA acknowledges the varied regulations are not widely read by cancer and HIV disease patients. One positions expressed on access to healthcare providers and consumers. comment recommended that FDA work investigational drugs for treatment use. Another comment stated that Federal more closely on early access programs The agency recognizes that this rule Register notices are not the best way of with disease-specific institutes at the

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National Institutes of Health (NIH) in clinical trials (i.e., other than phase 1 perceived as burdensome, may be a addition to the National Cancer Institute trials in which one group of participants deterrent to obtaining access to and the Office of AIDS Research in the is given an investigational drug subject investigational drugs for treatment use. National Institute for Allergy and to FDA’s jurisdiction, while the control However, FDA believes the evidentiary, Infectious Disease. One comment group receives either a standard submission, and data collection recommended outreach to better inform treatment for the disease or a placebo). requirements are generally non-labor minorities about access to If expanded access is for an intensive, straightforward, and investigational drugs for treatment use. investigational drug that is not the appropriate to the kind of assurances The comment suggested a program subject of certain controlled clinical needed to permit treatment use of specifically directed at African- trials, the statute does not require investigational drugs. We acknowledge American women because of their low information about the expanded access that compliance with the expanded rates of cancer survival relative to white in ClinicalTrials.gov. Thus, for example, access requirements might pose women. information about an expanded access particular challenges for physicians FDA’s Office of Special Health Issues program for an intermediate-size patient (whether in academic or nonacademic (OSHI) works closely with individual population for a drug that is being settings) who are not very familiar with patients and patient organizations, developed (see § 312.315(a)(2)) would IND and IRB regulations, as well as for including minority and special disease be included in ClinicalTrials.gov as long medical centers in which existing groups, and with the healthcare as the other requirements for inclusion administrative burdens already test the provider community and organizations. are met. However, information about an limits of available resources. However, The office responds to questions about expanded access program for an we believe that the burdens associated expanded access and directs inquiries intermediate-size patient population for with IND compliance and IRB review for specific treatment uses of a drug that is not being developed under under expanded access programs have investigational products to the a clinical trial (see § 312.315(a)(1)) and been minimized to the extent possible appropriate staff within FDA. The office therefore is not subject to the mandatory while still ensuring patient safety. maintains a Web site with general registration provisions in section 402(j) The majority of the data necessary to information about expanded access and of the PHS Act would not be required satisfy the IND submission requirements other ways of getting promising to be included in ClinicalTrials.gov. for a licensed physician obtaining an therapies to seriously ill patients (see IND for an individual patient will, in http://www.fda.gov/ForConsumers/ 2. Administrative Burdens Associated ByAudience/ForPatientAdvocates/ With Obtaining Expanded Access most cases, be provided by reference to SpeedingAccesstoImportant (Comment 4) A number of comments, the content of an IND held by a sponsor NewTherapies/default.htm). particularly from patient advocacy who is developing the investigational (Comment 3) Some comments urged groups, stated that the administrative drug for marketing. (In the case of that all expanded access INDs and burdens associated with expanded treatment access to an approved drug protocols be listed on ClinicalTrials.gov access could undermine FDA’s efforts to that is subject to a REMS, reference to (http://www.clinicaltrials.gov), the Web broaden access. The general concern a sponsor’s IND may not be necessary.) site maintained by NIH that is intended was that the requirements, particularly Therefore, in making an IND to include a listing of controlled clinical for physicians seeking individual submission, the physician will trials for drugs in development. One patient INDs, are too onerous and, ordinarily only be required to provide a comment asked that FDA clarify therefore, physicians will be reluctant or narrative explaining the rationale for the whether the public notification unwilling to seek investigational drugs intended use and dose, why there are no provision (the provision that describes for treatment use for their patients. Two comparable or satisfactory therapeutic what should be listed on comments argued that the burden would alternatives, a description of the ClinicalTrials.gov) applies to access be greatest in nonacademic settings patient’s disease or condition (including programs for intermediate-size patient because physicians in those settings are recent medical history and previous populations. typically not as familiar with IND treatments), and the monitoring, testing, (Response) ClinicalTrials.gov is regulations and Institutional Review or other procedures needed to minimize governed by section 402(j) of the Public Board (IRB) requirements. The the risks of the drug to the patient. For Health Service Act (PHS Act) (42 U.S.C. comments recommended that the the post-treatment submission, the 282(j)). The law, as amended by requirements for expanded access for physician must provide a written FDAAA, requires the registration of individual patients be simplified and summary of the results of the expanded certain controlled clinical trials on disconnected from compliance with access use, including adverse effects. ClinicalTrials.gov and specifically other sections of part 312 (e.g., The information needed for each of requires information to be included investigator and sponsor responsibilities these submissions is the same kind of about whether expanded access to an in subpart D (Responsibilities of information that is captured during investigational drug under section 561 Sponsors and Investigators)). Another routine patient care and, consequently, of the act is available for those who do comment stated that administrative is already known to the physician or can not qualify for enrollment in the clinical burdens are a particular problem in the be readily accessed. Therefore, FDA trial and how to obtain information academic research setting, where does not consider these submission about such access (section intensive IRB approval and oversight, requirements to be a burden that is out 402(j)(2)(A)(ii)(II)(gg) of the PHS Act). combined with the data collection of proportion with the risks inherent in The ClinicalTrials.gov provisions only requirements of the protocols, have using an investigational product for apply to certain controlled clinical trials forced some centers to forego treatment use (see response to comment (see definition of ‘‘applicable drug participation in expanded access 60 for discussion of IRB review issues). clinical trial’’ in section 402(j)(1)(iii) of programs until they can find a source of FDA intends to engage in educational the PHS Act). Thus, information about funding. efforts to help physicians understand expanded access is required to appear in (Response) FDA shares the concern the individual patient requirements and ClinicalTrials.gov when the drug at that the requirements for obtaining how to navigate those requirements in a issue is the subject of certain controlled access to investigational drugs, if way that minimizes the administrative

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burdens. These efforts will be directed investigational drugs for treatment use eligible patients receive care, provided at physicians in both academic and more accessible for diseases and there are appropriate controls and nonacademic settings. conditions and in clinical settings that oversight, as set forth in this final rule. For multi-patient expanded access have purportedly been underserved by 4. Supplies of Investigational Drugs INDs, FDA agrees that there are steps expanded access programs. that could be taken to minimize (Comment 5) Several comments (Comment 7) Several comments were administrative burdens at participating agreed that certain diseases, conditions, concerned that there seemed to be an sites. As with any use of investigational and regions have been underserved by implicit assumption in the proposed agents, FDA encourages the use of expanded access programs. Some rule that there will be an adequate centralized IRBs and standardized data comments maintained that minority supply of an investigational drug to collection documentation across populations, in particular African- meet the demand for the drug generated expanded access IND sites when there Americans and women, have been by potentially broader access over an are multiple sites. As part of its ongoing underserved by expanded access indefinite period of time. Some outreach efforts on expanded access, programs and that these populations comments pointed out that increasing FDA intends to work with constituents should be the focus of efforts to make demand for an investigational drug in patient advocacy, clinical settings, access to investigational drugs for could create supply constraints, which and the pharmaceutical industry to treatment use more equitable. could make it impossible to provide a minimize the burdens associated with (Response) FDA agrees that regions, drug for treatment use to all those who multi-patient expanded access programs diseases, or populations that have been seek it and could also threaten the generally, as well as the burdens underserved by expanded access completion of clinical studies of the associated with specific multi-patient programs should be the focus of efforts drug. One comment argued that access programs as they arise. to ensure more equitable access. FDA’s expanded access programs should focus FDA does not believe that licensed OSHI is committed to working with any on investigational drugs with an physicians and sponsors should be underserved constituencies to help adequate supply to meet the potential exempt from compliance with the address inequities in the access to demand. Two comments stated that sponsor and investigator requirements investigational drugs for treatment use. access should be fair and equitable in in subpart D of part 312. It is crucial to (Comment 6) One comment expressed situations in which the supply cannot keep in mind that expanded access concern that the implications of one of meet the demand. One comment involves use of an investigational FDA’s stated goals—to improve access recommended that the treatment IND therapy in a vulnerable population, so to investigational therapies outside provisions in the final rule include a the rationale for oversight, monitoring, academic medical centers—are way to ensure fair and equitable access recordkeeping and human subject unknown and may be harmful. The in situations in which there is not protections applicable to clinical trials comment suggested that a possible enough supply of a drug to meet the is equally applicable in the treatment reason that access to investigational demand. use context. Accordingly, § 312.305(c) of drugs for treatment use is more likely in (Response) FDA agrees that, in cases the final rule provides that investigators, academic medical centers is that these when there is not sufficient supply of an sponsors, and sponsor-investigators centers tend to treat more patients with investigational drug to make it available must comply with the responsibilities serious and immediately life-threatening to all patients who seek it, access to the for sponsors and investigators set forth diseases or conditions who have drug for treatment use should be as in subpart D of part 312 to the extent exhausted all available conventional equitable as reasonably possible. FDA they are applicable to the expanded treatment options. The comment noted does not agree that expanded access access use. Section 312.305(c)(1) that there is a lack of information in the programs should be limited to only provides that a licensed physician proposed rule concerning differences in those situations in which there is an under whose immediate direction an patient outcomes between patients adequate drug supply for all potential investigational drug is administered or treated with investigational drugs in subjects. Mechanisms to fairly allocate dispensed for an expanded access use is academic medical centers and those limited drug supply (e.g., lotteries) have considered an investigator. Section treated elsewhere and suggested that, been used in the past to provide drugs 312.305(c)(2) provides that an absent such data, it is not necessarily to at least some of the patients who individual or entity that submits an desirable for the use of investigational could benefit. FDA supports the use of expanded access IND or protocol is drugs for treatment use to become these mechanisms where they are considered a sponsor. Section significantly more prevalent outside needed. 312.305(c)(3) provides that a licensed academic medical centers. However, FDA does not believe that it physician under whose immediate (Response) FDA acknowledges that is necessary to include in the final rule direction an investigational drug is patients who have the diseases or a requirement that fair and equitable administered or dispensed, and who conditions for which treatment use of distribution mechanisms be used to submits an IND for expanded access investigational drugs is generally sought allocate an investigational drug in the use, is considered a sponsor- may be found in greater numbers in event of insufficient supply. Current IRB investigator. academic medical centers specializing regulations require an IRB to determine in the treatment of serious and that selection of subjects, in this case 3. Equitable Access immediately life-threatening conditions. patients to be treated, is equitable (21 The preamble to the proposed rule (71 FDA does not agree, however, that the CFR 56.111(a)(3)). FDA believes that FR 75147 at 75149) explains that, by intent to facilitate access in all settings provision is adequate to ensure describing in detail the categories of requires data on comparative quality of equitable access in cases in which the expanded access use and the criteria care across different settings, any more drug supply is not adequate to meet the and submission requirements for such than it would require such a comparison demand. use, and otherwise increasing awareness among academic centers in geographic FDA anticipates that the most of the mechanisms and processes for regions. FDA believes it is important to appropriate distribution mechanism for obtaining investigational drugs for foster use of investigational drugs for a drug with limited supply will be very treatment use, FDA hopes to make treatment use in all settings in which case specific, for example, requiring

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identification of threshold clinical 6. Data Obtained from Expanded Access a population not exposed to the drug in parameters for possible access and a Use clinical trials. However, a control group mechanism to randomly select from (Comment 9) One comment asked is more important to the utility of those who meet the parameters. whether data generated in expanded effectiveness data than safety data. Therefore, FDA believes it is advisable access programs must be submitted to Because expanded access programs are for the sponsor to work with the the NDA for the drug product and, if so, typically uncontrolled exposure (with relevant patient or disease advocacy how FDA evaluates this information limited data collection), it is very organizations, professional societies, when determining the safety and unlikely that an expanded access IND and other affected constituencies to efficacy of the drug for the proposed would yield effectiveness information devise the most appropriate mechanism indication and patient population. that would be useful to FDA in for allocating a limited drug supply in Another comment stated that FDA’s considering a drug’s effectiveness. a specific situation. However, it should historical reluctance to consider efficacy However, if a sponsor believes that be noted that FDA has no authority to information from expanded access uses effectiveness information from compel sponsors to participate in that as evidence of efficacy in an NDA or expanded access use can contribute to a collaboration or to make their supplemental NDA has been a determination that there is substantial investigational products available for disincentive for some companies to evidence of effectiveness, it should treatment use. make a product available for expanded submit the information and an explanation of its relevance to FDA. access. The comment maintained that it 5. Industry Support or Incentives to There are examples in which FDA has would be appropriate to consider safety Broaden Expanded Access made use of adverse events information (Comment 8) Some comments argued and efficacy information from an from expanded access use in the safety that the proposed rule would not expanded access IND or protocol in assessment of a drug. There are a small increase expanded access because a assessing the safety and effectiveness of number of cases in which an important substantial increase in access would a drug when the use and patient adverse event was first identified during require industry support. Some population in the expanded access IND expanded access use and those adverse comments suggested that FDA offer or protocol are similar to the use and events were included in product financial incentives to industry, such as population for which approval is labeling. This is not a negative from a extending periods of exclusivity or sought. The comment asked that FDA public health perspective—the sooner expediting drug review, to encourage revise the proposed rule to explicitly important adverse events are identified drug companies to make drugs available inform sponsors, investigators, patients, the better. Even from the sponsor’s for treatment use. and patient representatives that any viewpoint, early discovery of a rare (Response) FDA is aware that, for a safety and efficacy data collected in adverse event is, on the whole, a benefit. variety of reasons, there may be expanded access are expected to be Although adverse events first identified reluctance among pharmaceutical and reported in the initial NDA seeking during expanded access use of certain biotechnology companies to make approval for the drug or biological drugs have been included in the drugs’ investigational drugs available under product. One comment argued that a approved product labeling, we are expanded access programs. FDA’s company that makes a drug available for unaware of any cases in which adverse charging rule, published elsewhere in treatment use under an expanded access event information obtained from this issue of the Federal Register, is IND or protocol runs the risk of being expanded access use has resulted in intended to address concerns about adversely affected by unfavorable safety denial of approval for a product. financial barriers to providing access by observations from use in the expanded (Comment 10) One comment observed allowing companies to charge an access population, notwithstanding that that data from expanded access might amount for an investigational drug that the patients receiving the drug under an provide helpful information about use enables them to recover the costs expanded access IND or protocol are of a drug in patients who are sicker than associated with making the drug often sicker, nonresponders to prior those patients enrolled in clinical trials. available. Other financial incentives are treatments, and otherwise not (Response) FDA agrees that expanded beyond the scope of this regulation and representative of the population access use in a population with a FDA’s statutory authority. For example, evaluated in controlled clinical trials, particular disease or condition that is FDA’s existing authority to extend but there is no commensurate benefit to sicker than the population in the marketing exclusivity to induce certain the company from favorable efficacy clinical trials might yield some helpful behavior derives from congressional observations in the expanded access insights into the tolerability profile, but mandates. population. typically would not provide insight into FDA also does not believe that a (Response) As with any IND, sponsors the response to the drug (effectiveness) promise to expedite review of new drug of expanded access INDs must provide because of the uncontrolled nature of applications (NDAs) is a reasonable FDA with information on patient the access program and limited data option to encourage broader access to outcomes and adverse events observed collection. investigational drugs for treatment use. during an expanded access use. This (Comment 11) Some comments The types of drug products that meet the information must be included in IND recommended that investigational drugs requirements for treatment use— annual reports (§ 312.33) and/or IND be made available for expanded access investigational therapies to treat serious safety reports (§ 312.32) and, typically, only under protocols that are designed and immediately life-threatening an NDA must also contain at least a to capture some scientific knowledge. diseases or conditions—are likely to summary of the expanded access One comment recommended that the already be eligible for the shortest experience with a drug. The information final rule require all categories of review times currently available (6 obtained from an expanded access use expanded access to be conducted under months). Given the complexity of NDAs, can be useful to a drug’s safety a clearly defined research protocol. The FDA does not believe it can routinely assessment. For example, a relatively comment recommended that the final review applications in less time while rare adverse event might be detected rule require that: (1) An appropriate maintaining the integrity of the review during expanded access use, or such use sponsor be responsible for collecting process. might contribute safety information for patient outcomes data, (2) reports be

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submitted in a timely fashion to FDA, access uses (those involving applicable investigational drugs available to large and (3) patients be required by FDA to drug clinical trials) will be included in populations for treatment use, participate in official data-gathering the ClinicalTrials.gov results database particularly by identifying such processes within a formal cohort study (see response to comment 3 and http:// programs as ‘‘open-label safety studies.’’ or patient registry. www.clinicaltrials.gov). The goal of an open-label safety study (Response) FDA does not agree that is to better characterize the safety of a 7. Assessing the Impact of Expanded investigational drugs should be made drug late in its development. However, Access available only under expanded access in practice, many studies that are protocols designed to obtain meaningful (Comment 13) One comment described as open-label safety studies scientific data, or contingent on encouraged FDA to develop a tracking have characteristics that appear to be enrolling patients in a formal cohort system to evaluate how well the more consistent with treatment INDs or study or registry. As explained in expanded access program is working treatment protocols. FDA stated that, in § 312.300(a) of this final rule, the and to identify factors, such as the future, it intends to evaluate primary purpose of expanded access is economic obstacles, that might be submissions identified as open-label to diagnose, monitor, or treat a patient’s impeding access to investigational drugs safety studies to determine whether disease or condition, not to generate for treatment use. The comment those studies are more characteristic of scientific data intended to characterize recommended that the system include treatment INDs or treatment protocols. the drug. However, FDA agrees that information on patients and The proposed rule stated that a study there should be efforts to optimize the investigators, whether or not requests described as an open-label safety study information obtained from expanded for expanded access are granted, and if that provides broad access to an access exposures with an eye toward not, the reason for not granting such investigational drug in the later stages of detecting any unexpected outcomes or requests, the outcomes of the development, but lacks planned, events. treatments, and costs, if any, to patients systematic data collection and a design (Comment 12) FDA received several who pay for their treatments. appropriate to evaluation of a safety comments advocating more systematic (Response) FDA believes this final issue, is likely to be considered a collection of data on outcomes of rule, in conjunction with treatment IND or treatment protocol. expanded access programs, including implementation of electronic format (Comment 14) Several comments adverse events. One comment INDs and the expanded expressed support for FDA’s position maintained that current data collection ClinicalTrials.gov information, will that programs that make investigational practices for expanded access programs make it easier for the agency to compile drugs available to large populations for rarely yield useful information and that information about the types of diseases treatment use should be treatment INDs better collection of safety data might or conditions that are or are not being or treatment protocols, not open-label identify previously unknown safety treated under expanded access INDs. safety studies. One comment stated that concerns. One comment stated that data That information could, for example, mischaracterizing a treatment IND as an collection should focus on elements identify disease categories that appear to open-label safety study afforded the such as drug start and stop dates, dose, be underserved by expanded access study more credibility than it deserved. patient treatment outcomes, and INDs. FDA does not foresee that such Several comments opposed FDA’s significant adverse events, and that information would be able to position, stating that open-label safety collection of adverse events could use specifically identify economic or other studies are important in elucidating the standardized reporting forms (e.g., obstacles to obtaining access for certain safety profile of investigational drugs MedWatch), which might promote more diseases or conditions, but it could be prior to approval, the time required for consistent collection of reliable used to initiate discussions among formal review could affect expediting information. One comment also stated patient and disease advocacy drug development, and FDA’s plan that FDA should consider compiling a organizations, the relevant medical would result in fewer expanded access database of evidence derived from specialty professional society, programs. expanded access uses for use by pharmaceutical companies with (Response) In enunciating this policy, patients, clinicians, manufacturers, and products that could possibly be made FDA did not intend to limit the conduct researchers to help identify areas that available for expanded access, FDA, and of open-label safety studies intended to researchers might pursue for new other interested parties to help identify evaluate particular safety concerns, such treatments and therapies. barriers to access. As to the comment’s as long-term followup of subjects (Response) FDA agrees that more specific recommendation that a tracking initially enrolled in a randomized trial, standardized data collection methods system include information on patients safety studies in pediatric development and forms could ease some of the and investigators, whether or not programs, and other safety studies. documentation burdens associated with requests for expanded access are These types of studies are legitimate expanded access. However, FDA does granted, and if not, the reason for not open-label protocols and are an integral not believe it is in a position, at this granting such requests, the outcomes of part of a drug development program. time, to be able to describe in regulation the treatments, and costs, if any, to FDA will continue to encourage such or guidance the form and content of data patients who pay for their treatments, studies as appropriate. collection programs specific to FDA does not believe that such a system However, FDA continues to believe expanded access uses. FDA is willing to is necessary at this time, nor do that the treatment IND process is a more participate in collaborative efforts with resources permit establishment of such appropriate vehicle for providing access interested constituents to develop better a system. to investigational drugs for treatment data collection methods. FDA does not use to large populations outside believe that data collected from 8. Open-Label Safety Studies controlled clinical trials late in a drug’s expanded access use would, in most In the preamble to the proposed rule development. The treatment IND cases, be in a form that would be useful (71 FR 75147 at 75155), FDA expressed provides appropriate patient safeguards for hypothesis generation. It is concern that sponsors have used and permits FDA the necessary important to note, however, that programs other than treatment INDs or oversight over the development information about some expanded treatment protocols to make program. And as FDA explained in the

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preamble to the proposed rule (71 FR administration of the investigational associated with investigational drugs 75147 at 75155), authorization of drug. and ancillary care provided under expanded access use is subject to a more One comment from a health insurance expanded access programs. FDA agrees formal review process that explicitly company stated that the design of that drugs made available under considers the impact of expanded access insurance benefits already recognizes expanded access programs are typically on enrollment in any ongoing clinical that some patients should receive investigational and not approved for trials and the progress of drug benefit coverage for treatments that are marketing. However, FDA takes no development generally. The time for not yet supported by clinical evidence, position on how the terms ‘‘reasonable,’’ review of a treatment use program both in clinical trials and as treatment ‘‘necessary,’’ or ‘‘medically necessary’’ should not affect the timing of drug for promising but unproven treatments in health insurance contracts should be development because the need for such for life-threatening illnesses outside of interpreted. an expanded access program and the clinical trials. The comment asked FDA to clarify in the rule that therapies 10. Waiver of Liability for Harm Related protocol for the program can be to Expanded Access considered in advance and put in place provided under expanded access when needed. Therefore, FDA does not programs are experimental and not (Comment 17) One comment from a believe this policy will result in fewer FDA-approved and that making these pharmaceutical company stated that the expanded access programs. therapies available for treatment use proposed rule does not address the (Comment 15) One comment asked does not provide evidence that such significant liability issues for sponsors whether only patients with a serious treatments are ‘‘reasonable,’’ and investigators arising from making disease or condition could be enrolled ‘‘necessary’’ or ‘‘medically necessary,’’ investigational drugs available for expanded access. Many comments from in open-label studies that FDA would as defined in benefit documents. The individuals stated that receiving consider to be treatment INDs. comment stated that third-party payers would welcome a more standardized investigational drugs under expanded (Response) One of the threshold approach to the treatment of diseases access programs should be premised on criteria for a treatment IND is that the without established therapies, a patient’s waiver of liability for harm population to be enrolled has a serious particularly because these rules raise resulting from treatment with the or immediately life-threatening disease questions about responsibility for investigational drug. These comments or condition. Therefore, only protocols routine costs associated with otherwise maintained that liability should be intended to treat patients with serious excluded care. waived for doctors, hospitals, drug or life-threatening diseases or (Response) FDA’s intent in manufacturers, and FDA. conditions are subject to this promulgating the expanded access (Response) FDA does not believe it is requirement. regulation is to foster the availability of appropriate to insulate investigators or It should be noted that FDA has not investigational drugs for treatment use sponsors, whether they are treating taken the position that the agency will to as many patients with serious and physicians, hospitals or other clinical consider all open-label safety studies to life-threatening diseases as possible who settings, or drug manufacturers, from be treatment INDs. FDA will not lack known effective therapies for their potential liability arising from the consider an open-label safety study to disease or condition. FDA recognizes administration or provision of be a treatment IND when the purpose of that determinations that investigational investigational drugs for treatment use. the study is actually to study the safety drugs made available under expanded In fact, FDA’s informed consent profile of the drug. access programs, and patient care regulation, 21 CFR 50.20, states, ‘‘No 9. Insurance Coverage for Investigational related to administration of those drugs, informed consent, whether oral or Drugs and Related Patient Care Drug are not reimbursable would be likely to written, may include any exculpatory Coverage limit access to such therapies for some language through which the subject or patients (e.g., those who lack the the representative is made to waive or (Comment 16) Several comments were financial resources to pay out-of- appear to waive any of the subject’s concerned about the potential pocket). It is FDA’s hope, therefore, that legal rights, or releases or appears to implications of the proposed rule on health insurers and other third-party release the investigator, the sponsor, the coverage decisions by health insurers payers will make well-reasoned institution, or its agents from liability and other third-party payers. Some reimbursement decisions that will not for negligence.’’ The scope of FDA’s comments were concerned that, because impinge on the availability of liability, if any, for any harm resulting the drug made available is investigational drugs for treatment use. from decisions concerning expanded investigational, third-party payers To the extent that it is an insurer’s access to investigational drugs for would deny coverage for the drug and policy that care necessitated by treatment use is determined by statute may also deny coverage for patient care administration of an investigational and cannot be modified by a waiver necessitated by use of the drug. One drug in a clinical trial is reimbursable, provision in a regulation. comment noted an example of a patient FDA believes that care associated with seeking expanded access to an administration of an investigational 11. Inconsistency Between Subpart I investigational drug who would be drug in an expanded access program and Subpart E required to have frequent, expensive should be treated similarly for The expanded access regulations use monitoring, including reimbursement purposes. However, the terms ‘‘immediately life threatening electrocardiograms (EKGs) and monthly FDA recognizes it has no inherent disease or condition’’ and ‘‘serious Computed Tomography (CT) scans, and authority to dictate reimbursement disease or condition.’’ who might not be able to obtain access policy. (Comment 18) One comment if health insurance did not reimburse for FDA also recognizes that this final suggested that there was a discrepancy the required monitoring. One comment rule may have implications for health between terminology used in the argued that the goals of expanded access insurance coverage decisions because of proposed rule (subpart I of part 312) and are illusory if third-party payers do not existing language in health insurance terminology used in subpart E of part reimburse for drug costs (if any) and contracts and how that language is 312. The proposed rule uses the term routine patient care necessitated by interpreted with respect to costs ‘‘immediately life-threatening,’’ while

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subpart E uses the term ‘‘life- REMS, FDA did not intend that an when the drug is subject to elements to threatening.’’ The proposed rule uses expanded access IND under subpart I be assure safe use under a REMS. We will the term ‘‘serious,’’ while subpart E uses used to provide the approved drug to assess the impact of this rule on the term ‘‘severely debilitating.’’ The patients with a serious disease or expanded access to drugs subject to a comment recommended that this final condition when the approved drug is REMS and, if appropriate, will consider rule clear up the confusion arising from being used for an unapproved issuing a guidance on this matter. the use of similar but different terms in indication. Regardless of whether an In response to the comment on FDA regulations. approved drug is being tested in a insurance reimbursement, we note that (Response) The subpart I regulations clinical trial to treat a serious disease or FDA does not have jurisdiction over are being issued in response to a condition that is not part of the current coverage decisions by health insurance provision of FDAMA, now codified in approved indication, use of an approved companies and, in any case, is not section 561 of the act (21 U.S.C. drug off-label for an unapproved aware that allowing expanded access to 360bbb). The terms used in this final indication within the practice of an already approved drug under subpart rule are consistent with and drawn from medicine (i.e., to treat a patient in a I would influence coverage decisions by the terminology in section 561. clinical setting) is not subject to part 312 health insurance companies. Accordingly, any change to make the (the IND regulations), including subpart (Comment 20) One comment notes terms consistent would require revision I. By definition, in such a case, the drug that § 312.300(a) states that the intent is to subpart E. This final rule deals only is already being legally marketed. to make investigational drugs available with subpart I, and thus the comment However, in at least two situations, to ‘‘seriously ill patients,’’ while the asks for a remedy that is outside the expanded access under subpart I may be general criteria in § 312.305(a) require scope of this rule. appropriate for drugs that are already that patients to be treated with an Moreover, we note that subpart E and approved: First, it is conceivable that a investigational drug have ‘‘a serious or subpart I have different purposes. sponsor developing an approved drug immediately life-threatening disease or Subpart E provides procedures to for a new indication for treatment of a condition.’’ The comment pointed out expedite the development, evaluation, serious or immediately life-threatening that a patient can have a serious disease and marketing of new therapies. Subpart disease or condition may want to make or condition and not be seriously ill, for I provides procedures for making the approved drug available for the new example, in the early stages of a investigational drugs available when the indication under a treatment IND. For progressive disease. primary purpose is to diagnose, example, if the new indication involves (Response) FDA acknowledges that monitor, or treat a patient’s disease or a different route of administration or the use of the term ‘‘seriously ill’’ in the condition. Nonetheless, if subpart E dosage form, the sponsor may prefer to provision describing the intended scope were to be amended, FDA would then provide the new dosage form under a of the access provision could be consider the propriety of the treatment IND if it believes that failure interpreted as narrower in scope than terminology used in subpart E. to make the drug available under a was intended, and thus inconsistent treatment IND could lead to with the term ‘‘serious or immediately C. Comments on Specific Provisions of compounding of the drug (e.g., life-threatening disease or condition.’’ the Proposed Rule preparation of a new dosage form of a Therefore, FDA has changed 1. Scope (§ 312.300 and 312.300(a)) drug by a compounding pharmacist § 312.300(a) to make clear that subpart using the active ingredient of an I is intended to apply to all those with Proposed § 312.300(a) describes the approved drug product) and that such a serious disease or condition, whether intended scope of subpart I of part 312. compounding could expose patients to or not the patient would currently be It makes clear that the purpose of unnecessary risks. FDA would be considered seriously ill with that subpart I is to describe processes for amenable to receiving treatment INDs disease or condition. making investigational drugs available for unapproved uses of approved drugs in situations in which the primary in situations in which the sponsor 2. Definitions (§ 312.300(b)) purpose is to diagnose, monitor, or treat would prefer the use of a treatment IND a. Immediately life-threatening a serious or immediately life-threatening to make the drug available for treatment disease or condition. disease or condition in a patient who use outside the ongoing or completed Proposed section 312.300(b) defines has no comparable or satisfactory controlled trials of the unapproved use. the term ‘‘immediately life-threatening alternative therapeutic options. Second, for drugs that are subject to disease’’ as a stage of disease in which (Comment 19) Three comments asked a REMS, expanded access under subpart there is a reasonable likelihood that that FDA clarify whether it intended I may be available to allow treatment of death will occur within a matter of that an expanded access IND be used to patients who do not otherwise meet the months or in which premature death is make an approved drug available for an criteria under the REMS to receive the likely without early treatment. unapproved indication in a situation in drug. (Comment 21) One comment which a sponsor is conducting a clinical For these reasons, we have revised expressed support for the proposed trial of the approved drug under an IND § 312.300(a) to state that subpart I rule’s definition of the term for a new indication to treat a serious contains the requirements for the use of ‘‘immediately life-threatening disease’’ disease or condition. Two of these investigational new drugs and approved and encouraged FDA to include this comments urged that FDA modify the drugs where availability is limited by a definition in the final rule. One proposed rule to make clear that it REMS when the primary purpose is to comment maintained that the proposed applies to unapproved uses of approved diagnose, monitor, or treat a patient’s definition of immediately life- drugs. The comments believed that such disease or condition. This fulfills the threatening was unnecessary because modification would make it more likely mandate, codified in 505–1(f)(6) of the immediately life-threatening conditions that health insurance companies would act, for the Secretary of Health of are a subset of serious conditions and reimburse for unapproved use of Human Services to promulgate thus need not be defined. approved drugs. regulations concerning how a physician (Response) The proposed rule defined (Response) In general, for an already may provide a drug under the the term ‘‘immediately life-threatening approved drug that is not subject to a mechanisms of section 561 of the act disease’’ because the evidentiary criteria

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for authorizing a treatment IND under meant by the term would make access deliberations concerning what should proposed § 312.320 vary depending on to investigational drugs for treatment be considered a serious disease or whether the disease or condition is use overly broad. One of those condition and has served the agency merely serious or is also immediately comments argued that a definition well in its implementation of the Fast life-threatening. There is a lower would promote more consistent Track legislation. The Fast Track evidentiary threshold for a treatment application of the rule. One comment guidance (p. 4) states that whether a IND for an immediately life-threatening recommended that the definition err on disease or condition is serious ‘‘is a condition. The evidentiary distinction the side of inclusiveness. One comment matter of judgment, but generally is and definition are carried over from the asked for clarification of what is meant based on its impact on such factors as previous treatment IND regulation and by serious disease or condition because survival, day-to-day functioning, or the reflect the distinction between section it is unclear what serious conditions likelihood that the disease, if left 561(c)(6) and (c)(7) of the act. Because would have an important effect on untreated, will progress from a less the final rule retains the lower functioning or other aspects of quality of severe condition to a more serious one. evidentiary standard for authorizing a life as well as persistent or recurrent * * * For a condition to be serious, the treatment IND for an immediately life- morbidity. condition should be associated with threatening condition, FDA believes it is Some comments provided morbidity that has substantial impact on necessary to retain the definition. recommendations or specific language day-to-day functioning. Short-lived and (Comment 22) One comment from an on how to define serious disease or self-limiting morbidity will usually not organization representing epilepsy condition. Two comments be sufficient but the morbidity need not centers asked the agency to define recommended relying on existing be irreversible, provided it is persistent immediately life-threatening in such a language in the Fast Track guidance (pp. or recurrent.’’ FDA believes this way that it would include status 3 to 4). One comment recommended definition is also conceptually epilepticus and pointed out that the defining serious disease or condition consistent with the criteria identified in mortality rate from status epilepticus is based on the following criteria in a 1999 the IOM report, the definition of serious up to 6 percent. Institute of Medicine (IOM) Report adverse drug experience in the IND (Response) A disease or condition entitled ‘‘Definition of Serious and safety reporting regulation, and the with an acute mortality rate of six Complex Medical Conditions.’’ The IOM description of serious disease or percent would be considered an report gave the following examples of condition in the preamble to 21 CFR immediately life-threatening condition descriptive criteria for serious and part 314, subpart H (Accelerated for purposes of subpart I. complex medical conditions: Approval of New Drugs for Serious or b. Serious disease or condition. • Conditions that cause serious Life-Threatening Illnesses). Therefore, In the preamble to the proposed rule disability, such as stroke or closed head we have adopted this definition of (71 FR 75147 at 75151), the agency or spinal cord injuries. serious disease or condition in explained that, because of the difficulty • Conditions that cause significant § 312.300(b). in specifically describing regulatory pain or discomfort that can cause FDA recognizes, based on its own criteria that characterize a ‘‘serious serious interruptions to life activities, experience in trying to define and disease or condition,’’ the proposed rule such as arthritis and sickle cell disease. describe what is meant by serious does not provide a definition for the • Conditions that may require disease or condition, that this definition term. Because it is difficult to define frequent monitoring, such as will be subject to various ‘‘serious disease or condition’’ without schizophrenia and other psychotic interpretations. FDA intends to be appearing to exclude diseases or illnesses. flexible in its interpretation of the term conditions that should be considered • Conditions whose treatment carries to ensure that the definition does not serious or include those that should not, the risk of serious complications, such thwart access to an investigational drug FDA in the proposed rule elected to as most cancers or conditions requiring in a situation where access would be describe and illustrate by example what complex surgery. desirable. It is foreseeable that there is meant by serious disease or condition Another comment recommended that might even be situations in which a in other regulatory settings where the the definition of serious disease or serious health risk in the absence of seriousness of a disease or condition is condition be made consistent with the active serious disease should be an issue (e.g., Fast Track, Accelerated definition of serious adverse drug considered a serious condition. For Approval) (see FDA’s guidance for experience in § 312.32(a) (the definition example, it may be desirable to make an industry entitled ‘‘Fast Track Drug used for the IND safety reporting experimental vaccine available as a Development Programs—Designation, requirements), which defines a serious prophylactic measure to laboratory Development, and Application Review’’ adverse drug experience as including workers who have been inadvertently (Fast Track guidance) (63 FR 64093, inpatient hospitalization or exposed to a deadly pathogen but have November 18, 1998)). The preamble prolongation of existing hospitalization, not yet contracted the disease. solicited comment on this approach for a persistent or significant disability/ Notwithstanding the potential pitfalls in purposes of expanded access— incapacity, or a congenital anomaly/ defining serious disease or condition, implicitly asking whether the term birth defect. based on the views expressed in the should be defined or the agency’s (Response) Because of the support for comments received, FDA believes that previous practice of describing the defining the term ‘‘serious disease or stating a definition is preferable to concept and illustrating by example was condition’’ in the comments, FDA is providing only an explanation and acceptable. providing a definition in the final rule. illustration of the concept of serious (Comment 23) Several comments As recommended by some comments, disease or condition and will facilitate stated that FDA should define ‘‘serious FDA is basing the definition on the more consistent and equitable disease or condition.’’ No comments description of a serious disease or application of the expanded access recommended not defining the term. condition in the Fast Track guidance. regulations. Three comments stated that not defining That description and illustration of (Comment 24) One comment stated the term and relying on existing serious disease or condition was the that intractable epilepsy should be descriptions and illustrations of what is result of prolonged and careful considered a serious disease or

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condition. Another comment was b. Risk/benefit assessment— not be made by FDA reviewers. The concerned that in situ breast cancer evidentiary standards. comment also stated that this provision would not be considered a serious Proposed § 312.305(a)(2) provides that ‘‘represents a sea change’’ in FDA’s disease or condition for purposes of the FDA must determine that the potential policy because it would regulate the expanded access regulations. patient benefit justifies the potential practice of medicine. (Response) FDA agrees that risks of the treatment use and that those Another comment stated that the risk- intractable epilepsy and in situ breast risks are reasonable in the context of the benefit decision to be made for cancer would be considered serious disease or condition to be treated. For individual patient expanded access conditions for purposes of the expanded individual patients, proposed should be made only by the patient’s access regulations as each would § 312.310(a)(1) further provides that the physician, not also by FDA. The unquestionably cause morbidity and physician seeking access for a patient comment objected to the proposed potentially premature mortality if left must also determine that the probable criterion that FDA determine that the untreated. risk to the person from the potential patient benefit justifies the investigational drug is not greater than potential risks of the treatment use and 3. Requirements for All Expanded the probable risk from the disease or that those potential risks are not Access (§ 312.305) condition. For intermediate-size patient unreasonable in the context of the Proposed § 312.305 contains the populations, proposed § 312.315(b)(1) disease or condition to be treated general criteria for determining whether further provides that FDA must (§ 312.305(a)(2)). The comment argued access to investigational drugs for determine that there is enough evidence that, in interposing itself into the risk- treatment use is appropriate under the that the drug is safe at the dose and benefit decision, FDA had expanded access uses described in duration proposed for expanded access impermissibly changed the statutory subpart I (§ 312.305(a)), the general use to justify a clinical trial of the drug standard for deciding whether to grant submission requirements for the in the approximate number of patients individual patient expanded access. The expanded access INDs described in expected to receive the drug under comment recognized that section subpart I (§ 312.305(b)), and safeguards expanded access, and proposed 561(b)(2) of the act requires the applicable to those expanded access § 312.315(b)(2) provides that FDA must Secretary to determine that there is uses (§ 312.305(c)). determine that there is at least sufficient evidence of safety and Proposed § 312.305(a)(1) states that preliminary clinical evidence of effectiveness to support the use of the FDA must determine that the patient or effectiveness, or of a plausible investigational drug in an individual population to be treated has a serious or pharmacologic effect of the drug, to patient. However, the comment stated immediately life-threatening disease or make expanded access use a reasonable that this provision does not empower condition and there is no comparable or therapeutic option in the anticipated FDA to make a risk determination. (Response) FDA disagrees with the satisfactory alternative therapy to patient population. For treatment INDs or treatment protocols, § 312.320(a)(3)(i) recommendation to remove the diagnose, monitor, or treat the disease or further provides that for a serious requirement that the agency determine condition. disease or condition, there must be whether the potential patient benefit a. Comparable or satisfactory sufficient evidence of safety and justifies the potential risks and whether alternative therapy. effectiveness to support the use, which those risks are reasonable in the context (Comment 25) One comment from a would ordinarily consist of data from of the disease or condition to be treated. cancer patient appeared to assert that phase 3 trials but could consist of FDA also rejects the characterization of there should be more flexibility in compelling data from completed phase this policy as a ‘‘sea change.’’ This assessing whether there are comparable 2 trials. Section 312.320(a)(3)(ii) policy reflects the essence of FDA’s satisfactory or alternative therapies. The requires that, for an immediately life- long-standing approach to using comment stated that certain comparable threatening disease or condition, the investigational drugs for treatment use, alternative therapies may be more toxic available scientific evidence taken as whether under individual patient INDs and patients exposed to those therapies whole must provide a reasonable basis or multi-patient INDs, and reflects the may become too sick to survive any to conclude that the investigational drug act’s requirement of FDA involvement subsequent treatment, thus barring them may be effective for the expanded access in a determination of the propriety of from access to a promising experimental use and would not expose patients to an the expanded access use (see section treatment. unreasonable and significant risk of 561(b)(2), (b)(3), (c)(6), and (c)(7) of the (Response) FDA shares the comment’s illness or injury. Such evidence would act). The practice-of-medicine concern that existing alternative ordinarily consist of clinical data from exemption in the IND regulations therapies may have greater toxicity than phase 3 or phase 2 trials, but could be applies to use of an approved drug for an experimental treatment option, based on more preliminary clinical an unapproved use in a clinical setting, especially in the oncology setting. FDA evidence. not to the use of an unapproved drug. believes that the relative toxicity of (Comment 26) One comment from a With regard to treatment access to an potential alternative therapies is clearly physician with investigational drug approved drug subject to a REMS, an element to be considered in whether experience asked that FDA remove the because the risk profile of such a drug there are comparable or satisfactory requirement that the agency must means that it is not available for alternative therapies for a given patient. determine that the potential patient unrestricted use, FDA maintains a role, The potential lower toxicity of an benefit justifies the potential risks of the consistent with sections 505–1(f)(6) and experimental therapy would be treatment use and those potential risks 561 of the act, in assessing the considered in light of the more are not unreasonable in the context of appropriateness of the drug for established effectiveness profile of the the disease or condition to be treated. treatment use analogous to its role approved therapy, the patient’s ability The comment maintained that the regarding treatment access to to tolerate the approved therapy, and seriously ill patient and his/her investigational drugs. other clinical factors in assessing physician should be the ones to decide As to the comment that FDA has whether the approved therapy is a whether or not to accept the risks of the impermissibly aggregated to itself the satisfactory alternative therapy. treatment and that the decision should risk benefit decision to be made for

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individual patient expanded access, the there should no expanded access until standard is warranted. FDA believes comment itself acknowledges that the completion of phase 2 testing, and that to require less evidence would section 561(b)(2) of the act states that then only if the phase 2 data are significantly increase the likelihood that the criteria for individual patient compelling. Another comment patients would be more harmed than expanded access include that the recommended that there be no benefited by use of experimental Secretary determines that there is expanded access until evidence of a therapies. ‘‘sufficient evidence of safety and drug’s safety and effectiveness has been Conversely, FDA does not believe that effectiveness to support the use of the demonstrated in clinical trials that will there should categorically be a specified investigational drug.’’ If FDA were to be submitted for approval, which would minimum amount of data, such as data accede to the comment’s interpretation usually be data from phase 3 trials but from completed phase 2 or 3 trials, that the risk determination belongs may include phase 2 data. Other before any expanded access is solely to the physician, it would comments were concerned that the permitted. As detailed in the preamble effectively read out of existence section proposed rule required too much to the proposed rule (71 FR 75147 at 561(b)(2) of the act. In that section, evidence to obtain an investigational 75168), FDA believes there needs to be Congress expressly directed FDA to drug for treatment use. Those comments flexibility in the evidentiary standards make a determination regarding the believe that the evidentiary standards to be applied to the varied types of sufficiency of the evidence of both would inappropriately deny access to expanded access INDs and expanded safety and effectiveness to justify investigational drugs to some patients. access protocols that the agency is likely treatment use of an investigational (Response) The assessment of the to receive. Moreover, even if a specified product. While section 561(b)(1) of the risks and benefits of investigational minimum amount of data for expanded act requires a physician to make a therapies in the absence of complete access were desirable, FDA believes that determination that the probable risk to data about the safety and effectiveness completion of phase 2 or 3 testing is the patient is not greater than the of those therapies is challenging and more than should be required for certain probable risk from the disease or subject to varied interpretations and types of expanded access INDs and condition, this finding is a necessary, viewpoints. FDA believes the proposed expanded access protocols. rule strikes an appropriate balance and but not in itself sufficient, prerequisite (Comment 28) One comment argued sets forth a reasonable approach to to providing a drug for individual that access has the potential to increase balancing risks and benefits. That treatment use. Section 561(b)(2) of the the risk to patients with the possibility approach, as outlined in the discussion act clearly contemplates a determination of no commensurate benefit. The above, requires an assessment of risk by FDA regarding safety and comment maintained that safety issues and benefit based on the relative effectiveness, and the agency cannot related to exposure to an investigational seriousness of the disease or condition choose to ignore that responsibility. drug are best addressed in the context and the size of the population to be of clinical trials and asked FDA to (Comment 27) Some comments were treated under the expanded access IND require that access be provided only concerned that the proposed rule did or protocol—with the evidentiary not provide an adequate balance requirements decreasing as seriousness under a defined protocol, by a qualified between risks and benefits and, in increases and the size of the population investigator, with defined dosage range particular, did not provide a sufficiently decreases. Increasing the amount of and adverse event monitoring high evidentiary standard for providing evidence needed as the size of the procedures, and with specified time access, and as a result would expose population exposed increases is based intervals for assessing response. patients to unnecessary risks. One on FDA’s considerable experience with (Response) FDA agrees that access comment stated that because many of the clinical development of drugs that protocols should provide a detailed plan the drugs that would be made available demonstrates the need to cautiously for the conduct of the protocol, under access programs are highly likely increase the size of exposure in order to including plans for data collection and to prove ineffective in further clinical detect serious toxicities that occur in patient monitoring commensurate with testing, exposure to such drugs may not small percentages of those exposed (and the size of the population to be treated improve patients’ conditions and, in are thus not likely to be detected in a and the nature of the use (e.g., short- some cases, may increase patient small population exposure). Decreasing term versus long-term). However, suffering and hasten death. One the amount of evidence needed as the because of the broad range of potential comment provided an apparent seriousness of the disease or condition populations for which access may be illustration of the potential harm. The increases simply acknowledges that provided under an expanded access comment pointed out that autologous patients in greater peril are willing to protocol—from an individual patient to bone marrow transplants were assume greater risks. many thousands of patients—and the performed on approximately 30,000 FDA recognizes that investigational wide range of potential risks and women with advanced breast cancer drugs have risks, including unknown resulting need for variations in the before it was established that such risks, and that it is likely that some intensity of monitoring, it would not be treatment did more harm than good and drugs made available for treatment use good policy to require the same level of that, as a result, some of the women will ultimately be shown to have no detail and specificity for each protocol. who received this treatment had benefit, and in fact cause harm. As a The amount of detail and specificity increased suffering and shortened lives. result, there is the potential for some required will increase with increasing One comment stated that a patient patients to be harmed by such drugs. size of the population, increasing should have some assurance that an However, FDA believes that, on balance, complexity of the disease being treated, investigational drug may be potentially more patients are likely to gain some and greater risks associated with the use life-saving that would outweigh any benefit from investigational drugs than of the drug. For the same reasons, the potential negative risks of using the be harmed by them and, therefore, amount of data to be collected and the drug. Some comments maintained that, patient interests are best served by potential utility of that data might vary. until there is a certain threshold of data making such drugs available under Accordingly, FDA believes it would not available, there should be no access appropriate programs. FDA does not be useful to promulgate specific and whatsoever. One comment argued that believe that a lesser evidentiary uniform data collection and monitor

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requirements for all expanded access evidentiary threshold for individual (Comment 30) Two comments protocols. patient expanded access be evidence recommended that FDA have different i. Individual Patient Evidentiary from the clinical trials intended to evidentiary standards for individual Standard demonstrate safety and effectiveness for patient expanded access for patients Proposed § 312.310(a)(1) provides that marketing approval (which would with a serious disease or condition and the physician seeking access for a ordinarily be phase 3 studies but could the subset of those patients with an patient must determine that the include phase 2 studies that support immediately life-threatening disease or probable risk to the person from the approval). The comment added, condition. For immediately life- investigational drug is not greater than however, that this category could be threatening diseases or conditions, one the probable risk from the disease or used to provide continuity of care for a comment recommended that there be condition. Concerning the evidence patient who appeared to benefit from a data from completed phase 1 testing at needed before treating an individual drug during participation in an earlier doses similar to those to be used in the patient with an immediately life- clinical trial. treatment use and preliminary evidence threatening illness or disease or (Response) FDA agrees that making an suggesting possible effectiveness. The condition, the preamble to the proposed investigational drug available to an other comment recommended that the rule stated that to support expanded individual patient in the absence of any evidentiary standard that applies to access for an individual patient when clinical data to support the use may treatment INDs for immediately life- the patient has an immediately life- carry substantial risk. FDA does not threatening diseases or conditions apply threatening condition that is not believe, however, that access under to individual patient treatment use for responsive to available therapy, such circumstances should be entirely such conditions (i.e., the available ordinarily, completed phase 1 safety foreclosed by the expanded access scientific evidence taken as whole testing in humans at doses similar to provisions. FDA believes—and our provides a reasonable basis to conclude those to be used in the treatment use, experience has demonstrated—that that the investigational drug may be together with preliminary evidence there are circumstances in which such effective for the expanded access use suggesting possible effectiveness, would use may be appropriate. These and would not expose patients to an be sufficient to support such a use. circumstances might involve a patient unreasonable and significant risk of However, the preamble further stated with an imminently life-threatening illness or injury). Such evidence would that in some cases, there may be no disease or condition, a novel therapy ordinarily consist of clinical data from relevant clinical experience, and the that has a plausible pharmacologic phase 3 or phase 2 trials, but could be case for the potential benefit may be rationale suggesting it may potentially based on more preliminary clinical based on preclinical data or on the be beneficial for that disease or evidence. For individual patient mechanism of action (71 FR 75147 at treatment use for serious diseases or 75151). condition, and robust nonclinical safety data to support the use. FDA does agree conditions, both comments (Comment 29) Several comments were recommended that there be evidence of concerned that the evidentiary that use of an investigational drug for treatment purposes in an individual safety and effectiveness from phase 3 standards applicable to individual trials, although in some circumstances patient in the absence of any clinical patient expanded access allow for the compelling data from phase 2 trials may data should be extremely rare. FDA possibility of making a drug available to be sufficient (the same standard that anticipates that authorizing an a patient without evidence from clinical applies to treatment INDs for serious individual patient treatment use of a experience. One comment stated that ‘‘it diseases or conditions). is wrong to permit use in the absence of drug in the absence of clinical data on (Response) As discussed in the evidence in humans and to present this use of the drug for that indication would previous response, FDA believes that scenario as ‘treatment’ even for be more likely to occur when there was the suggested evidentiary requirements desperately ill patients.’’ Another some clinical data on the drug (e.g., are too high a barrier to access for comment stated that ‘‘it seems from a study for another use) but no individual patient treatment use. Where inappropriate and possibly dangerous to clinical data in the population or the population exposed to an permit this relatively uncontrolled disease for which treatment use is experimental therapy is small (in this access to an investigational drug to sought. case, a single individual), the amount of represent the first human exposure to a However, FDA does not agree that safety and effectiveness evidence drug.’’ Another comment recommended there should be no expanded access to needed to support the use is less than that there be at least preliminary clinical an investigational drug for anyone until would be needed to allow exposure in evidence (such as phase 1 safety testing) the evidence needed to support the size population that might be treated before there be any expanded access use approval is developed, which ordinarily under a treatment IND (often more than regardless of the number of patients. would not occur until the completion of 1,000 patients). One comment recommended that the phase 3 clinical testing. In addition, In contrast to treatment INDs, which final rule state that proceeding with FDA does not believe the expanded usually occur very late in a drug’s treatment use in an individual patient access provisions in subpart I are development, individual patient should be a rare circumstance that necessary to provide continuity of care treatment use may be sought quite early requires, at a minimum, submission to for patients who seemed to have in a drug’s development, and at any FDA of robust evidence from responded to an investigational therapy point during the development. nonclinical studies to show that it is during a clinical trial. A protocol Therefore, FDA also believes it is reasonably safe to proceed with the amendment adding a continuation important to have flexibility in the proposed treatment use, and phase to the clinical trial would evidentiary standards to permit it to information forming the basis from ordinarily be the preferred mechanism respond appropriately to wide nonclinical toxicokinetic studies and for providing an investigational therapy variations in the amount and nature of nonclinical pharmacology studies for to clinical trial participants who wish to evidence that might be presented in selecting dosage, dosage interval, and continue to receive the drug after the support of an individual patient IND. duration of treatment for use in patients. completion of the controlled phase of Thus, FDA would prefer to avoid One comment recommended that the the clinical trial. evidentiary standards pegged to data

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from specific phases of drug might be presented in support of an access under treatment INDs to development. FDA also believes a two- intermediate-size population IND. Thus, programs initiated very late in the drug tiered evidentiary standard—one FDA rejects the recommendation to development process. The comment standard for serious diseases and have evidentiary standards pegged to noted that if phase 3 data are required, conditions and a lower standard for data from a specific phase or phases of a treatment IND would typically only immediately life-threatening diseases or drug development. Again, because of provide access to the investigational conditions—is unnecessary for the flexibility inherent in the drug for a matter of months (i.e., the individual patient INDs because the evidentiary standards for intermediate- time between the initiation of a relative seriousness of the disease or size patient population INDs, FDA does treatment IND and approval of a drug condition is an implicit component of not believe it is necessary or useful to for marketing would be relatively short) the risk-benefit assessment for have different standards for serious and thus would not meet the needs of individual patient INDs, and the current diseases or conditions than for patients or substantially help small evidentiary standard allows for immediately life-threatening diseases or biotech companies. The comment considerable flexibility in the amount conditions. argued that to be truly useful, either and nature of evidence needed to iii. Treatment IND or treatment treatment INDs or treatment protocols support an individual patient IND. protocol evidentiary standards. need to be available based upon phase ii. Intermediate-size patient Proposed § 312.320(a)(3)(i) provides 1 data (at least in cases where population evidentiary requirements. that for a treatment IND or treatment appropriate because of the severity of Proposed § 312.315(b)(1) provides protocol for a serious disease or the disease and a relatively benign that, for expanded access under condition, there must be sufficient safety profile for the drug), the intermediate-size population INDs or evidence of safety and effectiveness to intermediate population programs need protocols, FDA must determine that support the use, which would ordinarily to be able to go well above 100 patients there is enough evidence that the drug consist of data from phase 3 trials, but (i.e., up to 500 or 1,000 patients), or is safe at the dose and duration could consist of compelling data from there needs to a fourth category between proposed for expanded access use to completed phase 2 trials. Section the intermediate and the large justify a clinical trial of the drug in the 312.320(a)(3)(ii) provides that, for an populations programs. Another approximate number of patients immediately life-threatening disease or comment stated that the proposed rule’s expected to receive the drug under condition, the available scientific evidentiary requirements for a treatment expanded access. Proposed evidence taken as whole must provide IND raise the bar to a level effectively § 312.315(b)(2) provides that FDA must a reasonable basis to conclude that the equivalent to the amount of data determine that there is at least investigational drug may be effective for required to obtain marketing approval. preliminary clinical evidence of the expanded access use and would not effectiveness or of a plausible expose patients to an unreasonable and (Response) FDA believes that the pharmacologic effect of the drug to significant risk of illness or injury. Such proposed evidentiary requirements for make expanded access use a reasonable evidence would ordinarily consist of authorizing treatment use under a therapeutic option in the anticipated clinical data from phase 3 or phase 2 treatment IND effectively balance patient population. trials, but could be based on more making an investigational drug available (Comment 31) One comment preliminary clinical evidence. to a substantial number of patients who recommended that FDA have different (Comment 32) Two comments were might benefit from the drug with evidentiary standards for intermediate- concerned that the proposed evidentiary simultaneously protecting those patients size expanded access for serious standards for authorizing a treatment from unreasonable risks associated with diseases or conditions and intermediate- IND or treatment protocol were not the drug. Our experience with this size expanded access for immediately sufficiently rigorous to protect patients. standard—spanning more than two life-threatening diseases or conditions. One comment recommended that, for decades—supports this assessment. For INDs for immediately life- treatment INDs or treatment protocols Moreover, the evidentiary standards threatening diseases or conditions, the for serious diseases or conditions, only provide a certain amount of flexibility, comment stated that there should be data from phase 3 clinical trials should particularly in the case of a treatment some preliminary evidence of clinical be used to assess the potential benefits IND to treat an immediately life- effectiveness. For INDs for serious and risks of the drug. The comment also threatening disease or condition, so that diseases or conditions, the comment recommended that for a treatment IND FDA can make investigational therapies recommended that there be evidence of or treatment protocol for immediately- available to substantial numbers of safety data from completed phase 1 life threatening diseases or conditions, patients as early in the development testing at doses similar to those to be only data from phase 3 clinical trials or process as is reasonably possible. FDA used in the treatment use and compelling data from phase 2 trials believes that more rigorous or inflexible preliminary evidence suggesting should be considered. One comment standards would present an possible effectiveness. objected to the proposed evidentiary inappropriate barrier to obtaining a (Response) Because intermediate-size standard for a treatment IND or a treatment IND in some cases. FDA also population INDs can occur earlier in treatment protocol for an immediately believes that relaxing these standards drug development than treatment INDs life-threatening disease or condition could potentially expose significant and because there are three different because it would permit authorization numbers of patients receiving intermediate-size population access of expanded access on the basis of investigational drugs under a treatment scenarios (for a drug being developed, clinical data more preliminary than IND to unnecessary harm. A key tenet for a drug not being developed, and for phase 2 or 3 data. of drug development is to gradually an approved or related drug that is not Two comments were concerned that increase the size of the population available through marketing channels), the evidentiary standards for a treatment exposed to an investigational drug so as FDA must have flexibility in the IND were overly rigorous. One comment to be able to detect relatively low- evidentiary standards to permit it to stated that requiring safety and frequency, serious toxicity as early as respond appropriately to variations in effectiveness data from phase 3 or phase possible, and before very large numbers the amount and nature of evidence that 2 studies limits the use of expanded of patients have been exposed. This

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principle applies with equal force to the stringent evidentiary standard for a a treatment IND for a serious disease or use of investigational drugs for treatment IND or treatment protocol for condition in § 312.320(a)(3) of this final treatment use. a serious disease or condition than was rule. FDA wishes to emphasize that the contained in FDA’s previous regulation c. Non-interference with drug evidentiary standards for a treatment in § 312.34. Section 312.34 was not development. IND are not the functional equivalent of specific about the nature of the evidence Proposed § 312.305(a)(3) states that, the amount and type of data needed for that would be needed to support a for all expanded access uses, FDA must marketing approval. The standards treatment IND for a serious, as opposed determine that providing the provide a degree of flexibility that to immediately life-threatening, disease investigational drug for the requested enables FDA to authorize a treatment or condition. Rather, the general use will not interfere with the initiation, IND on the basis of data often well short discussion in § 312.34(a) suggested an conduct, or completion of clinical of that needed to obtain marketing earliest point in time at which such a investigations that could support approval. FDA also does not believe that treatment IND could be allowed to marketing approval of the expanded there needs to be a fourth category of proceed (‘‘in appropriate circumstances, access use or otherwise compromise the treatment use in between an a drug may be made available during potential development of the expanded intermediate-size patient population phase 2’’). FDA has always interpreted access use. For a treatment IND, IND and a treatment IND. As discussed that requirement to mean that a proposed § 312.320(a)(1) also requires elsewhere in this preamble, FDA treatment IND for a serious, but non-life- FDA to determine that the drug is being intends that there be sufficient threatening, disease or condition would investigated in a controlled trial under flexibility in the size of the population have to be supported by some phase 2 an IND designed to support a marketing that might be treated under an data (controlled trial data on the disease application for the expanded access use, intermediate-size population IND to of interest), but that phase 2 did not or that all clinical trials of the drug have enable treatment of as many patients as have to be completed. Or, to put it been completed, and that the sponsor is is supported by the available evidence another way, at least one phase 2 trial actively pursuing marketing approval of of safety and effectiveness. would have to have been completed, but the drug for the expanded access use (Comment 33) One comment objected others could be ongoing. FDA has never with due diligence. to the proposed rule’s evidentiary interpreted this provision to mean that (Comment 34) Several comments standard for a treatment IND or a treatment IND for a serious disease or expressed concern that the proposed treatment protocol for a serious disease, condition could proceed without any rule would seriously impede the asserting that it was higher than both phase 2 data. Therefore, FDA believes initiation and completion of clinical the statutory and current regulatory that stating in this final rule that data trials and drug development generally. standards and thus further restricted needed to support for a treatment IND A number of comments stated that, access. The comment noted that section for a serious disease or condition could given a choice, patients would be more 561(c)(1) of the act only requires consist of compelling data from phase 2 likely to try to obtain an investigational ‘‘sufficient’’ evidence of safety and trials is consistent with the statement drug under an expanded access IND or effectiveness. The comment also noted that a drug may be made available for protocol than to participate in a clinical that § 312.34(a) of FDA’s current treatment use during phase 2. trial of the drug (and, for example, risk regulations allows drugs to be made FDA also does not agree that randomization to another treatment). available during Phase 2 ‘‘in appropriate characterizing the phase 2 data needed Two comments argued that making circumstances.’’ The comment pointed to support an treatment IND for a drugs more widely available under out that § 312.320(a)(3) of the proposed serious disease or condition as expanded access INDs would have a rule provides that the evidence needed compelling raises the bar compared to domino effect in which decreased for a treatment IND or treatment that in § 312.34. That provision made enrollment in clinical trials would lead protocol would ordinarily consist of clear that a treatment IND for a serious to less rigorous trial protocols, less data from phase 3 trials, but could disease or condition would ordinarily useful data, and ultimately decrease the consist of compelling data from not be permitted until some point amount of safety and efficacy completed phase 2 trials. The comment during phase 3 or at a point when all information on approved drugs. stated that, under the proposed rule, controlled trials were completed. To (Response) FDA believes that the phase 2 trials would have to be permit a treatment IND to proceed provisions in the proposed rule completed, not merely ongoing, thus during phase 2 was plainly intended to requiring that expanded access raising the standard for expanded access be an exceptional circumstance. FDA programs not impede clinical for treatment INDs and treatment does not believe that ambiguous, development of the investigational drug protocols. The comment also stated that inconclusive, or marginally statistically that is being made available for FDA has also raised the standard significant phase 2 data would justify treatment use are adequate to mitigate because the data would have to be the exceptional circumstance of the impact of expanded access on ‘‘compelling’’ The comment suggested permitting a treatment IND for a serious clinical development. In the case of that because of design limitations, many disease or condition based on phase 2 individual patient expanded access phase 2 trials could be considered not data. Therefore, FDA believes it is INDs, an individual patient is not compelling. The comment suggested reasonable to characterize the phase 2 eligible to obtain access under an that the proposed rule may result in data needed as compelling. FDA also individual patient expanded access IND treatment INDs and treatment protocols disputes the contention that the design if the patient can participate in a being less frequent than under FDA’s of a typical phase 2 could not yield clinical trial of the drug or obtain the current regulations. The comment stated compelling data. drug under a larger access IND. In the that the final rule should use the For the reasons stated previously, case of an intermediate-size patient language in § 312.34(a) of FDA’s current FDA also does not agree that there will population IND for a drug being regulation instead of the new proposed be fewer treatment INDs and treatment developed, the intent of such an IND is language in § 312.320(a)(3). protocols for serious disease or to make a drug available to patients who (Response) FDA does not agree that conditions because of the way FDA cannot enroll in a clinical trial; the proposed rule articulates a more articulated the evidentiary standard for therefore, there would be no effect on

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drug development. The other two of noninterference with clinical trials. finding that FDA must make under intermediate-size patient population First, the comment asserted that with section 561(c) of the act, which applies IND scenarios do not involve drugs that regard to ‘‘widespread’’ treatment INDs, to treatment INDs. are being actively developed. In the case the criteria imposed by § 312.305(a)(3) The comment seems to be based on of a treatment IND, in FDA’s experience, were broader than the authority in the mistaken assumption that under sponsors usually do not initiate section 561(c)(5) of the act and section 561(c)(5), the only treatment INDs until the clinical studies impermissibly permitted FDA to refuse determination that FDA must make is needed to support approval are to approve requests for expanded access whether an investigational drug will completed or fully enrolled. However, it for reasons other than the proposed ‘‘interfere with the enrollment of is possible to authorize a treatment IND treatment use’s effect on enrollment of patients in ongoing clinical before clinical trials needed to support clinical trials. The comment referred to investigations.’’ However, under section marketing approval are fully enrolled. In the proposed rule’s criterion that 561(c)(4) of the act, FDA also must such cases, it would be important for providing expanded access will not determine that the sponsor of the FDA to closely monitor the implications interfere with the initiation, conduct, or controlled clinical trial is actively of the treatment IND on the rate of completion of clinical investigations pursuing marketing approval of the accrual of subjects into the clinical trial that could support marketing approval investigational drug with due diligence. and other clinical development of the expanded access use or otherwise Such active pursuit of marketing milestones. compromise the potential development approval with due diligence implicitly (Comment 35) Some comments asked of the expanded access use includes a determination that the FDA to specify how it will determine (§ 312.305(a)(3)), and urged that the treatment use will not interfere with the that making an investigational drug final rule use statutory language rather initiation, conduct, or completion of available for treatment use will not than that used in the proposed rule. clinical investigations that could interfere with clinical trials or drug Second, in a section related to support marketing approval for the development generally. One comment individual patient access to investigational drug, which is why FDA stated that the expanded access rule investigational drugs, the comment included those particular terms in the should contain more explicit criteria for argued that FDA lacks statutory regulation. FDA could have simply determining that expanded access does authority for the proposed rule’s restated the statutory language in the not detrimentally affect clinical trials. product development criteria. regulation, but since the regulation (Response) FDA believes the criteria Specifically, the comment noted that in implementing the statute is aimed, in are sufficiently explicit to enable FDA to the case of the single patient IND, part, at shedding light on how FDA meaningfully assess the impact of an Congress gave FDA authority to interprets the statute, the agency expanded access program on authorize a single patient IND if the believes the proposed language provides development, and also provide FDA the Secretary determines that ‘‘provision of more helpful guidance than merely flexibility to ask for varied types of the investigational drug * * * will not restating the terms from the statute assurances that access will not impede interfere with the initiation, conduct, or without more. development, depending on the completion of clinical investigations to Regarding the argument that the particular situation. For example, before support marketing approval.’’ The statutory language does not allow FDA authorizing a treatment IND for an comment objected to the phrase ‘‘or to require a determination that investigational drug for which clinical otherwise compromise the potential provision of the investigational drug for trials are ongoing, FDA could seek development of the expanded access treatment use will not ‘‘otherwise specific assurances from the sponsor use’’ in proposed § 312.305(a)(3). compromise the potential development that the treatment IND would not (Response) FDA disagrees with the of the expanded access use,’’ FDA interfere with accrual of patients in the comment. Regarding the first assertion, disagrees for reasons similar to those clinical trial. FDA would likely request that FDA has applied a more stringent explained previously. In § 312.305(a)(3), that the sponsor submit a provision on noninterference with which is applicable to all treatment comprehensive investigational plan clinical trials than is called for in the uses, FDA included this term to with a timetable and milestones to its section of the act relating to expanded generically address other criteria IND (if it had not done so already), so access for treatment INDs, FDA required under different sections of that FDA could periodically assess disagrees that the language in section 561, including section 561(b)(4), whether the treatment IND is having an § 312.305(a)(3) impermissibly expands (c)(3) and (c)(4). FDA does not intend to effect on accrual or other parameters the grounds on which FDA may reject use this catchall language as a limitless related to the pace of clinical a proposed treatment IND. Section means to deny treatment use of development. If FDA determines that 312.305(a)(3) provides that, for all types investigational drugs. Rather, the intent the treatment IND is slowing the pace of of expanded access, FDA must is to endow the implementing drug development or the sponsor is not determine that providing the regulation with sufficient flexibility to actively pursuing marketing approval investigational drug for the requested allow FDA to address situations where with due diligence, FDA can place the use ‘‘will not interfere with the potential development of the treatment treatment IND on clinical hold. It is also initiation, conduct, or completion of use would be compromised by a worth noting that it is likely not in the clinical investigations that could particular treatment proposal, for sponsor’s interest to delay development support marketing approval of the instance, where a proposed use would because it delays marketing approval expanded access use or otherwise usurp the entire population of patients and commercial sale of the drug. compromise the potential development who might be studied in controlled Therefore, sponsors are unlikely to of the expanded access use.’’ While clinical trials. This particular regulatory provide expanded access in situations admittedly much of this language language is motivated by one of the core in which drug development would be matches terminology found in section notions underlying the act—namely, impeded. 561(b)(3) of the act, which applies to recognition that the best form of access (Comment 36) One comment raised individual patient treatment access and to a drug is full marketing approval. two objections to the provisions of the access by small groups of patients, it d. Impeding development of related proposed rule relating to FDA’s finding also generally describes the type of drug products.

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(Comment 37) One comment because such approval would impede enrollment or the demographics of the expressed concern about the potential development of a competing product is trial because those patients would not for expanded access to impede clearly not in the best interests of the have been able to participate in the development of other drug products public health because it would deny clinical trial because of geographical being developed for the same or a patients access to a proven effective constraints. similar indication as the investigational therapy. There do not appear to be any (Comment 40) One comment asked drug being sought for treatment use. The other regulatory options that could whether there have ever been any comment recommended that requests mitigate the impact on development or investigational drugs made available for expanded access include a statement approval of a related drug. through a treatment IND that were not that the public list of clinical trials has (Comment 38) One comment stated subsequently approved for marketing. been reviewed and the patient is not that expanded access would be more (Response) Yes, there have been drugs eligible or is otherwise unable to likely to impede development in the that were made available under a participate (e.g., because of distance) in early stages of drug development and treatment IND that did not obtain available studies. Another comment the development of orphan drugs. marketing approval. However, for these cited an example of a situation in which (Response) FDA agrees that expanded drugs, the failure to obtain marketing enrollment in a clinical trial had access has greater potential to impede approved was not due to the treatment decreased following accelerated development when a drug is available IND interfering with the clinical approval of drugs for the same use under an access IND early in development program. under subpart H. development, particularly if the access (Response) FDA acknowledges the is widespread. For this reason, FDA 4. Expanded Access IND Submission possibility that a large expanded access must determine that a patient seeking Requirements IND for a given product could impede access to an investigational drug under Section 312.305(b) describes the concurrent development of other an individual patient expanded access content of an IND submission or products for the same or a similar IND cannot participate in a clinical trial protocol amendment for expanded indication because trials for those of the drug or obtain the drug under a access. In the event that a licensed products would be competing with the larger expanded access IND or protocol physician, as opposed to a commercial access program for the same patient (§ 312.310(a)(2)). Similarly, an sponsor, is making the IND submission, population. However, requiring that the intermediate-size patient population it provides that the licensed physician sponsor of a proposed expanded access IND intended for a drug being may provide some of the required IND demonstrate that the expanded developed is intended to make the drug information by obtaining a right of access use will not impede development available only to those who cannot reference to the content of the existing of not only its drug but of any other participate in a clinical trial of the drug IND. Proposed § 312.305(b)(2) requires drug in clinical development for the (§ 312.315(a)(2)). FDA believes that that an expanded access submission same use would seem to present an these provisions should minimize the include: unreasonable obstacle to access. For potential for these types of expanded • A cover sheet (Form FDA 1571) example, it is not clear how a sponsor access INDs to impede drug meeting the requirements of § 312.23(a); would be able to demonstrate no effect development. • The rationale for the intended use on the development of a related therapy FDA also agrees that expanded access of the drug, including a list of absent some proprietary knowledge for drugs for orphan diseases has added therapeutic options that would about the development plans of the potential to impede drug development ordinarily be tried before resorting to related therapy. Because there is no due to the relatively smaller population the investigational drug or an obvious way that the sponsor of a from which clinical trial subjects can be explanation of why the use of the proposed expanded access plan could drawn. FDA will carefully evaluate any investigational drug is preferable to the provide proof that the plan would have expanded access submission for an use of available therapeutic options; no effect on another company’s orphan drug to ensure that the data • The criteria for patient selection or, development program, such needed to support approval of the for an individual patient, a description determinations would have to rely orphan product will not be of the patient’s disease or condition, primarily on conjecture. For that reason, compromised by the expanded access including recent medical history and such a requirement would likely be use. previous treatments of the disease or applied inconsistently and, as a result, (Comment 39) One comment condition; could unnecessarily deny access to maintained that expanded access would • The method of administration of the patients in desperate circumstances. be more likely to decrease clinical trial drug, dose, and duration of therapy; FDA also does not believe that the participation in more rural communities • A description of the facility where sponsor of a competing therapy under and that even if clinical trials were still the drug will be manufactured; development should have the ability to able to accrue adequate numbers of • Chemistry, manufacturing, and cause an ongoing expanded access IND subjects, the demographics of controls information adequate to ensure to be put on hold, as would be the case participation in clinical trials could be proper identification, quality, purity, if FDA were to require a sponsor to skewed toward more urban populations. and strength of the investigational drug; show that the expanded access IND (Response) FDA disagrees. The agency • Pharmacology and toxicology would not interfere with another believes that expanded access programs information adequate to conclude that company’s development program, and would have a neutral effect on clinical the drug is reasonably safe at the dose the other company were to demonstrate trial enrollment in rural areas because and duration proposed for the treatment such interference. the same criteria apply in rural and use (ordinarily, information that would FDA also acknowledges the potential more urban settings. Admittedly, be adequate to permit clinical testing of for marketing approval of a related patients in rural areas are more likely to the drug in a population of the size product for the same or a similar be unable to enroll in a clinical trial expected to be treated); and indication to impede development of because of geographical constraints, but • A description of clinical drugs for that indication. However, providing access to those patients procedures, laboratory tests, or other denial or delay of marketing approval would have no effect on clinical trial monitoring necessary to evaluate the

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effects of the drug and minimize its population if there is no existing IND or submission requirements present an risks. if the sponsor of the IND will not obstacle to the vast majority of patients (Comment 41) One comment asked provide the information needed to who seek to obtain investigational drugs whether the proposed submission support the expanded access request. for treatment use under the expanded requirements for expanded access apply The comment added that physicians access regulations, and the agency is to both sponsors and sponsor- may not know whether an IND exists or convinced that the requirements are an investigators. The comment also asked how to find that out. essential component of human subject whether some of the required (Response) In FDA’s experience, the protection. information could be incorporated into vast majority of expanded access INDs (Comment 43) Two comments the protocol rather than provided as for individual patients are for expressed the view that many parts of separate documents in the IND investigational drugs in development, Form FDA 1571 may not be appropriate submission, including the rationale for and submissions are made on behalf of for use by an individual doctor for the intended use of the investigational patients unable to participate in clinical expanded access purposes. The drug with a list of generally available trials. In these situations, the comments asked that FDA provide a treatment options and an explanation as submission requirements are not streamlined version of Form FDA 1571 to why they are not preferable, criteria onerous. The commercial sponsor that is that is specific to individual patient for patient selection, a description of the developing the drug may make a expanded access. One comment patient’s disease or condition (including submission for individual patient access recommended that FDA encourage or recent medical history), and previous as a protocol amendment to its existing require standard nomenclature on treatment use (for an individual patient IND, in which case the licensed expanded access submissions so such submission). physician must only provide the submissions could be readily (Response) The submission sponsor with the required information distinguished from non-expanded requirements are sponsor requirements about the individual patient. access submissions. The comment and thus are intended to apply to both Alternatively, the commercial sponsor stated that for a treatment IND, the sponsors and sponsor-investigators. The may elect only to provide the drug and sponsor should make two entries to Item listing of general submission require the physician to submit his or 11 of the 1571: Check the box for requirements in § 312.305 is not her own IND. In this situation, the INITIAL INVESTIGATIONAL NEW intended to convey the impression that commercial sponsor routinely permits DRUG APPLICATION, and enter each element of the submission be the licensed physician to refer to any ‘‘OTHER: Treatment IND’’ on the blank contained in a separate document. As needed information in its existing IND, line. For an expanded access protocol the comment points out, certain so, again, the licensed physician usually under an existing IND, the comment required submission elements are topics only has to provide the relevant suggested that the sponsor also make that are appropriate for inclusion in a information about the physician’s two entries to Item 11 of the 1571: single protocol. Other elements, such as patient. In each of these scenarios, the Check the box for PROTOCOL pharmacology/toxicology and information the licensed physician must AMENDMENT: NEW PROTOCOL, and chemistry, manufacturing, and controls provide is ordinarily readily available in enter ‘‘OTHER: New Protocol for (CMC), may more typically be found in patient medical records. Expanded Access’’ on the blank line. separate documentation. FDA’s primary In rare circumstances, a licensed (Response) FDA agrees that it is concern is not with the number of physician may seek to obtain access for desirable to be able to readily individual documents submitted, but an individual patient to an distinguish expanded access that the required elements be submitted investigational drug not being submissions from non-expanded access in a form that makes the information developed. If a drug is not being submissions. FDA does not believe, readily accessible and leaves no developed and has never been the however, that a new form specific to question that the submission contains subject of an IND, the submission expanded access is necessary to the necessary information. requirements become more complex. accomplish this task. FDA believes that a. Submissions for individual patient There may be other sources that could instructions for filling out Form FDA expanded access. provide some of the necessary 1571 for expanded access purposes and (Comment 42) Several comments information (e.g., materials data sheets) standardized nomenclature will suffice, expressed concern that individual to minimize the burden on the helping sponsors to complete the form physicians would not be able to comply physician to an extent. However, FDA appropriately and helping FDA to with the submission requirements for must have reasonable assurances about readily identify expanded access expanded access for an individual the integrity and safety of the product, submissions. FDA may develop patient. The comments stated that most so the IND submission will require a guidance to provide instructions for individual physicians will not have significant amount of information completing Form FDA 1571 and sample access to the drug’s CMC or concerning the manufacturing of the completed forms for each type of pharmacology and toxicology product and its pharmacology/ expanded access. information. One comment stated that toxicology profile for FDA to permit use b. Intermediate-size population IND FDA sometimes raises difficult of the drug for the expanded access use. submission requirements. manufacturing, pharmacology, FDA’s guidance for industry entitled In addition to the general submission toxicology, pharmacokinetic, clinical, ‘‘Content and Format of Investigational requirements, proposed § 312.315(c) and statistical issues, and these issues New Drug Applications (INDs) for Phase describes requirements specifically sometimes result in physicians 1 Studies of Drugs, Including Well- applicable to submissions for withdrawing expanded access requests. Characterized, Therapeutic, intermediate-size population expanded One comment opined that the Biotechnology-derived Products,’’ access INDs. Proposed § 312.315(c)(1) submission requirements for individual provides some insight into the amount requires that the submission state patient expanded access may have the and nature of the information that whether the drug is being developed or unintended effect of rendering the would be required in these situations. not being developed. For a drug not proposed rule relatively meaningless for However, because these situations are being developed, proposed the vast majority of the patient rare, FDA does not believe that the § 312.315(c)(2) requires that the sponsor

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explain why the drug cannot currently (Comment 46) One comment asked expanded access IND or protocol under be developed and under what where in the electronic common subpart I is considered a sponsor for circumstances the drug could be technical document (eCTD) to include purposes of part 312) use the term developed. the submission information that is ‘‘person’’ rather than ‘‘individual or (Comment 44) One comment specific to intermediate-size patient entity.’’ The comment pointed out that requested that the requirements in population INDs. ‘‘person’’ is defined in the act and proposed § 312.315(c)(2) and (c)(3) be (Response) The eCTD does not includes ‘‘individual, partnership, removed because they do not seem distinguish INDs of different-size corporation, and association.’’ relevant to the determination of whether patient populations. The information (Response) The term ‘‘individual or access is appropriate for the specific to an intermediate-size patient entity’’ is based on, and intended to be intermediate-size group. population IND would go in the same shorthand for, language in the definition (Response) FDA disagrees. One of location as one for a treatment IND or of a ‘‘sponsor’’ in § 312.3(b) that states FDA’s primary concerns with making a single patient treatment IND. that a sponsor may be an ‘‘individual or investigational drugs available for pharmaceutical company, governmental 5. Safeguards for Expanded Access treatment use is the potential for agency, academic institution, private treatment use to prevent the Proposed § 312.305(c) explains how organization, or other organization.’’ development of information necessary the responsibilities of sponsors and Because the term relates to an existing to demonstrate safety and effectiveness investigators set forth in subpart D definition of sponsor in the IND by usurping a population that could (Responsibilities of Sponsors and regulations, and because in FDA’s have been enrolled in a clinical trial. Investigators) of part 312 apply to experience that definition has been clear FDA believes that section 561 of the act expanded access INDs. Proposed and effective in describing who or what contemplates that expanded access to § 312.305(c)(1) states that a licensed may be considered a sponsor for investigational drugs is not appropriate physician under whose immediate purposes of part 312, FDA prefers to when that access prevents the direction an investigational drug is retain the language in the proposed rule. development of important safety and administered or dispensed for expanded b. Sponsor and investigator effectiveness information that could access use is considered an investigator responsibilities. have been developed if there were no for purposes of part 312 and, therefore, Proposed § 312.305(c)(5) provides that expanded access. Requiring a sponsor to must comply with the responsibilities for all expanded access INDs, sponsors explain why no development is possible for investigators set forth in subpart D are responsible for submitting IND when a drug is not being developed at to the extent they are applicable to the safety reports and annual reports (when all, or why a clinical trial cannot be expanded access use. Proposed the IND or protocol continues for 1 year conducted to study the treatment use § 312.305(c)(2) states that an individual or longer) to FDA as required by when a drug is being developed for a or entity that submits an expanded §§ 312.32 and 312.33, ensuring that use other than the treatment use, access IND or protocol under subpart I licensed physicians are qualified to squarely addresses FDA’s concerns. is considered a sponsor for purposes of administer the investigational drug for (Comment 45) One comment part 312 and must comply with the expanded access use, providing licensed recommended that before concluding responsibilities for sponsors set forth in physicians with the information needed that a patient or patient population is subpart D to the extent they are to minimize the risk and maximize the ineligible to enroll in a clinical trial for applicable to the expanded access use. potential benefits of the investigational purposes of this requirement, the Proposed § 312.305(c)(3) states that a drug (e.g., providing the investigator’s investigator, sponsor, and FDA should licensed physician under whose brochure if there is one), maintaining an carefully consider whether the clinical direction an investigational drug is effective IND for the expanded access study protocol could be amended to administered or dispensed, and who use, and maintaining adequate drug include the patient population submits an expanded access IND, is disposition records and retaining contemplated for treatment use without considered a sponsor-investigator and records in a manner consistent with the affecting the safety of the subjects or the must comply with the responsibilities of requirements of § 312.57. integrity of the study. sponsors and investigators in subpart D Proposed § 312.310(c)(3) further (Response) FDA agrees that the to the extent applicable to the expanded provides that FDA may also require optimal solution would be to somehow access use. sponsors to monitor an individual incorporate the potential intermediate- Proposed § 312.305(c)(4) provides that patient expanded access use if the use size treatment use population in an for all expanded access INDs, is for an extended duration. Proposed ongoing clinical trial by modifying the investigators are responsible for § 312.315(d)(2) states that the sponsor is inclusion/exclusion criteria while not reporting adverse events to the sponsor, responsible for monitoring the compromising safety or study integrity, ensuring that the informed consent intermediate-size population expanded or to enroll that population in a new requirements in part 50 (21 CFR part 50) access protocol to ensure that licensed study. FDA expects that sponsors would are met, ensuring that an IRB review of physicians comply with the protocol have explored all reasonably possible the expanded access use is obtained in and the regulations applicable to avenues for studying the patient a manner consistent with the investigators. Proposed § 312.320(c) population before seeking an expanded requirements of part 56 (21 CFR part states that the sponsor is responsible for access IND for treatment use in that 56), and maintaining accurate case monitoring the treatment protocol to population and that the submission histories and drug disposition records ensure that licensed physicians comply would explain why those avenues were and retaining records in a manner with the protocol and the regulations foreclosed. By requiring the sponsor to consistent with the requirements of applicable to investigators. explain why the population for which § 312.62. (Comment 48) One comment stated an intermediate-size expanded access a. ‘‘Person’’ v. ‘‘individual or entity.’’ that making physicians investigators for IND is sought is not eligible to be (Comment 47) One comment purposes of part 312 will be daunting enrolled in a clinical trial, FDA is recommended that proposed and extremely time-consuming and that encouraging, at least implicitly, this § 312.305(c)(2) (which states that an the typical gastroenterologist not thought process. individual or entity that submits an affiliated with a large teaching or

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research hospital will not be able to manufacturer/supplier, FDA sees no concern that may affect the risk-benefit satisfy these requirements. obstacle to the drug manufacturer/ assessment. (Response) FDA disagrees. For a supplier requiring, as a condition of (Response) FDA strongly disagrees. licensed physician providing access making the drug available to the FDA believes that all adverse events under an individual patient IND, the physician, that the physician agree to identified in expanded access uses responsibilities of an investigator provide the drug manufacturer/supplier should be reported to FDA in the closely parallel those necessary for with copies of all adverse event reports manner described in §§ 312.32 and providing routine patient care. For provided to FDA. 312.33. FDA’s primary interest is the example, the information about a In addition, in the preamble to the expedited reporting of serious and patient that a physician is required to proposed rule (71 FR 75147 at 75153), unexpected events as required by submit to obtain an IND would usually FDA expressed a strong preference for § 312.32(c). Data collected on be derived from the patient history and having commercial sponsors make nonserious or expected events from progress notes. In most cases, the investigational drugs available for expanded access use, in particular from remaining IND submission requirements treatment use under amendments to exposure of an individual patient or would be largely satisfied by obtaining their INDs rather than requiring small number of patients to a drug, is a right of reference to an IND physicians to obtain their own INDs. In not as useful as data collected from maintained by a commercial sponsor, that scenario, the physician is required controlled trials that may identity which is usually easily obtained. Any to report adverse events to the differences in event rates across required monitoring of the course of commercial sponsor under § 312.64. treatment groups (e.g., control group, treatment with the investigational drug (Comment 50) One comment across different doses). Nonetheless, would be similar to the type of suggested that adverse events for information from expanded access monitoring provided as part of routine individual patient INDs should be exposures on these types of adverse patient care. The patient outcomes addressed in a separate section of the events can still contribute to the safety information required to be submitted NDA or biologics license application assessment of a new molecular entity after treatment with the investigational (BLA) instead of being included in the (e.g., corroborate observations in other drug would closely parallel the content integrated summary of safety. The settings). In general, FDA believes it is of a typical discharge summary. comment stated that this approach important that a drug’s safety Therefore, FDA believes that, in most would help alleviate manufacturers’ assessment consider adverse events cases, the IND obligations imposed on concerns that allowing individual observed in the entire population licensed physicians by this final rule patient INDs (typically involving exposed to a drug. would not be significantly more especially sick patients) would (Comment 52) One comment inquired burdensome than the recordkeeping and exaggerate adverse events for the about how to report adverse events for patient evaluation required in the broader population. approved drugs made available under course of routine clinical care of a (Response) FDA does not believe it is an expanded access IND. patient. necessary or helpful to exclude adverse (Response) For an approved drug c. Adverse event reporting. events information from individual made available under an expanded (Comment 49) One comment from a patient INDs from the integrated access IND (e.g., in a circumstance in pharmaceutical company asked whether summary of safety (ISS) in an NDA. The which an approved drug is subject to a licensed physicians who obtain an ISS is intended to evaluate adverse restricted distribution agreement that investigational drug for expanded access events information from the total limits prescribing to a certain disease or use under their own INDs are required population exposed to a drug. The condition, and a patient is seeking to report adverse events to both the analysis takes into account the relative access to the drug for another use), pharmaceutical company supplying the strength of the data and the adverse events must be reported to FDA drug and FDA. The comment characteristics of subjects who under the IND in accordance with maintained that it is important for the experienced adverse events that may § 312.305(c)(5). pharmaceutical company developing bear on causality. For example, data d. Obtaining Informed Consent for the drug to be informed of any adverse indicating that an adverse event Expanded Access Use. events observed in expanded access use. occurred in multiple subjects in the (Comment 53) Many comments from (Response) Because the physician IND drug treatment arm of a controlled trial individual consumers stated that it is holder is both investigator and sponsor is much more reliable than adverse particularly important for patients in this scenario, the physician is not events information from uncontrolled, receiving investigational drugs in required by the IND regulations to individual patient expanded access expanded access programs to receive report adverse events to the drug exposures in patients who are very ill. full disclosure of the risks, and to fully manufacturer who provided the drug to The implication that inclusion of understand the risks, associated with the physician. The regulations require adverse events information from the investigational therapy. Two only that adverse events observed by the individual patient expanded access comments were very concerned that investigator (the physician) be reported exposures over-emphasizes negative patients receiving investigational drugs to the sponsor, who is also the safety information is unfounded and for treatment use not be misled about physician in this scenario. The plainly inconsistent with the the likelihood that the treatment will be physician, in his or her capacity as a methodology FDA uses to analyze drug beneficial. One comment stated that sponsor, is required to report adverse safety. many patients are led to believe that events to FDA and other investigators (Comment 51) Two comments stated access to an investigational intervention (not relevant for individual patient that, for investigational new molecular is their best hope, but often it is a false access), including reporting of serious entities, adverse event reporting for hope. Another comment stated that and unexpected adverse events in an expanded access use should be limited patients with immediately life- expedited manner. However, although to serious adverse events and deaths threatening conditions are extremely there is no regulatory provision that unless there are specific adverse events vulnerable and may not fully would require physicians to report that are identified a priori because they comprehend the information they are adverse events to the drug are related to an identified safety provided about a drug by health care

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practitioners. Another comment expanded access problems, in particular related to obtaining access, and the recommended that FDA provide issues concerning informed consent in particular concerns related to obtaining guidance on how to obtain informed vulnerable populations (see, e.g., parts informed consent from patients consent from patients who are 50 and 56). receiving investigational drugs for candidates to receive an investigational (Comment 55) One comment stated treatment use. FDA does not believe, drug for treatment use. that informed consent documents must however, that it is necessary to require (Response) FDA agrees that patients reflect that patients cannot expect to in regulation that IRBs have special who are candidates to receive personally benefit from the drug, but processes and procedures for reviewing investigational drugs under expanded that the knowledge gained from the expanded access protocols. Existing access programs, because they have experiment will help other patients in regulations already require IRBs to serious or immediately life-threatening the future. consider the vulnerable nature of the diseases or conditions and have (Response) FDA disagrees. The population that will receive an exhausted other treatment options, are a comment seems to misunderstand the investigational drug and to ensure that particularly vulnerable population. overarching purpose of expanded risks are minimized (which would Therefore, they should be afforded a access—to make investigational drugs necessarily involve some consideration rigorous informed consent process that available for treatment purposes to of whether there are any lower-risk effectively communicates the risks and patients with serious or immediately treatment options), and § 50.25(a)(4) potential benefits of any investigational life-threatening diseases or conditions requires that an informed consent therapy to be used for treatment use in and with no other treatment options disclose appropriate alternative a way that does not raise false because the investigational drugs could procedures or courses of treatment, if expectations about a positive outcome conceivably benefit these patients—not any, that might be advantageous to the from treatment and makes clear what is to systematically investigate the use of subject. unknown about the drug. Because of the the drug for the disease or condition. (Comment 57) One comment stated vulnerable nature of expanded access Treatment use under an expanded that a patient receiving expanded access patients, FDA encourages submission of access mechanism, in contrast to should be competent to give informed informed consent documents intended evaluation of an investigational drug in consent. to be used for expanded access a clinical trial, is not intended primarily (Response) While FDA agrees that programs to FDA for review. FDA will to develop data that could be used to valid informed consent is a necessary also consider whether guidance on how benefit future patients. However, as prerequisite to receiving an to obtain informed consent from such FDA made clear in response to comment investigational product in an expanded patients is needed. 54, patients receiving investigational access setting, FDA does not agree that (Comment 54) One comment stated drugs for treatment use should be access to investigational drugs under that because expanded access does not afforded a rigorous informed consent expanded access programs should be technically involve ‘‘research’’ or a process that is careful not to overstate limited to only those who are competent ‘‘clinical investigation,’’ the the expected benefits of the to give their own informed consent, if requirements and principles for investigational drug and is otherwise that is the intended implication of the obtaining the informed consent of cognizant of the inherent vulnerabilities comment. FDA’s regulations concerning subjects participating in clinical and information needs of patients protection of human subjects informed investigations in part 50 may not seeking access to investigational drugs consent (part 50) recognize that a adequately address the range of issues for treatment use. subject may not be competent to give that would arise in obtaining the (Comment 56) One comment informed consent and that valid informed consent of patients receiving recommended that before an IRB can be informed consent may be given by the investigational drugs under expanded allowed to review expanded access subject’s legally authorized access programs. The comment programs, FDA should require the IRB representative. Section 50.20 defines recommended that the expanded access to establish special criteria to ensure ‘‘legally authorized representative’’ as regulations include requirements that physicians have discussed all an individual or judicial or other body concerning the specific information that treatment options with patients as part authorized under applicable law to must be included in informed consent of the informed consent process and consent on behalf of a prospective documents for expanded access that patients and their families fully subject to the subject’s participation in programs. understand the experimental and the procedure(s) involved in the (Response) Again, because of the investigational nature of a drug or other research. The same definition should vulnerable nature of the typical patient therapy, the types and degrees of apply to treatment with an or population to receive an unknown risks, and the potential investigational product under an investigational drug under an expanded positive and negative health outcomes. expanded access program. access program, FDA agrees that (Response) Because patients seeking (Comment 58) One comment patients in expanded access programs access to investigational drugs for recommended requiring that IRBs should be afforded a rigorous informed treatment use are a particularly establish criteria for the length and consent process tailored to the unique vulnerable group and the intent is readability of informed consent issues that arise in the expanded access treatment of a disease or condition, as documents. context. FDA does not believe, however, opposed to a clinical investigation of the (Response) This comment is beyond that it is necessary to add specific use, FDA believes it is important for IRB the scope of this rule. The rule does not informed consent requirements to the review to be particularly sensitive to the address the requirements on IRBs and expanded access regulations or to unique issues raised by use of the comment raises a concern broader amend the informed consent regulations investigational drugs in expanded than expanded access. to incorporate specific requirements for access programs. FDA agrees that it e. IRB review of expanded access use. expanded access. FDA believes that would be useful for an IRB that is likely (Comment 59) Some comments were existing informed consent regulations to review expanded access use to be concerned that the requirement for IRB adequately address the range of issues familiar with the nature of expanded review was a potential obstacle to relevant to informed consent for access protocols, the rules and processes making investigational drugs available

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for treatment use under expanded FDA does not believe that current protections provided clinical trial access INDs, particularly for individual regulations provide authority for IRB participants by the IRB review process. patient INDs. One comment maintained review of individual patient expanded FDA equally strongly believes that all that the IRB review process is slow, access INDs by less than the full IRB. patients considering treatment with an tedious, cumbersome, and requires too The IRB regulations provide for investigational therapy under an much documentation, and that expedited review—under which an IRB expanded access IND should be fully physicians are not familiar with the IRB review may be done by only one or a informed about the risks and potential process. The comment suggested that small number of IRB members—of new benefits of the experimental therapy, some type of centralized IRB may be INDs or protocols only under minimal including disclosure that safety and needed for small- to medium-sized risk situations (§ 56.110(b)). Use of an effectiveness have not been established, access programs. Another comment investigational drug for treatment and give their informed consent prior to noted that in academic research settings, purposes would not be considered being treated with an investigational there is intensive IRB approval and minimal risk and, therefore, does not therapy. Patients seeking access to oversight, and recommended that FDA meet the criteria for expedited review. investigational therapies under explore standardizing expanded access Revising the IRB regulations to provide expanded access programs often are in program protocols so that some of the for a more limited IRB review of somewhat dire clinical circumstances administrative work, in particular IRB individual patient expanded access and thus are a particularly vulnerable submissions, can be lessened. One INDs involves significant human subject population. Therefore, such patients are, comment recommended that, for protections issues that were not arguably, even more in need of the individual patient expanded access considered in this rulemaking and, human subjects protections provided by INDs, FDA reduce or limit the scope of therefore, such revision is beyond the IRB review and informed consent than the requirement for IRB review because scope of this rulemaking. many clinical trial participants. (Comment 60) One comment stated of the time, difficulty, and, in some (Comment 61) One comment that FDA should eliminate the proposed cases, the expense (e.g., when a recommended the elimination of the requirements for IRB review and commercial IRB must be used) of requirements for prior IRB review and obtaining informed consent for obtaining IRB review. The comment approval in accordance with part 56 and individual patient treatment use INDs. recommended that FDA permit review the requirement for written informed The comment maintained that the use of by a subset of the full IRB or waive IRB consent in accordance with part 50 for an investigational drug for treatment use review if a drug has completed phase 1 individual patient expanded access use safety testing (see response to comment is not part of a clinical investigation and therefore beyond the intended scope of (but recommended the retention of these 60 for discussion of why waiver of IRB requirements for intermediate-size review is not a viable option). parts 56 and 50. The comment further argued that these safeguards are population and treatment INDs). The (Response) FDA recognizes that there unnecessary for individual patient comment argued that use of an are circumstances in which IRB review treatment use because there is an investigational drug for the emergency for an expanded access use, particularly established physician-patient treatment of individual patients is not an individual patient use, may be relationship and, therefore, individual part of a clinical investigation and thus difficult to obtain because an patient treatment use is analogous to the is not consistent with the scope of parts institution’s IRB cannot or will not physician-patient relationship in a 50 and 56. The comment stated that provide a timely review or because the typical clinical setting in which such eliminating the requirement would hospital or other clinical setting does safeguards are unnecessary. solve problems and avoid confusion not have an affiliated IRB. FDA (Response) FDA does not agree that it related to differences between FDA’s recommends that IRBs affiliated with lacks legal authority to require IRB IRB regulations and IRB regulations institutions that are likely to have review and informed consent for applicable to Federal agencies and patients seeking access to individual patient expanded access use grantees under 45 CFR part 46 (the so- investigational drugs for treatment use or any other expanded access use. called ‘‘Common Rule’’). Current FDA under individual patient access INDs Expanded access use involves regulations (§§ 56.104(c) and 50.23) consider establishing processes or administration of unapproved products allow for the emergency use of an procedures to facilitate timely IRB that have not yet been shown to be safe investigational drug without prospective review of these INDs. In addition, use of and effective, and raises sufficiently IRB review and approval and a waiver centralized IRB review and other similar concerns to clinical research that of the requirement for prospective cooperative arrangements could informed consent and IRB review are informed consent of the involved facilitate IRB review at these institutions warranted. Moreover, section 561 of the patient-subject, but the Common Rule as well as in settings that are not act contains numerous references to specifies that all research involving affiliated with IRBs. FDA fully supports ‘‘conditions determined by the human subjects must be prospectively centralized IRB review under Secretary’’ and to protocol compliance reviewed and approved by a convened appropriate circumstances and with ‘‘regulations promulgated under IRB committee (with the exception of encourages sponsors to help make this section 505(i)’’ (which include informed certain minimal risk categories of option available where possible. FDA consent and IRB regulations), indicating research, which do not include believes these mechanisms could ease that Congress intended FDA to require expanded access use). The comment the burdens associated with obtaining conditions such as informed consent maintained that the Common Rule IRB review of individual patient INDs and IRB review, consistent with FDA’s applies unless the requested emergency and limit the need to rely on long-standing practice regarding use is considered ‘‘treatment’’ rather commercial INDs. Therefore, FDA is not treatment use with investigational than ‘‘research’’ and thus is not subject persuaded that obtaining IRB review is products. In addition, FDA strongly to prior IRB review and approval under an excessive burden and potential believes that recipients of the Common Rule. The comment obstacle to obtaining access to investigational products under any type maintained that prior FDA review of investigational therapies under of expanded access IND should be individual patient expanded access expanded access INDs. afforded the same human subject would suffice to ensure patient safety

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and compliance with the protocol and investigational drug would be consistent (Response) FDA does not believe the applicable regulations. with the investigator reporting recommended language is necessary or (Response) Although FDA agrees that requirements in § 312.64(b). desirable. Section 312.305(c)(5) requires it is accurate to characterize the use as (Response) FDA agrees that the simply that sponsors assure themselves ‘‘expanded access’’ or ‘‘treatment use’’ licensed physician may be unaware of that the licensed physicians who will be rather than a ‘‘clinical investigation’’ of what events are expected or unexpected participating in an expanded access the drug, which places individual and, therefore, should be required to program are qualified to administer the patient INDs outside the scope of the include information on all observed drug for the expanded access use. FDA Common Rule, FDA disagrees that prior adverse events. Therefore, section believes the requirement concerning the FDA review, without additional review 312.310(c)(2) has been revised to state qualifications of the licensed physician- by a qualified third party, provides that at the conclusion of treatment, the investigator is narrowly focused on the adequate safeguards. The types of licensed physician or sponsor must most germane issue—whether the patients that would typically be eligible provide FDA with a written summary of physician is qualified to administer the to obtain investigational drugs under the results of the expanded access use, drug for the expanded access use. FDA expanded access programs are including adverse effects. believes the language proposed in the vulnerable and have somewhat (Comment 63) One comment stated comment minimizes the qualifications desperate clinical circumstances and, that adverse event reporting for of the licensed physician to too great an therefore, are in particular need of the expanded access use should take extent because it eliminates even the protections afforded by IRB review and advantage of technological cursory inquiry as to whether the the informed consent process. FDA modernization in adverse event physician is qualified to administer the acknowledges that in emergency reporting, such as by using a centralized drug. situations involving individual patient electronic database. The comment stated h. Investigator’s brochure. access, there is not always prospective that such a database could provide Proposed § 312.305(c)(5) also requires IRB review. However, FDA believes that access to basic tabulation and analysis the sponsor to provide the licensed some type of retrospective IRB review is of the voluminous serious adverse event physician with information needed to still important in most cases, especially reports that, in their present form, are minimize the risk and maximize the if treatment with the investigational virtually useless to individual site potential benefits of the investigational drug is ongoing. FDA also believes that investigators and site IRBs. drug, including ‘‘providing the informed consent is an important (Response) FDA has no plans to investigator brochure, if there is one.’’ element of any treatment use, even in implement an electronic data capture (Comment 65) One comment emergency situations. From a medical and analysis system for adverse events requested that this language be revised ethics perspective, the need for that is devoted exclusively to adverse to state that the sponsor provide the informed consent increases with the events observed during expanded access investigator’s brochure ‘‘if required seriousness of the disease or condition use. FDA is actively involved in efforts and the exigency of the clinical under § 312.55 (Informing to develop and implement electronic situation, so it would be all the more investigators).’’ data systems for adverse event reporting important in emergency situations with (Response) FDA does not agree with generally, for both pre- and individual patients. The purported the proposed change because it would advantages of eliminating any postmarketing adverse event reporting. appear to narrow the circumstances in prospective third-party IRB review and FDA believes these systems will also which a sponsor would be required to informed consent are not enough to contribute to improved data collection provide an investigator’s brochure. It offset the potential harm. and analysis of adverse events could be interpreted as requiring that a f. Investigator reporting information obtained from exposure to sponsor make the investigator’s responsibilities for individual patient investigational drugs in expanded brochure available only if the treatment INDs. access programs. use is the same use as is being Proposed § 312.310(c)(2) states that g. Qualifications of licensed developed (i.e., the use for which the ‘‘at the conclusion of treatment, the physicians to participate in expanded investigator’s brochure was written). licensed physician or sponsor must access. FDA believes that the investigator’s provide a summary of the results of the Proposed § 312.305(c)(5) requires, brochure would typically contain expanded access use, including among other things, that sponsors information that would be important for unexpected adverse effects.’’ ensure that licensed physicians any proposed use of the investigational (Comment 62) One comment participating in expanded access drug (e.g., information about adverse recommended that the licensed programs are qualified to administer the events associated with use of the drug) physician be required to provide a investigational drug for the expanded and, therefore, should be made available summary of ‘‘all adverse effects possibly access use. by the sponsor to licensed physicians in related to the investigational drug’’ (Comment 64) One comment an expanded access program whenever rather than only ‘‘unexpected adverse recommended that FDA revise an investigator’s brochure exists. To effects.’’ The comment stated that it is § 312.305(c)(5) to state: ‘‘In general any more accurately express this intent, likely that many private practice licensed physician may participate in an FDA has revised the provision in the physicians requesting expanded access expanded access protocol. Additional final rule to state as follows: ‘‘In all for the emergency treatment of their specific qualifications may be necessary expanded access cases, sponsors are individual patients will not be familiar in some situations.’’ The comment responsible for * * * providing with all of the current information recommended that FDA clarify its licensed physicians with the related to the adverse event profile of expectations about investigator information needed to minimize the risk the investigational drug and/or FDA’s qualifications for expanded access and maximize the potential benefits of regulatory definition of ‘‘unexpected programs to reduce the burden for the investigational drug (the adverse effects.’’ The comment added sponsors and facilitate broader investigator’s brochure must be that requiring physicians to report all physician participation in expanded provided if one exists for the drug) adverse effects possibly related to the access programs. * * *’’

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i. Monitoring of expanded access may not need onsite monitoring). is limited to the use of an INDs. Therefore, it is reasonable to require investigational drug in an established The proposed rule makes the sponsor monitoring for individual patient physician-patient relationship. responsible for monitoring of expanded protocols of extended duration and (Response) FDA does not believe the access INDs or protocols. Proposed necessary for appropriate patient name of the category needs to be § 312.305(c)(2) states that an individual protection. changed. In FDA’s experience, or entity that submits an expanded (Comment 67) Two comments individual patient treatment use arises access protocol or IND is a sponsor for questioned why an industry sponsor in the context of an established purposes of part 312 and, therefore, should be required to monitor an physician-patient relationship, so FDA must comply with the responsibilities individual patient IND when the does not think that point needs for sponsors concerning the oversight of licensed physician holds the IND. clarification. Moreover, FDA is clinical investigations in subpart D of (Response) Where the licensed uncertain how the recommended name part 312, including monitoring of physician is the IND holder for an change would clarify that issue. ongoing protocols (§ 312.56). Proposed individual patient expanded access IND, Proposed § 312.310(a)(1) states that a § 312.310(c)(3) provides that FDA may as opposed to the entity that is licensed physician seeking to obtain an require sponsors to monitor an providing the investigational drug for investigational drug for treatment use individual patient expanded access use the expanded access use, the entity for a patient must determine that the if the use is for an extended duration. providing the drug is not a sponsor with probable risk to the person from the (Comment 66) One comment respect to that IND and, therefore, has investigational drug is not greater than maintained that the requirement that no sponsor responsibilities under part the probable risk from the disease or sponsors monitor the conduct of 312. condition. FDA must also determine individual patient expanded access Proposed § 312.315(d)(2) provides that the potential patient benefit protocols is impractical and that the sponsor is responsible for justifies the potential risks of the burdensome and should be eliminated. monitoring the conduct of an treatment use and those potential risks Another comment objected to the intermediate-size patient population are not unreasonable in the context of requirement to monitor individual access protocol to ensure that licensed the disease or condition (proposed expanded access when the use is for an physicians who are providing the drug § 312.305(a)(2)). extended duration. The comment stated to their patients are complying with the (Comment 70) Some comments were that this provision inappropriately protocol and applicable regulations. concerned that the licensed physician interfered with the patient-physician (Comment 68) One comment would typically lack sufficient relationship and implied that the requested that FDA eliminate the information about an investigational individual physician may be incapable requirement for sponsor monitoring of drug to make an informed decision of monitoring the patient for an intermediate-size access programs. The about the risk to the patient from the extended duration. comment urged FDA to replace the investigational drug versus the risk from (Response) FDA does not believe the monitoring requirement with additional the disease or condition. One comment provision that gives FDA the option to information about the criteria for stated that the very nature of require monitoring for an individual selection of investigators, the method experimental drugs limits patients’ and patient access protocol of extended for data collection by investigators, the physicians’ abilities to know and fully duration is overly burdensome or circumstances under which a understand the risks and benefits of a impractical. The provision is intended commercial IRB might be used to particular drug. One comment to provide the option to monitor for provide IRB oversight for investigators maintained that it is also unlikely there relatively long-term use, such as chronic who practice in a setting without an IRB would be any published literature or open-ended use that is likely to (and also in settings that have an IRB), other sources of information available to continue for many months. In FDA’s and the sponsor’s prospective plan for physicians for drugs that are early in experience, the majority of individual demonstrating due diligence in development. To address this problem, patient treatment uses do not go on for obtaining data from investigators. the comment requested that FDA revise an extended duration, so the number of (Response) FDA does not believe that the final rule to include a requirement instances in which FDA is likely to the provisions the comment suggests that FDA provide information to the require monitoring is small. Moreover, adding to the intermediate-size patient medical profession and patient uses that go on for an extended duration population IND submission are advocacy organizations about the are likely to have greater potential risk adequate to replace real-time monitoring availability of investigational drugs for and, therefore, warrant higher scrutiny. intended to determine whether expanded access, including a full Also, the monitoring need not be investigators are complying with the accounting of the scientific evidence resource-intensive. Guidance protocol and their investigator supporting expanded access uses. concerning acceptable monitoring responsibilities. FDA believes such (Response) The requirement that the practice in the International Conference monitoring is important to ensure licensed physician determine that the on Harmonisation guidance document appropriate use of the investigational probable risk to the person from the entitled ‘‘E6 Good Clinical Practice: drug and patient safety. investigational drug is not greater than Consolidated Guideline’’ provides that the probable risk from the disease or the sponsor should determine the extent 6. Issues Specific to Individual Patients, condition originates in Congress’s and nature of monitoring needed based Including Emergency Use mandate in FDAMA to expand access to on considerations such as the objective, (Comment 69) One comment investigational drugs for treatment use purpose, design, complexity, blinding, recommended that FDA change the (section 561(b)(1) of the act) and is size, and endpoints of the trial. These name of this expanded access category intended to provide greater autonomy to factors are either absent from an from ‘‘individual patients, including for individual patients and their physicians extended duration individual patient emergency use’’ to ‘‘individually in decisions about expanded access use. treatment use or favor low-intensity identified patients for treatment use, The underlying premise of the monitoring (e.g., n = 1), so minimal including for emergency use’’ to make it requirement is that physicians know monitoring would likely suffice (e.g., clear that this expanded access category more about the clinical situations of

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their patients than does FDA and, therapy, but additional courses are specifically to the IND. FDA has revised therefore, should have considerable warranted. the language to clarify who should input into the assessment of risks and (Response) FDA does not believe it is receive this summary as follows: ‘‘At the benefits. FDA acknowledges that there necessary to describe in the regulations conclusion of treatment, the licensed is often limited information available to specific requirements and processes for physician or sponsor must provide FDA physicians about the risks and benefits submissions to extend an expanded with a written summary of the results of of an investigational drug and no access treatment for an individual the expanded access use, including practical way to provide the physician patient. FDA anticipates that, in most adverse effects.’’ the information at FDA’s disposal cases, the submission would require a Proposed § 312.310(c)(4) provides that (information is typically proprietary and minimal amount of information to when a significant number of similar generally can only be disclosed to a demonstrate that the criteria for the individual patient expanded access member of the public on consent of the expanded access use continue to be met requests have been submitted, FDA may commercial sponsor). and would focus primarily on the ask the sponsor to submit an IND or That the physician will often have response to treatment to date, including protocol for the use under § 312.315 or limited information does not, however, any adverse events. § 312.320. make access to investigational drugs for (Comment 73) One comment stated (Comment 75) One comment objected individual patients inherently that the proposed rule’s requirement to this provision because it may increase dangerous. In these situations, in that the duration of an individual the amount of time it takes for an addition to the licensed physician’s patient treatment use generally be individual to obtain access and, because determination, FDA must determine limited to a single course of therapy there is a higher evidentiary standard that the potential benefit to the patient unless FDA expressly authorizes for authorizing an intermediate-size justifies the potential risks of the multiple courses or chronic therapy population IND than for an individual treatment use and that those potential usurps the physician’s role, restricts patient IND, may make a drug less risks are not unreasonable in the context access, and therefore should be accessible for treatment use. (Response) FDA does not believe that of the disease or condition to be treated. eliminated. (Response) FDA disagrees. This rule § 312.310(c)(4) will increase the amount FDA has access to considerably more provides for treatment use of an of time it takes for an individual patient information about the investigational investigational drug in a vulnerable to obtain access. The intent of this drug and can evaluate the potential population, often on the basis of very provision is to make access more benefits and risks of the therapy in light little information about effectiveness efficient at the point it becomes of the information provided by the and safety. To fairly weigh the risks and apparent that there will be more than a physician about risks and benefits in benefits of an investigational drug for few isolated requests for expanded relation to the individual patient’s use in this setting, FDA believes there access by individual patients. By condition. FDA believes that its has to be a clear understanding between obtaining a submission for an expanded knowledge of the drug combined with the treating physician and FDA about access IND that can enroll multiple the licensed physician’s knowledge of the planned course of therapy. For patients, FDA believes this provision the patient’s clinical condition will lead example, to fairly evaluate the risks, it will decrease the amount of time needed to expanded access decisions for will usually be necessary to consider the to get an investigational drug to any individual patients that are in the best planned dose and duration of therapy in patient seeking access under the multi- interests of those patients. relation to what is known about the patient IND because it avoids the Proposed § 312.310(a)(2) states that occurrence of toxicity for that dose and submission and review of many FDA must determine that the individual duration of therapy. For the same individual patient INDs. In addition, patient for whom expanded access use reason, it will usually be necessary to even at the point FDA believes it is is sought cannot obtain the drug under consider the extent of prior exposure appropriate to request a submission of a another type of IND or protocol. and the planned duration of subsequent multi-patient access IND under (Comment 71) One comment therapy before authorizing additional § 312.315 or § 312.320, FDA does not recommended that the word ‘‘type’’ be courses of an investigational drug intend to delay responding to individual deleted from the language in beyond the original treatment plan. patient submissions that are received § 312.310(a)(2) that ‘‘FDA must Therefore, FDA does not believe it is during the time it takes a sponsor to determine that the patient cannot obtain reasonable or wise to authorize access of prepare a submission for an the drug under another type of IND or unspecified duration at the discretion of intermediate-size population expanded protocol.’’ the treating physician. FDA also does access IND. (Response) FDA agrees that the intent not believe this provision unreasonably FDA agrees that the evidentiary of § 312.310(a) is accurately conveyed restricts access. FDA believes that requirement is somewhat higher as the when the words ‘‘type of’’ are omitted subsequent courses of therapy will size of the population to be treated and has revised the provision routinely be permitted where under the access IND increases (e.g., accordingly. appropriate. from individual patient to intermediate- Section 312.310(c)(1) of the proposed Proposed § 312.310(c)(2) requires, size population IND). However, FDA rule states: ‘‘Treatment is generally among other things, that ‘‘the licensed does not foresee that this will be an limited to a single course of therapy for physician or sponsor must provide a obstacle to obtaining access. FDA will a specified duration unless FDA written summary of the results of the not request submission of an expanded expressly authorizes multiple courses or expanded access use.’’ access IND that can enroll multiple chronic therapy.’’ (Comment 74) One comment stated patients until there has been some (Comment 72) One comment that the proposed rule should make volume of experience under several recommended that the final rule clear to whom—presumably FDA—the individual patient INDs. Therefore, at describe submission requirements and written summary of the results of the time FDA requests submission of a processes to extend the treatment use in treatment use must be submitted. multi-patient expanded access IND those instances where the initial (Response) FDA agrees. The written under § 312.315 or § 312.320, FDA will authorization was for a single course of summary should be submitted to FDA, have probably already concluded that

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there is enough patient experience (Response) FDA’s intent in without a written submission, that the under individual patient INDs and other articulating criteria for when it is licensed physician or sponsor explain evidence to justify broader exposure appropriate to consider authorizing how the expanded access use will meet under an IND that can enroll multiple access without a written submission is the requirements of §§ 312.305(a) and patients (e.g., to permit treatment of 10 intended to differentiate true emergency 312.310(a) and, further, that the licensed patients under an intermediate-size situations in which treatment must physician or sponsor make a written population IND). occur within a fairly narrow time frame submission that complies with the (Comment 76) One comment pointed from situations in which there is requirements of §§ 312.205(b) and out an apparent discrepancy between sufficient time to make a written 312.310(b) within 5 working days of the the codified language in § 312.310(c)(4) submission. The emergency process is, onset of the use. of the proposed rule and the preamble by its exigent nature, not as deliberative (Comment 79) Two comments discussion of the section. Section and thorough a consideration of the expressed concern about the 312.310(c)(4) states that ‘‘* * * FDA risks and benefits of a proposed requirement to make a written may ask the sponsor to submit an IND treatment use in an individual patient as submission within 5 working days in or protocol for use under § 312.315 or is afforded by a review of a written situations in which a commercial § 312.320.’’ However, the preamble submission. Therefore, the emergency sponsor has agreed to make the drug states that ‘‘* * * FDA will consider procedures may expose patients to available under its own IND (as opposed whether to request that a potential somewhat higher risk than a more to making the licensed physician obtain sponsor submit an intermediate-size deliberative, non-time-sensitive review an IND). These comments stated that in patient population IND or protocol for and, therefore, should be used only in these situations the commercial sponsor the expanded access use and, possibly, true emergencies. FDA is confident, is dependent on the licensed physician conduct a clinical trial of the expanded however, that the rule as proposed will to obtain the information needed to access use.’’ The comment stated that it permit evaluation of all true emergency make a written submission and, in their appears that the preamble goes beyond treatment use requests using the experience, it takes approximately 30 the language of the regulation and asks emergency procedures. days to obtain all the information what is meant by ‘‘conduct a clinical (Comment 78) One comment noted needed to complete the written trial of expanded access use’’ in the that the proposed regulations on submission from the licensed physician. preamble. emergency INDs require that licensed They ask that FDA provide a longer time (Response) FDA does not believe physicians obtaining an IND take on period in which to make a submission. there is an inconsistency between the responsibilities more commonly (Response) FDA acknowledges that in two statements in the preamble and associated with commercial sponsors situations in which a commercial proposed § 312.310(c)(4). If FDA asks such as monitoring, reporting adverse sponsor makes an investigational drug the sponsor to submit an IND or events, and submitting annual reports available for treatment use under its protocol for use under § 312.315 for a (where applicable). The comment was own IND, it is dependent, to a certain drug being developed, that submission concerned that these responsibilities extent, on the patient’s physician to would have to address why the patients may make physicians less willing to obtain the information needed to make to be treated under the intermediate-size obtain investigational drugs for their the submission. Therefore, FDA agrees expanded access IND cannot be enrolled patients. that the time to make a written in a clinical trial and under what (Response) The agency recognizes that submission should be extended. FDA circumstances the sponsor would the licensed physician who must obtain believes that 15 working days should be conduct a clinical trial in these patients. his or her own IND to make a drug sufficient time to obtain whatever Based on the information submitted, available for treatment use to an information is needed to make a written FDA must conclude that enrollment in individual patient, whether or not in an submission. FDA is concerned that a clinical trial is not possible before the emergency situation, is subject to providing a longer period of time, such intermediate-size population expanded regulatory obligations usually as 30 days, may reduce compliance with access protocol can begin. However, applicable to commercial sponsors and the written submission requirement and FDA might reasonably conclude, based with which the physician may not be may negatively impact patient safety. on that information, that a clinical trial familiar. However, the agency believes FDA also believes it is inefficient and in the intended treatment population is that for an individual patient IND, these potentially confusing to have different possible and ask the sponsor to conduct obligations will not be too onerous time frames for making a written a clinical trial of the treatment use, because they closely parallel the type of submission for a commercial sponsor either in lieu of, or in addition to, an monitoring and documentation that are who must obtain information from a intermediate-size population expanded routine in a clinical practice (e.g., patient’s physician to complete a access IND. routine patient care, progress notes, submission and a licensed physician Proposed § 312.310(d) sets out discharge summary) and, therefore, are who must complete his or her own IND emergency procedures for expanded not a substantial added burden. FDA submission. Therefore, 15 working days access for individual patients. If there is also believes these obligations are will be the time for making a written an emergency that requires a patient to essential elements of human subject submission for each of these situations. be treated before a written submission protection. In addition, FDA can Accordingly, the § 312.310(d)(2) has can be made, FDA may authorize the provide assistance to licensed been revised to provide 15 working days use of the drug without a written physicians in complying with their for making a written submission submission. The proposed rule provides expanded access IND regulatory following emergency authorization to that emergency use can be authorized by requirements (e.g., FDA’s Office of treat an individual patient with an telephone. Special Health Issues is a good resource investigational drug. (Comment 77) One comment was for physicians concerning expanded (Comment 80) One comment stated concerned that emergency use might be access (see http://www.fda.gov/oashi/ that there were a number of too narrowly defined and thus home.html)). administrative steps FDA should take to unnecessarily restrict access in a true Proposed § 312.310(d)(2) requires, as a make expanded access for individual emergency. condition for authorizing emergency use patients easier to obtain. The comment

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stated that different divisions at FDA (Response) FDA agrees that a intended to address a situation in which had different requirements concerning potential advantage is to reduce the an investigational drug once available expanded access. The comment burdens of individual physicians trying under a treatment IND would no longer suggested that FDA make its internal to obtain access for individual patients. be available under a treatment IND, but requirements for individual patient Ideally, only a limited number of would then become available under an expanded access consistent among the physicians would make submissions for intermediate-size patient population divisions. The comment also stated that individual patients before patients expanded access IND. FDA believes this FDA should post the name and contact receiving the investigational drug for the would be an unusual circumstance, but information of the person in each expanded access use could be a foreseeable one, and that the rule as division who is responsible for helping consolidated under an intermediate-size proposed could accommodate that physicians submit individual patient population IND. That consolidation circumstance. For example, clinical expanded access requests. would ease the burden considerably for trials of an investigational drug (Response) One of the purposes that subsequent physicians seeking the drug available under a treatment IND might will be served by this final rule is to for treatment use because they would demonstrate lack of effectiveness on a improve consistency in the way not have to make their own IND primary endpoint that is compatible expanded access INDs are handled submissions. with the expanded access use under the within FDA. FDA believes that (Comment 82) One comment treatment IND, but also provide including clear criteria and submission recommended that this expanded access preliminary evidence of effectiveness on requirements in the regulations should category be renamed from secondary endpoints or in subset help improve consistency in the ‘‘Intermediate-size patient populations’’ analyses, and such evidence could individual patient expanded access to ‘‘Limited patient populations for support a different expanded access use process. In addition, FDA intends to treatment use.’’ The comment (e.g., a more narrowly defined educate reviewers and other review maintained this change would clarify population within a disease or a division staff on these new rules. FDA that the intent of this expanded access different indication) under an also plans to assess the implementation category is to provide ‘‘compassionate’’ intermediate-size population expanded of these rules and will determine at a treatment use of the investigational drug access IND. In this circumstance, some later time whether additional guidance and involves only a limited number of of the patients who were receiving the is needed. prospective patients. drug under the treatment IND might be (Response) FDA does not believe it is eligible to receive the drug under the 7. Issues Specific to Intermediate-Size necessary to further clarify the intent of Patient Populations intermediate-size population IND on the this category of expanded access or of basis of lesser evidence than supported Proposed § 312.315 provides for expanded access generally. Section the treatment IND. However, FDA does expanded access use for multiple 312.300(a) plainly describes the intent not see why this would be a problem patients under a single IND or protocol of expanded access. It states that ‘‘[t]his (e.g., expose any patient to unreasonable for patient populations smaller than subpart contains the requirements for risk), provided the evidence is adequate those typical in treatment INDs or the use of investigational new drugs to support the size population to be treatment protocols, and sets forth the when the primary purpose is to treated under the intermediate-size criteria, submission requirements, and diagnose, monitor, or treat a patient’s population IND. safeguards specific to expanded access disease or condition.’’ Moreover, it is b. Number of patients. INDs for intermediate-size patient apparent throughout the various The preamble to the proposed rule populations. The primary purpose of the requirements set forth in this subpart stated that FDA anticipates that the intermediate-size patient population that the intent is treatment rather than typical intermediate-size patient IND or protocol is to consolidate assessment of the safety and population treatment use IND or expanded access under a single IND to effectiveness of an investigational drug protocol will provide access to between promote better monitoring, oversight, in a controlled setting. In addition, FDA 10 and 100 patients. and ease of administration for an believes the term ‘‘intermediate-size (Comments 84) Some comments were expanded access use compared to population’’ better reflects the intent to concerned that FDA’s estimated range multiple individual patient INDs. describe an expanded access category for the number of patients that could be a. General comments. intended to accommodate populations enrolled in an intermediate-size patient (Comments 81) Several comments in between individual patients and the population IND was too narrow. One expressed approval for the creation of large populations that are typical of comment stated that FDA substantially the intermediate-size patient population access to investigational drugs under underestimated the sizes of the potential IND to formally bridge the gap between treatment INDs or treatment protocols. populations that would need access to individual patient access and large (Comment 83) One comment stated an investigational drug under an population access under treatment INDs that the proposed rule does not address intermediate-size patient population, late in development. One comment the situation in which an investigational and that the estimated range (between agreed that this category would promote drug being made available under a 10 and 100 patients) leaves a significant greater efficiency by aggregating various treatment IND would no longer be gap between the intermediate-size types of individual requests. Another available under a treatment IND because population IND and the treatment IND. comment stated that creation of this of new information about the drug, but The comment recommended the category might diminish the burdens of could still be made available under an creation of a fourth category of individual physicians in complying intermediate-size patient population expanded access IND to bridge this gap. with the expanded access submission IND. The comment was concerned that, One comment asked FDA to clarify the requirements for individual patient in that situation, the evidentiary difference in size of population between INDs, presumably because individual threshold for expanded access would the intermediate category and larger physicians would not have to make actually be lower than for the treatment populations under treatment INDs or submissions once the individual patient IND. protocols because FDA did not provide INDs have been consolidated under an (Response) FDA agrees that the any estimate of the lower end of the intermediate-size population IND. proposed rule was not specifically range for a treatment IND. Two

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comments stated that, although the be used to provide access to greater than believes, therefore, that the criteria set proposed rule contemplated that 100 patients. forth in § 312.315 are adequate to ensure § 312.315(a)(3)(i) and (a)(3)(ii) would be Because there is a need for flexibility that the risks associated with use of for an intermediate-size population of to provide access to greater than 100 drugs made available in each of these 10 to 100 patients, the situations patients under an intermediate-size four situations are minimized and the described in these subsections could population IND in some circumstances, potential benefits maximized across a easily involve much larger numbers of FDA has elected not to provide a variety of different treatment use patients. specific estimate of the population range situations and size populations. (Response) The population range (10 for this category in this final rule. FDA (Comment 86) One comment to 100) for the intermediate-size patient continues to believe that the population recommended deleting the option to population IND identified in the range identified in the proposed rule— make an investigational drug available preamble to the proposed rule is simply 10 to 100 patients—would under an intermediate-size population an estimate and is not intended to accommodate most intermediate-size IND when the drug is not being exclude the possibility that more (or population INDs. However, FDA developed. The comment argued that fewer) patients could be treated under believes foremost that the size because the disease is so rare that it is an intermediate-size patient population population that can be treated under an not possible to recruit patients for a IND. For a drug being developed, it is intermediate-size population IND clinical trial, the sponsor would not possible that more than 100 patients should be dictated by the available ordinarily maintain an active IND, nor could be treated under an intermediate- evidence—the amount of exposure that would the sponsor be manufacturing size population IND. However, our the evidence will support—and the investigational drug supplies (so, experience suggests that programs circumstances of a given case, rather presumably, there is no reason for the substantially larger than this are best than by a somewhat arbitrary estimate of category). The comment stated that the administered under a treatment IND. the size of the upper bound of the proposed rule also implies that this FDA expects that there would ordinarily population. situation may be an open-ended be a seamless transition from c. Sub-categories of intermediate-size commitment to expanded access, which intermediate-size population IND to patient population expanded access. is likely to further deter commercial treatment IND at the point when there Proposed § 312.315 provides for sponsors. One comment asked how FDA was adequate evidence to support the access to an intermediate-size would determine that the drug is the treatment IND, adequate progress with population in four situations: only promising therapy for the people • To provide a drug that is not being drug development, a sponsor willing to with a rare condition without clinical developed to patients who may benefit make the drug available to a larger data to support the use. The comment from the drug (typically patients with a stated that this provision of the population under a treatment IND, and rare disease or condition) proposed rule would further erode the sufficient numbers of patients who need (§ 312.315(a)(1)) possibility of conducting a controlled the drug to justify a treatment IND. • To make a drug that is being clinical trial in this situation. For a drug not being developed, there developed available to patients who (Response) This category of expanded is also the possibility that greater than cannot participate in clinical trials of access use is based on FDA’s experience 100 patients will need access to an the drug (§ 312.315(a)(2)) with situations in which there has been investigational drug under an • To provide an approved drug that no alternative but to make a drug not intermediate-size patient population has been withdrawn for safety reasons, being developed available under an IND IND. Although FDA anticipates that a or cannot be marketed due to failure to to a small number of patients who could relatively small number of patients meet the conditions of the approved benefit from it. In FDA’s experience, it would be receiving access at any given application (usually a manufacturing has not been difficult to determine that point in time under such an IND, it is problem) to a limited number of patients a drug is the treatment of choice for a foreseeable that, for some drugs in this who are dependent on the drug discrete group of patients with a category, conditions will never be right (§ 312.315(a)(3)(i)) particular rare disease or condition. For for development, and over a period of • To provide a drug that is related to example, some antivenins and drugs for years the IND will provide access to an approved drug, but is not approved tropical diseases are not commercially more than 100 patients. However, if for marketing in the United States, in marketed in the United States because substantially more than 100 patients situations where there is a shortage of there is simply not a large enough seek or continue to need access under the approved drug or the approved drug market to develop the product for this category within a fairly narrow time is unavailable due to failure to meet the marketing, but these products are frame, FDA believes there would likely conditions of the approved application nonetheless needed on occasion by be an adequate number of potential (§ 312.315(a)(3)(ii)) readily identifiable patients. FDA has subjects to initiate a clinical trial and (Comment 85) One comment objected made other products available to treat formal development of the drug. to the range of situations in this obscure conditions when the population When a drug has been withdrawn for category, stating that the situations are is seemingly too small for even orphan safety reasons or in a drug shortage too diverse to be accommodated in a drug development. For example, situation, it is also foreseeable that there single expanded access category. thalidomide was made available for a will be greater than 100 patients who (Response) FDA disagrees. Because variety of conditions under several of may need access to the drug—for the amount of evidence needed to make these types of INDs before there was patients in whom the benefits of the an investigational drug available under sufficient data to approve it. Currently, withdrawn drug continue to exceed the an intermediate-size population IND is there are INDs for products not being risks associated with the drug or based on the size of population actively developed that are ongoing, and patients who need to rely on a drug not anticipated to be treated under the IND, FDA anticipates that it will encounter approved for marketing in the United the category can accommodate situations in the future in which this States to substitute for an approved drug situations with significant variations in type of IND is needed. Because these in short supply. In those cases, the the size of the treatment population (see types of INDs exist, and because one of intermediate-size population IND could also preceding comment response). FDA FDA’s goals with this rulemaking to

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make the agency’s various mechanisms studied for one cancer available to treat would permit access to patients who for expanded access transparent and patients with another type of cancer have not previously been treated with thereby make investigational drugs more before there is definitive evidence of the drug, even though the drug is unsafe widely available to those who might effectiveness in the other type of cancer. for marketing. However, a manufacturer benefit, the agency believes it is As discussed above, FDA also believes may be reluctant to make an open-ended important to describe this type of it is important to be able to provide commitment to provide a drug that has expanded access in the regulations. access to multiple patients in a been withdrawn for safety reasons to a FDA recognizes that a commercial controlled manner under an subset of patients when there is no sponsor might not be inclined to be a intermediate-size patient population commercial benefit to the manufacturer. sponsor for this type of IND or to make IND at a point in time in which the use This reluctance could also affect a potentially open-ended commitment for which the drug is being made whether new patients would be able to to manufacture products to provide to available would not yet meet the criteria obtain the drug. another sponsor under this type of IND. for a treatment IND. In FDA’s (Comment 89) One comment In FDA’s experience, these types of experience, it has been helpful from an recommended that the final rule clarify INDs are not usually held by administrative, clinical safety, and that some situations in which a commercial sponsors. They are more monitoring perspective to provide for a marketed drug is found to benefit only commonly held by government agencies multi-patient expanded access IND to a subset of the population for which it and academic institutions. So the fact bridge the gap between individual was approved can be addressed through that this type of IND is of little interest patient INDs and treatment INDs. a restricted distribution program of the to a commercial sponsor is no reason to (Comment 88) One comment stated FDA-approved product in accordance remove it from the expanded access that it is not clear why patients should with subpart H of part 314, rather than regulations, particularly when it meets a receive expanded access to a drug that through withdrawal of the drug for demonstrated public health need. is no longer marketed for safety reasons. safety reasons and use of an FDA also recognizes that this type of The comment stated that a clinical trial intermediate-size patient population access could potentially usurp the entire is the appropriate setting to identify IND to make the drug available to the population that could possibly be patients for whom the potential benefits subset population. enrolled in a clinical trial of a drug. of a drug outweigh the risks. One (Response) FDA agrees that, in However, FDA thinks this situation is comment agreed that, when a drug is situations in which a drug is found to not very likely because drugs are rarely withdrawn from marketing because of be beneficial in only a subset of the developed (at least not in the United safety reasons, there may be a subset of population in which it was originally States) for the types of indications for patients for whom the benefits of approved, it may be possible to allow which drugs are made available under treatment would outweigh the risks. The continued marketing of the drug under this category. Nonetheless, where comment also pointed out that by a restricted distribution program appropriate, FDA intends to make every stating in the preamble to the proposed (Lotronex was originally marketed effort to encourage potential sponsors to rule that those patients for whom the without restrictions and is now study such a drug in a clinical trial benefits of treatment are believed to marketed under a restricted distribution rather than provide it under an outweigh the risks ‘‘could continue to program). In these situations, there expanded access IND. receive the drug under an intermediate- would usually be more compelling data (Comment 87) One comment stated size patient population IND,’’ FDA to support the use in the subset that there was no reason to have an implied that only patients who were population than would be needed for an intermediate-size population expanded already receiving the drug when expanded access IND (i.e., a more access IND for a drug being developed. marketing ceased could obtain the drug rigorously defined subset population). The comment stated that there is no under such an IND. The comment asked The appropriate mechanism for making justification for allowing access under FDA to clarify whether this provision is a drug available to the subset of patients such an IND for a disease different from intended to make a drug available only in whom the benefits continue to the one being studied in the clinical to patients who were receiving the drug outweigh the risks would depend on the trials. For the other situations in which when it was withdrawn for safety circumstances of the particular case. a patient is unable to participate in the reasons or if it would also be possible FDA is always willing to explore the full clinical trial (different disease stage, to provide the drug to patients who had range of options with the manufacturer patient otherwise fails to meet not yet received it. of such a drug. enrollment criteria, enrollment is (Response) In FDA’s experience, there d. Drug shortage. closed, or the trial site is not are multiple examples of situations in (Comment 90) One comment stated geographically accessible), the comment which a drug has been withdrawn from that it is not clear that the expanded stated that the treatment IND would be the market for safety reasons and there access rule would be the right the appropriate vehicle for expanded has been a need to make the drug mechanism for access in a drug shortage access. available to a subset of patients in situation because the numbers of (Response) FDA believes there is whom the benefits of treatment patients needing access could be well in adequate justification for allowing outweigh the risks. Although those who excess of the 100 patients that the expanded access under an intermediate- receive the drug will ordinarily be those preamble suggests are the upper bound size patient population IND for a disease who were already receiving the drug at of the intermediate-size population IND different from the one being studied in the time of withdrawal and appear to category. the clinical development program. For have benefited, it was not FDA’s intent (Response) FDA is retracting a an oncology drug, for example, the to absolutely foreclose the possibility statement in the preamble to the characteristic of a cancer that is the that new patients could receive a drug proposed rule suggesting that there is a target of a given chemotherapeutic agent that had been withdrawn from 100-patient upper bound on the (e.g., specific receptor or enzyme) may marketing for safety reasons. It is population for an intermediate-size be present in other types of cancers. In possible that a population in whom expanded access IND. FDA agrees that that situation, it may be appropriate to benefits continue to outweigh risks a drug shortage situation could result in make an investigational drug being could be characterized in a way that a need for access in more than 100

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patients and more patients than could continue to describe the type of regulated (e.g., surgery) and (2) off-label reasonably be accommodated by an expanded access for treatment use that use (i.e., not labeled for use for the intermediate-size expanded access IND. makes investigational drugs available to relevant condition or disease, but In such situations, FDA would be more large populations as the ‘‘treatment supported by compelling literature likely to exercise its enforcement IND’’ or ‘‘treatment protocol.’’ reference) (71 FR 75147 at 75151). To discretion, the effect of which would be (Comment 92) One comment avoid this perceived problem, the to permit marketing of a related product expressed the view that, despite 20 comment suggested that FDA take one that did not meet the FDA approval years of use, these terms are confusing. of three steps: (1) Put the definition of requirements to substitute for the drug The comment recommended that the ‘‘available therapy’’ stated in FDA’s in short supply until supply issues for terminology be changed to ‘‘large-size guidance for industry entitled the FDA-approved product were patient populations’’ to be consistent ‘‘Available Therapy’’ in a formally resolved. FDA included the drug with the names of the other two issued rule, (2) revert back to the shortage provision in the expanded categories of expanded access. requirement that the investigational new access regulations to address a situation (Response) FDA continues to believe drug must only be measured against in which there is a relatively small, that it would be preferable to retain the other FDA-approved marketed products, discrete population affected by a drug terms ‘‘treatment IND’’ and ‘‘treatment or (3) approve the unapproved therapy shortage. Which mechanism would be protocol.’’ Because these terms have for the new indication so that its use appropriate to make a related drug been in use for more than 20 years, FDA becomes ‘‘on-label.’’ available in a drug shortage situation— believes they have become so strongly (Response) The Available Therapy an intermediate-size population IND or associated with making investigational guidance (p. 4) states that ‘‘available enforcement discretion—would depend drugs available to large populations that therapy (and the terms existing on the circumstances of that situation. to replace the terms would generate treatments and existing therapy) should e. Good manufacturing practices needless confusion. FDA recognizes that be interpreted as therapy that is (GMP) issues. the term ‘‘treatment use’’ is now widely specified in the approved labeling of (Comment 91) One comment used to refer generically to use of an regulated products, with only rare suggested that expanded access was not investigational drug for treatment exceptions.’’ This guidance was the appropriate vehicle for providing purposes outside of a clinical trial, and intended to apply to the use of the term access to a drug that is approved but is not just to use under a treatment IND or in § 312.34(b)(1)(ii) of FDA’s current not being manufactured in a manner protocol. However, FDA believes the regulations concerning treatment INDs consistent with the approval. The confusion that would result from and treatment protocols. That regulation comment stated that because the drug is changing the name of the treatment IND includes the criterion that ‘‘[t]here is no not investigational, access should be outweighs any potential confusion comparable or satisfactory alternative handled under a different mechanism. resulting from use of the word drug or other therapy available to treat The comment added that there should ‘‘treatment’’ in the title of the large that stage of the disease in the intended be assurance of close oversight of the population expanded access IND but not patient population.’’ Section manufacturer to minimize harm to in the other expanded access categories. 312.34(b)(1)(ii) is intended to apply patients. Another comment asked how it (Comment 93) One comment noted equally to the use of the term in new would be determined that the risk due that FDA’s current regulation subpart I. FDA believes this guidance to manufacturing problems is concerning the submission requirements has effectively addressed confusion acceptable. The comment pointed out for a treatment protocol (§ 312.35(a)(ii)) associated with use of the term that the IND would have to cross- provides that a submission for a ‘‘available therapy’’ in the varied reference the NDA for CMC information treatment protocol must explain why contexts in which it is used in FDA’s and also describe the good the use of the investigational drug is regulations. Therefore, FDA does not manufacturing practices (GMP) issues. preferable to the use of available believe it is necessary at this time to (Response) As in the case of a drug marketed treatments. The comment promulgate a regulation defining the shortage, GMP issues for a product pointed out that § 312.305(b)(2)(ii) of the term or revise the guidance so that only could create a need for access in a proposed rule provides that submissions approved therapies could be considered population too large to be for all expanded access uses must available therapy. Nor would it be accommodated under an intermediate- explain why the use of the appropriate to simply approve the size expanded access IND. As with a investigational drug is preferable to the unapproved therapy for the new drug shortage, in these situations FDA use of available therapeutic options. The indication for use, apparently without would be more likely to use comment interpreted this provision of regard to the evidence supporting the enforcement discretion to make the drug the proposed rule as permitting use, so that its use becomes ‘‘on-label.’’ available to a very large number of expanded access for a treatment 9. Clinical Holds of Expanded Access patients. FDA agrees that, whether protocol only when the treatment INDs enforcement discretion or an expanded protocol explains why the use of the access IND is used, there must be investigational drug is preferable to any Proposed § 312.42(b)(3) specifies the careful consideration of the safety approved or unapproved therapies, not conditions under which FDA may place implications of the manufacturing just preferable to any available marketed an expanded access IND or protocol on concerns, including possible monitoring treatment. The comment contended that clinical hold. Proposed § 312.42(b)(3)(i) mechanisms to ensure that patients are this provision could be interpreted to allows FDA to place a proposed not being harmed by a product that has require companies to show that the expanded access use on clinical hold if GMP concerns but is nonetheless being product to be used for treatment use is the pertinent criteria in subpart I for made available to patients. better than both approved and authorizing the use are not met (e.g., unapproved therapies because the non-serious disease or condition, 8. Issues Specific to Treatment IND and preamble states that ‘‘available therapy’’ satisfactory or comparable therapies are Treatment Protocol includes not just FDA-approved available, insufficient evidence to The proposed rule specifically products for that indication, but also support the use) or the IND does not solicited comment on FDA’s decision to includes (1) treatments not FDA- comply with the pertinent submission

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requirements in subpart I. Proposed patients already being treated with a investigational drugs will be used as § 312.42(b)(3)(ii) allows FDA to place an drug to continue treatment) where first-line therapy, second-line therapy, ongoing expanded access IND on appropriate. monotherapy, and combined therapy clinical hold if the agency determines with FDA-approved medications. The 10. Comments on Analysis of Impacts that the pertinent criteria in subpart I comment stated that the aggregate are no longer satisfied. (Comment 95) Three comments from additive cost per year to all U.S. private- (Comment 94) One comment pharmaceutical companies and a trade sector payers would be $273,600,000. emphasized the importance of providing association stated that the rule would The comment maintained that these a high degree of clarity about the likely increase sponsors’ administrative, estimates actually understate the burden reasons for imposing a clinical hold on medical, and regulatory burdens to private-sector payers because they an access program to assure that other associated with expanded access. The exclude potential annual costs to studies of the investigational drug are comments specifically mentioned the Medicare Advantage plans. not unintentionally affected. The costs of providing the investigational (Response) Based on our analysis, we comment stated that lack of clarity drug, conducting clinical laboratory concluded that the costs of this final could shut down an entire development tests, and monitoring, collecting, rule should be small. The cost estimate program and suggested that in the final processing, analyzing, and summarizing provided in the comment appears to rule, FDA cite specific reasons for data. include costs for investigational drugs imposing a clinical hold on an access (Response) Based on our analysis, we under provisions of the charging final program. The comment asserted that conclude that the final rule will not rule published elsewhere in this issue of FDA should apply the same level of have a substantial economic impact. the Federal Register. In response to the rigor for imposing holds on access The final rule clarifies and expands on comment, we have included estimates programs as is applied to clinical holds regulations in place since 1986 but does of the number of individual patients of clinical trials. Another comment not substantially change those with access to investigational drugs suggested that FDA propose an regulations; therefore, the overall under current rules and the number of approach for supplying drugs to patients economic impact should be small. additional patients we expect to gain who are clearly benefiting from Treatment use of investigational drugs is expanded access to investigational treatment and are participating in an relatively uncommon and a particular drugs under this final rule. FDA’s expanded access program that is put on sponsor would be expected to submit a estimates indicate that, on average, as clinical hold. treatment use request only infrequently. many as 53,159 patients per year have (Response) FDA does not believe it is Therefore any additional regulatory access to investigational drugs under necessary or desirable to cite in the burden is expected to be small and current rules. In addition, we estimate regulations specific potential reasons for widely dispersed among affected that as many as 3,095 additional a clinical hold of an expanded access entities. Most treatment use requests are patients will gain expanded access to IND. Section 312.42(b)(3) makes clear for individuals or single patients for investigational drugs under this final that failure to meet any of the criteria or which the drug, clinical laboratory rule. These estimates are based on submission requirements pertinent to testing, monitoring, data processing, and assumptions used in our Analysis of authorizing any of the expanded access reporting costs are expected to be small. Impacts for the proposed rule that were IND categories may be a basis for a The proposed rule does not require not substantively challenged in any clinical hold. It also makes clear that if sponsors to make investigational drugs comments received. It appears that the any of the criteria that were the basis for available for treatment use. Such a estimate of 67,500 patients per year in authorizing an expanded access IND are decision is the sponsor’s alone and will the comment draws no distinction no longer satisfied, FDA may place an presumably be based on a number of between patients receiving ongoing expanded access IND on factors, including cost. If the sponsor investigational drugs under current clinical hold. If FDA were to cite can demonstrate that the clinical trial rules and the additional patients who specific potential reasons for a hold, it could not be conducted unless the will have expanded access under this could give the misimpression that sponsor is able to charge for the final rule. In assessing the impact of the failure to meet criteria or submission investigational drug, the sponsor may final rule, it is the incremental effect, or requirements not expressly mentioned request permission to charge patients additional patients that will gain would not be a basis for a hold. and recover the direct costs associated expanded access, that must be FDA anticipates that clinical holds for with the treatment use. considered. Patients with access to expanded access INDs will be handled (Comment 96) A comment from an investigational drugs under current in the same manner as for INDs for insurance company provided an rules are not relevant to an analysis of clinical trials. That is, the clinical hold estimate of the costs to enrollees in impacts for this final rule. The only letter will cite the relevant regulation commercial private health plans direct costs that are relevant to this final and explain in detail how the criteria associated with the expanded access rule are the costs to drug sponsors to that are the basis for the hold are not rule that indicates the costs to be much prepare and submit expanded access met. FDA further anticipates that, in the larger than those stated in the proposed requests. The comment did not provide event that the basis for a clinical hold rule. The comment assumed that an estimate of these costs. is relevant only to an expanded access physicians would request access to (Comment 97) A comment from a IND and not to the clinical development investigational drugs only when capital fund disagreed with the program, the relevant clinical hold available therapies have failed or when proposed rule’s assertion that the rule documentation will make this conventional therapies do not exist. would not have a significant economic abundantly clear. Additional information related to the impact on a substantial number of small In addition, in situations in which an comment and submitted to the docket at entities. The comment stated that FDA ongoing expanded access IND is placed FDA’s request indicated that ‘‘* * * the had overlooked the extensive role of on hold, FDA will carefully consider the grand total number of patients projected small biotech companies in developing needs of patients already receiving the to utilize INDs under these proposals novel kinds of investigational drugs that drug. FDA will not hesitate to use a each year is approximately 67,500.’’ The are often the most sought-after therapies partial clinical hold (which permits comment also stated its belief that for expanded access. The comment also

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stated that small biotech companies overly optimistic because Federal therapy available and the probable risk severely lack funding and also face Register notices are not the best way of to the person from the investigational special difficulties in getting their disseminating information to the lay drug is not greater than the probable risk therapies to the stage where they are public or their physicians and the from the disease or condition; (2) FDA able to obtain significant partnering proposed rule did not mention any must determine that there is sufficient arrangements. The comment stated that additional efforts to disseminate evidence of safety and effectiveness to such companies could be substantially information about expanded access. support the use of the investigational helped by expanded access programs by (Response) Issuance of the final rule drug in the particular case; (3) FDA permitting them to reach larger numbers is not the only way FDA plans to must determine that provision of the of patients sooner and to generate larger disseminate information on expanded investigational drug will not interfere amounts of supporting data sooner. The access programs to the lay public and with the initiation, conduct, or comment stated that the most powerful physicians. FDA intends to develop and completion of clinical investigations to boost for small biotech companies and engage in a broad range of publicity and support marketing approval; and (4) the the patients seeking their new therapies educational efforts in a variety of forums sponsor or clinical investigator of the would come from combining expanded and media to increase awareness of the investigational drug must submit a access programs with policies allowing mechanisms for obtaining clinical protocol consistent with the cost recovery and reimbursement (the investigational drugs for treatment use. provisions of section 505 of the act (21 subject of the charging proposed rule). IV. Legal Authority U.S.C. 355) describing the use of the The comment also advocated minimal investigational drug in a single patient efficacy requirements for expanded The agency believes it has the or a small group of patients. The final access and stated that such a policy authority to impose requirements rule sets forth factors that FDA will would not impose substantial costs on regarding expanded access to consider in making the necessary investigational drugs under various society or the healthcare system because determinations and explains the sections of the act, including sections sponsors would be paying for the costs procedures and criteria for physicians, 505(i), 561, 701(a) (21 U.S.C. 371(a)), of producing and supplying the therapy sponsors, and/or investigators to make and 505–1(f)(6). in most expanded access programs. The the necessary representations and comment added that if such programs Section 505(i) of the act directs the 1 submissions to FDA. enable a product to reach marketing agency to issue regulations exempting Section 561(c) of the act specifically approval sooner than otherwise, that from the operation of the new drug authorizes expanded access under a would greatly reduce the costs that approval requirements drugs intended treatment IND if FDA makes the sponsors must recoup in pricing solely for investigational use by experts following determinations: (1) Under the products for commercial sale. qualified by scientific training and (Response) The comment suggests expertise to investigate the safety and treatment IND, the investigational drug that investigational drugs produced by effectiveness of drugs. The final rule is intended for use in diagnosing, small biotech companies are often the explains procedures for obtaining FDA monitoring, or treating a serious or most sought-after therapies for authorization for expanded access uses immediately life-threatening disease or expanded access, but provides no of investigational drugs and factors condition; (2) there is no comparable or examples. While small biotech relevant to making necessary satisfactory alternative therapy available companies may face a number of determinations. to diagnose, monitor, or treat that stage difficulties—including a lack of funding Section 561 of the act, added by of the disease or condition in the and partnering opportunities—such FDAMA, provides significant additional population of patients to which the obstacles are neither the subject of this authority for this final rule. Section investigational drug is intended to be final rule nor the responsibility of FDA. 561(a) of the act states that FDA may, administered; (3) the investigational The purpose of the proposed expanded under appropriate conditions drug is already under investigation in a access rule is not to help sponsors reach determined by the agency, authorize the controlled clinical trial for the same use larger numbers of patients and generate shipment of investigational drugs for the under an IND under section 505(i) of the larger amounts of supporting data diagnosis, monitoring, or treatment of a act, or all clinical trials necessary for sooner. The agency believes that these serious disease or condition in approval of that use of the goals are best pursued through the emergency situations. This final rule investigational drug have been normal drug development process. FDA sets forth factors that the agency will completed; (4) the sponsor of the believes that cost recovery for expanded consider in determining whether to controlled clinical trials is actively access—the subject of the charging authorize shipment of investigational pursuing marketing approval of the proposed rule—is appropriate only in drugs in emergency situations. investigational drug, with due diligence, limited circumstances. Further, the Section 561(b) of the act allows any for the same intended use; (5) provision agency has determined that the amount person, acting through a physician of the investigational drug will not to be charged should be limited to the licensed in accordance with State law, interfere with the enrollment of patients direct costs of providing the to request from a manufacturer or in ongoing clinical investigations under investigational drug for the treatment distributor an investigational drug for section 505(i) of the act; (6) in the case use. Cost recovery through charging is the diagnosis, monitoring, or treatment of serious diseases, there is sufficient not intended as a mechanism through of a serious disease or condition if four evidence of safety and effectiveness to which sponsors may generate funds to conditions are met: (1) The physician support the intended use; and (7) in the support drug development generally. must determine that the person has no case of immediately life-threatening The agency agrees with the comment comparable or satisfactory alternative diseases, the available scientific that the proposed rule would not evidence, taken as a whole, provides a impose substantial costs on society or 1 In light of section 903(d) of the act (21 U.S.C. reasonable basis to conclude that the the healthcare system. 393(d)) and the Secretary’s delegations to the investigational drug may be effective for Commissioner of Food and Drugs, statutory (Comment 98) One comment stated references to ‘‘the Secretary’’ in the discussion of its intended use and will not expose that the estimates of increased expanded legal authority have been changed to ‘‘FDA’’ or ‘‘the patients to an unreasonable and use in the Analysis of Impacts appeared agency.’’ significant risk of illness and injury. The

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final rule sets forth factors that FDA will that does not individually or result from increased patient access to consider in making the necessary cumulatively have a significant effect on investigational drugs generally and from determinations. the human environment. Therefore, expanded access being made available Section 561 of the act further requires neither an environmental assessment for a broader variety of disease that protocols submitted under section nor an environmental impact statement conditions and treatment settings. 561 be subject to section 505(i) of the act is required. Private benefits will accrue to including regulations issued under individual patients receiving drugs for VI. Analysis of Economic Impacts section 505(i). Section 561(d) of the act expanded access use, whereas social permits the agency to terminate FDA has examined the impacts of the benefits will accrue if information expanded access for failure to comply final rule under Executive Order 12866 obtained contributes to the development with the requirements of section 561 of and the Regulatory Flexibility Act (5 of new therapies generally. Due to the act. The final rule sets forth the U.S.C. 601–612), and the Unfunded uncertainty with respect to the potential conditions under which FDA will place Mandates Reform Act of 1995 (Public magnitude of such benefits, and a lack an expanded access use on clinical Law 104–4). Executive Order 12866 of necessary data, FDA did not generate hold. directs agencies to assess all costs and quantitative estimates of expected This final rule establishes three benefits of available regulatory benefits. categories of expanded access. While alternatives and, when regulation is authority for individual patient access is necessary, to select regulatory A. Objectives of the Final Action based on section 561(b) of the act, and approaches that maximize net benefits FDA is proposing this action to authority for treatment INDs and (including potential economic, describe in greater detail all of the ways treatment protocols is based on section environmental, public health and safety, patients may obtain expanded access to 561(c) of the act, there is also authority and other advantages; distributive investigational drugs for treatment use. in the statute for FDA to issue impacts; and equity). The agency Specifically, the final rule establishes regulations for intermediate-size patient believes that this final rule is not an eligibility criteria, submission populations. Section 561(b)(4) of the act economically significant regulatory requirements, and safeguards for the requires submission of a protocol for the action under the Executive Order. expanded access use of investigational expanded access use that is consistent The Regulatory Flexibility Act drugs by individual patients, including with the requirements of the IND requires agencies to analyze regulatory in emergencies; intermediate-size regulations describing the use of the options that would minimize any patient populations; and larger investigational drug in a single patient significant impact of a rule on small populations under a treatment protocol or a small group of patients. The entities. Our economic analysis for the or treatment IND. The proposal is also provisions of the final rule concerning proposed rule did not indicate any intended to increase public knowledge expanded access for intermediate-size significant new regulatory burden, and and awareness of expanded access and, patient populations address the use of we did not receive any comments that thus, to make investigational drugs more the investigational drug in the small would cause us to reconsider this widely available. In addition, by groups of patients mentioned in the determination. Therefore, the agency establishing clear eligibility criteria and statute. certifies that the final rule will not have submission requirements, the final rule Section 701(a) of the act provides a significant economic impact on a will ease administrative burdens on general authority to issue regulations for substantial number of small entities. physicians seeking investigational drugs the efficient enforcement of the act. By Section 202(a) of the Unfunded for their patients and on sponsors who clarifying the criteria and procedures Mandates Reform Act of 1995 requires are willing to make promising relating to expanded access to that agencies prepare a written unapproved therapies available for investigational products, this final rule statement, which includes an treatment use. is expected to aid in the efficient assessment of anticipated costs and benefits, before proposing ‘‘any rule that B. Nature of the Problem Being enforcement of the act. Addressed Finally, section 505–1(f)(6) of the act, includes any Federal mandate that may added by FDAAA, states that ‘‘[t]he result in an expenditure by State, local, The fundamental problem addressed mechanisms under section 561 to and tribal governments, in the aggregate, by the final rule is one of incomplete provide for expanded access for patients or by the private sector, of $100,000,000 information. In some circumstances, a with serious or life-threatening diseases or more (adjusted annually for inflation) lack of clearly defined eligibility criteria or conditions may be used to provide in any one year.’’ The current threshold and submission requirements has access for patients with a serious or life- after adjustment for inflation is $133 created inefficiencies that limit patient threatening disease or condition, the million, using the most current (2008) access to potentially beneficial treatment of which is not an approved Implicit Price Deflator for the Gross investigational drugs. The final rule is use for the drug, to a drug that is subject Domestic Product. FDA does not expect also intended to address concerns that, to elements to assure safe use under this this final rule to result in any 1-year historically, cancer and Acquired subsection.’’ FDA ‘‘shall promulgate expenditure that will meet or exceed Immunodeficiency Syndrome (AIDS) regulations for how a physician may this amount. patients have had better access to provide the drug under the mechanisms The agency estimates that the total investigational drugs than patients with of section 561.’’ Because the expanded costs to drug sponsors and physicians to other serious diseases or conditions, and access mechanisms in this final rule submit the additional expanded access that patients under the care of may be used by patients seeking access submissions expected under this final physicians based in academic medical to a drug that is subject to elements to rule will be between $1.5 million and centers are more likely to obtain such assure safe use, this rule fulfills the $3.0 million per year. Because a typical access than patients whose physicians FDAAA requirement. sponsor will submit an expanded access practice outside such centers. In use request only infrequently, these addition, the lack of clearly defined V. Environmental Impact costs are expected to be widely eligibility criteria and submission The agency has determined under 21 dispersed among affected entities. The requirements has led some physicians CFR 25.30(h) that this action is of a type benefits of the final rule are expected to and drug sponsors to devote more

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resources than necessary to the under a treatment protocol or treatment record of the number of submissions in preparation of expanded access IND. this category. However, based on an internal survey of drug review divisions, submissions. Through this final rule, the C. Baseline for the Analysis agency seeks to correct these FDA estimates that approximately 55 shortcomings. During the period 1997 through 2005, other expanded access submissions FDA received an average of 2,046.6 were received each year between 2000 The final rule establishes general INDs per year. Of this number, on and 2002. While it is not possible to eligibility criteria, submission average, approximately 659, or 32.2 determine the precise number that will requirements, and safeguards for the percent (0.322 = 659 / 2,046.6) were be considered intermediate-size patient expanded access use of investigational individual patient or emergency INDs. population expanded access drugs. The requirements that apply to In addition, FDA received submissions, FDA experts believe that all types of expanded access use are approximately 4.6 treatment IND or most of the 55 other submissions each discussed in section III.C.3 of this treatment protocol submissions per year year will fall under this category. document. The final rule also describes during this time period. Thus, treatment Thus, approximately 2.7 percent more specific eligibility criteria, IND or treatment protocol submissions (0.0269 = 55 / 2,046.6) of all INDs submission requirements, and represent about 0.2 percent (0.0022 = received by FDA each year may be safeguards for three specific categories 4.6 / 2,046.6) of all INDs received by the associated with intermediate-size of expanded access: (1) Expanded access agency each year. Because expanded patient population expanded access for individual patients, (2) expanded access for intermediate-size patient requests. The information presented access for intermediate-size patient populations is not currently established previously is summarized in table 1 of populations, and (3) expanded access in the regulations, FDA does not have a this document.

TABLE 1.—BASELINE DATA FOR THE NO. OF INDS AND EXPANDED ACCESS REQUESTS BY CATEGORY

Individual Patient or Treatment IND Category Total INDs Emergency IND or Protocol Other

Number 2046.6 659 4.6 55

Percent of all INDs 100 32.2 0.2 2.7

One comment submitted in response under single patient or emergency INDs. patients. Thus, an average of 4.6 to the proposed rule provided an FDA believes that it is reasonable to treatment IND or protocol submissions estimate of the number of patients that assume that a typical expanded access could affect between 460 and 46,000 might be affected by this rule. As part submission for an intermediate-size individuals. Based on this information, of our response, we have generated patient population will affect between FDA estimates that between 1,669 and estimates of the number receiving 10 and 100 individuals. Given that FDA 52,159 individuals currently receive investigational drugs under current currently receives an average of 55 such investigational drugs through expanded expanded access programs, in place submissions per year, we estimate that access programs. The wide range of since 1986. between 550 and 5,500 individuals these estimates reflects significant Based on the information presented currently receive investigational drugs variation in the number of patients in previously, FDA currently receives an under intermediate-size patient intermediate-size patient populations, average of 659 individual patient or population or other expanded access and treatment INDs or protocols. These emergency INDs per year. Thus, programs. A treatment IND or protocol approximately 659 individuals per year can vary significantly in size and may estimates are summarized in table 2 of currently receive investigational drugs include between 100 and 10,000 this document.

TABLE 2.—APPROXIMATE NO. OF INDIVIDUALS AFFECTED BY EXPANDED ACCESS PROGRAMS IN PLACE SINCE 1986

Average No. No. of Minimum No. Maximum No. Category of Submissions Patients of Individuals of Individuals

Individual Patient or Emergency IND 659 1 659 659

Small Patient Population/Other 55 10 to 100 550 5,500

Treatment IND or Protocol 4.6 100 to 10,000 460 46,000

Total 1,669 52,159

D. Nature of the Impact available to patients, and FDA in its serious and immediately life-threatening The final rule will affect patients who oversight role in the process for making conditions who lack satisfactory lack effective therapeutic alternatives investigational drugs available for therapeutic alternatives. Therefore, FDA and may benefit from access to expanded access use. As discussed in anticipates that the final rule will investigational drugs, physicians the preamble of the proposed rule (71 increase the number of patients who attempting to obtain investigational FR 75147 at 75149 to 75150), a major obtain access to investigational drugs for drugs for their patients, drug sponsors purpose of this rule is to expand access treatment use. This increase in volume who make investigational drugs to investigational drugs for patients with will lead to more expanded access

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submissions from sponsors and patients obtaining investigational drugs From 1997 to 2005, FDA received, on physicians seeking investigational drugs under expanded access INDs or average, approximately 659 individual for their patients and, as a consequence, protocols for individual patients and patient and emergency IND submissions will require FDA to review more intermediate-size patient populations. per year. Although FDA is confident submissions. Given the relatively small Because this final rule does not this final rule will increase this volume, burden associated with expanded access significantly change the existing it is difficult to predict with precision use submissions under the previous regulations concerning treatment INDs the extent of the increase. There is regulations (although such submissions or treatment protocols, the number of uncertainty concerning the extent to are approximately one-third of all IND patients receiving investigational drugs which patients who desire expanded under these mechanisms should be submissions, the vast majority of those access to investigational drugs are largely unaffected. are for individual patients and do not unable to obtain them; the extent to typically require substantial agency 1. Individual Patient Expanded Access which better information about the resources to review), and the small Submissions mechanisms and processes for obtaining additional burden associated with the access to investigational drugs will expanded access provisions in this final By increasing awareness of the ways rule, FDA expects that the economic individual patients can obtain expanded stimulate more patients, or their impact of the final rule will be small. access to investigational drugs for physicians, to seek investigational drugs treatment use, and decreasing the for expanded access use; and the extent The final rule also attempts to perceived difficulty of obtaining such to which drug manufacturers will be minimize the potential administrative access, the final rule should increase the willing to make investigational drugs burdens for physicians, sponsors, and number of individual patients seeking more broadly available for expanded FDA that will result from an increased access to investigational drugs. FDA volume of patients obtaining access use. Although FDA is confident anticipates that this increase in there will be an increase in the volume investigational drugs for expanded individual patient expanded access access use. The final rule encourages the of individual patient expanded access submissions will be greatest in the years use following issuance of this final rule, consolidation of multiple individual immediately following implementation patient INDs or protocols for a given use because of these uncertainties the of the final rule and will at some point agency can provide only an estimate of under an intermediate-size patient level off or possibly even decline. This population IND or protocol. By reducing the range of potential increase. FDA leveling off or decline will occur when believes that, after publication of the the total volume of submissions that a significant volume of individual final rule, it is reasonable to anticipate will have been prepared if all patients patient expanded access has a 40 to 60 percent increase in the were to obtain a drug under individual accumulated for a variety of drugs, and patient INDs or protocols, consolidation the individual patient expanded access volume of individual patient expanded will limit the additional administrative INDs or protocols for those drugs are access submissions by year 3. As burdens from increased patient access. then replaced with intermediate-size discussed previously in this document, In addition, by explicitly clarifying the patient population INDs or protocols we anticipate that growth will be most eligibility criteria and submission that enroll multiple subjects. Making the rapid in the years immediately requirements for expanded access, the transition from multiple individual following publication of the final rule final rule should make the process of patient INDs or protocols to a single and will eventually plateau or possibly obtaining access to investigational drugs intermediate-size patient population even decline. The implications of these more efficient for all affected parties. IND or protocol should reduce the assumptions for the total number of It is expected that any increase in the overall administrative burden associated individual patient expanded access volume of submissions will result with making a particular investigational submissions are summarized in table 3 primarily from greater numbers of drug available for treatment use. of this document.

TABLE 3.—EXPECTED PERCENT INCREASE AND ESTIMATED NO. OF INDIVIDUAL PATIENT EXPANDED ACCESS SUBMISSIONS

Year After Implementation of Final Rule Expected Percent Increase in Individual Pa- Expected No. of Individual Patient Submis- tient Submissions sions1

1 20 to 40 791 to 923

2 30 to 50 857 to 988

3 40 to 60 923 to 1054

4 0 923 to 1054

5 0 923 to 1054 1 Based on the current average of 659 individual patient treatment use submissions per year and the estimated percent increases in column 2.

2. Intermediate-Size Patient Population treatment use. Based on an internal agency anticipates that this final rule Expanded Access Submissions survey of review divisions, FDA will increase the number of such Although intermediate-size patient estimates that for the period 2000 submissions. Because this previously population expanded access has not through 2002 it received approximately informal mechanism will be described previously been described in the 55 submissions per year that would be in the regulations for the first time, there regulations, this general type of considered intermediate- size patient will be greater awareness, which is mechanism has been used informally to population expanded access likely to stimulate submissions. In make investigational drugs available for submissions under the final rule. The addition, the anticipated increase in

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volume of individual patient expanded individual patient expanded access estimate of the range of potential access submissions discussed submissions are likely to be appropriate increase. FDA believes it is reasonable previously in this document is expected for consolidation. to anticipate a 25 to 50 percent growth to increase the number of intermediate- Based on our experience, we believe in the volume of submissions for size patient population expanded access that many of the individual patient intermediate-size population expanded submissions because the final rule expanded access submissions we access INDs or protocols over a 5-year encourages the consolidation of receive will be appropriate for period. multiple individual patient INDs or consolidation. However, some Compared with the growth in protocols for a given expanded access individual patient expanded access individual patient expanded access use. submissions will be for expanded access submissions, this increase is likely to be The extent to which submissions for uses that are sufficiently rare that it is more gradual in the years immediately expanded access for intermediate-size unlikely that there will be enough following implementation of a final patient populations will increase is similar uses to consolidate them under rule, and will increase more sharply uncertain. Section 312.315 of the final an intermediate-size patient population after 2 to 3 years as some of the increase rule concerns expanded access for IND or protocol. There is also in volume of individual patient intermediate-size patient populations. uncertainty about the extent to which expanded access submissions is shifted This section provides that FDA may ask sponsors will be willing to make to intermediate-size population INDs or a sponsor to consolidate expanded investigational drugs available for protocols. As in the case of expanded access under this section when the expanded access use under access for individual patients, growth in agency has received a significant intermediate-size patient population the number of submissions is expected number of requests for individual INDs or protocols. Although FDA is to plateau or even decline after a few patient expanded access to an confident that there will be growth in years. The implications of these investigational drug for the same use. the volume of intermediate-size patient assumptions for the number of FDA does not have historical population expanded access INDs or individual patient expanded access information that will permit us to protocols, because of the uncertainties submissions are summarized in table 4 accurately predict what portion of identified, we can provide only an of this document.

TABLE 4.—EXPECTED PERCENT INCREASE AND ESTIMATED NO. OF INTERMEDIATE-SIZE PATIENT POPULATION EXPANDED ACCESS SUBMISSIONS

Year After Implementation of Final Rule Expected Percent Increase in Intermediate- Expected No. of Intermediate-Size Patient Size Patient Population Submissions Population Submissions1

1 5 to 10 58 to 61

2 10 to 20 61 to 66

3 20 to 40 66 to 77

4 25 to 50 69 to 82

5 0 69 to 82 1 Based on the current average of 55 intermediate-size patient population submissions per year and the estimated percent increases in column 2.

3. Expanded Access under Treatment or treatment protocols or under less Reclassification of an open-label INDs and Treatment Protocols formal open-label (also referred to as protocol as a treatment IND or treatment open-access) protocols. The agency protocol may also increase publicity for, The number of treatment INDs and intends to be more vigilant in ensuring and awareness of, the access program. treatment protocols should be largely that a use of an investigational drug that Sponsors of treatment INDs or treatment unaffected by the final rule. The concept has the characteristics of a treatment protocols may, in certain circumstances, of large access programs is well be required to list those programs at established and most drugs that meet an IND or treatment protocol is submitted and authorized as such, rather than as http://www.clinicaltrials.gov, a Web site unmet medical need for a serious or maintained by the NIH as a resource for immediately life-threatening condition an open-label protocol. While this increased vigilance may increase the patients seeking to enroll in clinical have had some kind of large access trials or obtain access to investigational number of treatment INDs or treatment program late in their development. drugs for treatment use. The additional protocols, any increase will be primarily Therefore, the number of large access exposure generated by this site may programs is primarily a function of the attributable to reclassifying open-label attract more patients than will have had number of new drugs to treat serious safety studies as treatment INDs or access under an open-label protocol. As and immediately life-threatening treatment protocols rather than a net a result, any given treatment IND or conditions that reach the latter stages of increase in the overall number of large treatment protocol may be somewhat drug development (e.g., become NDA access programs. This reclassification more costly than a less-publicized open- submissions). This rule is unlikely to should also improve safety monitoring label protocol due to the volume of influence that number. of large access programs without patients enrolled. FDA is not able to As stated in the preamble of the significantly increasing administrative predict the impact on patient volume as proposed rule (71 FR 75147 at 75155), costs, because the costs for a treatment a result of reclassifying open-label or sponsors have instituted large expanded IND or treatment protocol and an open- open-access protocols as treatment INDs access programs under treatment INDs label protocol are similar. or treatment protocols. However, FDA

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anticipates that there will be some protocols. FDA believes that this action, effectiveness, obtaining the informed economies of scale, so that the along with detailed eligibility criteria consent of the patient, approval of an incremental costs will be relatively and submission requirements IRB, and a careful assessment of the small on a per-patient basis. FDA established in the final rule, will potential risks and benefits to the believes any added costs will be improve access to investigational drugs patient. In addition, the final rule will justified by the potentially greater and result in making expanded access place limits on the scope and duration number of patients who will benefit use more widely available to patients of certain types of expanded access use, from access to investigational drugs. regardless of treatment setting. require that sponsors of such INDs or In formulating the final rule, FDA protocols monitor the expanded access E. Benefits of the Final Rule considered its statutory mandate and use and comply with safety and annual Because FDA currently has no data the interests of individuals and special reporting requirements for INDs, and that will allow us to predict the extent patient populations, drug sponsors, and subject ongoing INDs or protocols to to which the amendments to existing the general public. The agency found periodic reassessment. The agency IND regulations will generate direct that in many situations, individuals or believes these safeguards will benefits for consumers, it is not possible special patient populations have adequately protect the safety and to accurately quantify the magnitude of benefited from increased access to a welfare of patients who will seek, and any expected incremental benefits at drug that has not yet been approved for may benefit from, expanded access to this time. The number of patients marketing (e.g., in the case of cancer or investigational drugs. obtaining expanded access to HIV therapies). These individuals or investigational drugs is expected to patient groups generally have serious or F. Costs of the Final Rule increase. However, because eligible immediately life-threatening conditions To the extent that the final rule results patients will have serious or and have not responded to available in an increase in the number of immediately life-threatening conditions therapies or cannot participate in expanded access submissions, drug that have failed to respond to available ongoing clinical trials for some reason. sponsors and physicians requesting therapies, and because the On the other hand, unrestricted access investigational drugs on behalf of their investigational drugs are unproven, FDA to investigational drugs for treatment patients will incur some additional cannot predict the extent to which use could reduce the patient population costs. Because the final rule does not individual patients will benefit from available for enrollment in the clinical include any new, mandatory reporting access to these drugs. Thus, the trials required to demonstrate safety and requirements, the agency believes that following discussion describes, in efficacy in support of new drug the one-time costs associated with this general terms, the nature of the potential marketing applications. If expanded rule will be negligible. Thus, the benefits associated with the final rule. access to investigational drugs were to incremental burden imposed by this The benefits of the final rule are adversely affect the marketing approval final rule will be in the form of expected to result from improved process, the general population will additional annual or recurring costs patient access to investigational drugs experience diminished social benefits associated with the increased number of generally and from expanded access due to the reduced or delayed expanded access submissions estimated being made available for a broader availability of new therapies approved previously in this document. variety of disease conditions and for marketing by FDA. The agency estimates that preparation treatment settings. In particular, the The final rule addresses these and submission of an individual patient clarification of eligibility criteria and competing interests by allowing expanded access submission will submission requirements will enhance investigational drugs to be made require a total of approximately 8 hours. patient access by easing the available for expanded access use only This time burden will be divided among administrative burdens on individual if providing the drug for the requested physicians (approximately 15 percent or physicians seeking investigational drugs use will not interfere with the initiation, 1.2 hours) and nurses, nurse for their patients and on sponsors who conduct, or completion of clinical practitioners, or medical administrators make investigational drugs available for investigations that could support (approximately 85 percent or 6.8 hours). expanded access use. Expanded access marketing approval, or otherwise According to the U.S. Department of to investigational drugs may generate compromise the potential development Labor, Bureau of Labor Statistics,2 total both private and social benefits. Private of the expanded access use. In this way, employer costs per hour worked for benefits will accrue to individual the final rule effectively balances the employee compensation for registered patients receiving drugs for expanded interests of those patient populations nurses in the health care and social access use, whereas social benefits will who will benefit from having greater assistance sector was $44.21 as of March accrue if these private benefits are also access to investigational drugs with the 2008. Thus, the cost of the estimated 6.8 valued by society at large, or if any broader interests of society in having hours of nurse time required to prepare information obtained contributes to the safe and effective new therapies and submit an individual patient development of new therapies generally. approved for marketing and widely expanded access submission will be The final rule is also designed to available. approximately $301 ($300.62 = $44.21 address concerns that many physicians The agency is also aware that per hour x 6.8 hours). and their patients, particularly those allowing expanded access to Historically, most of the treatment use outside of academic medical centers, are investigational drugs before they are requests submitted to the agency have unaware of the availability of fully evaluated for safety may have been prepared by physicians in the investigational drugs for expanded adverse consequences for the seriously hematology/oncology specialty category. access use. In FDAMA, Congress ill patients who receive them. The Data available on the Internet indicate included language in section 561(c) of safeguards in the final rule are also the act to authorize the Secretary to designed with this concern in mind. 2 See http://www.bls.gov/news.release/ inform medical associations, medical Authorization of a particular expanded ecec.toc.htm, last viewed July 11, 2008. (FDA has verified the Web site address, but FDA is not societies, and other appropriate persons access use is generally contingent upon responsible for any subsequent changes to the Web of the availability of investigational a number of factors, including some site after this document publishes in the Federal drugs under treatment INDs or treatment evidence of the drug’s safety and Register.)

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that the median expected total physician time required to prepare and $301 + $224). Applying this cost figure compensation for a physician in the submit an individual patient expanded to the number of additional individual hematology/oncology specialty category access submission is about $224 patient expanded access submissions was $387,739 as of March 2008.3 This ($223.69 = $186.41 per hour x 1.2 estimated previously in this document median total compensation figure hours). Therefore, the agency estimates suggests the pattern of incremental corresponds to approximately $186 per that the total cost to prepare and submit annual costs summarized in table 5 of hour ($186.41 = $387,739 / 2,080 hours). an individual patient expanded access this document. Thus the cost for the 1.2 hours of submission will be about $525 ($525 =

TABLE 5.—NO. OF ADDITIONAL INDIVIDUAL PATIENT EXPANDED ACCESS SUBMISSIONS AND ESTIMATED ANNUAL COSTS

Expected Cost of Additional Individual Pa- Year After Implementation of Final Rule Expected Increase in the No. of Individual Patient Submissions1 tient Submissions2

1 132–264 $69,300 to $138,600

2 198–329 $103,950 to $172,725

3 264–395 $138,600 to $207,375

4 264–395 $138,600 to $207,375

5 264–395 $138,600 to $207,375 1 Based on increases in the number of individual patient expanded access submissions implied by the estimates presented in table 2 of this document. 2 Based on an estimated cost of $525 per individual patient expanded access submission.

Preparation and submission of an intermediate-size patient population hourly total compensation figure of intermediate-size patient population expanded access submission is about $42 ($41.77 = $86,890 / 2,080 expanded access IND or protocol is approximately $9,120 ($9,120 = 60 hours). Thus, the cost associated with expected to require a total of about 120 hours x $152). the 36 hours of Clinical Research hours of staff time. This time burden Information available on the Internet Associate time required to prepare and will be divided between a Medical also indicates that the median total submit an intermediate-size patient Director or Director of Clinical Research, compensation for a Regulatory Affairs population expanded access submission typically a medical doctor Director is approximately $235,149 per is approximately $1,512 ($1,512 = 36 5 (approximately 50 percent or 60 hours), year. This translates into an estimated hours x $42). a Regulatory Affairs Director hourly total compensation figure of (approximately 20 percent or 24 hours), about $113 ($113.05 = $235,149 / 2,080 Based on the information presented, and a Clinical Research Associate hours). Thus, the cost associated with the agency estimates that the total cost (approximately 30 percent or 36 hours). the 24 hours of Regulatory Affairs to prepare and submit an intermediate- Information available on the Internet Director time required to prepare and size patient population expanded access suggests that the median total submit an intermediate-size patient submission will be approximately compensation for a physician serving as population expanded access submission $13,350 ($13,344 = $9,120 + $2,712 + a Medical Director is about $316,134 per is approximately $2,712 ($2,712 = 24 $1,512). Applying this figure to the year.4 This translates into an estimated hours x $113). increases in the number of intermediate- hourly total compensation figure of Finally, information available on the size patient population expanded access about $152 ($151.98 = $316,134 / 2,080 Internet indicates that the median total submissions estimated previously in hours). Thus, the cost associated with compensation for a Clinical Research this document suggests the pattern of the 60 hours of Medical Director time Associate is approximately $86,890 per annual cost increases summarized in required to prepare and submit an year.6 This translates into an estimated table 6 of this document.

TABLE 6.—NO. OF ADDITIONAL INTERMEDIATE-SIZE PATIENT POPULATION EXPANDED ACCESS SUBMISSIONS AND ESTIMATED ANNUAL COSTS

Expected Increase in the No. of Inter- Year After Implementation After Final Rule mediate-Size Patient Population Submis- Expected Cost of Additional Intermediate- Size Patient Population Submissions2 sions1

1 3 to 6 $40,050 to $80,100

2 5 to 11 $66,750 to $146,850

3 11 to 22 $146,850 to $293,700

3 See http://swz.salary.com/salarywizard/ changes to the Web site after this document but FDA is not responsible for any subsequent layoutscripts/swzl_newsearch.asp, last viewed July publishes in the Federal Register). changes to the Web site after this document 11, 2008. (FDA has verified the Web site address, 4 See http://swz.salary.com/salarywizard/ publishes in the Federal Register.) but FDA is not responsible for any subsequent layoutscripts/swzl_newsearch.asp, last viewed July 5 See footnote 4 of this document. 11, 2008. (FDA has verified the Web site address, 6 See footnote 4 of this document.

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TABLE 6.—NO. OF ADDITIONAL INTERMEDIATE-SIZE PATIENT POPULATION EXPANDED ACCESS SUBMISSIONS AND ESTIMATED ANNUAL COSTS—Continued

Expected Increase in the No. of Inter- Year After Implementation After Final Rule mediate-Size Patient Population Submis- Expected Cost of Additional Intermediate- Size Patient Population Submissions2 sions1

4 14 to 27 $186,900 to $360,450

5 14 to 27 $186,900 to $360,450 1 Based on increases in the number of intermediate-size patient population expanded access submissions implied by the estimates presented in table 3 of this document 2 Based on an estimated cost of $11,000 per intermediate-size patient population expanded access submission.

For reasons discussed previously in Therefore, FDA does not expect the cost burdens associated with this final this document, the agency does not provisions of this final rule regarding rule are summarized in table 7 of this expect that the final rule will have an treatment INDs or treatment protocols to document. impact on the overall number of impose any incremental cost burden. treatment INDs or treatment protocols. The total estimated variable and annual

TABLE 7.—COST SUMMARY

One-Time Fixed 1 Year After Implementation of Final Rule Cost Variable Cost Annual Cost

1 $0 $109,350 to $218,700 $109,350 to $218,700

2 $0 $170,700 to $319,575 $170,700 to $319,575

3 $0 $285,450 to $501,075 $285,450 to $501,075

4 $0 $325,500 to $567,825 $325,500 to $567,825

5 $0 $325,500 to $567,825 $325,500 to $567,825 1 Since estimated one-time fixed costs are negligible, annual costs equal variable costs.

For reasons discussed previously in consolidation should, to some extent, also the drug developer or the developer this document, the agency expects that offset incremental administrative will generally be willing to grant the the total one-time costs of the final rule burdens caused by increased patient request. To the extent that these will be negligible. FDA expects that the access. Making the transition from provisions minimize the informational annual costs of this final rule will range multiple individual patient expanded burden on potential sponsors or from a low of about $109,000 to access INDs or protocols to a single IND physicians, the final rule will enhance $219,000 in the first year following or protocol for an intermediate-size both efficiency and cost effectiveness. publication of the final rule, to a high patient population should reduce for One comment submitted in response of about $325,000 to $568,000 in the sponsors the administrative burdens to the proposed rule provided an fourth and fifth years. These estimates associated with making a drug available estimate of the number of patients that suggest total annual costs for the final for expanded access use. In addition, might be affected by this final rule. As rule of between $1.2 and $2.2 million provisions of the final rule are designed part of our response, we have generated for the 5-year period following to minimize the amount of information estimates of the number additional implementation of the final rule. and paperwork required to support a individuals that will gain access to The agency expects that the estimated particular expanded access request. investigational drugs as a result of the incremental cost burdens associated Physicians and drug sponsors will need final rule. with this final rule are likely to be to review the rule to become familiar Information presented in table 5 of widely dispersed among affected with its provisions and to gather the this document indicates that FDA entities for several reasons. First, given evidence and information necessary to expects this final rule to generate the historical volume of various types of support an expanded access submission. between 132 and 395 additional treatment use submissions, the agency However, in instances where a current individual patient or emergency INDs believes that a particular drug sponsor— IND already exists, a sponsor need only per year. Thus, we estimate that or a physician acting on behalf of a submit an amendment describing the between 132 and 395 additional patient—will submit a request for information relevant to the expanded individuals per year will have expanded expanded access to investigational access protocol. Also, another sponsor access to investigational drugs under drugs fairly infrequently. Second, as or individual physician acting on behalf single patient or emergency INDs as a noted previously, the final rule of a patient may, with the written result of this final rule. Information encourages the consolidation of permission of the original sponsor, presented in table 6 of this document multiple expanded access INDs or reference information in the current IND indicates that FDA expects this final protocols for individual patients for a already on file. The agency believes that rule to generate between 3 and 27 particular expanded access use under an a majority of expanded access additional expanded access submissions intermediate-size patient population submissions will have such a right of for intermediate-size patient expanded access IND or protocol. Such reference, either because the sponsor is populations. As discussed previously,

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we believe that an intermediate-size populations. Finally, because FDA receive investigational drugs through patient population or other expanded expects this final rule to have no impact expanded access programs as a result of access program will generally include on the number of treatment INDs or this final rule. The range of these between 10 and 100 individuals. protocols, the number of patients with estimates reflects significant variation in Therefore, we estimate that between 30 access to investigational drugs will be the number of patients in intermediate- (30 = 3 x 10) and 2,700 (2,700 = 27 x unaffected. Based on this information, size patient populations. These 100) additional individuals per year will FDA estimates that between 162 (162 = estimates are summarized in table 8 of have expanded access to investigational 132 + 30) and 3,095 (3,095 = 395 + this document. drugs under intermediate-size patient 2,700) additional individuals will

TABLE 8.—APPROXIMATE NO. OF ADDITIONAL INDIVIDUALS AFFECTED BY EXPANDED ACCESS PROGRAMS UNDER THE FINAL RULE

Expected No. of No. of Minimum No. of Maximum No. of Category Additional Submissions Patients Additional Individuals Additional Individuals

Individual Patient or Emergency IND 132 to 395 1 132 395

Small Patient Population/Other 3 to 27 10 to 100 30 2,700

Treatment IND or Protocol 0 100 to 10,000 0 0

Total 162 3,095

G. Minimizing the Impact on Small unidentified sponsors for research the probable risk from the disease or Entities purposes. Because nearly all individual condition; and FDA determines that The agency does not believe the final patient treatment use submissions are there is sufficient evidence of safety and rule will have a significant economic made by various types of entities for effectiveness to support the use of the impact on a substantial number of small research purposes, the agency believes investigational drug. FDAMA also entities. Nevertheless, in the proposed that most of these entities will be largely incorporated into the act FDA’s rule, we recognized our uncertainty classified as small entities. current regulation concerning treatment Because there is currently no formal regarding the number and size INDs or treatment protocols under mechanism in place for tracking the distribution of affected entities, as well which large populations currently other types of expanded access (e.g., as the economic impact of the final rule receive investigational drugs for intermediate-size patient population on those entities, and requested detailed treatment use. Because FDAMA did not submissions), no data exist that will comment on these important issues. We require that FDA adopt implementing allow the agency to identify the number received no comments that would cause of sponsors in this category that will regulations, the agency could have us to change our determination that the qualify as small entities. chosen not to do so. final rule will not have a significant Thus, while highly uncertain, the However, the agency believes that economic impact on a substantial agency believes that at least some of the implementing regulations will further number of small entities. entities submitting expanded access improve expanded access to Agency records indicate that the requests will qualify as small entities. investigational drugs for treatment use. majority of submissions for treatment As discussed in section VI.F of this use of investigational drugs (about 78 One of the major criticisms about access document, the agency expects that any to investigational drugs is that the percent) are submitted by commercial incremental burden associated with the drug sponsors. Other entities making criteria for authorizing access are final rule will be small and widely unclear and that there is not broad treatment use submissions include dispersed among affected entities. government agencies (approximately 14 knowledge among affected, or percent), individual physicians (7 H. Alternatives potentially affected, parties about the percent), and academic institutions (1 FDA considered several alternatives mechanisms or procedures to obtain percent). Thus, the agency believes that to the final rule. They are discussed in access. FDA believes the final the vast majority (92 percent) of the following paragraphs. regulations are needed to address these sponsors of expanded access INDs or concerns. The regulations provide to protocols (consisting of commercial 1. Do Not Propose Implementing sponsors, patients, and licensed drug sponsors or government agencies) Regulations for the Expanded Access physicians who will be seeking will not be considered small entities. Provisions of FDAMA investigational drugs for their patients The remaining 8 percent of treatment FDAMA revised the act to specifically clear direction about the criteria for use submissions are made by individual authorize the use of investigational new authorizing expanded access and what physicians and academic institutions drugs by licensed physicians to information must be submitted to the that the agency believes will meet Small diagnose, monitor, or treat individual agency to enable it to evaluate a Business Administration small business patients who have a serious disease or proposed expanded access submission. criteria. condition if, among other things, the Clearer direction and greater knowledge Of the average of 659 individual physician determines that the person of the mechanisms and procedures for patient treatment use submissions has no comparable or satisfactory obtaining investigational drugs for submitted annually, very few are alternative therapy to diagnose, monitor, expanded access use should reduce associated with commercial sponsors. or treat the disease or condition, and barriers to access. The vast majority are submitted by that the probable risk from the individual physicians and various other investigational drug is not greater than

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2. Propose a Regulation Describing Only more transparent about the processes for A. The Final Rule Individual Patient Expanded Access and making drugs available for expanded 1. Submission Requirements for All the Treatment IND or Treatment access. As stated previously, FDA has Expanded Access Uses Protocol used this intermediate category Section 312.305(b) describes the As discussed in the previous informally in the past and believes it submission requirements applicable to paragraphs, FDAMA specifically will have reason to use this category in all types of expanded access. authorized the use of investigational the future. Therefore, FDA believes it is appropriate to formalize and fully Section 312.305(b)(1) states that an new drugs by licensed physicians to expanded access submission is required diagnose, monitor, or treat individual describe in the regulations the intermediate expanded access category, for each type of expanded access. The patients in certain circumstances. submission may be a new IND or a FDAMA also essentially repeated FDA’s as well as the two other categories of expanded access. protocol amendment to an existing IND. current regulation concerning treatment Information required for a submission INDs or treatment protocols under 3. Propose a Regulation Describing More may be supplied by referring to which large populations currently Than Three Expanded Access Categories pertinent information contained in an receive investigational drugs for FDA also considered proposing a rule existing IND if the sponsor of the treatment use. existing IND grants a right of reference FDA could have chosen to adopt that will include more than three expanded access categories, but rejected to the IND. regulations that described only these Section 312.305(b)(2) describes the two categories of expanded access. this alternative. In internal discussions, FDA found that the distinctions expanded access submission However, FDA has had a long history of requirements. The following items must using an informal mechanism to make between the proposed categories and the additional categories it considered were be included: investigational drugs available to • A cover sheet (Form FDA 1571) intermediate-size patient populations. unclear. FDA was concerned that the additional categories would create meeting the requirements of § 312.23(a); This mechanism has been used in • The rationale for the intended use situations in which both: (1) The confusion rather than provide the clarity that is the goal of the final regulations. of the drug, including a list of available expanded access use did not meet the therapeutic options that will ordinarily criteria for a treatment IND under the FDA concluded that the additional categories could be merged into the be tried before resorting to the previous regulation and (2) it would investigational drug or an explanation of have been excessively burdensome for three proposed categories and that these categories will be able to provide access why the use of the investigational drug sponsors and FDA to require large is preferable to the use of available numbers of individual patient INDs for to investigational drugs in all situations FDA is likely to encounter. therapeutic options; the same use. The agency concluded • The criteria for patient selection; or, that, consistent with the terminology of VII. Paperwork Reduction Act of 1995 for an individual patient, a description section 561(b)(4) of the act, it is of the patient’s disease or condition, preferable to establish an intermediate This final rule contains information collection requirements that are subject including recent medical history and category for expanded access, with previous treatments used for the disease additional criteria and monitoring to review by the Office of Management and Budget (OMB) under the Paperwork or condition; requirements, that will be used for more • The method of administration of the Reduction Act of 1995 (44 U.S.C. 3501– than an individual patient, but fewer drug, dose, and duration of therapy; 3520) (the PRA). The title, description, than the large numbers of patients in • A description of the facility where and respondent description of the treatment INDs or treatment protocols. the drug will be manufactured; In FDA’s experience, there is often a information collection provisions are • Chemistry, manufacturing, and need for a middle ground between an shown below with an estimate of the controls information adequate to ensure individual patient IND or protocol and annual reporting burden. Our estimate the proper identification, quality, a treatment IND or treatment protocol. includes the time for reviewing purity, and strength of the For some drugs in development, there is instructions, searching existing data investigational drug; considerable demand for expanded sources, gathering and maintaining the • Pharmacology and toxicology access before the use meets the criteria data needed, and completing and information adequate to conclude that for a treatment IND or treatment reviewing each collection of the drug is reasonably safe at the dose protocol. There are also situations in information. and duration for expanded access use which investigational drugs that are not Title: Expanded Access to (ordinarily, information that will be being actively developed are the best Investigational Drugs for Treatment Use adequate to permit clinical testing of the available therapy for a significant Description: The final rule clarifies drug in a population of the size number of patients and should be made existing regulations and revises them by expected to be treated); and available to patients under an expanded adding new types of expanded access • A description of clinical access process. In these situations, for treatment use. Under the final rule, procedures, laboratory tests, or other making the drug available under a series expanded access to investigational monitoring necessary to evaluate the of individual patient expanded access drugs will be available to individual effects of the drug and minimize its INDs or protocols is burdensome on patients, including in emergencies; to risks. physicians, sponsors, and FDA, and intermediate-size patient populations; makes it difficult to monitor the and to larger populations under a 2. Individual Patient Expanded Access expanded access use to identify treatment protocol or IND. The final rule Section 312.310(b) contains significant safety concerns such as is intended to improve access to additional submission requirements that serious adverse events. investigational drugs for patients with apply to use of an investigational drug Describing this intermediate category serious or immediately life-threatening for the treatment of an individual in the regulations is also consistent with diseases or conditions who lack other patient by a licensed physician. The FDA’s goal of maximizing awareness of therapeutic options and may benefit expanded access submission must expanded access programs by being from such therapies. include information adequate to satisfy

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FDA that the criteria for all expanded studied in a clinical trial, the sponsor submissions (primarily from physicians) access uses and those specific to must explain why the patients to be and a survey of our review divisions on individual patient expanded access treated cannot be enrolled in the clinical the prevalence of individual patient have been met. The individual patient trial and under what circumstances the protocol exception submissions expanded access criteria are: sponsor will conduct a clinical trial in received from commercial drug • The physician must determine that these patients. sponsors. As indicated in the table the probable risk to the person from the below, we expect an increase in the 4. Treatment IND or Protocol investigational drug is not greater than number of individual patient expanded the probable risk from the disease or Section 312.320 describes the access submissions because the final condition, and treatment IND or treatment protocol rule will increase awareness of the • FDA must determine that the currently codified in §§ 312.34 and option for individual patients to gain patient cannot obtain the drug under 312.35. Section 312.320(b) states that access to investigational drugs and another type of IND. the expanded access submission must decrease the perceived difficulty of Section 312.310(b)(1) states that if the include information adequate to satisfy obtaining such access. We anticipate drug is the subject of an existing IND, FDA that the criteria for all expanded that the increase in individual patient the expanded access submission may be access uses and those specific to the expanded access INDs or protocols will made by a commercial sponsor or by a treatment IND or protocol have been be greatest in the years immediately licensed physician. met. The criteria specific to a treatment following implementation of the final Section 312.310(b)(2) states that a IND or treatment protocol are: (1) The rule and will at some point level off or sponsor may satisfy the submission drug is being investigated in a possibly even decline. This leveling off requirements by amending its existing controlled clinical trial designed to or decline will occur when a significant IND to include an individual patient support a marketing application for the volume of individual patient expanded expanded access protocol. expanded access use or all clinical trials access INDs or protocols have Section 312.310(b)(3) states that a of the drug have been completed, (2) the accumulated for a variety of drugs, and licensed physician may satisfy the sponsor is pursuing marketing approval the individual patient expanded access submission requirements by obtaining a of the drug for the expanded access use INDs or protocols for those drugs are right of reference to pertinent with due diligence, and (3) there is then replaced with intermediate-size information in the IND and providing sufficient clinical evidence of safety and patient population expanded access any other required information not effectiveness to support the treatment INDs or protocols that enroll multiple contained in the IND (usually only the use. Such evidence will ordinarily subjects. information specific to the individual consist of data from phase 3 trials, but We estimate that preparation and patient). could consist of compelling data from submission of an individual patient 3. Intermediate-Size Patient Populations completed phase 2 trials. When the expanded access IND or protocol expanded access use is for an submission will require a total of Section 312.315(c) states that an immediately life-threatening disease or approximately 8 hours. expanded access submission for an condition, the available scientific 2. Intermediate-Size Patient Population intermediate-size patient population evidence, taken as a whole, could Expanded Access must include information adequate to provide a reasonable basis to conclude satisfy FDA that the criteria for all that the investigational drug may be Although intermediate-size patient expanded access uses and those specific effective for the expanded access use population expanded access INDs or to intermediate-size patient populations and will not expose patients to an protocols have not previously been have been met. The intermediate-size unreasonable and significant risk of described in regulation, investigational patient population criteria are: (1) There illness or injury. This evidence will drugs have been made available is enough evidence that the drug is safe ordinarily consist of clinical data from informally for treatment use to such at the dose and duration proposed for phase 3 or phase 2 trials, but could be populations. Based on an internal treatment use to justify a clinical trial of based on more preliminary clinical survey of our review divisions, we the drug in the approximate number of evidence. estimate that, for the period 2000 patients expected to receive the drug for through 2002, we received treatment use; and (2) there is at least B. Estimates of Reporting Burden approximately 55 submissions per year preliminary clinical evidence of Our estimate of the amount of time that we consider expanded access for an effectiveness of the drug or of a required to complete an expanded intermediate-size patient population plausible pharmacologic effect of the access submission is based on the under the final rule. As indicated in drug to make expanded access use a assumption that either the submission table 9, we anticipate that this number reasonable therapeutic option in the will be made by the drug developer or will increase under the final rule anticipated patient population. Section the submitter will have obtained a right because there will be greater awareness 312.315(c) contains additional of reference from the drug developer. of this option. In addition, the submission requirements that apply to We expect an increase in the number of anticipated increase in volume of use of an investigational drug for submissions for expanded access for submissions for expanded access for intermediate-size patient populations. individual patients and for individual patients discussed The expanded access submission must intermediate-size patient populations as previously is expected to increase the state whether the drug is being a result of this final rule. number of submissions for expanded developed or is not being developed and access for intermediate-size patient describe the patient population to be 1. Individual Patient Expanded Access populations because the final rule treated. If the drug is not being actively From 1997 to 2005, we received on encourages the consolidation of developed, the sponsor must explain average approximately 659 submissions multiple individual patient INDs or why the drug cannot currently be for the treatment use of investigational protocols for a given expanded access developed for the expanded access use drugs by individual patients per year. use. and under what circumstances the drug This estimate is based on our records of Information provided by our review could be developed. If the drug is being the number of individual patient IND divisions indicates that preparation and

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submission of an intermediate-size do not expect the provisions of this final Table 9 of this document presents the patient population IND will require a rule regarding treatment INDs or annualized reporting burden for the total of approximately 120 hours. treatment protocols to impose any total number of expanded access increased paperwork burden. The 3. Treatment IND or Treatment Protocol submissions by type of expanded access burden for these submissions, as use. The estimates in the table are based We do not expect the final rule to currently required under § 312.35, is on data from section VI of this have an impact on the overall number already approved by OMB under OMB document and are calculated by of treatment INDs or treatment protocols control number 0910–0014. averaging the projected number of because this type of expanded access is Description of Respondents: Licensed submissions for the first 3 years after already established in FDA regulations physicians and manufacturers, implementation of this final rule. at §§ 312.34 and 312.35. Therefore, we including small business manufacturers.

TABLE 9.—ESTIMATED ANNUAL REPORTING BURDEN1

No. of No. of Responses Total Hours per 21 CFR Section Respondents per Respondent Responses Response Total Hours

§§ 312.305 and 312.310(b) 988 1 988 8 7,904

§§ 312.305(b) and 312.315(c) 68 1 68 120 8,160

Total 16,064 1 There are no capital costs or operating and maintenance costs associated with this collection.

The information collection provisions Medical research, Reporting and ■ 6. Section 312.42 is amended by in this final rule have been submitted to recordkeeping requirements. revising paragraph (b)(3) to read as OMB for review. Prior to the effective ■ Therefore, under the Federal Food, follows: date of this final rule, FDA will publish Drug, and Cosmetic Act and under a notice in the Federal Register § 312.42 Clinical holds and requests for authority delegated to the Commissioner modification. announcing OMB’s decision to approve, of Food and Drugs, 21 CFR parts 312 modify, or disapprove the information and 316 are amended as follows: * * * * * collection provisions in this final rule. (b) * * * An agency may not conduct or sponsor, PART 312—INVESTIGATIONAL NEW (3) Clinical hold of an expanded and a person is not required to respond DRUG APPLICATION access IND or expanded access protocol. FDA may place an expanded to, a collection of information unless it ■ displays a currently valid OMB control 1. The authority citation for 21 CFR access IND or expanded access protocol number. part 312 is revised to read as follows: on clinical hold under the following Authority: 21 U.S.C. 321, 331, 351, 352, conditions: VIII. Federalism 353, 355, 360bbb, 371; 42 U.S.C. 262. (i) Final use. FDA may place a ■ FDA has analyzed this final rule in 2. Section 312.30 is amended by proposed expanded access IND or revising paragraph (c) to read as follows: accordance with the principles set forth treatment use protocol on clinical hold if it is determined that: in Executive Order 13132. FDA has § 312.30 Protocol amendments. tentatively determined that the rule (A) The pertinent criteria in subpart I * * * * * of this part for permitting the expanded does not contain policies that have (c) New investigator. A sponsor shall access use to begin are not satisfied; or substantial direct effects on the States, submit a protocol amendment when a (B) The expanded access IND or on the relationship between the new investigator is added to carry out a expanded access protocol does not National Government and the States, or previously submitted protocol, except comply with the requirements for on the distribution of power and that a protocol amendment is not expanded access submissions in subpart responsibilities among the various required when a licensed practitioner is I of this part. levels of government. Accordingly, the added in the case of a treatment agency has tentatively concluded that protocol under § 312.315 or § 312.320. (ii) Ongoing use. FDA may place an the rule does not contain policies that Once the investigator is added to the ongoing expanded access IND or have federalism implications as defined study, the investigational drug may be expanded access protocol on clinical in the order and, consequently, a shipped to the investigator and the hold if it is determined that the federalism summary impact statement is investigator may begin participating in pertinent criteria in subpart I of this part not required. the study. The sponsor shall notify FDA for permitting the expanded access are no longer satisfied. List of Subjects of the new investigator within 30 days of the investigator being added. * * * * * 21 CFR Part 312 * * * * * ■ 7. Part 312 is amended by adding and reserving subpart H, and by adding Drugs, Exports, Imports, § 312.34 [Removed] subpart I, consisting of §§ 312.300 Investigations, Labeling, Medical ■ 3. Section 312.34 is removed. through 312.320, to read as follows: research, Reporting and recordkeeping requirements, Safety. § 312.35 [Removed] Subpart H—[Reserved] 21 CFR Part 316 ■ 4. Section 312.35 is removed. Subpart I—Expanded Access to Investigational Drugs for Treatment Use § 312.36 [Removed] Administrative practice and Sec. procedure, Drugs, Investigations, ■ 5. Section 312.36 is removed. 312.300 General.

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312.305 Requirements for all expanded satisfactory alternative therapy to (3) The expanded access submission access uses. diagnose, monitor, or treat the disease or and its mailing cover must be plainly 312.310 Individual patients, including for condition; marked ‘‘EXPANDED ACCESS emergency use. (2) The potential patient benefit SUBMISSION.’’ If the expanded access 312.315 Intermediate-size patient submission is for a treatment IND or populations. justifies the potential risks of the 312.320 Treatment IND or treatment treatment use and those potential risks treatment protocol, the applicable box protocol. are not unreasonable in the context of on Form FDA 1571 must be checked. the disease or condition to be treated; (c) Safeguards. The responsibilities of Subpart I—Expanded Access to and sponsors and investigators set forth in Investigational Drugs for Treatment (3) Providing the investigational drug subpart D of this part are applicable to Use for the requested use will not interfere expanded access use under this subpart with the initiation, conduct, or as described in this paragraph. § 312.300 General. completion of clinical investigations (1) A licensed physician under whose (a) Scope. This subpart contains the that could support marketing approval immediate direction an investigational requirements for the use of of the expanded access use or otherwise drug is administered or dispensed for an investigational new drugs and approved compromise the potential development expanded access use under this subpart drugs where availability is limited by a of the expanded access use. is considered an investigator, for risk evaluation and mitigation strategy (b) Submission. (1) An expanded purposes of this part, and must comply (REMS) when the primary purpose is to access submission is required for each with the responsibilities for diagnose, monitor, or treat a patient’s type of expanded access described in investigators set forth in subpart D of disease or condition. The aim of this this subpart. The submission may be a this part to the extent they are subpart is to facilitate the availability of new IND or a protocol amendment to an applicable to the expanded access use. (2) An individual or entity that such drugs to patients with serious existing IND. Information required for a submits an expanded access IND or diseases or conditions when there is no submission may be supplied by protocol under this subpart is comparable or satisfactory alternative referring to pertinent information considered a sponsor, for purposes of therapy to diagnose, monitor, or treat contained in an existing IND if the this part, and must comply with the the patient’s disease or condition. sponsor of the existing IND grants a responsibilities for sponsors set forth in (b) Definitions. The following right of reference to the IND. definitions of terms apply to this subpart D of this part to the extent they (2) The expanded access submission are applicable to the expanded access subpart: must include: Immediately life-threatening disease use. (i) A cover sheet (Form FDA 1571) (3) A licensed physician under whose or condition means a stage of disease in meeting the requirements of § 312.23(a); which there is reasonable likelihood immediate direction an investigational (ii) The rationale for the intended use that death will occur within a matter of drug is administered or dispensed, and of the drug, including a list of available months or in which premature death is who submits an IND for expanded therapeutic options that would likely without early treatment. access use under this subpart is ordinarily be tried before resorting to Serious disease or condition means a considered a sponsor-investigator, for the investigational drug or an disease or condition associated with purposes of this part, and must comply explanation of why the use of the morbidity that has substantial impact on with the responsibilities for sponsors investigational drug is preferable to the day-to-day functioning. Short-lived and and investigators set forth in subpart D use of available therapeutic options; self-limiting morbidity will usually not of this part to the extent they are (iii) The criteria for patient selection be sufficient, but the morbidity need not applicable to the expanded access use. or, for an individual patient, a be irreversible, provided it is persistent (4) Investigators. In all cases of description of the patient’s disease or or recurrent. Whether a disease or expanded access, investigators are condition, including recent medical condition is serious is a matter of responsible for reporting adverse drug history and previous treatments of the clinical judgment, based on its impact events to the sponsor, ensuring that the disease or condition; on such factors as survival, day-to-day informed consent requirements of part (iv) The method of administration of functioning, or the likelihood that the 50 of this chapter are met, ensuring that the drug, dose, and duration of therapy; disease, if left untreated, will progress IRB review of the expanded access use (v) A description of the facility where from a less severe condition to a more is obtained in a manner consistent with the drug will be manufactured; serious one. the requirements of part 56 of this (vi) Chemistry, manufacturing, and chapter, and maintaining accurate case § 312.305 Requirements for all expanded controls information adequate to ensure histories and drug disposition records access uses. the proper identification, quality, and retaining records in a manner The criteria, submission purity, and strength of the consistent with the requirements of requirements, safeguards, and beginning investigational drug; § 312.62. Depending on the type of treatment information set out in this (vii) Pharmacology and toxicology expanded access, other investigator section apply to all expanded access information adequate to conclude that responsibilities under subpart D may uses described in this subpart. the drug is reasonably safe at the dose also apply. Additional criteria, submission and duration proposed for expanded (5) Sponsors. In all cases of expanded requirements, and safeguards that apply access use (ordinarily, information that access, sponsors are responsible for to specific types of expanded access are would be adequate to permit clinical submitting IND safety reports and described in §§ 312.310 through testing of the drug in a population of the annual reports (when the IND or 312.320. size expected to be treated); and protocol continues for 1 year or longer) (a) Criteria. FDA must determine that: (viii) A description of clinical to FDA as required by §§ 312.32 and (1) The patient or patients to be procedures, laboratory tests, or other 312.33, ensuring that licensed treated have a serious or immediately monitoring necessary to evaluate the physicians are qualified to administer life-threatening disease or condition, effects of the drug and minimize its the investigational drug for the and there is no comparable or risks. expanded access use, providing licensed

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physicians with the information needed obtaining from the sponsor permission § 312.315 Intermediate-size patient to minimize the risk and maximize the for FDA to refer to any information in populations. potential benefits of the investigational the IND that would be needed to Under this section, FDA may permit drug (the investigator’s brochure must support the expanded access request an investigational drug to be used for be provided if one exists for the drug), (right of reference) and by providing any the treatment of a patient population maintaining an effective IND for the other required information not smaller than that typical of a treatment expanded access use, and maintaining contained in the IND (usually only the IND or treatment protocol. FDA may ask adequate drug disposition records and information specific to the individual a sponsor to consolidate expanded retaining records in a manner consistent patient). access under this section when the with the requirements of § 312.57. (c) Safeguards. (1) Treatment is agency has received a significant Depending on the type of expanded generally limited to a single course of number of requests for individual access, other sponsor responsibilities therapy for a specified duration unless patient expanded access to an under subpart D may also apply. FDA expressly authorizes multiple investigational drug for the same use. (d) Beginning treatment—(1) INDs. An (a) Need for expanded access. courses or chronic therapy. expanded access IND goes into effect 30 Expanded access under this section may days after FDA receives the IND or on (2) At the conclusion of treatment, the be needed in the following situations: earlier notification by FDA that the licensed physician or sponsor must (1) Drug not being developed. The expanded access use may begin. provide FDA with a written summary of drug is not being developed, for (2) Protocols. With the following the results of the expanded access use, example, because the disease or exceptions, expanded access use under including adverse effects. condition is so rare that the sponsor is a protocol submitted under an existing (3) FDA may require sponsors to unable to recruit patients for a clinical IND may begin as described in monitor an individual patient expanded trial. § 312.30(a). access use if the use is for an extended (2) Drug being developed. The drug is (i) Expanded access use under the duration. being studied in a clinical trial, but emergency procedures described in patients requesting the drug for § 312.310(d) may begin when the use is (4) When a significant number of expanded access use are unable to authorized by the FDA reviewing similar individual patient expanded participate in the trial. For example, official. access requests have been submitted, patients may not be able to participate (ii) Expanded access use under FDA may ask the sponsor to submit an in the trial because they have a different § 312.320 may begin 30 days after FDA IND or protocol for the use under disease or stage of disease than the one receives the protocol or upon earlier § 312.315 or § 312.320. being studied or otherwise do not meet notification by FDA that use may begin. (d) Emergency procedures. If there is the enrollment criteria, because (3) Clinical holds. FDA may place any an emergency that requires the patient enrollment in the trial is closed, or expanded access IND or protocol on to be treated before a written submission because the trial site is not clinical hold as described in § 312.42. can be made, FDA may authorize the geographically accessible. § 312.310 Individual patients, including for expanded access use to begin without a (3) Approved or related drug. (i) The emergency use. written submission. The FDA reviewing drug is an approved drug product that Under this section, FDA may permit official may authorize the emergency is no longer marketed for safety reasons an investigational drug to be used for use by telephone. or is unavailable through marketing due the treatment of an individual patient by (1) Emergency expanded access use to failure to meet the conditions of the a licensed physician. may be requested by telephone, approved application, or (a) Criteria. The criteria in facsimile, or other means of electronic (ii) The drug contains the same active § 312.305(a) must be met; and the communications. For investigational moiety as an approved drug product following determinations must be made: biological drug products regulated by that is unavailable through marketing (1) The physician must determine that the Center for Biologics Evaluation and due to failure to meet the conditions of the probable risk to the person from the Research, the request should be directed the approved application or a drug investigational drug is not greater than to the Office of Communication, shortage. (b) Criteria. The criteria in the probable risk from the disease or Outreach and Development, Center for § 312.305(a) must be met; and FDA must condition; and Biologics Evaluation and Research, 301– determine that: (2) FDA must determine that the 827–1800 or 1–800–835–4709, e-mail: (1) There is enough evidence that the patient cannot obtain the drug under [email protected]. For all other drug is safe at the dose and duration another IND or protocol. investigational drugs, the request for proposed for expanded access use to (b) Submission. The expanded access authorization should be directed to the justify a clinical trial of the drug in the submission must include information Division of Drug Information, Center for approximate number of patients adequate to demonstrate that the criteria Drug Evaluation and Research, 301– expected to receive the drug under in § 312.305(a) and paragraph (a) of this 796–3400, e-mail: expanded access; and section have been met. The expanded [email protected]. After normal access submission must meet the (2) There is at least preliminary working hours, the request should be clinical evidence of effectiveness of the requirements of § 312.305(b). directed to the FDA Office of Emergency (1) If the drug is the subject of an drug, or of a plausible pharmacologic Operations, 301–443–1240, e-mail: existing IND, the expanded access effect of the drug to make expanded [email protected]. submission may be made by the sponsor access use a reasonable therapeutic or by a licensed physician. (2) The licensed physician or sponsor option in the anticipated patient (2) A sponsor may satisfy the must explain how the expanded access population. submission requirements by amending use will meet the requirements of (c) Submission. The expanded access its existing IND to include a protocol for §§ 312.305 and 312.310 and must agree submission must include information individual patient expanded access. to submit an expanded access adequate to satisfy FDA that the criteria (3) A licensed physician may satisfy submission within 15 working days of in § 312.305(a) and paragraph (b) of this the submission requirements by FDA’s authorization of the use. section have been met. The expanded

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access submission must meet the (2) The sponsor is responsible for unreasonable and significant risk of requirements of § 312.305(b). In monitoring the expanded access illness or injury. This evidence would addition: protocol to ensure that licensed ordinarily consist of clinical data from (1) The expanded access submission physicians comply with the protocol phase 3 or phase 2 trials, but could be must state whether the drug is being and the regulations applicable to based on more preliminary clinical developed or is not being developed and investigators. evidence. describe the patient population to be § 312.320 Treatment IND or treatment (b) Submission. The expanded access treated. protocol. submission must include information (2) If the drug is not being actively Under this section, FDA may permit adequate to satisfy FDA that the criteria developed, the sponsor must explain an investigational drug to be used for in § 312.305(a) and paragraph (a) of this why the drug cannot currently be widespread treatment use. section have been met. The expanded developed for the expanded access use (a) Criteria. The criteria in access submission must meet the and under what circumstances the drug § 312.305(a) must be met, and FDA must requirements of § 312.305(b). could be developed. determine that: (c) Safeguard. The sponsor is (3) If the drug is being studied in a (1) Trial status. (i) The drug is being responsible for monitoring the treatment clinical trial, the sponsor must explain investigated in a controlled clinical trial protocol to ensure that licensed why the patients to be treated cannot be under an IND designed to support a physicians comply with the protocol enrolled in the clinical trial and under marketing application for the expanded and the regulations applicable to what circumstances the sponsor would access use, or investigators. conduct a clinical trial in these patients. (ii) All clinical trials of the drug have PART 316—ORPHAN DRUGS (d) Safeguards. (1) Upon review of the been completed; and IND annual report, FDA will determine (2) Marketing status. The sponsor is actively pursuing marketing approval of ■ 8. The authority citation for 21 CFR whether it is appropriate for the part 316 continues to read as follows: expanded access to continue under this the drug for the expanded access use section. with due diligence; and Authority: 21 U.S.C. 360aa, 360bb, 360cc, (3) Evidence. (i) When the expanded 360dd, 371. (i) If the drug is not being actively access use is for a serious disease or developed or if the expanded access use ■ 9. Section 316.40 is revised to read as condition, there is sufficient clinical follows: is not being developed (but another use evidence of safety and effectiveness to is being developed), FDA will consider support the expanded access use. Such § 316.40 Treatment use of a designated whether it is possible to conduct a evidence would ordinarily consist of orphan drug. clinical study of the expanded access data from phase 3 trials, but could use. Prospective investigators seeking to consist of compelling data from obtain treatment use of designated (ii) If the drug is being actively completed phase 2 trials; or orphan drugs may do so as provided in developed, FDA will consider whether (ii) When the expanded access use is subpart I of this chapter. providing the investigational drug for for an immediately life-threatening expanded access use is interfering with disease or condition, the available Dated: July 20, 2009. the clinical development of the drug. scientific evidence, taken as a whole, Jeffrey Shuren, (iii) As the number of patients provides a reasonable basis to conclude Associate Commissioner for Policy and enrolled increases, FDA may ask the that the investigational drug may be Planning. sponsor to submit an IND or protocol for effective for the expanded access use [FR Doc. E9–19005 Filed 8–12–09; 8:45 am] the use under § 312.320. and would not expose patients to an BILLING CODE 4160–01–S

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Part III

Department of Health and Human Services Centers for Medicare & Medicaid Services

42 CFR Parts 409, 424, 484, and 489 Medicare Program; Home Health Prospective Payment System Rate Update for Calendar Year 2010; Proposed Rule; Republication

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DEPARTMENT OF HEALTH AND DATES: To be assured consideration, Comments mailed to the addresses HUMAN SERVICES comments must be received at one of indicated as appropriate for hand or the addresses provided below, no later courier delivery may be delayed and Centers for Medicare & Medicaid than 5 p.m. on September 28, 2009. received after the comment period. Services ADDRESSES: In commenting, please refer Submission of comments on to file code CMS–1560–P. Because of paperwork requirements. You may 42 CFR Parts 409, 424, 484, and 489 staff and resource limitations, we cannot submit comments on this document’s [CMS–1560–P] accept comments by facsimile (FAX) paperwork requirements by following transmission. the instructions at the end of the RIN 0938–AP20 You may submit comments in one of ‘‘Collection of Information Requirements’’ section in this Medicare Program; Home Health four ways (please choose only one of the document. Prospective Payment System Rate ways listed): For information on viewing public Update for Calendar Year 2010 1. Electronically. You may submit electronic comments on this regulation comments, see the beginning of the SUPPLEMENTARY INFORMATION section. Editorial Note: Federal Register proposed to http://www.regulations.gov. Follow rule document E9–18587, originally the instructions under the ‘‘More Search SUPPLEMENTARY INFORMATION: published at pages 39436 to 39496 in the Options’’ tab. Inspection of Public Comments: All issue of Thursday, August 6, 2009, included 2. By regular mail. You may mail comments received before the close of incorrect tables from pages 39471 to 39496. written comments to the following the comment period are available for This document, along with the correct tables, address only: viewing by the public, including any is being republished in its entirety. Centers for Medicare & Medicaid personally identifiable or confidential AGENCY: Centers for Medicare & Services, Department of Health and business information that is included in Medicaid Services (CMS), HHS. Human Services, Attention: CMS–1560– a comment. We post all comments ACTION: Proposed rule. P, P.O. Box 8016, Baltimore, MD 21244– received before the close of the 1850. comment period on the following Web SUMMARY: This proposed rule sets forth Please allow sufficient time for mailed site as soon as possible after they have an update to the Home Health comments to be received before the been received: http:// Prospective Payment System (HH PPS) close of the comment period. www.regulations.gov. Follow the search rates; the national standardized 60-day 3. By express or overnight mail. You instructions on that Web site to view episode rates, the national per-visit may send written comments to the public comments. rates, the non-routine medical supply following address ONLY: Comments received timely will also (NRS) conversion factor, and the low Centers for Medicare & Medicaid be available for public inspection as utilization payment amount (LUPA) Services, Department of Health and they are received, generally beginning add-on payment amount, under the Human Services, Attention: CMS–1560– approximately 3 weeks after publication Medicare prospective payment system P, Mail Stop C4–26–05, 7500 Security of a document, at the headquarters of for home health agencies effective Boulevard, Baltimore, MD 21244–1850. the Centers for Medicare & Medicaid January 1, 2010. In addition, this rule 4. By hand or courier. If you prefer, Services, 7500 Security Boulevard, proposes a change to the HH PPS outlier you may deliver (by hand or courier) Baltimore, Maryland 21244, Monday policy and proposes to require the your written comments before the close through Friday of each week from 8:30 submission of OASIS data as a of the comment period to either of the a.m. to 4 p.m. EST. To schedule an condition for payment under the HH following addresses: appointment to view public comments, PPS. Also, this rule proposes payment a. For delivery in Washington, DC— phone 1–800–743–3951. safeguards that would improve our Centers for Medicare & Medicaid FOR FURTHER INFORMATION CONTACT: enrollment process, improve the quality Services, Department of Health and Randy Throndset, (410)786–0131 of care that Medicare beneficiaries Human Services, Room 445–G, Hubert (overall HH PPS). Sharon Ventura, (410) receive from HHAs, and reduce the H. Humphrey Building, 200 786–1985 (for information related to Medicare program’s vulnerability to Independence Avenue, SW., payment rates and wage indexes). James fraud. This rule also proposes clarifying Washington, DC 20201. Bossenmeyer, (410) 786–9317 (for language to the ‘‘skilled services’’ (Because access to the interior of the information related to payment section and Condition of Participation Hubert H. Humphrey Building is not readily safeguards). Doug Brown, (410) 786– (CoP) section of our regulations. This available to persons without Federal 0028 (for quality issues). Kathleen proposed rule also clarifies the coverage government identification, commenters are Walch, (410) 786–7970 (for skilled of routine medical supplies under the encouraged to leave their comments in the services requirements and clinical HH PPS. We are also soliciting CMS drop slots located in the main lobby of issues). comments on: Physician/patient the building. A stamp-in clock is available for interaction associated with the home persons wishing to retain a proof of filing by Table of Contents health plan of care (POC); a Consumer stamping in and retaining an extra copy of the comments being filed.) I. Background Assessment of Healthcare Providers and A. Requirements of the Balanced Budget Systems (CAHPS) Home Health Care b. For delivery in Baltimore, MD— Act of 1997 for Establishing the Survey; the Outcome and Assessment Centers for Medicare & Medicaid Prospective Payment System for Home Information Set (OASIS), Version C, Services, Department of Health and Health Services effective January 1, 2010; proposed pay Human Services, 7500 Security B. Deficit Reduction Act of 2005 for reporting measures for use in CY Boulevard, Baltimore, MD 21244–1850. C. System for Payment of Home Health Services 2011; and a number of minor payment- If you intend to deliver your D. Updates to the HH PPS related issues. We are also responding to comments to the Baltimore address, II. Analysis of and Responses to Comments comments received as a result of our please call (410) 786–7195 in advance to on the HH PPS Refinement and Rate solicitation in the CY 2008 HH PPS final schedule your arrival with one of our Update for CY 2008 rule with comment period. staff members. III. Provisions of the Proposed Regulation

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A. Outlier Policy PPS for all costs of home health services enacted on November 29, 1999. The B. Case-Mix Measurement Analysis paid under Medicare. requirements include the C. Proposed CY 2010 Payment Rate Update Section 1895(b)(3)(A) of the Act implementation of a HH PPS for home 1. Home Health Market Basket Update requires that: (1) The computation of a health services, consolidated billing 2. Home Health Care Quality Improvement standard prospective payment amount 3. Home Health Wage Index requirements, and a number of other 4. Proposed CY 2010 Payment Update include all costs for home health related changes. The HH PPS described a. National Standardized 60-Day Episode services covered and paid for on a in that rule replaced the retrospective Rate reasonable cost basis and be initially reasonable cost-based system that was b. Proposed Updated CY 2010 National based on the most recent audited cost used by Medicare for the payment of Standardized 60-Day Episode Payment report data available to the Secretary, home health services under Part A and Rate and (2) the prospective payment Part B. For a complete and full c. Proposed National Per-Visit Rates Used amounts be standardized to eliminate description of the HH PPS as required To Pay LUPAs and Compute Imputed the effects of case-mix and wage levels by the BBA, see the July 2000 HH PPS Costs Used in Outlier Calculations among HHAs. final rule (65 FR 41128 through 41214). d. Proposed LUPA Add-On Payment Section 1895(b)(3)(B) of the Act Amount Update addresses the annual update to the B. Deficit Reduction Act of 2005 e. Proposed Non-Routine Medical Supply Conversion Factor Update standard prospective payment amounts On February 8, 2006, the Deficit D. OASIS Issues by the home health applicable Reduction Act of 2005 (Pub. L. 109–171) 1. HIPPS Code Reporting percentage increase. (DRA) was enacted. Section 5201 of the 2. OASIS Submission as a Condition for Section 1895(b)(4) of the Act governs DRA requires HHAs to submit data for Payment the payment computation. Sections purposes of measuring health care E. Qualifications for Coverage as They 1895(b)(4)(A)(i) and (b)(4)(A)(ii) of the quality, and links the quality data Relate to Skilled Services Requirements Act require the standard prospective submission to payment. This F. OASIS for Significant Change in payment amount to be adjusted for case- requirement is applicable for CY 2007 Condition No Longer Associated With mix and geographic differences in wage and each subsequent year. If an HHA Payment levels. Section 1895(b)(4)(B) of the Act does not submit quality data, the home G. Proposed Payment Safeguards for Home requires the establishment of an Health Agencies health market basket percentage H. Physician Certification and appropriate case-mix change adjustment increase will be reduced 2 percentage Recertification of the Home Health Plan factor that adjusts for significant points. In accordance with the statute, of Care variation in costs among different units we published a final rule (71 FR 65884, I. Routine Medical Supplies of services. 65935) in the Federal Register on IV. Collection of Information Requirements Similarly, section 1895(b)(4)(C) of the November 9, 2006 to implement the A. ICRs Regarding the Requirements for Act requires the establishment of wage pay-for-reporting requirement of the Home Health Services adjustment factors that reflect the DRA, codified at 42 CFR 484.225(h) and B. ICRs Regarding Deactivation of Medicare relative level of wages, and wage-related (i). Billing Privileges costs applicable to home health services C. ICRs Regarding Prohibition Against Sale furnished in a geographic area C. System for Payment of Home Health or Transfer of Billing Privileges Services D. ICRs Regarding Patient Assessment Data compared to the applicable national V. Response to Comments average level. Pursuant to 1895(b)(4)(c), Generally, Medicare makes payment VI. Regulatory Impact Analysis the wage-adjustment factors used by the under the HH PPS on the basis of a Secretary may be the factors used under national standardized 60-day episode I. Background section 1886(d)(3)(E) of the Act. payment rate that is adjusted for the Section 1895(b)(5) of the Act gives the applicable case-mix and wage index. A. Requirements of the Balanced Budget Secretary the option to make additions The national standardized 60-day Act of 1997 for Establishing the or adjustments to the payment amount episode rate includes the six home Prospective Payment System for Home otherwise paid in the case of outliers health disciplines (skilled nursing, Health Services because of unusual variations in the home health aide, physical therapy, The Balanced Budget Act of 1997 type or amount of medically necessary speech-language pathology, (BBA) (Pub. L. 105–33) enacted on care. Total outlier payments in a given occupational therapy, and medical August 5, 1997, significantly changed fiscal year (FY) or year may not exceed social services). Payment for non- the way Medicare pays for Medicare 5 percent of total payments projected or routine medical supplies (NRS), is no home health services. Section 4603 of estimated. longer part of the national standardized the BBA mandated the development of In accordance with the statute, we 60-day episode rate and is computed by the home health prospective payment published a final rule (65 FR 41128) in multiplying the relative weight for a system (HH PPS). Until the the Federal Register on July 3, 2000, to particular NRS severity level by the NRS implementation of a HH PPS on October implement the HH PPS legislation. The conversion factor (See section III.C.4.e). 1, 2000, home health agencies (HHAs) July 2000 final rule established Durable medical equipment covered received payment under a cost-based requirements for the new HH PPS for under the home health benefit is paid reimbursement system. home health services as required by for outside the HH PPS payment. To Section 4603(a) of the BBA mandated section 4603 of the BBA, as adjust for case-mix, the HH PPS uses a the development of a HH PPS for all subsequently amended by section 5101 153-category case-mix classification to Medicare-covered home health services of the Omnibus Consolidated and assign patients to a home health provided under a plan of care (POC) that Emergency Supplemental resource group (HHRG). Clinical needs, were paid on a reasonable cost basis by Appropriations Act (OCESAA) for Fiscal functional status, and service utilization adding section 1895 of the Social Year 1999 (Pub. L. 105–277), enacted on are computed from responses to selected Security Act (the Act), entitled October 21, 1998; and by sections 302, data elements in the OASIS assessment ‘‘Prospective Payment For Home Health 305, and 306 of the Medicare, Medicaid, instrument. Services’’. Section 1895(b)(1) of the Act and SCHIP Balanced Budget Refinement For episodes with four or fewer visits, requires the Secretary to establish a HH Act (BBRA) of 1999 (Pub. L. 106–113), Medicare pays on the basis of a national

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per-visit rate by discipline; an episode support, pre-admission location, clinical information, documentation and consisting of four or fewer visits within severity, and non-home health Part A evidence describing the Abt case-mix a 60-day period receives what is referred Medicare expenditure data to predict study and CMS’ rationale for the to as a low utilization payment the average case-mix weight for 2005. reductions. Accordingly, we believe we adjustment (LUPA). Medicare also As a result of that analysis, CMS have provided sufficient time and adjusts the national standardized 60-day recognized that an 11.75 percent information to the public to fully review episode payment rate for certain increase in case-mix was due to changes and comment upon the rate reductions intervening events that are subject to a in coding practices and documentation that will take effect in CY 2011. partial episode payment adjustment rather than to treatment of more Comment: A commenter suggested (PEP adjustment). For certain cases that resource-intensive patients. that the 4th year cut of 2.71 percent be exceed a specific cost threshold, an To account for the changes in case- eliminated or indefinitely deferred until outlier adjustment may also be mix that were not related to an better data are available. Some available. underlying change in patient health commenters stated that an additional status, CMS implemented a reduction year of rate cuts will place a financial D. Corrections over 4 years in the national burden on HHAs, and will result in We published a final rule with standardized 60-day episode payment limited access to home care, especially comment period in the Federal Register rates and the NRS conversion factor. in rural areas. These commenters further on August 29, 2007 (72 FR 49762) that That reduction was to be taken at 2.75 state that limited access may result in set forth a refinement and rate update to percent per year for three years more hospitalizations and/or care being the 60-day national episode rates and beginning in CY 2008 and at 2.71 provided in more costly settings. the national per-visit rates under the percent for the fourth year in CY 2011. Commenters also stated that imposing a Medicare prospective payment system CMS indicated that it would continue to 4th year reduction on HHAs would be for home health services for CY 2008. In monitor for any further increase in case- detrimental and unduly harsh, as many this final rule with comment period, in mix that was not related to a change in HHAs are already struggling to meet the Table 10B (72 FR 49854), the short patient status, and would adjust the rising costs of providing care, and that description for ICD–9–CM code 250.8x percentage reductions and/or the reductions will cause HHAs to & 707.10–707.9 should read ‘‘PRIMARY implement further case-mix change operate at negative margins and likely DIAGNOSIS = 250.8x AND FIRST adjustments in the future. close. OTHER DIAGNOSIS=707.10–707.9’’. The CY 2008 HH PPS final rule with Several commenters suggested Instead of a formal correction notice, we comment period specifically solicited alternatives to CMS’ approach to are notifying the public of this comments on the 2.71 percent reduction adjusting for nominal case-mix. For correction in this proposed rule, and that is scheduled to occur in 2011. In example, one commenter suggested subsequent final rule. response, we received approximately 44 spreading the total cuts across a 6-year items of correspondence from the period rather than a 4-year period, E. Updates to the HH PPS public. Comments originated from trade enabling CMS to better monitor the As required by section 1895(b)(3)(B) associations, HHAs, hospitals, and impact of the CY 2008 HH PPS of the Act, we have historically updated health care professionals such as refinements and CY 2008 and 2009 the HH PPS rates annually in the physicians, nurses, social workers, and reductions prior to imposing additional Federal Register. physical and occupational therapists. In reductions. We published a notice in the Federal the HH PPS Rate Update for CY 2009, Another commenter suggested that Register on November 3, 2008 (73 FR we stated that we would delay our CMS withdraw its decision to reduce 65351) that set forth the update to the responses to these comments until the payment rates until CMS could 60-day national episode rates and the future rulemaking, enabling us to design and implement a better method national per-visit rates under the respond more comprehensively as more to analyze changes in the case-mix, Medicare prospective payment system current data became available. The based on adjusted final claims data that for home health services for CY 2009. following discussion, arranged by would utilize patient characteristics in the model, as well as changes in per- II. Analysis of and Responses to subject area, includes our responses to patient annual expenditures, patient Comments on the HH PPS Refinement the comments. clinical, functional, and service and Rate Update for CY 2008 A. Payment Reductions in the 4th Year utilization data, and dynamic factors in Our August 29, 2007 final rule with (2011) the Medicare system that impact on the comment period set forth an update to Comment: Commenters requested that nature of patients served with home the 60-day national episode rates and CMS release the Abt technical report so health care. the national per-visit rates under the that the industry could review the data Response: Our continued analysis Medicare prospective payment system and information within it. Without the shows that Medicare nominal case-mix for HHAs for CY 2008. For that final Abt report, the commenters stated the continues to increase. Therefore, we rule, analysis performed on home health industry would be unable to offer continue to believe it necessary to claims data, from CY 2005, indicated a meaningful comments on the case-mix reduce rates through 2011 to 12.78 percent increase in the observed reductions. counterbalance the Medicare case-mix since 2000. The case-mix Response: The Abt Technical Report expenditure effects of this nominal represented the variations in conditions was posted online and made available to increase. We also continue to believe of the patient population served by the the public on April 30, 2008 at: that phasing in the reductions over a HHAs. We then performed a more http://www.cms.hhs.gov/Reports/ four year period provides fair and ample detailed analysis on the 12.78 percent downloads/ time for HHAs to prepare for the increase in case-mix to see if any Coleman_Final_April_2008.pdf. reductions. portion of that increase was associated Although we posted the report later As more current data become with a real change in the actual clinical than anticipated, we believe that the CY available, we will continue to update condition of home health patients. CMS 2008 HH PPS final rule with comment our case-mix analysis. As discussed in examined data on demographics, family period adequately presented Section III.B. of this proposed rule,

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based on analysis of data through 2007, most years, the rate of actual cost changes in patient characteristics than nominal case-mix has further increased. growth in HHAs has been lower than had been used in the proposed rule. The We now estimate that the nominal case- the rate of inflation indicated by the commenter recommended that CMS mix has grown by an estimated 13.56 home health market basket. MedPAC engage in another cycle of rulemaking in percent between FY 1999 (the Interim reports that payments for HHAs have order to provide further opportunity to Payment System (IPS) baseline period) exceeded costs for all of the period comment. and 2007, an additional 1.81 percentage under PPS by a wide margin. Response: The policy adopted in the points above the previously recognized Also, in their March 2009 report, August 2007 final rule was a policy that increase. If we were to account for the MedPAC reports a 32 percent growth in adjusted payments in order to account entire 13.56 percent increase in nominal the number of HH agencies since 2003, for increases in nominal case-mix. This case-mix in one year (taking into stating that the supply of agencies policy was both proposed and finalized. account that we have already imposed continues to increase faster than the The commenter is addressing not the 2.75 percentage reductions in CY 2008 growth in the overall number of policy of adjusting payments for and CY 2009), we estimate that the Medicare beneficiaries. We believe that nominal case-mix increases, but rather, percentage reduction in the national new home health providers continue to how CMS implements this policy; that standardized 60-day episode payment enter the home health industry because is, the methodology CMS uses for rates and the NRS conversion factor Medicare payment levels give them determining the level of nominal case- would be 6.89 percent in CY 2010. If we adequate incentive to do so. mix increase. While we do not believe In response to commenters who were to account for the entire 13.56 we are required to subject our exact, suggested that we consider alternative percent increase in nominal case-mix final calculations regarding the increase methods to identify nominal case-mix over two years (taking into account that to public comment, it is also important before we impose the CY 2011 we have already imposed 2.75 to note that our final methodology percentage reductions in CY 2008 and reductions, we continue to believe that the Abt model adequately identifies clearly was an outgrowth of the CY 2009), we estimate that the proposed rule. The proposed rule percentage reduction in the national nominal case-mix. As we described in our August 2007 final rule, our included a detailed analysis of various standardized 60-day episode payment kinds of data, such as an extensive rates and the NRS conversion factor for enhanced model included variables such as changes in the age structure of review of the content of changes in each of the remaining two years (2010 OASIS instructions, a review of changes and 2011) would be 3.51 percent per the home health user population, changes in the types of patients being in the frequencies of severity levels of year. As discussed in Section II.C. of the case-mix system, and a detailed this proposed rule, we currently plan to admitted to home health, utilization of Medicare Part A services in the 120 days presentation of how OASIS items other move forward with the CY 2010 leading up to home health, the type of than those used for case-mix frequently reduction of 2.75 percent, as set forth in preadmission acute care stays when the changed little, if at all. We also the CY 2008 final rule. However, we patient last had such a stay and discussed the pattern of change in note that, in light of, among other variables describing living situations. functional items, showing that for a things, new policy developments, more Many of these model enhancements number of items, some changes recent information, or changed addressed suggestions made by the occurred at the high-functioning end, circumstances from the time the CY industry in their proposed rule while the worst-functioning levels 2008 rule was published, the Secretary comments. didn’t increase in the population. There is also considering making additional was a similar analysis of wound item changes in the final rule to account for B. General Case-Mix Comments changes. Our interpretation of the the residual increase in nominal case- Our August 29, 2007 final rule with totality of the data was that real case- mix discussed above. In such an comment period solicited comments mix did not materially change since the instance, we would consider accounting only on the 2.71 percent fourth year IPS baseline. We also identified a large for the residual increase in nominal reduction (72 FR 49762). Nevertheless, increase in post-surgical patients with case-mix in one year in the final rule, we received several comments unrelated their traditionally lower case-mix index. which we estimate would result in a to the fourth year reduction. Because However, we made an adjustment to our 6.89 percent reduction to the national such comments (including comments on estimate of case-mix change to account standardized 60-day episode payment outliers, LUPAs (Low Utilization for the change in the composition of the rates and the NRS conversion factor for Payment Adjustments), OASIS, wage home health industry on account of the CY 2010. We are seeking comments on index, operational issues, diagnosis exit of some hospital-owned agencies. the full range of potential nominal case- coding, HHRGs, and wound care These details enabled the home health mix reduction percentages. payment) are out of the scope of this industry to analyze our proposed With high projected HH margins and rulemaking, we are not responding to methodology and provide comments continued growth in the number of new these comments in this proposed rule. suggesting specific types of changes in HH agencies, we do not believe that the However, we are responding to patient acuity that could help to explain 2.71 percent reduction for 2011 will comments on case-mix measurement identified changes in home health case- result in decreased access to home methodology, as we believe such mix. For the final rule, we enhanced our health care for Medicare beneficiaries. comments are tangentially related to the formal estimate of case-mix change, The Medicare Payment Advisory reduction for CY 2011, and because we which we had statistically adjusted to Commission’s (MedPAC) March 2009 wish to fully address this issue. account for change in the presence of Annual Report states that the home Comment: A commenter stated that hospital-owned agencies in the health industry margin for 2007 was the August 27, 2007 final rule with industry, with a methodology that 16.6 percent and projects that average comment period was not a ‘‘logical statistically adjusted for multiple margins for 2009, which considers the outgrowth’’ of the May 4, 2007 proposed factors, including the types of factors 2.75 reduction, will be 12.2 percent. rule. The commenter stated that CMS mentioned by commenters. Application MedPAC also analyzed the average rate used a different methodology for of this model allowed us to of HH cost growth and found that in evaluating case-mix weight scores and simultaneously ‘‘subtract’’ from the

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growth in the national case-mix index results to arrive at the nominal case-mix that therapy treatment plans were the effects of a multitude of factors reductions ¥2.75 percent for 3 years sometimes ‘‘padded’’ to reach the ten- besides the change in hospital-owned and ¥2.71 percent for the fourth year of visit therapy threshold; we consider this agencies. Additionally, in the May 4, the phase-in. (Refer to Section III.B. of behavior a component of nominal case- 2007 proposed rule (72 FR 25395) we this proposed rule for an update based mix change, because therapy visits help indicated that our analysis for the final on analysis of data through 2007.) Thus, to determine the case-mix group. rule would be updated to include 2005 our model allowed and presumed some In response to the comment that CMS data. real case-mix change. The model data should have started with the Specifically, for the final rule, we relied on claims data instead of OASIS assumption that all case-mix growth updated the case-mix index and some of data (with the exception of one variable, was real, and then calculate what the statistical data (e.g., average which described the patient’s living portion, if any, was nominal, the model resources per episode) to include 2005 situation), to avoid reliance on data did assess real case-mix using a variety data. We also added analyses focusing which we knew were subject to coding of Part A claims. We then compared the on certain types of patients, including changes such as those resulting from model’s prediction of real case-mix with those mentioned in public comments on educational improvements, changes in the actual billed case-mix, determining the proposal (e.g., knee replacement OASIS instructions, and financial the calculated difference to be nominal. patients). Further, as just discussed in incentives. The model takes into The May 4, 2007, proposed rule put the the paragraph above, we added results account the total change between the case-mix of the Medicare home health from a multivariate model of case-mix baseline and the follow-up year (2005) population in historical perspective. It that isolated real case-mix change in the sources of patients (hospital, described the changes affecting the between the HH IPS baseline and 2005. inpatient rehabilitation facility, and home health benefit since the Balanced The newly added data and the model skilled nursing facility). It also takes Budget Act of 1997 and cited MedPAC, responded to comments that cited into account total change in the types of GAO and other literature findings that circumstances of particular types of acute hospital problems and hospital- the HH IPS had a strong impact on the patients and/or sought additional types recorded comorbidities experienced by types of patients served. We compared of evidence. These added data and patients before they entered home the case-mix index from the Abt analyses were made in response to the health care, total change in living Associates study sample with the case- proposed rule comments. The data and situation, and total change in patients’ mix index of the HH IPS baseline (1999– information added for the final rule, Part A expenditures incurred in the 120 2000), a comparison that suggested that along with the entire array of evidence days leading up to the beginning of each changes in real case-mix did occur as a we presented in the proposed and the episode (expenditures were adjusted for result of the HH IPS. Literature findings final rule are the bases for the price increases). Length of stay is also (GAO, ‘‘Medicare Home Health Benefit: identification of nominal case-mix accounted for by summing the number Impact of Interim Payment System and change. of inpatient days of various types. Agency Closures on Access to Services,’’ Comment: Some commenters focused Additionally, we added analyses September 1998, GAO/HEHS–98–238) on the finding that only 8 percent of the focusing on certain types of patients, describe an HH IPS incentive to admit case-mix change from 2000 to 2005 was including those mentioned in public many different patients with short-term real. These commenters recommended comments on the proposal (e.g., knee or rehabilitation needs instead of that CMS start with the assumption that replacement patients). lengthy low skilled care needs. We did all case-mix change is real, and only Every predictive model has its not rule out that some of the change consider the amount that could be limitations; however, we believe the during that period was nominal, in part estimated as nominal to be unjustified. model and data we used were the best because the HH PPS proposed rule of Another commenter pointed to CMS’ available for the purposes of measuring 1999 probably affected provider assertion that ‘‘real’’ case-mix increased case-mix in an unbiased manner. For behavior. prior to implementation of the HH PPS example, we relied on hospital claims Moreover, our analysis of changes in (prior to September 2000) and argued data instead of OASIS data (with the resource use showed that resource use that this fact demonstrates that it was exception of one OASIS variable), and stayed below the resource use level of unreasonable for CMS to assume that enhanced our calculation method to the HH IPS period for much of the none of the change after that point was include a multivariate approach to case- succeeding five years, casting doubt on real. mix measurement. For those patients the commenters’ assertion that patient Commenters suggested that case-mix who were hospitalized before home acuity increased. Specifically, after the has increased due to several factors, care, the model included whether the IPS was implemented, we saw a decline including earlier discharges from hospitalization was surgical or medical, in visit use from 73 visits per person in general acute hospitals, PPS changes and in many cases the model identified 1997 to 42 visits per person in 1999. that provided incentives to treat higher- the particular, detailed conditions that The number of visits further decreased acuity patients, and other post-acute were responsible for that hospital stay. under the HH PPS, decreasing to 37 in care regulations issued by CMS (such as These additions to the model were 2000, and 31 for each year 2001 through the inpatient rehabilitation ‘‘75% suggested by the industry in comments 2004. Rule’’), which diverts more medically on the proposed rule. Comment: A commenter believes that complex patients to homecare. One Moreover, we again note that the Abt CMS’s decision to implement these commenter urged CMS to defer any model was not the sole basis for the payment reductions is unjustified and adjustment for case-mix change and to final regulation provision on nominal flawed for two basic reasons: (1) There perform an analysis that accounted for case-mix change. The basis for the final have been actual changes in the home these factors. provision was the entire array of health population; and (2) providers Response: The predictive model evidence we presented in the proposed have improved the accuracy of OASIS isolated 8.03 percent of the overall 12.78 and the final rules. In addition, in the coding. The commenter refers to percent increase in case-mix as real, May 4, 2007, proposed rule (72 FR recently released data by Outcome resulting in an 11.75 percent nominal 25362–25366) we noted data as well as Concept Systems citing the average 2005 increase in case-mix. We relied on those commentary from observers indicating adjusted case-mix weight nationally and

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in New York was approximately 1.15, improvements in OASIS coding were data-gathering, or the quality or source not 1.2361, as CMS asserts. implemented. CMS subsequently of the data sources used by Outcome The commenter believes that the adjusted the standardized payment Concept Systems. average case-mix weight has changed amount to compensate for the nominal Comment: A commenter stated that because CMS fails to consider therapy change in case-mix used to pay claims CMS’ review of 20 percent of claims as a patient characteristic and because in the years following the introduction (OASIS for 2004–2005) does not reflect patients’ clinical severity has increased. of the PPS. the patient characteristics in 2007, and Furthermore, the commenter believes We acknowledge that therapy it certainly does not reflect those that the increase in patients’ clinical treatment services were used as a case- receiving services in 2010 and 2011. needs is largely due to an inpatient mix characteristic in the case-mix Response: We based our proposals on hospital payment system that has model, in the absence of sufficient the latest statistically representative created incentives for early discharge of explanatory power from OASIS data data available, and those data were from patients who require more care. The items to model resource use by 2005 at the time of the preparation of result is a home health population with themselves. However, we found a the final regulation. We will continue to higher acuity and more intense resource dramatic change in the distribution of update the data as they become needs. The commenter also states that episodes according to the number of available. growth in Medicare Advantage plans therapy visits between the HH IPS Comment: A commenter stated that has shifted lower acuity patients out of baseline period and the early years of CMS should look more closely at traditional Medicare, leaving higher the HH PPS period, and the new specific agencies it suspects may be need and higher cost beneficiaries distribution has persisted. We continue upcoding and then seek financial within the traditional Medicare to believe that the change in this short restitution from those that are ultimately program. period is an indication of behavioral deemed to be following this practice. A commenter stated that current change on the part of home health Across-the-board cuts of this magnitude OASIS data show that HHAs are agencies, and is not necessarily related are unwarranted at a time when the admitting increased numbers of to real case-mix change. Moreover, the home health industry should be beneficiaries with: (1) Comorbidities distributional shift occurred in the receiving additional support to serve an such as diabetes and obesity; (2) absence of convincing evidence from expanding older population. abnormalities of gait; (3) wound various OASIS items that patients were Response: As we stated in the CY infections; (4) urinary incontinence; and actually more impaired and sickly. 2008 HH PPS final rule (72 FR at (5) increased cognitive function deficits. Furthermore, when we took account of 49837), we believe that it is more The accumulative effect of these patient characteristics in the model of appropriate to implement a nationwide admissions has necessitated increased real case-mix change, the results did not approach to the issue of a case-mix therapy services which have resulted in support a large difference in patient change adjustment. An individual higher clinical and functional scores in acuity. agency approach would be case-mix weights. In addition, the We also note that the reporting of administratively burdensome and commenter believes that physical more comorbidities by HHAs is not difficult to implement. Policies to therapy services were underutilized clear evidence of change in patient address the identity of agencies in light during the HH IPS and at the onset of status, as it could be a result of of changes to organizational structures the HH PPS because of lack of clinical improvements in coding training alone. and configurations would need to be knowledge and understanding of best In addition, changes in regulations developed. Furthermore, smaller practice standards. The delivery of affecting rehabilitation hospitals are agencies might have difficulty in medical services in the home has represented in the case-mix change providing accurate measures of real improved over recent years. This is model by the variables that measure the case-mix changes because of their small evident by implementation of quality source of admission. caseloads. Because the nominal increase measures and outcomes data. Several To the extent that the home health in case-mix grew significantly from commenters believe that the increase in industry has accomplished 2003 to 2005 (8.7 percent to 11.75 average case-mix can be attributed fully improvements in patient function percent), we spread out the schedule of to an improvement in each agency’s without adding significant resources to adjustments from 3 years to 4 years in ability to correctly answer OASIS items the provision of care in home health order to ameliorate the impact that and increased emphasis on OASIS episodes, we understand this is likely would have been felt by HHAs had we validity by Quality Improvement attributable to shifts in the service mix decided to account for the entire 11.75 Organizations (QIO). Another provided within the episode, as well as percent increase in case-mix over 3 commenter stated that their agency has improved care practices. Again, years. experienced a change in the percentage however, the situation does not Comment: A commenter is concerned of orthopedic patients due to changes in necessarily indicate a real change in that CMS has not correctly addressed regulations for rehabilitation hospitals. case-mix. factors measuring the apparent ‘‘creep’’. Response: In the May 4, 2007 HH PPS Without more detailed information Additionally, the commenter states that proposed rule, we indicated that the about their analysis, we are unable to it was useful to have CMS clarify that analysis of national case-mix would be comment on the implication in the they had excluded LUPAs from the two updated using 2005 data in that year’s statistic from Outcome Concept Systems measurement bases utilized and that HH PPS final rule, and that the annual in New York State (as reported by the fact raises an issue that CMS did not adjustments for nominal case-mix commenter) that the average case-mix address in the rule. When the original change would be modified accordingly. rose only 1.15 as compared to 1.2361 in HH PPS was proposed (October 1999) As we have noted elsewhere, CMS’s analysis. The average case-mix is and finalized (July 2000), CMS asserted improvements in coding do not computed from an extremely large that it expected LUPA incidence, as represent real case-mix changes, which representative sample of national home estimated by its actuaries, would be five means that the Medicare program health claims data. The commenter does percent. Actual incidence has, since arguably may have overpaid for some of not provide information about the implementation, averaged sixteen the services which were provided after method of adjustment, the conditions of percent of total reimbursements. Using

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just a five percent rate of occurrence LUPA episodes. In addition to the exceeds a threshold amount. The resulted in every original HHRG commenters 16 percent being inaccurate episode’s estimated cost is the sum of assigned a lower value than if CMS had (as mentioned above), it is important to the national wage-adjusted per-visit rate used, say, a fifteen percent rate of point out that even in doing the math, amounts for all visits delivered during incidence. Accordingly, the commenter an inaccurate 16 percent minus 5 the episode. The outlier threshold is argues that home health agencies were percent actually reflects that there is an defined as the national standardized 60- under-compensated by approximately 11 percentage point difference between day episode payment rate for that case- 11 percent for LUPA savings. the two, not an 11 percent under- mix group plus a fixed dollar loss (FDL) Response: While this comment is compensation in payment as the amount. Both components of the outlier outside the scope of the topic (the 4th commenter suggests. Because the threshold are wage-adjusted. The wage- year reductions) which we solicited incidence of LUPAs is considerably adjusted FDL amount represents the comments on, we will briefly respond. lower than the 16 percent that the amount of loss that an agency must In the July 2000 final rule (65 FR commenter suggests, and the average experience before an episode becomes 41162), we stated that the estimate of number of home health visits per eligible for outlier payments. The wage- the percentage of LUPA episodes was an episode is far less than originally adjusted FDL amount is computed by actuarial estimate, as were the estimates estimated, HHAs have not been under- multiplying the national standardized of incidence of SCICs, PEPs, and compensated by 11 percent, as the 60-day episode payment amount by the outliers. Our base episode payment rates commenter suggests. FDL ratio, and wage-adjusting that are derived using the best data available Since the inception of the HH PPS, we amount. That wage-adjusted FDL at that time. The commenter is correct have monitored home health utilization amount is added to the HH PPS that the actual number of LUPA in preparing the refinements to the HH payment amount to arrive at the wage- episodes is higher than our original PPS. We have always contended that it adjusted outlier threshold amount. The estimate. However, while it is true that would not be appropriate to address outlier payment is defined to be a 16 percent of episodes from the 1998 single aspects of the system, as the proportion of the wage-adjusted pre-PPS data analysis were shown to be many pieces/aspects of the system estimated costs beyond the wage- LUPA-type episodes (65 FR 41186), we interact and there are causes and effects adjusted outlier threshold amount. The also provided reasoning in that that each has on one another. proportion of additional costs paid as discussion as to why we believed actual Consequently, we have addressed those outlier payments is referred to as the LUPA incidence under the HH PPS issues for which we believed we had would be lower. Granted, the incidence adequate information, as a result of our loss-sharing ratio. The FDL ratio and the of LUPAs did not drop to the level of analysis in the CY 2008 HH PPS loss-sharing ratio were selected so that 5 percent of the total number of proposed and final rules. In doing so, as the estimated total outlier payments episodes as was originally estimated, is generally done in a prospective would not exceed the 5 percent level. however the average actual incidence of payment system, we decided not to We chose a value of 0.80 for the loss- LUPAs is, and has always been make retroactive adjustments for actual sharing ratio, which is relatively high, considerably lower than the 16 percent utilization that differed from estimates. but preserves incentives for agencies to suggested by the commenter. In fact, attempt to provide care efficiently for III. Provisions of the Proposed Rule data analysis shows us that the outlier cases. A loss-sharing ratio of 0.80 incidence of LUPA episodes was first A. Outlier Policy means that Medicare pays 80 percent of measured at approximately 15.2 percent the additional costs above the wage- 1. Background of the total number of episodes and has adjusted outlier threshold amount. A continued to decrease under the HH Section 1895(b)(5) of the Act allows loss-sharing ratio of 0.80 is also PPS. Specifically, recent analysis of for the provision of an addition or consistent with the loss-sharing ratios home health claims shows that LUPA adjustment to the regular 60-day case- used in other Medicare PPS outlier episodes made up approximately 10.6 mix and wage-adjusted episode policies, such as inpatient hospital, percent of the total number HH PPS payment amount in the case of episodes inpatient rehabilitation, long-term episodes in CY 2007. that incur unusually high costs due to hospital, and inpatient psychiatric Another important fact that should patient home health care needs. This payment systems. In CY 2000, we not be lost, as part of this discussion, is section further stipulates that total estimated that a FDL ratio of 1.13 would that while the incidence of LUPAs is outlier payments in a given year may yield estimated total outlier payments less than originally estimated, we note not exceed 5 percent of total projected that were projected to be no more than that the average number of home health or estimated HH PPS payments. Section 5 percent of total HH PPS payments. As visits provided per episode for non- 1895(b)(3)(C) of the Act stipulates that discussed in the October 1999 proposed LUPAs episodes is also lower than what the standard episode payment be rule (64 FR 58169) and the July 2000 we originally estimated (65 FR 41171) reduced by such a proportion to account final rule (65 FR 41189), the percentage when we built the base payment rates for the aggregate increase in payments constraint on total outlier payments (21.16 vs 25.5 home health visits). resulting from outlier payments. creates a tradeoff between the values Hence, the national standardized 60-day In the July 2000 final rule (65 FR selected for the FDL amount and the episode payment is currently based on 41189), we described and subsequently loss-sharing ratio. For a given level of the delivery of significantly more home implemented an HH PPS outlier policy outlier payments, a higher fixed dollar health visits per episode (25.5) than is under which we reduce the standard loss amount reduces the number of currently being delivered (21.16). episode payment by 5 percent, and cases that receive outlier payments, but It is also worth noting that the manner target up to 5 percent of total projected makes it possible to select a higher loss- in which the commenter appears to estimated HH PPS payments to be paid sharing ratio and therefore increase arrive at their under-compensation of as outlier payments. The July 2000 final outlier payments per episode. payment percentage is by subtracting rule described a methodology for Alternatively, a lower fixed dollar loss the original estimate for LUPA episodes determining outlier payments. Under amount means that more episodes of 5 percent from their inaccurate this system, outlier payments are made qualify for outlier payments but outlier estimate of 16 percent incidence of for episodes whose estimated cost payments per episode must be lower.

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Therefore, setting these two parameters FDL ratio. That analysis derived a final rule suggested that CMS should involves policy choices about the FDL ratio of 0.89 for CY 2008. consider targeting a lower percentage in number of outlier cases and their rate of In order to determine the appropriate outlier payments to total estimated HH payment. value for the FDL ratio for the CY 2009 PPS payments. When the data became available, we rate update, in the November 3, 2008 Commenters suggested that by performed an analysis of CY 2001 home HH PPS Rate Update for CY 2009 notice lowering the target outlier percentage to health claims data. This analysis (73 FR 65351), we performed an total estimated HH payments, CMS revealed that outlier episodes analysis using the most recent, complete could then return to the national represented approximately 3 percent of available data at the time (CY 2006), standardized 60-day episode payment total episodes and 3 percent of total HH applying a methodology similar to that rate, a portion of that 5 percent which PPS payments. Additionally, we which we used to update the FDL ratio was originally withheld from the rates performed the same analysis on CY in the CY 2008 HH PPS final rule. That to fund the 5 percent of total estimated 2002 and CY 2003 home health claims updated analysis projected that in CY HH PPS outlier payments. In our data and found the number of outlier 2009 we would expend an estimated response to the CY 2008 comments, we episodes and payments held at 10.26 percent of total estimated HH PPS described our concern that reducing the approximately 3 percent of total payments in outlier payments, more target outlier percentage could risk episodes and total HH PPS payments, than twice our 5 percent statutory limit. access to home care for high needs respectively. Based on these analyses Our analysis also revealed that this patients. However, recent analysis of and comments we received, we decided growth in outlier payments was more current data, specifically CY 2007 that an update to the FDL ratio would primarily the result of excessive growth and CY 2008 data, suggests that a target be appropriate. in outlier payments in a few discrete around that of 2.5 percent in outlier To that end, for the October 22, 2004 areas of the country. We noticed payments to total estimated HH PPS HH PPS rate update for the CY 2005 statistical anomalies in outlier payments payments may be a more appropriate final rule, we performed data analysis in terms of both high outlier dollars and target than 5 percent, while not risking on CY 2003 HH PPS claims data. The as a percentage of total HH PPS access to care for high needs patients. results of that analysis indicated that a payments, in areas such as Miami-Dade Section 1895(b)(5) of the Act states that FDL ratio of 0.70 was consistent with Florida, where outlier payments to the Secretary ‘‘may’’ provide for an the existing loss-sharing ratio of 0.80 providers far exceed the national addition or adjustment to the payment and a projected target percentage of average and the 5 percent target for amount otherwise made in the case of estimated outlier payments of no more outlier payments. Using similar analysis outliers. It goes on to say that if the to what was performed for the CY 2008 Secretary decides to provide such a than 5 percent. Consequently, we final rule with comment, we estimated payment, that the total amount of the updated the FDL ratio from the initial that we would need to raise our FDL additional payments or payment ratio of 1.13 to an FDL ratio of 0.70. Our ratio from 0.89 to 2.71 for CY 2009 in adjustments may not exceed 5 percent analysis showed that reducing the FDL order for estimated outlier payments to of the total payment projected or ratio from 1.13 to 0.70 would increase be no more than 5 percent of total HH estimated to be made under the the percentage of episodes that qualified PPS payments. In addition, the size of payment system. Consequently, for outlier episodes from 3.0 percent to these statistical anomalies raised providing an addition or adjustment to approximately 5.9 percent. A FDL ratio concerns about the medical necessity of the payment amount for outliers is of 0.70 also better met the estimated 5 the outlier episodes in some areas. optional and not statutorily required. percent target of outlier payments to However, in our CY 2009 payment We performed an analysis of all total HH PPS payments. We believed update, we did not raise the FDL ratio providers who receive outlier payments, that this updated FDL ratio of 0.70 to 2.71, given the statistical outlier data focusing our analysis on total HH PPS preserved a reasonable degree of cost anomalies that we identified in certain payments, total outlier payments, sharing, while allowing a greater targeted areas, because program number of episodes, number of outlier number of episodes to qualify for outlier integrity efforts, such as payment episodes, and location of provider. As payments. suspensions for suspect HHAs, were discussed below under ‘‘Proposed Our CY 2006 update to the HH PPS underway to address excessive, suspect Outlier Cap Policy’’, our analysis rates (70 FR 68132) updated the FDL outlier payments that were occurring in incorporates a proposed 10 percent cap ratio from 0.70 to 0.65 to allow even these areas. Instead, we maintained the on outliers and looks at outlier more home health episodes to qualify then-current (CY 2008) FDL ratio of 0.89 payments as a percentage of total HH for outlier payments and to better meet in CY 2009 while actions to remedy any PPS payments with that 10 percent cap the estimated 5 percent target of outlier inappropriate outlier payments in these in place. In our analysis of 2007 data, payments to total HH PPS payments. target areas of the country were after implementing the 10 percent cap, For the CY 2006 update, we used CY effectuated. outlier dollars accounted for 2004 home health claims data. approximately 2.1 percent of total HH 2. Proposed Change To Target Outlier In our CY 2007 update to the HH PPS PPS payments. rates (71 FR 65884) we again updated Payment Percentage Additionally, we performed a separate the FDL ratio from 0.65 to 0.67 to better For CY 2010 rulemaking, we have analysis on a major association of home meet the estimated 5 percent target of expanded our outlier analysis. In health agencies who claim to be safety- outlier payments to total HH PPS addition to assessing what FDL ratio net providers, serving sicker, more payments. For the CY 2007 update, we would most accurately achieve the 5 costly patients. The average outlier used CY 2005 home health claims data. percent target of outlier payments as a payment to these agencies is also under In the CY 2008 final rule with percentage of total HH PPS payments, 2 percent. Therefore, we believe a target comment period, in the interest of using we also performed analyses to assess the of less than 5 percent for outlier dollars the latest data and best analysis appropriateness of adopting a lower as a percentage of total estimated HH available, we performed supplemental target percentage of outlier payments to PPS payments is appropriate. However, analysis on the most recent data total HH PPS payments. Some past years’ data trends show us that available in order to best estimate the commenters to our CY 2008 proposed outlier payments will likely continue to

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grow. Consequently, we propose to an outlier cap, at the agency level, such outlier payments, their relatively high change our target percentage of outlier that in any given year, an individual outlier payment percentages to total payments from 5 percent to HHA would receive no more than a set agency HH PPS payments led us to approximately 2.5 percent of total percentage of its total HH PPS payments suspect inappropriate payments. We estimated HH PPS payments. in outlier payments. We performed believe that the remaining 170 agencies, Currently, we reduce the national extensive analyses to model the impact representing less than 2 percent of all standardized 60-day episode payment to HHAs of a variety of percent caps in Medicare home health agencies, are rates, the national per-visit rates, the outlier payments. A primary focus of representative of the types of agencies LUPA add-on amount, and the NRS this analysis was to identify HHAs we are most concerned about conversion factor by 5 percent in order which would be representative of the disadvantaging with an outlier policy to create an outlier pool that types of agencies we are most concerned that included a 10 percent cap at the accommodates estimated outlier about disadvantaging with an outlier agency level. payments of 5 percent of total HH PPS policy that included an outlier cap at This analysis showed that almost all payments. Targeting the percentage of the agency level. Our analysis revealed of the 170 agencies are in urban areas, outlier payments at approximately 2.5 that a 10 percent agency cap in outlier with only 16 agencies in rural areas. The percent will allow us to create a smaller payments would mitigate potential total number of episodes that resulted in outlier pool and return the remaining inappropriate outlier billing outlier payments is 4,497, about 15 2.5 percent to the HH PPS rates. We vulnerabilities while minimizing the percent of their total episodes. The total would retain a 2.5 percent reduction to access to care risk for high needs HH PPS payments for these agencies the national standardized 60-day patients. equaled about $85 million in CY 2007. episode rates, the national per-visit We used CY 2007 claims data to The total outlier payments for these rates, the LUPA add-on payment perform a detailed impact analysis. We agencies equaled $14.4 million, amount, and the NRS conversion factor identified 1137 HH agencies whose representing an average of about 17 to fund the proposed target of outlier payments exceeded 10 percent of percent of their total HH PPS payments. approximately 2.5 percent of total their total HH PPS payments in CY The total amount of payments that estimated HH PPS payments in outlier 2007. However, we excluded 700 of would be lost by these providers due to payments, adhering to the statutory these agencies from the impact analysis, a 10 percent cap would be $6.6 million, requirement in Section 1895(b)(3) of the because these agencies received sizeable representing an average of Act. outlier payments (totaling at least approximately 7.9 percent of their total around $100,000), had high percentages HH PPS payments. However, because 3. Proposed Outlier Cap Policy (at least around 30 percent) of outlier most affected agencies are in urban Although program integrity efforts payments to total HH PPS payments, areas, and there is not an access associated with excessive outlier and were located in the counties in FL, problem with regard to receiving home payments continue in targeted areas of TX and CA where we believe possible health services in urban areas, we do the country, we continue to be at risk of program integrity issues had been not expect that an outlier cap of 10 exceeding the 5 percent statutory limit identified. percent at the agency level would result on estimated outlier expenditures. We targeted our in-depth impact in any access to care issues. Therefore, our recent analysis also analysis to the remaining 437 agencies, Additionally, we also performed a focused on whether a broader policy about 5 percent of all Medicare home separate analysis of the major home change to our outlier payment policy health agencies. We analyzed these health agency association which claims might also be warranted, to mitigate agencies as a group and individually. to service a sicker, more costly possible billing vulnerabilities Our analysis focused on total HH PPS population. In 2007, only one of these associated with excessive outlier payments, total outlier payments, agencies exceeded 10 percent of its total payments, and to adhere to our statutory number of episodes, number of outlier episode payments in outlier payments, limit on outlier payments. episodes, percentage reductions in receiving approximately 15 percent of We also considered eliminating payments if a 10 percent outlier cap its total HH PPS payments in outlier outlier payments altogether and were imposed, and location. Analyzing payments. restoring the 5 percent, originally taken CY 2007 data, these 437 agencies would Finally, we performed an analysis of out of the national standardized 60-day have experienced about a 10 percent the impact that imposing an outlier cap episode rates, the national per-visit decrease in their total HH payments if of 10 percent at the agency level would rates, the LUPA add-on payment an outlier cap of 10 percent, at the have on total outlier payments as a amount, and the NRS conversion factor agency level, were imposed. As we percentage of total HH PPS payments. to pay for the existing outlier policy, looked closely at the individual 437 The FDL ratio for CY 2007 was 0.67. In back into the HH PPS rates. Eliminating agencies, we excluded additional simulating for 2010 using 2007 data, outlier payments would simplify agencies for a number of reasons. imposing an outlier cap of 10 percent at payments to HHAs and remove the Specifically, we excluded 70 agencies the agency level, we estimate that we vulnerability associated with that had fewer than 20 Medicare HH would pay approximately 2.32 percent inappropriate outlier payments. episodes, believing that Medicare of total HH PPS payments in outlier However, we are concerned that beneficiaries account for such a small payments. eliminating outlier payments to HHAs part of their business that they are not Therefore, to mitigate possible billing could result in denying added representative of the types of agencies vulnerabilities associated with excessive protection to HHAs that historically we are most concerned about outlier payments, and to adhere to our treat sicker, more costly patients. disadvantaging with an outlier cap statutory limit on outlier payments, we In attempts to better estimate outlier policy. propose to implement an agency level payments as a percentage of total HH We excluded an additional 197 outlier cap such that in any given PPS payments and to mitigate agencies because they are also located in calendar year, an individual HHA vulnerabilities associated with the counties identified as experiencing would receive no more than 10 percent inappropriate outlier payments, we also program integrity problems. While these of its total HH PPS payments in outlier looked into options that would impose 197 agencies did not receive exorbitant payments. Additionally, we propose to

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reduce the FDL ratio to 0.67 for CY level, making it even harder for claims processing system would be 2010. This combination of a 10 percent legitimate episodes to qualify for outlier triggered to pay outlier payments, agency level outlier cap, and reduced payments, is the appropriate policy, adjusting prior final claims by paying FDL ratio of 0.67, and allowing for especially given the fact that we believe previously unpaid outlier payments, as future growth in outlier payments, it is these high suspect outlier payments the YTD total HH PPS payments for that results in a projected target outlier in suspect areas of the country that are calendar year allowed, never exceeding payment outlay of approximately 2.5 causing outlier payments as a 10 percent of total YTD HH payments percent of total HH PPS payments in percentage of total HH PPS payments to for that calendar year. In cases where a outlier payments. continue to increase to levels beyond provider submitted a claim with an Our analysis demonstrates that the existing 5 percent target. Conversely, outlier payment early in the year when approximately 2 percent of HH agencies we believe that our proposed outlier YTD total HH PPS payments for that may experience an average 7.9 percent policy that includes a 10 percent cap on calendar year were low, outlier decrease in payments. This decrease outlier payments at the agency level, in payments would be delayed until YTD will be mitigated by a 2.5 percent concert with a new 2.5 percent outlier total HH PPS payments for that calendar increase in the HH PPS rates, as a result pool (as opposed to the existing 5 year reached a level to pay the outlier of lowering the outlier pool from 5 percent outlier pool), and returning 2.5 payment. percent to 2.5 percent. However, these percent back into the national More specifically, instead of a given impacts are averages. Some agencies standardized 60-day episode rates, the claim being readjusted several times as that legitimately serve a sicker national per-visit rates, the LUPA add- total HH PPS payments increase, but not population may experience a larger on payment amount, and the NRS enough to pay an entire outlier payment decrease. Because MedPAC reported in conversion factor, with a 0.67 FDL ratio, on a given claim, we are considering a their January 2009 public meeting would be the appropriate policy at this process by which an outlier payment on (http://www.medpac.gov/transcripts/ time. We expect the new outlier policy a previous claim would not be adjusted 0108–0109MedPAC.final.pdf) that to curtail approximately $340 million, until total HH PPS payments for that Medicare beneficiaries have access to an in CY 2010, in what we believe to be calendar year were such that the entire adequate number of HHAs, we do not inappropriate outlier payments. outlier payment could be made without believe this policy will result in access Finally, CMS will continue to monitor exceeding 10 percent of total HH PPS to home care issues for high needs the trends in outlier payments and these payments for a particular HHA for that patients. policy effects. Specifically, CMS plans calendar year. Doing so would avoid not As discussed in the CY 2009 HH PPS to analyze overall national spending on only the cost of possible multiple Update notice (73 FR 65357), past outlier payments relative to the new 2.5 adjustments to a given claim, but would experience has shown that outlier percent outlier pool by geographic area also simplify the process making payments have been increasing as a and provider type. CMS also plans on adjustments easier to track and percentage of total payments from 4.1 looking at outlier payments, per HHA, understand. We solicit comments on percent in CY 2005, to 5.0 percent in CY relative to the proposed 10 percent cap these proposed outlier policy changes. 2006, to 6.4 percent in CY 2007. on outlier payments at the agency level B. Case-Mix Measurement Analysis Analysis at the time of the above notice by geographic area and provider type. indicated that we could expect outlier So far as activities related to high In the CY 2008 HH PPS final rule with payments as a percentage of total HH suspect outlier payments, CMS is comment period, we stated that we PPS payments to be approximately 8.1 continuing with program integrity would continue to monitor case-mix percent of total payments in CY 2008, efforts including possible payment changes in the HH PPS and to update and increase to approximately 10.26 suspensions for suspect agencies. If we our analysis to measure change in case- percent in CY 2009. Given that are unable to see measurable mix, both nominal and real. We have predicted trend in outlier payments, we improvements with respect to suspected continued to monitor case-mix changes estimated that we would have had to fraudulent billing practices as they and our latest analysis supports the raise our FDL ratio from 0.89 to 2.71 for relate to HHA outlier payments, CMS payment adjustments which we CY2009 in order to ensure that may consider eliminating the outlier implemented in the CY 2008 HH PPS. estimated outlier payments would be no policy entirely in future rulemaking. We have updated our examination of more than 5 percent of total HH PPS Proposed implementation approach five conditions that commenters on our payments. We believe that it is the high to a 10 percent agency level outlier cap. case mix change adjustment suggested suspect outlier payments in suspect CMS envisions the proposed 10 indicate a real case mix change. This areas of the country that cause existing percent cap on outlier payments at the analysis was originally summarized as data analysis to seemingly require such agency level would be managed by the Table 8 in the August 29, 2007, final a high FDL ratio in order to meet the claims processing system. For each HH rule. The updated results (see Table 1 target 5 percent of total HH PPS provider, for a given calendar year, the below) show that the shares of episodes payments. claims processing system would preceded by a hospital discharge for hip Because outlier payments continue to maintain a running tally of YTD total fracture, congestive heart failure, and grow, and those outlier payments as a HH PPS payments and YTD actual cerebrovascular accident have percentage of total HH PPS payments outlier payments. The claims processing continued to decline since the IPS already exceed the statutory limit, system would ensure that each time a baseline. The percent share for hip and absent our proposed outlier cap of 10 claim for a provider was processed; YTD knee replacements rose and then began percent at the agency level, we would be outlier payments for that calendar year to decline slightly around the middle of required to raise the FDL ratio to a level could never exceed 10 percent of YTD the time series shown. (Note: Data since much higher than either the current 0.89 total HH PPS payments for that provider 2005 for joint replacements differ or the proposed 0.67, and doing so for that calendar year. As a provider’s slightly from the original Table would deleteriously affect agencies claims (RAPs and final claims) were regarding the five conditions published providing legitimate care to home health processed and YTD HH PPS payments in the August 29, 2007, Final Rule beneficiaries. We do not believe that for that calendar year increased because we changed our methodology to raising the FDL ratio to such a high throughout the course of the year, the recognize several ICD–9 procedure code

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changes that affected joint replacements, it appears that shares may entering home health exhibits no clear replacements). The increase in joint have ceased climbing. Our trend. For joint replacements, as in the replacements as a proportion of all interpretation of the knee replacement earlier analysis, we saw a continuing episodes was not sustained at the 2004– trend in the August 29, 2007, final rule decline in the average number of days 2005 level by the end of the period, was that this category constituted a prior to entering home health. These perhaps because whatever mechanism small share, that the Abt case mix patients may present in a more sickly operated to cause the growth lost some change model took account of it, and condition than was the case under IPS, of its strength, or perhaps because even that based on the model results the knee but they are no longer a growing share faster growth occurred in other types of replacement change apparently was not of the HH caseload and represent episodes (such as outlier episodes and/ enough to move the estimate of real case slightly less than 4% of the episodes. or later episodes). mix change very much. The updated Combined with the downward or Our interpretation of these trends in data now suggest that knee the Aug. 29, 2007, Final Rule was that, replacements leveled off as a share of stabilizing trends in the shares for all with the possible exception of knee total episodes since around 2005. As a five conditions, the shortening of the replacements, the trends observed at result, we have not changed our time period to admission for the two that time were not clearly indicative of interpretation of the trends in episode joint replacement conditions does not a more-severe case mix. If anything, the shares for these five conditions. suggest an overall more-acute case mix, sustained downward trend for hip Our estimates of average number of at least as indicated by these five fracture, CHF, and CVA suggests that days from hospital discharge to entrance conditions. As we noted in the CY 2008 the burden of these diseases on home into home health was an attempt to final rule, the Abt Associates model health providers is lighter now than it examine the hypothesis that patients simultaneously takes account of all of used to be. For hip replacement, the were entering home health in a more the kinds of patients incurring home share appears to have ended up (thus sickly condition. We did not see any health episodes, including the five far) below the share of such patients evidence of that for the three medical conditions detailed here. during the IPS period. For knee conditions; the number of days prior to

TABLE 1

FY2000 CY2001 CY2002 CY2003 CY2004 CY2005 CY2006 CY2007 CY2008 *

Hip fracture...... pct share...... 0.82 0.83 0.75 0.73 0.70 0.62 0.56 0.50 0.48 days prior to entering .... 7.19 7.12 7.17 7.21 7.30 7.10 7.08 7.20 7.00 Congestive heart fail- pct share...... 3.31 3.06 2.96 2.89 2.72 2.45 2.23 1.95 2.06 ure. days prior to entering .... 3.38 3.28 3.35 3.33 3.36 3.40 3.40 3.53 3.55 Cerebrovascular acci- pct share...... 1.52 1.45 1.40 1.29 1.15 1.03 0.92 0.85 0.82 dent. days prior to entering .... 4.32 4.23 4.21 4.29 4.20 4.32 4.31 4.42 4.59 Hip replacement...... pct share...... 1.47 1.65 1.64 1.59 1.63 1.49 1.38 1.33 1.27 days prior to entering .... 6.45 6.32 6.26 6.29 5.92 5.56 5.30 5.01 4.78 Knee replacement..... pct share...... 1.89 2.20 2.31 2.44 2.59 2.74 2.62 2.49 2.64 days prior to entering .... 5.40 5.30 5.42 5.19 4.93 4.60 4.25 3.99 3.71 Note: Based on a 10% beneficiary HH user sample. * CY 2008 data for first quarter of the year only.

In the course of updating the estimate came from correcting the handling of change, as a percentage of total case-mix of real case-mix change, our analysis missing data. Correcting this error (by change, is slightly lower (11.45 percent). contractor, Abt Associates, discovered a imputing values for cases with missing This is due to the combination of number of errors in data handling for data) caused an increase in the continued strong annual growth the case-mix change model. The estimated real change in case-mix. Our between 2005 and 2006 in the average analysis files included relatively small original estimate, published in the CY case-mix weight, along with little numbers of records that should have 2008 HH PPS final rule (72 FR 49842), change between 2005 and 2006 in been excluded, and relatively small was that about 8.03 percent of the patient characteristics. numbers that were dropped but that increase in case-mix between the IPS We have further updated our case-mix should have been included. Another baseline (1999–2000) and 2005 was due analysis, for this rule, using PPS data error was in the handling of missing to actual changes in patient from 2007. That analysis indicated a data for one of the key variables in the characteristics (i.e., ‘‘real’’). After this 15.03 percent increase in the overall regression model (patient’s living correction, the real case-mix change observed case-mix since 2000. We next situation); data were not recognized as estimate for the same period increased determined what portion of that missing and were therefore miscoded. by several percentage points. Had the increase was associated with a real Methodologically, an improvement was data corrections and improvements been change in the actual clinical condition implemented to ensure that the implemented in the CY 2008 HH PPS of home health patients. As was done observation period for the IPS baseline final rule, our estimate of real case-mix for the CY 2008 final rule, using Abt sample was consistent with the change, as a percentage of total case-mix Associates’ 6-phase model, we observation period for the PPS sample change, would have been approximately examined data on demographics, family (2005). 14.15 percent as opposed to 8.03 support, pre-admission location, clinical Abt Associates made corrections in percent (73 FR 49833, 49842). Updating severity, and non-home health Part A response to each problem identified. that analysis, using PPS data from 2006, Medicare expenditure data to predict The only significant change in results our best estimate of real case-mix the average case-mix weight for 2007.

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As such, our best estimate is that 2010 and CY 2011. We are planning to accelerated in 2006. Therefore, another approximately 9.77 percent of the 15.03 move forward with our existing policy, enhancement that we may test is a percent increase in the overall observed as implemented in the August 22, 2007 variable measuring managed care case-mix between the IPS baseline and HH PPS Refinement and Rate Update for penetration in the beneficiary’s area; 2007 is real, that is, due to actual CY 2008 final rule with comment, of this variable is intended to capture any changes in patient characteristics. imposing a 2.75 percent reduction to the possible effects of attrition from FFS The estimate of real case-mix change national standardized 60-day episode Medicare due to growing enrollment in continues to decrease for a number of rates and the NRS conversion factor for Medicare Advantage plans. Attrition reasons: First, because the nominal CY 2010. We are accepting comments might result in the exit of relatively change in case-mix continues to grow, on the reduction percentages. We will healthy beneficiaries from the FFS real case-mix as a percentage of the total continue to monitor any future changes program, leaving a population in FFS change/increase in case-mix becomes in case-mix as more current data whose average health status worsens less. With each successive sample, become available. Given the continued over time. It is only the FFS population beginning with 2005 data (in the CY growth in nominal case-mix, we expect that is at risk for home health benefit 2008 final rule), the predicted average to revise, upward, the 2.71 percent use in the HH PPS. national case-mix weight is moving very reduction to the national standardized little because the variables in the model 60-day episode rates and the NRS C. Proposed CY 2010 Rate Update used to predict case-mix are not conversion factor for CY 2011 in next 1. The Home Health Market Basket changing much. At the same time, the year’s rule. Analysis in next year’s rule Update actual average case-mix continues to will update the measure of the nominal grow steadily. Thus, the gap between increase in case-mix and compute the Section 1895(b)(3)(B) of the Act the predicted case-mix value, which is appropriate percent reduction to the requires for CY 2010 that the standard based on information external to the national standardized 60-day episode prospective payment amounts be OASIS, and the actual case-mix value, rates and the NRS conversion factor to increased by a factor equal to the grows with each successive sample. account for that increase. applicable home health market basket Consequently, as a result of this We may update the above-mentioned update for those HHAs that submit analysis, CMS recognizes that a 13.56 analysis for the final rule in a number quality data as required by the percent nominal increase of ways. We have been assembling data Secretary. ((15.03¥(15.03 × 0.0977)) in case-mix is to enhance the Abt model to take into The proposed HH PPS market basket due to changes in coding practices and account factors that might have been update for CY 2010 is 2.2 percent. This documentation rather than to treatment unmeasured in the original model. We is based on Global Insight Inc.’s first of more resource-intensive patients. plan to introduce diagnostic summaries quarter 2009 forecast, utilizing historical To compensate for this growth over created from a broader sweep of the data through the fourth quarter 2008. A four years, an increase of this magnitude patient’s claims history, including Part detailed description of how we derive (13.56 percent), had it existed when the B claims. Specifically, we may add the HHA market basket is available in CY 2008 final rule was published, information from the Medicare the CY 2008 Home Health PPS proposed would have implied reductions in the Hierarchical Coexisting Condition rule (72 FR 25356, 25435). rates of 3.13 percent per year for 4 years (HCC) data file to identify diagnoses for 2. Home Health Care Quality (CY 2008–CY 2011). We stated in our home health users and their impact on Improvement CY 2008 HH PPS proposed and final the predicted real case-mix weight. The rules that we might find it necessary to HCC system is used for risk adjustment Section 1895(b)(3)(B)(v)(II) of the Act adjust the offsets as new data became in Part C of the Medicare program. CMS requires that ‘‘each home health agency available. Given that we have adjusted annually produces an HCC record shall submit to the Secretary such data the rates for two consecutive years by containing diagnosis flags and an HCC that the Secretary determines are ¥2.75 percent in each year, based on ‘‘score’’ for every beneficiary. The appropriate for the measurement of 2007 data available for this proposed diagnoses used for HCC risk adjustment health care quality. Such data shall be rule, if we were to account for the come from hospital inpatient claims submitted in a form and manner, and at residual increase in nominal case-mix (primary and secondary diagnoses) a time, specified by the Secretary for over the next two years, maintain our (including rehabilitation, long-term, and purposes of this clause.’’ In addition, existing policy of a ¥2.75 percent case- psychiatric hospitals), hospital section 1895(b)(3)(B)(v)(I) of the Act mix change in 2010, and account for the outpatient department claims, physician dictates that ‘‘for 2007 and each residual increase in nominal case-mix in claims, and claims from clinically subsequent year, in the case of a home 2011, we estimate that the percentage trained nonphysicians such as health agency that does not submit data reduction in the rates for nominal case- podiatrists, psychologists, and physical to the Secretary in accordance with mix change in 2011 would be 4.26 therapists. Until now, diagnostic subclause (II) with respect to such a percent. If we were to account (in the information for the Abt model came year, the home health market basket final rule) for the full residual increase from Part A inpatient claims only. percentage increase applicable under in nominal case-mix in CY 2010, we Commenters have suggested that we such clause for such year shall be estimate that the percentage reduction take into account changes in the role of reduced by 2 percentage points.’’ This to the national standardized 60-day managed care in the Medicare program. requirement has been codified in episode rates and the NRS conversion These commenters stated that growth in regulations at § 484.225. factor would be 6.89 percent. Similarly, managed care enrollment implies a CMS published information about the if we were to account (in the final rule) generally sicker population remaining quality measures in the Federal Register for the full residual increase in nominal in the fee-for-service program; a change as a proposed rule on May 4, 2007 (72 case-mix in two years, we estimate that in home health users’ general health FR 25449, 25452) and as a final rule the percentage reduction to the national status might be reflected in OASIS items with comment period on August 29, standardized 60-day episode payment that determine the episode’s HHRG. 2007 (72 FR 49861, 49864). We rates and the NRS conversion factor Medicare managed care began to grow proposed and made final the decision to would be 3.51 percent, per year, in CY modestly in 2004, but growth use a subset of OASIS data that is

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publicly reported on Home Health through a separate mechanism, and that full home health market basket Compare as the appropriate measure of the costs associated with the percentage increase. HHAs that do not home health quality. development and testing of a new meet the reporting requirements would Reporting these quality data has also reporting mechanism can be avoided. be subject to a 2 percent reduction to the required the development of several We are proposing for CY 2010 to home health market basket increase. We supporting mechanisms such as the consider OASIS assessments submitted provide the proposed payment rates in HAVEN software, used to encode and by HHAs to CMS in compliance with Tables 1, 2, and 3. transmit data using a CMS standard HHA conditions of participation for Section 1895(b)(3)(B)(v)(III) of the Act electronic record layout, edit episodes beginning on or after July 1, further requires that ‘‘[t]he Secretary specifications, and data dictionary. The 2008 and before July 1, 2009 as fulfilling shall establish procedures for making HAVEN software includes the required the quality reporting requirement for CY data submitted under subclause (II) OASIS data set that has become a 2010. This time period would allow 12 available to the public. Such procedures standard part of HHA operations. These full months of data collection and shall ensure that a home health agency early investments in data infrastructure would provide us the time necessary to has the opportunity to review the data and supporting software that CMS and analyze and make any necessary that is to be made public with respect HHAs have made over the past several payment adjustments to the payment to the agency prior to such data being years in order to create this quality rates in CY 2010 and each year made public.’’ To meet the requirement reporting structure have been successful thereafter. We propose to reconcile the for making such data public, we propose in making quality reporting and OASIS submissions with claims data in to continue using the Home Health measurement an integral component of order to verify full compliance with the Compare Web site, which lists HHAs the HHA industry. quality reporting requirements in CY geographically. Currently, the Home Development and selection of home 2010 and each year thereafter on an Health Compare Web site lists 12 health quality measures is a constant annual cycle July 1 through June 30 as quality measures from the OASIS set as and dynamic process based on the described above. described above. The Home Health characteristics and needs of the As set forth in the CY 2008 final rule Compare Web site is located at the population served. A total of 54 quality with comment period (72 FR 49863), following Web address: http:// measures are currently reported to home agencies do not need to submit quality www.medicare.gov/HHCompare/ health agencies for use in their measures for reporting purposes for Home.asp. Each HHA currently has pre- Outcomes Based Quality Improvement those patients who are excluded from publication access (through the CMS (OBQI) activities. Every three years a the OASIS submission requirements contractor) to its own quality data selection of Home Health quality under the Home Health Conditions of (which the contractor updates measures are submitted to the National Participation (CoP). The conditions of periodically). We plan to continue this Quality Forum (NQF) for consideration participation (42 CFR 484.200–484.265) process, to enable each agency to view and endorsement through their that require submission also provide for its quality measures before public consensus process. A subset of measures exclusions from this requirement if: posting of data on Home Health • are chosen by CMS for public reporting Those patients are receiving only Compare. non-skilled services, CMS is requesting OMB approval to on the Home Health Compare Web site. • The following twelve measures are Neither Medicare nor Medicaid is modify the OASIS data set. This process currently publicly reported: paying for home health care (patients is in the final stages of OMB clearance. • Improvement in ambulation/ receiving care under a Medicare or Pending OMB approval, CMS intends to locomotion, Medicaid Managed Care Plan are not implement the use of the OASIS–C • Improvement in bathing, excluded from the OASIS reporting (Form Number CMS–R–245 (OMB# • Improvement in transferring, requirement), 0938–0760)) on January 1, 2010. This • Improvement in management of • Those patients are receiving pre- or revision to the current OASIS version oral medications, post-partum services, or B–1 has undergone additional testing as • • Improvement in pain interfering Those patients are under the age of part of the information collection with activity, 18 years. request approved under OMB control • Acute care hospitalization, As set forth in the CY 2008 final rule number 0938–1040. As part of the OMB • Emergent care, with comment period (72 FR 49863), approval process, the revision to the • Discharge to community, agencies that certify on or after May 31 current OASIS version was also • Improvement in dyspnea, of the preceding year involved are distributed for public comment and • Improvement in urinary excluded from any payment penalty for other technical expert recommendations incontinence, quality reporting purposes for the over the past few years. We propose that • Improvement in status of surgical following CY. Therefore, HHAs that are this new version of OASIS be collected wounds, and certified on or after May 1, 2009 are on episodes of care with a • Emergent care for wound infections, excluded from the quality reporting corresponding OASIS item (M0090) date deteriorating wound status. requirement for CY 2010 payments of January 1, 2010 or later. The OASIS– Accordingly, for CY 2010, we propose since data submission and analysis will C can be found using the following link: to continue to use submission of OASIS not be possible for an agency certified http://www.cms.hhs.gov/Paperwork data and the quality measures that are this late in the reporting time period. At ReductionActof1995/PRAL/itemdetail. publicly reported on Home Health the earliest time possible after obtaining asp?filterType=none&filterByDID=- Compare to meet the requirement that the CMS Certification Number (CCN), 99&sortByDID=2&sortOrder= the HHA submit data appropriate for the reporting would be mandatory. These descending&itemID=CMS1217682 measurement of health care quality. exclusions only affect quality reporting &intNumPerPage=10. Continuing to use the specified requirements and do not affect the We are also planning to update Home measures from the OASIS instrument HHA’s reporting responsibilities under Health Compare to reflect the addition for purposes of measuring health care the CoP. of the following 13 new process of care quality ensures that providers will not HHAs that meet the reporting measures: have an additional burden of reporting requirements would be eligible for the Æ Timely initiation of care,

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Æ Influenza immunization received perspectives of the home health quality survey received NQF endorsement on for current flu season, of care from the agency cannot be March 31, 2009. Æ Pneumococcal polysaccharide obtained from any other quality measure The HHCAHPS survey includes 34 vaccine ever received, in the program. The Home Health Care questions that cover topics such as Æ Heart failure symptoms addressed Survey is part of a family of CAHPS® specific types of care provided by home during short-term episodes, surveys that ask patients to report on health providers, communication with Æ Diabetic foot care and patient and rate their experiences with health providers, interactions with the HHA, education implemented during short- care. The HHCAHPS survey developed and global ratings of the agency. For term episodes of care, by the Agency for Healthcare Research public reporting purposes, CMS will Æ Pain assessment conducted, and Quality (AHRQ), which is part of utilize composite measures and global Æ Pain interventions implemented the Department of Health and Human ratings of care. Each composite measure during short-term episodes, Services, presents home health patients consists of four or more questions that Æ Depression assessment conducted, with a set of standardized questions Æ ask about one of the following related Drug education on all medications about their home health care providers topics: provided to patient/caregiver during and the quality of their home health • Patient care; short-term episodes. care. Prior to this survey, there was no • Æ Communications between providers Falls risk assessment for patients 65 national standard for collecting and patients; and older, information about patient experiences • Æ Specific care issues (medications, Pressure ulcer prevention plans that would enable valid comparisons home safety and pain). implemented, across all HHAs. Æ There are also two global ratings; the Pressure ulcer risk assessment AHRQ developed the HHCAHPS first rating asks the patient to assess the conducted, and survey with the assistance of many Æ care given by the HHA’s care providers, Pressure ulcer prevention included entities (for example, government and the second asks the patient about in the plan of care. agencies, professional stakeholders, his/her willingness to recommend the Also under consideration are three consumer groups and other key HHA to family and friends. additional process of care measures that individuals and organizations involved We are proposing two options for may be added to Home Health Compare in home health care). The HHCAHPS administering the HHCAHPS survey. based on results of consumer testing. survey was designed to measure and The agency can choose to administer the Those additional process measures are: assess the experiences of those persons Æ Drug education on high risk receiving home health care with the existing HHCAHPS survey, or the HHA medications provided to patient/ following three goals in mind: can integrate additional questions caregiver at start of episode; • To produce comparable data on within the HHCAHPS survey. If an Æ Potential medication issues patients’ perspectives of care that allow agency chooses to implement an identified and timely physician contact objective and meaningful comparisons integrated survey, the core questions at start of episode; between home health agencies on from the HHCAHPS survey (questions 1 Æ Potential medication issues domains that are important to through 25) must be placed before any identified and timely physician contact consumers; specific/supplemental questions that the during episode. • To create incentives for agencies to HHA wishes to add to the survey. The implementation of OASIS–C will improve their quality of care through Questions 26 through 34 (the ‘‘About impact the quality data reporting public reporting of survey results; and You’’ survey questions) must be requirement for the CY 2011 HH PPS. • To hold health care providers administered as a unit—although they However, we expect the conversion accountable by informing the public may be placed either before or after any from OASIS–B1 to OASIS–C to have about the providers’ quality of care supplemental questions that the HHA little to no impact on HHAs’ ability to (http://www.homehealthcahps.org). wishes to add to the HHCAHPS survey. meet the quality data reporting These three goals support Section If no HHA-specific questions are to be requirements under Section 1861(o)(8) of the Act, which requires added to the HHCAHPS survey, the 1895(b)(3)(B)(v). any Medicare participating HHA to ‘‘About You’’ questions should follow For CY 2011, CMS proposes to ‘‘meet [] such additional requirements the core questions (numbered 1 through expand the home health quality * * * as the Secretary finds necessary 25) on the HHCAHPS survey. measures reporting requirements to for the effective and efficient operation The survey is currently available in include the Consumer Assessment of of the program.’’ both English and Spanish. HHAs and Healthcare Providers and Systems The development process for the their survey vendors will not be (CAHPS®) Home Health Care Survey survey began in 2006 and included a permitted to translate the HHCAHPS (pending OMB approval). The CAHPS® public call for measures, review of the survey into any other languages on their Home Health Care Survey (hereafter existing literature, consumer input, own. However, CMS will provide ‘‘HHCAHPS’’) is a quality tool that we stakeholder input, public response to additional translations of the survey believe that we can use to collect quality Federal Register notices, and a field test over time. The Web site https:// of care data, as required by section conducted by AHRQ. AHRQ conducted www.homehealthcahps.org will provide 1895(b)(3)(B)(v)(II) of the Act, and as this field test to validate the length and information about the subsequent permitted under section 1861(o)(8) of content of the HHCAHPS survey. CMS availability of additional translations. the Act, which requires any Medicare submitted the survey to the National CMS also solicits user suggestions for participating HHA to ‘‘meet [ ] such Quality Forum (NQF) for consideration any additional language translations. additional requirements * * * as the and endorsement via their consensus Such suggestions should be submitted Secretary finds necessary for the process. NQF endorsement represents online to the HHCAHPS Survey effective and efficient operation of the the consensus opinion of many Coordination Team, at program’’. The HHCAHPS data healthcare providers, consumer groups, [email protected]. HHAs interested in collection will support the effective and professional organizations, health care learning about the survey are efficient operation of the program purchasers, Federal agencies and encouraged to view the HHCAHPS because patients’ feedback on their research and quality organizations. The survey Web site, at https://

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www.homehealthcahps.org. Agencies CAHPS® Home Health Care each monthly sample would have to be can also call toll-free 1–866–354–0985, (HHCAHPS) survey data in accordance completed within six weeks (42 days) or send an e-mail to the HHCAHPS with the Protocols and Guidelines after data collection began. CMS has Survey Coordination Team at Manual located on the HHCAHPS Web approved three modes of the survey to [email protected] for more information. site https://www.homehealthcahps.org. be used: Mail only, telephone only, and The following types of home health HHAs shall contract with approved mail with telephone follow-up (the care patients will be considered eligible HHCAHPS survey vendors that are ‘‘mixed mode’’). We are proposing that to participate in the HHCAHPS survey: posted on https:// for mail-only and mixed-mode surveys, • Current or discharged patients who www.homehealthcahps.org to conduct data collection for a monthly sample had at least one home health visit at any the survey on behalf of HHAs. CMS would have to end six weeks after the time during the sample month; proposes that participating home health first questionnaire was mailed. For • Patients who were at least 18 years agencies conduct a dry run of the survey telephone-only surveys, data collection of age at any time during the sample for at least one month in the first quarter would have to end six weeks following period, and are believed to be alive; of 2010 (January, and/or February, and/ the first telephone attempt. • Patients who received at least two or March 2010), and submit the dry run CMS is aware that there is a wide visits from HHA personnel during a 60- data to the Home Health CAHPS® Data variation in the size of Medicare- day look-back period (Note that the 60- Center by 11:59 p.m. EST on June 23, certified HHAs. CMS proposes that the day look-back period is defined as the 2010. The dry run data would not be requirement to collect HHCAHPS 60-day period prior to and including the publicly reported on the Home Health survey data be waived for agencies that last day in the sample month.); serve fewer than 60 HHCAHPS eligible • Compare. This dry run would provide Patients who have not been selected an opportunity for vendors and HHAs to patients annually. We are proposing this for the monthly sample during any acquire first-hand experience with data threshold amount in order to exempt month in the current quarter or during collection, including sampling and data agencies that serve a very small home the 5 months immediately prior to the submission to the Home Health health eligible population. These sample month; CAHPS® Data Center, with no public agencies serve, on average, 5 or fewer • Patients who are not currently reporting of the results. CMS proposes patients per month. The HHCAHPS receiving hospice care; that all Medicare-certified HHAs eligible, unduplicated patient counts for • Patients who do not have routine the period of October 1 through ‘‘maternity’’ care as the primary reason continuously collect HHCAHPS survey data every quarter beginning in the September 30 for a given year would be for receiving home health care; and used to determine if the HHA would • Patients who have not requested second quarter (April, May and June) of 2010, and submit these data for the have to participate in the HHCAHPS ‘‘no publicity status.’’ survey in the next calendar year. If a CMS has modeled HHCAHPS after the second quarter of 2010 to the Home Health CAHPS® Data Center by 11:59 Medicare-certified HHA had fewer than Hospital CAHPS survey where both the 60 eligible, unduplicated HHCAHPS CAHPS and clinical data are collected p.m. EST on September 22, 2010. CMS proposes that these data submission eligible patients for the period October for both Medicare and non-Medicare 1 through September 30, then they patients to get a complete picture of deadlines are firm; that is, there will be no late submissions allowed. would be excluded from the HHCAHPS hospital quality. Since HHCAHPS data requirement for the next calendar year. used to develop case-mix collection of The Medicare-certified HHAs will For example, if a small HHA had 85 data for HHCAHPS are not carried out need to provide their respective survey patients in the period October 1, 2008 under the auspices of section 4602(e) of vendors with information about their through September 30, 2009, and 45 of the BBA, such collections are not survey-eligible patients (either current the patients were routine maternity subject to the OASIS limitation to or discharged) every month in patients, then there would only be 40 Medicare and Medicaid patients only, accordance with the Protocols and HHCAHPS eligible patients. This agency set out under section 704(a) of the Guidelines Manual posted on https:// would therefore not be required to MMA. To collect and submit HHCAHPS www.homehealthcahps.org. The details participate in the HHCAHPS survey. data to CMS, Medicare-certified about selecting the HHA sample are Alternatively, if a small HHA had 85 agencies will need to contract with an delineated in the Protocols and patients for the period October 1, 2008 approved HHCAHPS survey vendor. Guidelines manual on the Web site through September 30, 2009, and 70 of Interested vendors can now apply to https://www.homehealthcahps.org. It is these patients were eligible to become approved HHCAHPS vendors. proposed that the HHCAHPS survey participate in the HHCAHPS survey The application process is delineated data be submitted and analyzed (i.e., because they: (1) Were 65 years or online at https:// quarterly, and that the sample selection older; (2) were recently discharged from www.homehealthcahps.org. Vendors and data collection occur on a monthly the hospital to their homes; (3) were not will also be required to attend training basis. HHAs should target 300 receiving hospice care; (4) were not conducted by CMS and the HHCAHPS HHCAHPS survey completes annually. designated as ‘‘no publicity’’ patients; Survey Coordination Team. HHAs that Smaller agencies that are unable to and (5) had received at least two home are interested in participating in the reach 300 survey completes by sampling health visits) this agency would be HHCAHPS survey may do so on a should survey all HHCAHPS eligible required to participate in the HHCAHPS voluntary basis for the remaining patients. For reasons of statistical survey. Only Medicare-certified HHAs months of 2009. Such agencies must precision, a target minimum of 300 or with fewer than 60 eligible, select a vendor from the list of more completed Home Health CAHPS unduplicated patients for the period HHCAHPS approved survey vendors. surveys has been set for each home October 1, 2008 through September 30, This listing will be available on the Web health agency. 300 completes is based 2009 would submit their patient counts site https://www.homehealthcahps.org on a reliability target of 0.8 or higher. to the HHCAHPS Data Center by during the summer of 2009. We propose that survey vendors initiate Wednesday, January 13, 2010. CMS proposes that beginning in the the survey for each monthly sample We also propose that newly Medicare- first quarter of CY 2010, all Medicare- within three weeks after the end of the certified HHAs (that is, those certified certified HHAs shall begin to collect the sample month. All data collection for on or after January 1, 2010 for payments

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to be made in CY 2011) be excluded materials relevant to survey results in the appropriate adjustment to from the HHCAHPS survey reporting administration would be subject to the labor portion of the costs as required requirement, as data submission and review. The proposed systems and by statute. analysis would not be possible for an program review would include, but not In the November 9, 2005 final rule for agency so late in the reporting period. be limited to: (a) Survey management CY 2006 (70 FR 68132), we adopted In future years, agencies that first certify and data systems; (b) printing and revised labor market area definitions on or after January 1 of the preceding mailing materials and facilities; (c) data year would be excluded from any receipt, entry and storage facilities; and based on Core-Based Statistical Areas payment penalty for reporting purposes (d) written documentation of survey (CBSAs). At the time, we noted that in the following CY. We note that this processes. Organizations would be given these were the same labor market area exclusion for new HHAs pertains only a defined time period in which to definitions (based on OMB’s new CBSA to the HHCAHPS survey reporting correct any problems and provide designations) implemented under the requirement. follow-up documentation of corrections Hospital Inpatient Prospective Payment CMS strongly recommends that HHAs for review. Survey vendors will be System (IPPS). In adopting the CBSA participating in the HHCAHPS survey subject to follow-up site visits as designations, we identified some promptly review the required Data needed. geographic areas where there are no Submission Summary Reports that are CMS strongly recommends that all hospitals and, thus, no hospital wage delineated in the Protocols and HHAs participating in the HHCAHPS data on which to base the calculation of Guidelines Manual posted on https:// survey regularly check the Web site, the home health wage index. We www.homehealthcahps.org. These https://www.homehealthcahps.org for continue to use the methodology reports will enable the HHA to ensure program updates and information. discussed in the November 9, 2006 final that its survey vendor has submitted As mandated in current law, all rule for CY 2007 (71 FR 65884) to HHAs, unless covered by specific their data on time, and that the data address the geographic areas that lack exclusions, will continue to be required have been accepted/received by the hospital wage data on which to base the ® to meet the quality reporting Home Health CAHPS Data Center. calculation of their home health wage CMS anticipates first reporting requirements or be subject to a 2 percent index. For rural areas that do not have HHCAHPS survey data in early 2011 on reduction in the home health market IPPS hospitals, we use the average wage Home Health Compare. The HHCAHPS basket percentage increase in survey data would be updated quarterly. accordance with section index from all contiguous CBSAs as a HHAs would be provided a preview of 1895(b)(3)(B)(v)(I) of the Act. A reasonable proxy. This methodology is the data each quarter before it was reconsideration and appeals process is used to calculate the wage index for reported on Home Health Compare. being developed for HHAs who fail to rural Massachusetts. However, we could CMS proposes that vendors and HHAs meet the HHCAHPS reporting not apply this methodology to rural be required to participate in HHCAHPS requirements. These procedures would Puerto Rico due to the distinct survey oversight activities to ensure be outlined in the HH PPS proposed economic circumstances that exist there, compliance with HHCAHPS survey rule for CY 2011 in which we are but instead continue using the most protocols, guidelines and survey proposing that the HHCAHPS survey recent wage index previously available requirements. The purpose of the would be linked to home health for that area (from CY 2005). For urban oversight activities is to ensure that payment, as a requirement under the areas without IPPS hospitals, we use the HHAs and approved survey vendors regulation requiring the reporting of average wage index of all urban areas follow the Protocols and Guidelines quality data. within the State as a reasonable proxy Manual. It is proposed that all approved 3. Home Health Wage Index for the wage index for that CBSA. The survey vendors develop a Quality only urban area without IPPS hospital Assurance Plan (QAP) for survey Sections 1895(b)(4)(A)(ii) and (b)(4)(C) of the Act require the Secretary to wage data is Hinesville-Fort Stewart, administration in accordance with the Georgia (CBSA 25980). Protocols and Guidelines Manual. The establish area wage adjustment factors that reflect the relative level of wages QAP should include the following: On November 20, 2008, OMB issued • Organizational chart; and wage-related costs applicable to the Bulletin No. 09–01 located at Web • Work plan for survey furnishing of home health services and address http://www.whitehouse.gov/ implementation; to provide appropriate adjustments to omb/bulletins/fy2009/09-01.pdf. This • Description of survey procedures the episode payment amounts under the bulletin highlights three geographic and quality controls; HH PPS to account for area wage areas that were previously classified as • Quality assurance oversight of on- differences. As discussed previously, we Micropolitan Statistical Areas but now site work and of all subcontractors apply the appropriate wage index value qualify as Metropolitan Statistical work; and to the labor portion (77.082 percent) of Areas. The three areas are (1) CBSA • Confidentiality/Privacy and the HH PPS rates based on the site of 16020, Cape Girardeau-Jackson, MO–IL service for the beneficiary (defined by Security procedures in accordance with (this includes Alexander County in section 1861(m) of the Act as the the Health Insurance Portability and Illinois and Bollinger and Cape Accountability Act (HIPAA). beneficiary’s place of residence). As part of the oversight activities the Generally, we determine each HHA’s Girardeau Counties in Missouri); (2) HHCAHPS Survey Coordination Team labor market area based on definitions CBSA 31740, Manhattan, KS (this would conduct on-site visits or of Metropolitan Statistical Areas (MSAs) includes Geary, Pottawatomie, and Riley conference calls. The HHCAHPS Survey issued by the Office of Management and Counties in Kansas); and (3) CBSA Coordination Team would review the Budget (OMB). We have consistently 31860, Mankato-North Mankato, MN survey vendor’s survey systems, and used the pre-floor, pre-reclassified (this includes Blue Earth and Nicollet will assess administration protocols hospital wage index data to adjust the Counties in Minnesota). These three based on the Protocols and Guidelines labor portion of the HH PPS rates. We new CBSAs and their associated wage Manual posted on https:// believe the use of the pre-floor, pre- index values are shown in Addendum www.homehealthcahps.org. All reclassified hospital wage index data B.

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4. Proposed CY 2010 Payment Update For CY 2010, we will base the wage • An outlier payment as set forth in a. National Standardized 60-Day index adjustment to the labor portion of § 484.205(e) and § 484.240. the HH PPS rates on the most recent Episode Rate b. Proposed Updated CY 2010 National pre-floor and pre-reclassified hospital Standardized 60-Day Episode Payment The Medicare HH PPS has been in wage index. As discussed in the July 3, Rate effect since October 1, 2000. As set forth 2000 HH PPS final rule, for episodes in the final rule published July 3, 2000 with four or fewer visits, Medicare pays In calculating the annual update for in the Federal Register (65 FR 41128), the national per-visit amount by the CY 2010 national standardized 60- the unit of payment under the Medicare discipline, referred to as a LUPA. We day episode payment rates, we first look HH PPS is a national standardized 60- update the national per-visit rates by at the CY 2009 rates as a starting point. day episode rate. As set forth in discipline annually by the applicable The CY 2009 national standardized 60- § 484.220, we adjust the national home health market basket percentage. day episode payment rate is $2,271.92. standardized 60-day episode rate by a We adjust the national per-visit rate by As previously discussed in section case-mix relative weight and a wage the appropriate wage index based on the II.B., ‘‘Outlier Policy’’, of this proposed index value based on the site of service site of service for the beneficiary, as set rule, in our proposed policy of targeting for the beneficiary. forth in § 484.230. We will adjust the outlier payments to be approximately In the CY 2008 HH PPS final rule with labor portion of the updated national 2.5 percent of total HH PPS payments in comment period, we refined the case- per-visit rates used to calculate LUPAs CY 2010, we are proposing to return 2.5 mix methodology and also rebased and by the most recent pre-floor and pre- percent back into the HH PPS rates, to revised the home health market basket. reclassified hospital wage index, as include the national standardized 60- The labor-related share of the case-mix discussed in the CY 2008 HH PPS final day episode payment rate. As such, to adjusted 60-day episode rate is 77.082 calculate the proposed CY 2010 national percent and the non-labor-related share rule with comment period. We are also standardized 60-day episode payment is 22.918 percent. The proposed CY updating the LUPA add-on payment rate, we first increase the CY 2009 2010 HH PPS rates use the same case- amount and the NRS conversion factor mix methodology and application of the by the applicable home health market national standardized 60-day episode wage index adjustment to the labor basket update of 2.2 percent for CY payment rate ($2,271.92) to adjust for portion of the HH PPS rates as set forth 2010. the 5 percent originally set aside for in the CY 2008 HH PPS final rule with Medicare pays the 60-day case-mix outlier payments. We then reduce that comment period. We multiply the and wage-adjusted episode payment on adjusted payment amount by 2.5 national 60-day episode rate by the a split percentage payment approach. percent, the proposed target percentage patient’s applicable case-mix weight. The split percentage payment approach of outlier payments as a percentage of We divide the case-mix adjusted includes an initial percentage payment total HH PPS payment. Next, we update amount into a labor and non-labor and a final percentage payment as set by the current proposed CY 2010 home portion. We multiply the labor portion forth in § 484.205(b)(1) and health market basket update percentage by the applicable wage index based on § 484.205(b)(2). We may base the initial of 2.2 percent. the site of service of the beneficiary. We percentage payment on the submission As previously discussed in Section add the wage-adjusted portion to the of a request for anticipated payment II.C., ‘‘Case-Mix Measurement non-labor portion yielding the case-mix (RAP) and the final percentage payment Analysis’’, of this proposed rule, our and wage adjusted 60-day episode rate on the submission of the claim for the updated analysis of the change in case- subject to any additional applicable episode, as discussed in § 409.43. The mix not due to an underlying change in adjustments. claim for the episode that the HHA patient health status reveals additional In accordance with section submits for the final percentage increase in nominal change in case-mix. 1895(b)(3)(B) of the Act, we update the payment determines the total payment However, we are maintaining our HH PPS rates annually in a separate amount for the episode and whether we existing policy to reduce rates by 2.75 Federal Register document. The HH make an applicable adjustment to the percent in CY 2010. Consequently, to PPS regulations at 42 CFR 484.225 set 60-day case-mix and wage-adjusted calculate the proposed CY 2010 national forth the specific annual percentage episode payment. The end date of the standardized 60-day episode payment update. In accordance with § 484.225(i), 60-day episode as reported on the claim rate, we then reduce the rate by 2.75 in the case of a HHA that does not determines which calendar year rates percent, for a proposed updated CY submit home health quality data, as Medicare would use to pay the claim. 2010 national standardized 60-day episode payment rate of $2,325.79. The specified by the Secretary, the We may also adjust the 60-day case- proposed updated CY 2010 national unadjusted national prospective 60-day mix and wage-adjusted episode standardized 60-day episode payment episode rate is equal to the rate for the payment based on the information rate for an HHA that submits the previous calendar year increased by the submitted on the claim to reflect the applicable home health market basket required quality data is shown in Table following: index amount minus two percentage 2. The proposed updated CY 2010 • points. Any reduction of the percentage A low utilization payment provided national standardized 60-day episode change will apply only to the calendar on a per-visit basis as set forth in payment rate for an HHA that does not year involved and will not be taken into § 484.205(c) and § 484.230. submit the required quality data (home account in computing the prospective • A partial episode payment health market basket update of 2.2 payment amount for a subsequent adjustment as set forth in § 484.205(d) percent is reduced by 2 percent) is calendar year. and § 484.235. shown in Table 3.

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TABLE 2—PROPOSED NATIONAL STANDARDIZED 60-DAY EPISODE PAYMENT RATE UPDATED BY THE PROPOSED HOME HEALTH MARKET BASKET UPDATE FOR CY 2010, BEFORE CASE-MIX ADJUSTMENT AND WAGE ADJUSTMENT BASED ON THE SITE OF SERVICE FOR THE BENEFICIARY

Adjusted to return the Proposed CY 2010 CY 2009 National outlier funds, that paid Adjusted to account Multiply by the pro- Reduce by 2.75 National Standardized Standardized 60-Day for the original 5% for the proposed 2.5% posed home health percent for nominal 60-Day Episode Payment target for outlier outlier policy market basket update change in case-mix Episode Payment 1 Rate payments (2.2 percent) Rate

$2,271.92 / 0.95 × 0.975 × 1.022 × 0.9725 $2,317.47 1 The proposed estimated home health market basket update of 2.2 percent for CY 2010 is based on Global Insight Inc., 1st Qtr 2009 forecast with historical data through 4th Qtr 2008.

TABLE 3—FOR HHAS THAT DO NOT SUBMIT THE REQUIRED QUALITY DATA; PROPOSED NATIONAL STANDARDIZED 60- DAY EPISODE PAYMENT RATE UPDATED BY THE PROPOSED HOME HEALTH MARKET BASKET UPDATE FOR CY 2010, BEFORE CASE-MIX ADJUSTMENT AND WAGE ADJUSTMENT BASED ON THE SITE OF SERVICE FOR THE BENEFICIARY

Proposed CY 2010 Multiply by the National Standardized Total CY 2009 Adjusted to return the Adjusted to account proposed home Reduce by 2.75 60-Day Episode National Standardized outlier funds, that paid for the proposed 2.5% health market basket percent for nominal Payment Rate for 1 60-Day Episode Pay- for the original 5% outlier policy update (2.2 percent) change in case-mix HHAs That Do Not ment Rate target for outliers minus 2 percent for a Submit 0.2 percent update Required Quality Data

$2,271.92 / 0.95 × 0.975 × 1.002 × 0.9725 $2,272.12 1 The proposed estimated home health market basket update of 2.2 percent for CY 2010 is based on Global Insight Inc., 1st Qtr 2009 forecast with historical data through 4th Qtr 2008.

c. Proposed National Per-Visit Rates adjust for the 5 percent originally set nominal increase in case-mix because Used To Pay LUPAs and Compute aside for outlier payments. We then they are per-visit rates and hence not Imputed Costs Used in Outlier reduce those national per-visit rates by case-mix adjusted. The proposed CY Calculations 2.5 percent, the proposed target 2010 national per-visit rates per In calculating the proposed CY 2010 percentage of outlier payments as a discipline are shown in Table 4. The six national per-visit rates used to calculate percentage of total HH PPS payment. home health disciplines are Home payments for LUPA episodes and to Next we update by the by the current Health Aide (HH aide), Medical Social compute the imputed costs in outlier proposed CY 2010 home health market Services (MSS), Occupational Therapy calculations, we start with the CY 2009 basket update percentage of 2.2 percent. (OT), Physical Therapy (PT), Skilled national per-visit rates. We first adjust National per-visit rates are not subject to Nursing (SN), and Speech Language the CY 2009 national per-visit rates to the 2.75 percent reduction related to the Therapy (SLP). TABLE 4—PROPOSED NATIONAL PER-VISIT RATES FOR LUPAS (NOT INCLUDING THE LUPA ADD-ON PAYMENT AMOUNT FOR A BENEFICIARY’S ONLY EPISODE OR THE INITIAL EPISODE IN A SEQUENCE OF ADJACENT EPISODES) AND OUTLIER CALCULATIONS UPDATED BY THE PROPOSED CY 2010 HOME HEALTH MARKET BASKET UPDATE, BEFORE WAGE INDEX ADJUSTMENT

For HHAs that DO submit For HHAs that DO NOT the required quality data submit the required qual- ity data Adjusted to Multiply by CY 2009 return the Adjusted to CY 2010 the pro- CY 2010 Per-Visit outlier funds account for Multiply by per-visit posed home per-visit Home Health Discipline Type Amounts that paid for the pro- the pro- payment health mar- payment Per 60-Day the original posed 2.5% posed home amount for ket basket amount for Episode for 5% target outlier policy health mar- HHAs that update (2.2 HHAs that LUPAs for outlier ket basket 1 payments update (2.2 DO submit percent) DO NOT 1 the required minus 2 submit the percent) quality data percent, for required a 0.2 per- quality data cent update

Home Health Aide ...... $48.89 / 0.95 × 0.975 × 1.022 $51.28 × 1.002 $50.28 Medical Social Services ...... 173.05 / 0.95 × 0.975 × 1.022 181.51 × 1.002 177.96 Occupational Therapy ...... 118.83 / 0.95 × 0.975 × 1.022 124.64 × 1.002 122.20 Physical Therapy ...... 118.04 / 0.95 × 0.975 × 1.022 123.81 × 1.002 121.39 Skilled Nursing ...... 107.95 / 0.95 × 0.975 × 1.022 113.23 × 1.002 111.01 Speech-Language Pathology ...... 128.26 / 0.95 × 0.975 × 1.022 134.53 × 1.002 131.90 1 The proposed estimated home health market basket update of 2.2 percent for CY 2010 is based on Global Insight Inc., 1st Qtr 2009 forecast with historical data through 4th Qtr 2008.

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d. Proposed LUPA Add-on Payment adjust for the 5 percent originally set the per-visit rates paid to HHAs that do Amount Update aside for outlier payments. We then not submit the required quality are Beginning in CY 2008, LUPA episodes reduce that amount by 2.5 percent, the reduced by 2 percent, the additional that occur as the only episode or initial proposed target percentage of outlier LUPA payment should be reduced by 2 episode in a sequence of adjacent payments as a percentage of total HH percent also. In neither the CY 2008 nor episodes are adjusted by adding an PPS payment. Next we update by the the CY 2009 HH PPS rulemaking did we additional amount to the LUPA current proposed CY 2010 home health include such an adjustment to the LUPA payment before adjusting for area wage market basket update percentage of 2.2 add-on payment amount. For CY 2010, differences. As previously discussed, we percent. The LUPA add-on payment we propose that the add-on to the LUPA are proposing to return 2.5 percent back amount is not subject to the 2.75 percent payment to HHAs that submit the into the HH PPS rates, to include the reduction related to the nominal required quality data would be updated LUPA add-on payment amount, as a increase in case-mix because it is an by the home health market basket result of our proposed policy to target add-on to the per-visit rates which are update. We propose that the add-on to outlier payments to be approximately not case-mix adjusted. The proposed CY the LUPA payment to HHAs that do not 2.5 percent of total HH PPS payments in 2010 LUPA add-on payment amount is submit the required quality data would CY 2010. As such, we first adjust the CY shown in Table 5 below. Just as the be updated by the home health market 2009 LUPA add-on payment amount to standardized 60-day episode rate and basket update minus two percent.

TABLE 5—PROPOSED CY 2010 LUPA ADD-ON PAYMENT AMOUNTS

For HHAs that DO submit the required For HHAs that DO NOT submit the CY 2009 LUPA quality data required quality data add-on payment Adjusted to return Multiply by the Proposed CY amount Adjusted to ac- Proposed CY proposed home adjusted to return the outlier funds, count for the pro- Multiply by the 2010 LUPA add- 2010 LUPA add- that paid for the health market on payment the outlier funds, posed 2.5% outlier proposed home on payment basket update that paid for the original 5% target policy health market amount for HHAs amount for HHAs (2.2 percent) 1 original 5% target for outliers basket update that DO submit that DO NOT 1 minus 2 percent, for outliers (2.2 percent) required quality for a 0.2 percent submit required data update quality data

$90.48 / 0.95 × 0.975 × 1.022 $94.90 × 1.002 $93.05 1 The proposed estimated home health market basket update of 2.2 percent for CY 2010 is based on Global Insight Inc., 1st Qtr 2009 forecast with historical data through 4th Qtr 2008.

e. Proposed Non-Routine Medical adjust for the 5 percent originally set adjusted payment amount by 2.75, to Supply Conversion Factor Update aside for outlier payments. We then account for the increase in nominal reduce that amount by 2.5 percent, the case-mix. The proposed CY 2010 NRS Payments for non-routine medical proposed target percentage of outlier conversion factor is shown in Table 6a supplies (NRS) are computed by payments as a percentage of total HH below. The NRS conversion factor for multiplying the relative weight for a PPS payment. Next we update by the CY 2009 was $52.39. Consequently, for particular severity level by the NRS current proposed CY 2010 home health CY 2010, the proposed NRS conversion conversion factor. We first adjust the CY market basket update percentage of 2.2 factor would be $53.44. 2009 NRS conversion factor ($52.39) to percent. Finally, we then reduce that

TABLE 6a—PROPOSED CY 2010 NRS CONVERSION FACTOR FOR HHAS THAT DO SUBMIT THE REQUIRED QUALITY DATA

Adjusted to return the Proposed CY 2010 outlier funds, that paid Adjusted to account Multiply by the pro- Reduce by 2.75 NRS conversion CY 2009 NRS for the original 5% for the proposed 2.5% posed home health percent for nominal factor for HHAs that conversion factor target for outlier outlier policy market basket update change in case-mix do submit the re- payments (2.2 percent) quired quality data

$52.39 / 0.95 × 0.975 × 1.022 × 0.9725 $53.44

The proposed payment amounts, 2010 NRS conversion factor ($53.44), for proposed updated conversion factor are using the above computed proposed CY the various severity levels based on the calculated in Table 6b.

TABLE 6b—RELATIVE WEIGHTS FOR THE 6-SEVERITY NRS SYSTEM

Proposed NRS Severity level Points (scoring) Relative payment weight amount

1 ...... 0 ...... 0.2698 $14.42 2 ...... 1 to 14 ...... 0.9742 52.06 3 ...... 15 to 27 ...... 2.6712 142.75 4 ...... 28 to 48 ...... 3.9686 212.08 5 ...... 49 to 98 ...... 6.1198 327.04

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TABLE 6b—RELATIVE WEIGHTS FOR THE 6-SEVERITY NRS SYSTEM—Continued

Proposed NRS Severity level Points (scoring) Relative payment weight amount

6 ...... 99+ ...... 10.5254 562.48

For HHAs that do not submit the amount by 2.5 percent, the proposed Finally, we then reduce that adjusted required quality data, we again begin target percentage of outlier payments as payment amount by 2.75, to account for with the CY 2009 NRs conversion factor. a percentage of total HH PPS payment. the increase in nominal case-mix. The We first adjust the CY 2009 NRS Next we update by the current proposed proposed CY 2010 NRS conversion conversion factor ($52.39) to adjust for CY 2010 home health market basket factor is shown in Table 7a below.5 the 5 percent originally set aside for update percentage of 2.2 percent minus outlier payments. We then reduce that 2 percent) for a 0.002 percent update.

TABLE 7a—PROPOSED CY 2010 NRS CONVERSION FACTOR FOR HHAS THAT DO NOT SUBMIT THE REQUIRED QUALITY DATA

Multiply by the pro- Adjusted to return the posed home health Proposed CY 2010 CY 2009 NRS outlier funds, that paid Adjusted to account market basket update Reduce by 2.75 NRS conversion conversion factor for the original 5% for the proposed 2.5% (2.2 percent) minus 2 percent for nominal factor for HHAs that target for outlier outlier policy percent for a 0.25 change in case-mix do submit the re- payments update quired quality data

$52.39 / 0.95 × 0.975 × 1.002 × 0.9725 $52.39

The proposed payment amounts for for HHAs that do not submit quality the various severity levels based on the data, are calculated in Table 7b, below. proposed updated conversions factor,

TABLE 7b—RELATIVE WEIGHTS FOR THE 6-SEVERITY FOR HHAS THAT DO NOT SUBMIT QUALITY DATA

Proposed NRS Severity level Points Relative weight payment scoring) amount

1 ...... 0 0.2698 ...... $14.13 2 ...... 1 to 14 0.9742 ...... 51.04 3 ...... 15 to 27 2.6712 ...... 139.94 4 ...... 28 to 48 3.9686 ...... 207.91 5 ...... 49 to 98 6.1198 ...... 320.62 6 ...... 99+ 10.5254 ...... 551.43

D. OASIS Issues transmitted by the HHA to CMS used by the CMS OASIS submission includes a HIPPS code, generated by system in its validation, is the official 1. HIPPS Code Reporting grouper software at the HHA. When an grouping software of the HH PPS, and We would first like to clarify our HHA electronically transmits OASIS thus the HIPPS code produced by the policy regarding the submission of the assessments to CMS (via the State CMS OASIS submission system is the Health Insurance Prospective Payment agency), the CMS OASIS submission HIPPS code that should ultimately be System (HIPPS) code to CMS via the system performs a validation check of billed on the claim. Consequently, in OASIS. § 484.250 requires HHAs to the transmitted OASIS items, including the interest of accurate coding and submit to CMS the OASIS data the submitted HIPPS code. If the CMS billing, we propose that the HHA be described in § 484.55(b)(1) and OASIS submission system validation required to ensure that the HIPPS code § 484.55(d)(1) in order for CMS to determines that the submitted HIPPS billed on the claim is consistent with administer the payment rate code is in error, it informs HHAs of that that which CMS’ OASIS submission methodologies. Also, as described in error via the Final Validation Report system calculated. In the case where the § 484.20, HHAs must electronically which is returned to HHA. The Final report all OASIS data collected in Validation Report will include the valid, Final Validation Report returns to the accordance with § 484.55 as a condition CMS OASIS submission system HHA a HIPPS code which is different of participation, and HHAs must encode calculated HIPPS code. We have become than the HIPPS code submitted to CMS and electronically transmit the aware of a proliferation of incidents by the HHA on the OASIS, the HHA completed OASIS assessment to CMS in where the HIPPS code submitted to must ensure that the HIPPS code from the standard data format as described in CMS on the OASIS does not match the the Final Validation report is the HIPPS § 484.20(d). For those OASIS HIPPS code which is calculated by the code reported on the bill. assessments required for payment, the CMS OASIS submission system. The standard format which is electronically HH PPS Grouper Software, which is

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2. OASIS Submission as a ‘‘Condition of language pathology which meets the educational initiative to improve the Payment’’ requirements of § 409.44(c); or have a ability of HHAs, State Agencies, and Section 484.20 requires that HHAs continuing need for occupational CMS contractors to make appropriate must electronically report to CMS (via therapy that meets the requirements of coverage decisions, resulting in an the State agency or OASIS contractor) § 409.44(c), subject to the limitations improved ability by HHAs to identify all OASIS data collected in accordance described in § 409.42(c)(4). the appropriate payer for services provided, ultimately improving HHA with § 484.55 as a condition of Basis for Revisions to § 409.42(c)(1), participation. Additionally, § 484.250 billing accuracy. 409.44(b), and § 424.22 As part of its provider education requires that HHAs must submit to CMS In recent years, MedPAC, the HHS program, CMS focused on clarifying the OASIS data described at Office of the Inspector General (OIG), § 409.42 ‘‘Beneficiary qualifications for § 484.55(b)(1) and (d)(1) in order for and Medicaid State agencies suggested coverage of services’’. During the course CMS to administer the payment rate the need for CMS to clarify the Medicare of the training, it became apparent that methodologies. Building on the above home health coverage criteria regarding confusion existed among certain clarification for HHAs to ensure the the skilled services specified at § 409.42. Medicaid State Agencies and HHAs HIPPS code reported on the bill is In their March 2004 report (http:// regarding under what circumstances the consistent with that which CMS’ OASIS www.medpac.gov/documents/ overall management and evaluation of a submission system calculated, and in Mar04_Entire_reportv3.pdf), MedPAC care plan would constitute a skilled order to be consistent with § 484.250, reported that the Medicare eligibility service. HHAs asked what underlying we are proposing to require the criteria for the home health benefits conditions, complications, or electronic reporting of OASIS to CMS as leaves a great deal open to circumstances would require a patient a condition of payment in § 484.210. interpretation, describing a particular otherwise receiving unskilled services Currently, as a requirement for pay for concern with the lack of clarity to need care plan management and reporting, HHAs are required to submit regarding the Medicare home health evaluation by a registered nurse, thus quality data (that being OASIS data) in skilled nursing services requirement. In rendering such care skilled. CMS order to receive the full home health their Memorandum Report dated therefore ensured that the training market basket update to the rates. The February 5, 2009 titled ‘‘Medicaid and provided a particular focus on the burden associated with the requirement Medicare Home Health Payments for requirement that a beneficiary be in for the HHA to submit the OASIS is Skilled Nursing and Home Health Aide need of skilled services. CMS provided currently accounted for under OMB# Services’’ (http://oig.hhs.gov/oei/ comprehensive guidance to clarify that 0938–0761. Making OASIS submission a reports/oei-07–06–00641.pdf), the OIG in the home health setting, management condition for payment is consistent with also stated that Medicare coverage and evaluation of a patient care plan is both OASIS submissions being a policy regarding skilled nursing services considered a reasonable and necessary condition of participation and a lacked clarity. The OIG indicated that skilled service only when underlying requirement to receive full market our payment methodology might be conditions or complications are such basket updates under pay for reporting. prone to error. HHAs were unclear that only a registered nurse can ensure As such, we are proposing to revise about which skilled nursing services that essential non-skilled care is § 484.210 ‘‘Data used for the calculation were covered by Medicare’s home achieving its purpose. Another area of of the national prospective 60-day health benefit. Further, Medicaid State confusion that surfaced during the episode payment’’ to reflect this agencies have also communicated to training was when the need for patient requirement. CMS their concerns that HHAs find it education services constitutes skilled E. Qualifications for Coverage as They difficult to accurately determine when services in the home health setting. Relate to Skilled Services Requirements services provided to dually Medicare HHAs questioned which specific sorts and Medicaid eligible individuals of educational services would render To qualify for Medicare coverage of (‘‘dual eligibles’’) meet the Medicare the education a skilled service in the home health services a Medicare coverage criteria, especially the home health setting. beneficiary must meet each of the requirements for needing skilled To address the concerns identified by following requirements as stipulated in nursing care on an intermittent basis. OIG, MedPAC, State Medicaid agencies § 409.42: Be confined to the home or an State Medicaid agencies have and the clarity concerns home health institution that is not a hospital, SNF, or communicated to CMS that this agencies communicated to CMS during nursing facility as defined in sections ambiguity is resulting in some HHAs the 2006 training, we propose to revise 1861(e)(1), 1819(a)(1) or 1919 of Act; be routinely submitting all claims for dual- § 409.42(c)(1) to further clarify that in under the care of a physician as eligible persons with chronic care needs order for services to be considered described in § 409.42(b); be under a plan to their State Medicaid agencies for skilled in the home health setting, of care that meets the requirements payment. State Medicaid agencies and certain limitations (discussed below) specified in § 409.43; the care must be CMS are concerned about this practice, would apply. We believe these revisions furnished by or under arrangements referencing the requirement under the would assist HHAs in their made by a participating HHA, and the Social Security Act that Medicaid must determination of home health eligibility beneficiary must be in need of skilled be the payer of last resort. State agencies and will enable HHAs to more services as described in § 409.42(c). have told CMS that some of these claims accurately bill for their dual eligible Subsection 409.42(c) of our regulations would have been covered and paid by population. requires that the beneficiary need at Medicare if they were submitted for least one of the following services as payment. Other State agencies have Proposed Revisions to § 409.42(c)(1) certified by a physician in accordance used Medicaid post payment reviews to To clarify what constitutes skilled with § 424.22: Intermittent skilled identify claims they believe should have services in the home health setting, we nursing services and the need for skilled been paid by another payer (e.g., are proposing the following revision to services which meet the criteria in Medicare). § 409.42. We propose to add a qualifying § 409.32; Physical therapy which meets In 2006, CMS and certain Medicaid instruction to § 409.42(c)(1) to explain the requirements of § 409.44(c), Speech- State Agencies embarked on an that intermittent skilled nursing services

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meeting the criteria for skilled services service would not be deemed a skilled recovery and safety could be ensured and the need for skilled services found nursing service merely because it was only if the care was planned, managed, in § 409.32 (with examples in § 409.33 performed by or under the supervision and evaluated by a registered nurse. We (a) and (b)) are subject to certain of a licensed nurse. Where a service can believe that this revision would address limitations in the home health setting. be safely and effectively performed (or HHAs’ questions regarding the specific We propose to describe the limitations self administered) by the average non- circumstances which would necessitate in two new paragraphs, § 409.42(c)(1)(i) medical person without the direct the need for skilled management and and § 409.42(c)(1)(ii). supervision of a nurse, the service evaluation of the care plan. cannot be regarded as a skilled service Proposed New Paragraph Additionally, we believe this although a nurse actually provided the § 409.42(c)(1)(i) requirement would be an important step service. in enhancing the physician Our policy at § 409.33(a)(1) describes accountability and involvement in the that the development, management, and Proposed New Paragraph § 409.42(c)(1)(ii) patient’s plan of care. evaluation of a patient’s care plan based As we described above, many on physician’s orders constitute skilled Additionally, we also propose a new Medicaid State Agencies and HHAs services when, because of the patient’s § 409.42(c)(1)(ii), which would clarify contend that there is confusion as to physical or medical condition, oversight when patient education services as when overall management and by technical or professional personnel is described in § 409.33(a)(3) constituted evaluation of a care plan constitute a needed to promote recovery and ensure skilled services in the home health skilled service. They questioned what medical safety. The examples described setting. Current § 409.32(a)(3) states that specific beneficiary underlying in § 409.33(a)(1)(ii) further describe that patient education services are skilled conditions, or complications or when the patient’s overall condition services if the use of technical or circumstances would warrant a patient supports a finding that recovery and professional personnel is necessary to who was receiving unskilled services to safety can be ensured only if the total teach patient self-maintenance. need care plan management and care is planned, managed, and evaluated However, to address the concerns and evaluation by a registered nurse, thus by technical or professional personnel, lack of clarity surrounding when rendering the care skilled. To clarify for it is appropriate to infer that skilled education services are skilled services home health agencies what specific services are being provided. as described above, we are proposing to circumstances would necessitate the We propose in § 409.42(c)(1)(i) that in add a new paragraph, § 409.42(c)(1)(ii). involvement of a registered nurse in the the home health setting, management In the home health setting, skilled development, management, and and evaluation of a patient care plan is education services would be deemed to evaluation of a patient’s care plan when considered a reasonable and necessary no longer be needed when it became only unskilled services are being skilled service only when underlying apparent, after a reasonable period of provided, we propose additions to the conditions or complications are such time, that the patient, family, or home health certification content that only a registered nurse can ensure caregiver could not or would not be requirements as described at that essential non-skilled care is trained. Further teaching and training § 424.22(a)(i) and recertification content achieving its purpose. would cease to be reasonable and requirements at § 424.22(b)(2). Further, in § 409.42(c)(1)(i) we also necessary in this case, and would cease Specifically, when a patient’s propose to clarify that to be considered to be considered a skilled service. underlying condition or complication a skilled service, the complexity of the Notwithstanding that the teaching or requires exclusively that a registered necessary unskilled services that are a training was unsuccessful, the services nurse ensure that essential non-skilled necessary part of the medical treatment for teaching and training would be care is achieving its purpose, and must require the involvement of considered to be reasonable and necessitates a registered nurse be licensed nurses to promote the patient’s necessary prior to the point that it involved in the development, recovery and medical safety in view of became apparent that the teaching or management, and evaluation of a the overall condition. Where nursing training was unsuccessful, as long as patient’s care plan, we propose to visits are not needed to observe and such services were appropriate to the require the physician include a written assess the effects of the nonskilled patient’s illness, functional loss, or narrative on the certification and services being provided to treat the injury. illness or injury, skilled nursing care recertification describing the would not be considered reasonable and Proposed Change to § 409.44(b) physician’s clinical justification of this necessary, and the management and We are proposing to revise the need. evaluation of the care plan would not be introductory material at § 409.44(b)(1), In the Physician Fee Schedule considered a skilled service. to refer to the newly proposed proposed rule published in the July 7, Additionally, we propose to further limitations of skilled services in the 2008 Federal Register (73 FR 38578), we clarify in § 409.42(c)(1)(i) that in some home health benefit at § 409.42(c)(1)(i) solicited comments asking the industry cases, the condition of the patient may and 409.42(c)(1)(ii). The clauses under to suggest options to enhance contact require that a service that would the revised paragraphs (i) through (iv) between the physician and the patient. normally be considered unskilled be would remain unchanged. In that solicitation of comments, we classified as a skilled nursing service described policy options that we had given a patient’s unique circumstances. Proposed Revision to § 424.22(a)(1)(i) been considering such as a review of the This would occur when the patient’s and § 424.22(b)(2) RVUs associated with the certification underlying condition or complication We also propose to revise and recertification of the HH plan of required that only a registered nurse § 424.22(a)(1)(i) and § 424.22(b)(2) to care (POC), and that we were could ensure that essential non-skilled require a written narrative of clinical considering proposing new care was achieving its purpose. The justification on the physician requirements, for example, a registered nurse would ensure that certification and recertification for the requirement for ‘‘direct’’ patient contact services were safely and effectively targeted condition where the patient’s with the physician, to ensure more performed. However, any individual overall condition supports a finding that active physician involvement in the

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certification and recertification of the significant change in the patient’s proliferation has been an even bigger HH POC. condition. We are not proposing to problem in Texas. Between October As a result of this solicitation, some change that requirement. An HHA 2002 and October 2006, the number of commenters suggested that CMS would still be required to perform an HHAs in the State doubled, while— establish documentation expectations assessment in the event that a patient during this same period—the number of associated with the certification and experienced a significant change in HHAs in Harris County, Texas (which recertification of the need for Medicare condition. The proposed modification is includes the city of Houston) increased home health services. We are continuing only that a new case-mix assignment is by almost 150 percent. As with to consider policy options to enhance no longer associated with this California, these figures are out of all the physician-patient interaction in the assessment. proportion with any increase in the home health setting. We believe that the In addition, we propose to revise beneficiary population or demand for commenters’ suggestion that CMS § 484.250 to delete an obsolete reference HHA services in Texas or Harris County. establish documentation expectations to § 484.237. § 484.237 referred to the The aforementioned GAO report associated with the certification and SCIC payment policy and was removed expressed similar concerns. It noted recertification, such as our proposed in the CY 2008 HH PPS final rule (72 that, nationwide, ‘‘spending on the clinical justification narrative FR 49879). Medicare home health benefit grew requirement, may be a first step in about 44 percent from 2002 through G. Proposed Payment Safeguards for achieving this goal. 2006, despite an increase of just less Home Health Agencies Finally, we believe that this new than 17 percent in the number of requirement would increase physician The provisions contained in this beneficiaries using the benefit during accountability and oversight of the section are designed to: (1) Improve our that 5-year period.’’ The report also certification and recertification of home ability to verify that home health noted discrepancies in States other than health services and plan of care by agencies (HHAs) meet minimum Texas and California. To illustrate, focusing attention on the physician’s enrollment criteria; (2) ensure that between 2002 and 2006, the number of responsibility to set out the clinical HHAs that are changing ownership meet HHAs that billed Medicare rose in basis for this skilled need as indicated and continue to meet the Conditions of Florida by 100 percent, in Michigan by in the patient’s medical record. Participation for HHAs found in 42 CFR 62 percent, in Illinois by 59 percent, in This brief narrative could be written Part 484; and (3) improve the quality of Ohio by 42 percent, in Arizona by 32 or typed on the certification form itself. care that Medicare beneficiaries receive percent, and in the District of Columbia We do not believe that this brief from HHAs. by 67 percent. However, the increases in narrative should be allowed as an 1. Program Integrity Concerns Involving the number of Part A beneficiaries who attachment to the certification form Home Health Agencies (HHAs) used HHA services in these six because an attachment could easily be jurisdictions were as follows: Florida— prepared by someone other than the The fraudulent business practices of 28 percent; Michigan—19 percent; physician, and what we are seeking is certain HHAs continue to cost the Illinois—23 percent; Ohio—14 percent; more direct involvement on part of the Medicare program millions of dollars Arizona—4 percent; and the District of physician. We seek comments on nationwide. This issue was discussed in Columbia—2 percent. whether this proposed requirement a recent report issued by the The disparity in many jurisdictions would increase physician engagement Government Accountability Office between the increase in the number of in the certification and recertification (GAO) entitled ‘‘Improvements Needed HHAs and the rise in the number of process, and clarify industry confusion to Address Improper Payments in Home beneficiaries is so overwhelming that it associated with when a patient’s Health’’ (GAO–09–185). This report, cannot be attributed solely to an aging condition would require the need for a discussed in more detail below, populace. The fact that, as shown above, registered nurse to oversee the patient’s concluded, in part, that ‘‘In the absence between 2002 and 2006, the number of care plan, thus rendering such ‘‘skilled of greater prevention, detection, and HHAs in Arizona rose at a rate 8 times care’’ under our payment system. enforcement efforts, the Medicare home greater than the number of Part A health benefit will continue to be a beneficiaries that use HHA services— F. OASIS for Significant Change in ready target for fraud and abuse.’’ and that the rate was an astounding 33 Condition: No Longer Associated With The problem has been especially times greater in Washington, DC—must Payment acute in, though by no means limited to, raise serious questions as to the We propose to remove an obsolete the States of Texas and California. In legitimacy of some of these entities. reference to ‘‘new case-mix Los Angeles County in California, for The GAO report also outlined a assignments’’ as a result of significant instance, the amount of money for number of instances of allegedly changes in a patient’s condition that which HHAs in that county billed fraudulent activities on the part of appears in 42 CFR 484 subpart E at Medicare between Fiscal Years 2003 HHAs. In a particularly glaring example § 484.55(d)(1)(ii). The significant change and 2006 rose from $569 million to $921 in Houston, Texas, the GAO noted the in condition (SCIC), as it relates to new million—an increase of 62 percent, and following: ‘‘One PSC (Program case-mix assignments affecting one that was not accompanied by a Safeguard Contractor) interviewed 670 payment, was an element of the HH PPS similar increase in the county’s Houston beneficiaries who had the most at the time of its first implementation in Medicare beneficiary population. There severe clinical rating and who were fiscal year 2000. However, as part of the has also been an abnormal proliferation patients of HHAs identified by the PSC HH PPS payment refinements of HHAs in California as a whole. as having aberrant billing patterns. The implemented in CY 2008, we eliminated Between October 2002 and May 2007, PSC found 91 percent of claims for these the SCIC policy, and the assignment of the number of HHAs in the State rose beneficiaries to be in error. Nearly 50 subsequent case-mix assignments under by 25 percent—again, without a percent of the beneficiaries were not the HH PPS. However, it should be concomitant upswing in the number of homebound and therefore were not noted that it was not the SCIC payment Medicare beneficiaries in California. eligible to receive any Medicare home policy that required the HHA to perform This suggests that there may also be an health services. The investigators also the assessment, but rather the increase in improper billing. HHA found that while 39 percent of the

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beneficiaries they interviewed were has control over the space, staff, comments on whether there are eligible for the benefit, their clinical equipment, etc. We do not believe that legitimate business reasons for a severity had been exaggerated. The PSC legitimate HHA providers share Section Medicare-enrolled HHA to engage in concluded that only 9 percent of claims 4 practice locations or bases of leasing or subleasing arrangements with for the 670 beneficiaries were properly operations with another Medicare- a Medicare-enrolled supplier when coded. In addition, the PSC found that enrolled HHA or supplier. there is common ownership. other home health beneficiaries it At § 489.19, we are proposing a 3. Sale or Transfer of Ownership Within interviewed were not homebound; for provision that would prohibit an HHA 3 Years of Enrollment instance, some were mowing their from sharing, leasing, or subleasing its lawns when investigators came to practice location or base of operations We have recently found instances interview them.’’ listed in Section 4 of its Medicare where owners of a HHA, some of which Of particular concern to CMS is that provider enrollment application with or were working in concert with brokers or the problems discussed above have been to another Medicare-enrolled HHA or organizations operating ‘‘turn-key’’ seen with HHAs on a far greater scale supplier. We believe that this provision businesses, have enrolled or have than with any other type of certified is consistent with existing provisions attempted to enroll in the Medicare provider. The dramatic rise in the found in § 410.33(g)(15), which program for the specific purpose of number of HHAs in relation to the established limitations on the sharing of selling the Medicare billing privileges increase in Medicare beneficiaries has space (that is, a practice location) by and the Medicare provider agreement of not been even remotely duplicated with independent diagnostic testing facilities their HHA to a third-party. In this other Part A entities. In sum, the relative (IDTF). scenario, the buyer or seller of the HHA level of potentially fraudulent behavior At § 489.12(a)(5), we are proposing to typically would notify Medicare of the among HHAs exceeds that of other allow CMS to refuse to enter into a sale or change of ownership via the certified provider types, and it is for this provider agreement with a prospective Medicare enrollment application (CMS– reason that CMS needs to take HHA if we determined, under proposed 855A) after the billing privileges have additional steps to ensure that only 42 CFR 489.19, that the HHA was been transferred when the HHA is sold. legitimate, bona fide HHAs remain sharing, leasing, or subleasing its Current CMS policy recommends enrolled in the Medicare program. practice location or base of operations surveys when there is a change of listed in Section 4 of its Medicare ownership. However, surveys in cases of 2. Prohibition on Sharing of Practice provider enrollment application with or a change of ownership do not occur Location to another Medicare-enrolled HHA or with the frequency that they do when In 2008, we determined that a number supplier. providers initially enroll in Medicare. of HHAs had enrolled or attempted to At § 424.530(a)(8), we are proposing Consequently, there are instances in enroll into the Medicare program using to allow a Medicare contractor, which a change of ownership takes the same practice location or base of including a Regional Home Health place yet the new owner does not operations listed in Section 4 of their Intermediary or A/B MAC, to deny undergo a survey, in which case respective Medicare provider Medicare billing privileges to an HHA if Medicare cannot conclusively ascertain enrollment applications. In one case, a it determined, under proposed 42 CFR whether the business, under new business attempted to enroll more than 489.19, that the HHA was sharing, ownership, meets the Conditions of twenty different HHAs with the same leasing, or subleasing its practice Participation under 42 CFR part 484. Section 4 practice location as the base location or base of operations listed in This serves as an incentive for certain of operations. Section 4 of its Medicare provider prospective providers to enroll in the We believe that allowing HHAs to enrollment application with or to Medicare program with the sole purpose share practice locations, operations, and another Medicare-enrolled HHA or of transferring Medicare billing other aspects of the provider’s supplier. privileges and the associated provider operations (for example, patient and At § 424.535(a)(11), we are proposing agreement when the business is sold. financial records) in this manner to allow a Medicare contractor, This is problematic for two reasons. constitutes a significant risk to the including a Regional Home Health First, the prospective provider has Medicare program. To allow an HHA to Intermediary or A/B MAC, to revoke the minimal incentive for ensuring quality share its Section 4 practice location or Medicare billing privileges of an HHA care for its patients after it is enrolled base of operations with another that it determined, under proposed 42 because its exclusive objective for Medicare-enrolled HHA or supplier CFR 489.19, was sharing, leasing, or participating in Medicare in the first limits the ability of CMS, a State survey subleasing its practice location or base place is to sell the business shortly after agency, or an accreditation organization of operations listed in Section 4 of its receiving Medicare billing privileges. In to ensure that each HHA meets the Medicare provider enrollment other words, the provider, aware that it Conditions of Participation specified at application with or to another Medicare- may be able to sell the business without 42 CFR part 484. Indeed, pursuant to enrolled HHA or supplier. the HHA having to undergo a survey, Section 1866(j)(1)(A) of the Act, the We are, nevertheless, soliciting may have little motivation to ensure that Secretary is required to establish by comments on whether there are it is in compliance with the Conditions regulation a process for the enrollment legitimate business reasons for a of Participation under 42 CFR part 484, of providers and suppliers into the Medicare-enrolled HHA to share space since it intends on selling the business Medicare program. However, the with another Medicare-enrolled HHA or in any event. Medicare beneficiaries, sharing of HHA practice locations or supplier when there is common therefore, may receive inadequate bases of operations listed in Section 4 of ownership. We are also soliciting services as a result of this activity. the Medicare provider enrollment comments on whether there are Second, without the protection that a application hinders CMS’s ability to legitimate business reasons for a survey provides, the HHA may attempt properly enroll HHAs into Medicare Medicare-enrolled HHA to be co-located to bill Medicare for these insufficient because of the extreme difficulty in with another Medicare-enrolled HHA or services. These circumstances increase determining which site is in operation supplier when there is no common the risk for an HHA to submit at a particular time, and which provider ownership. In addition, we are soliciting inappropriate and potentially fraudulent

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claims to Medicare, which places the At 42 CFR 424.550(b)(1), we are becomes effective, would be subject to Medicare Trust Funds at risk. proposing that an HHA undergoing an this provision. ownership change (including asset sales We further note that 42 CFR 4. Home Health Agency Reactivations of and stock transfers) must obtain an 424.550(a) states that a provider or Medicare Billing Privileges supplier ‘‘is prohibited from selling its initial State survey or accreditation by Medicare billing number or privileges to an approved accreditation organization In order to help address CMS’ any individual or entity, or allowing if the change takes place within 36 concerns about potentially another individual or entity to use its months after the effective date of the inappropriate activity by HHAs, an Medicare billing number.’’ We believe HHA’s enrollment in Medicare. This additional tool that we therefore believe that the ‘‘turn-key’’ scenarios described means that any change of ownership is necessary to help stem this behavior in this subsection 2 fall within the that occurs during the 36 months involves enhanced safeguards for use as general intent and purview of this following an initial enrollment would part of the reactivation process provision, in that the broker may focus not result in the transfer of the HHA’s identified in § 424.540(a). more on the selling of the HHA’s billing provider agreement and Medicare To ensure that HHAs whose Medicare privileges, rather than of the HHA itself. billing privileges to the new owner. The billing privileges have been deactivated Nevertheless, while the provisions of 42 new owner of the existing HHA would for 12 months of non-billing and who CFR § 424.550(a) and (b) were designed instead be required to enroll in the seek to reactivate these privileges are to prohibit this type of practice, we Medicare program as a new provider still in compliance with the Conditions cannot realistically enforce the under the provisions of § 424.510 and of Participation in 42 CFR part 484, we prohibitions on the sale, including an obtain an initial State survey or propose to revise § 424.540(b)(3) from asset sale or stock transfer, or transfer of accreditation by an approved its current form, ‘‘Reactivation of billing privileges, unless we can confirm accreditation organization. This is to Medicare billing privileges does not the nature of the financial arrangements ensure that the HHA under new require a new certification of the involved therein. ownership remains in compliance with provider or supplier by the State survey We recognize that the issue of a the Conditions of Participation in 42 agency or the establishment of a new CFR part 484. We believe that this will potential lack of a survey in HHA provider agreement’’ to ‘‘With the help deter turn-key entities from ownership changes exists with respect exception of home health agencies, purchasing HHAs for the sole purpose to other types of providers and certified reactivation of Medicare billing of selling them, in that the facility will suppliers. Yet there are several reasons privileges does not require a new be unable to undergo a change of as to why this concern is more acute certification of the provider or supplier ownership within the above-referenced with HHAs than with other provider by the State survey agency or the 36-month period without the HHA types. First, and as already outlined in establishment of a new provider being subject to a State survey. subsection 1, the level of fraud in the agreement.’’ We are also proposing to We further believe that 36 months is add § 424.540(b)(3)(i), which states that HHA sector appears to be more an appropriate period of time for which prevalent than with other provider any HHA whose Medicare billing to apply this requirement. It is long privileges are deactivated under the categories. Second, CMS has not seen enough to ensure that a newly-enrolled the types of turn-key arrangements provisions found in § 424.540(a) are also HHA is serious about furnishing quality required to obtain an initial State survey described above with any type of services to Medicare beneficiaries and is provider or certified supplier other than or accreditation by an approved not merely looking to sell the HHA’s accreditation organization before its HHAs. It is the combination of these two Medicare billing privileges at the factors that, in our view, make it Medicare billing privileges can be earliest possible moment. Conversely, a reactivated. necessary for us to focus the proposed 36-month timeframe is, in our view, not provisions below on HHAs, rather than As already explained, CMS remains so extensive as to greatly hinder the concerned about the excessive level of on provider types with whom our ability of a bonafide HHA to sell its concerns are not nearly as acute. We potentially inappropriate activity in the business after the HHA has been HHA arena. To this end, CMS believes stress that CMS in the past has operational and providing legitimate undertaken a number of enrollment that the proposed provisions outlined in Medicare services for a reasonable this subsection will, for reasons already initiatives to ensure that only eligible period of time. While we do recognize and qualified providers and suppliers identified, help address the concerns that some legitimate, newly-enrolling outlined in the aforementioned GAO obtain and maintain Medicare billing HHAs may be inconvenienced by their privileges; specifically, CMS report by ensuring that HHAs are in inability to utilize, for a certain amount constant and verifiable compliance with promulgated rules to address fraud and of time, the change of ownership abuse and quality of care concerns for the HHA Conditions of Participation provisions in 42 CFR 489.18, we also found in 42 CFR part 484, and that only IDTFs (in 42 CFR 410.33(g)) as well as stress that the aforementioned survey suppliers of durable medical equipment, qualified and legitimate home health requirement will, to a substantial extent, providers are enrolled in Medicare. prosthetics, orthotics and supplies benefit legitimate members of the HHA (DMEPOS) (42 CFR 424.57(c)). We provider community, in that it will help H. Physician Certification and therefore believe, for the reasons just ensure that unqualified HHAs are no Recertification of the Home Health Plan stated, that a similar approach is longer in the Medicare program. This of Care warranted here with respect to HHAs. will, for bonafide HHAs, reduce a. Background With that said, and in view of the competition from less than legitimate aforementioned schemes that appear to HHAs and, on a larger level, help Sections 1814(a)(2)(C) and be designed to subvert Medicare’s protect the Medicare Trust Funds. 1835(a)(2)(A) of the Act require that a existing statutory and regulatory Finally, if adopted, we believe that plan for furnishing home health services authorities related to enrollment and any change of ownership (including be established and periodically State survey procedures, we maintain asset sales or stock transfers) that is reviewed by a physician in order for that additional tools are needed to pending a Medicare contractor’s review Medicare payments for those services to address this program vulnerability. and approval at the time this rule be made. Our regulations at § 409.43(e)

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specifically states that a home health ‘‘in-person’’ contact with the patient, physicians in lieu of face-to-face plan of care (HH POC) must be during the certification and contact. reviewed, signed, and dated by the recertification of the HH POC is Other commenters suggested that we physician who reviews the POC (as essential for the delivery of high quality actively support amending the Medicare specified in § 409.42(b)) in consultation HH services. statute to allow nurse practitioners with agency clinical staff at least every In the Physician Fee Schedule (NPs) to certify and recertify HH POCs. 60 days (or more frequently as specified proposed rule published in the July 7, Some commenters suggested that we in § 409.43(e)(1). Additionally, 2008 Federal Register (73 FR 38578), we actively support demonstrations and § 424.22(b) states that a recertification is mentioned several options to enhance legislative proposals to build on the required at least every 60 days, direct contact between the physician concept of merging home care with preferably at the time the plan is and the patient. First, we considered a primary care under a single care reviewed, and must be signed by the review of the RVUs associated with the management entity for persons in the physician who reviews the home health certification and recertification of the advanced stages of chronic illnesses. POC. These schedules, for the review of HH POC. As a result of that review, the Other commenters suggested that the POC and the recertification, payment amounts to physicians could payment to medical directors should be coordinate well with the 60-day episode be reduced based on a more accurate restored to HHAs, along with payment unit under the HH PPS. In determination of the actual RVUs requirements for their education and a implementing the statutory requirement required to provide these services. We definition of their role, and that we as well as these regulations, we believed also considered proposing new consider reimbursement for a planning that these requirements would requirements; for example, a teleconference between the physician encourage enhanced physician requirement for ‘‘direct’’ patient contact and home health personnel. involvement in the HH POC and patient with the physician, to ensure more In the November 19, 2008 final rule, management, and would include more active physician involvement in the we expressed our appreciation for the direct ‘‘in-person’’ patient encounters certification and recertification of the comments and responded that we would continue to analyze and consider (as logistically feasible). HH POC. We specifically solicited the comments and suggestions in future Currently, physicians are paid for comments on these policy options. The rulemaking. Additionally, as a result of both the certification and recertification following is a summary of the comments comments received on the above of the HH POC under HCPCS codes and our responses as published in the physician rule, as it relates to physician- G0180 and G0179, respectively. The Physician Fee Schedule final rule patient contact, we are considering the basis for the payment amounts of these published in the November 19, 2008 possibility of requiring physicians to physician services is the relative Federal Register (73 FR 69855). resources in RVUs required to furnish make phone calls to patients at various Most commenters suggested that we these services. We believe physician times over the course of home health leave our current policies and payment involvement is very important in treatment (prior to recertifications), as a to physicians unchanged, at least until maintaining quality of care under the means to promote that physician-patient HH PPS. further analysis is completed. To that contact and to help ensure the delivery In the HH PPS proposed rule end, it was suggested that we continue of high quality HH services to our published in the October 28, 1999 to study the role of the physician in beneficiaries. Federal Register (64 FR 58196), we had home care and determine which factors In this HH PPS proposed rule for CY proposed to require the physician to enhance a physician’s ability to conduct 2010, we are specifically soliciting certify the case-mix weight/home health oversight activities, ensure additional comments on this topic. resource group (HHRG) as part of the appropriateness of care, and work I. Routine Medical Supplies required physician certification of the collaboratively with HHAs without POC. This reflected our belief that the further burdening Medicare HHAs have expressed to the HHS physician should be more involved in beneficiaries. Commenters urged CMS Office of the Inspector General (OIG) the decentralized delivery of home to engage with industry organizations some confusion regarding routine health services. However, in the final that represent the physicians that medical supplies and how we account rule published in the July 3, 2000 furnish these services, to determine for the cost of those supplies. Therefore, Federal Register (65 FR 41163), we did goals and assess options. Commenters we would like to reiterate our policy not finalize that proposal and decided to further suggested that goals and options regarding routine medical supplies and focus our attention on physician could include revising the procedure how they are reimbursed under the HH certification and education in order to codes used for billing, assessing the PPS. better involve the physician in the current RVUs, and establishing Section 1895(b)(1) states that ‘‘all delivery of home health services. documentation expectations. services covered and paid on a Some commenters suggested that reasonable cost basis under the b. Solicitation of Comments payments to physicians for certifying Medicare home health benefit as of the It has come to our attention that and recertifying HH POCs should be date of the enactment of this section, physician involvement in the restructured to provide incentives for including medical supplies, shall be certification and recertification of HH greater physician involvement, to paid for on the basis of a prospective POC varies greatly. While some include personally seeing the patients. payment amount * * *’’. The cost of physicians have direct contact with Specifically, some commenters routine medical supplies was included their patients in the delivery of home suggested adding different payments for in the average cost per visit amounts health services, we believe that a the varying levels of physician derived from the audit sample. These significant number of physicians involvement in the certification and average cost per visit amounts were provide only a brief, albeit thorough, recertification of HH POCs. Other used to calculate the initial HH PPS review of the HH POC, without any commenters urged CMS to consider how rates published in the July 3, 2000 HH direct contact with the patient. We home telehealth can be employed to a PPS final rule (FR 65 41184). Because continue to believe that active greater degree to increase input of reimbursement for routine medical involvement of the physician, including clinical information directly to supplies is bundled into the HH PPS 60-

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day episode rate and the per-visit rates, section 3506(c)(2)(A) of the Paperwork C. ICRs Regarding Prohibition Against HHAs may not bill separately for Reduction Act of 1995 requires that we Sale or Transfer of Billing Privileges routine supplies. solicit comment on the following issues: At § 424.550(b)(1) we propose that an • As noted in Chapter 7—Home Health The need for the information HHA undergoing an ownership change Services of the Medicare Benefit Policy collection and its usefulness in carrying would have to obtain an initial State Manual (Pub. L. 100–02), sections out the proper functions of our agency. survey or accreditation by an approved • 50.4.1.2 and 50.4.1.3, routine supplies The accuracy of our estimate of the accreditation organization if the change are supplies that are customarily used in information collection burden. takes place within 36 months after the small quantities during the course of • The quality, utility, and clarity of effective date of the HHA’s participation most home care visits. They are usually the information to be collected. in Medicare. Between April 2008 and included in the staff’s supplies and not • Recommendations to minimize the April 2009, approximately 2,000 designated for a specific patient. information collection burden on the Medicare-enrolled HHAs—or 22.5 Routine supplies would not include affected public, including automated percent of the 9,000 total number of those supplies that are specifically collection techniques. HHAs enrolled in Medicare—underwent ordered by the physician or are essential We are soliciting public comment on a change of ownership. Naturally, the to HHA personnel in order to effectuate each of these issues for the following magnitude of the ownership changes the plan of care. Examples of supplies sections of this document that contain varied by HHA, but the fact that almost which are usually considered routine information collection requirements one-quarter of all Medicare-enrolled include, but are not limited to: (ICRs): HHAs changed ownership in some form A. Dressings and Skin Care within the past year is, for the reasons • Swabs, alcohol preps, and skin prep A. ICRs Regarding the Requirements for outlined in the preamble to this pads; Home Health Services proposed rule, significant. • Tape removal pads; Section 424.22 proposes that if a It is also important to note that of the • Cotton balls; patient’s underlying condition or 2,000 ownership changes, • Adhesive and paper tape; • complication required a registered nurse approximately 20 percent occurred in Nonsterile applicators; and to ensure that essential non-skilled care • 4x4’s. Texas, another 20 percent in Florida, was achieving its purpose, and B. Infection Control Protection and 14 percent in California, meaning necessitated a registered nurse be • Nonsterile gloves; that over one-half of all changes in involved in the development, • Aprons; ownership occurred in three States. • Masks; and management, and evaluation of a Though it is possible that, if this • Gowns. patient’s care plan, the physician would provision was implemented, the number C. Blood Drawing Supplies include a written narrative describing of total annual ownership changes • Specimen containers. the clinical justification of this need. would decrease, we will assume that the D. Incontinence Supplies The burden associated with this figure of 2,000 would remain constant. • Incontinence briefs and Chux requirement would be the time and The burden associated with the covered in the normal course of a effort put forth by the physician to proposed requirement in § 424.550(b)(1) visit. For example, if a home health include the written narrative. We would be twofold. First, the HHA would aide in the course of a bathing visit estimate it would take one physician need to complete and submit a Medicare to a patient determines the patient approximately 5 minutes to meet this enrollment application (paper or requires an incontinence brief requirement. We estimate the frequency electronic) as an initial applicant. This change, the incontinence brief in of such a situation to occur in about 5 can be done electronically via the this example would be covered as a percent of episodes (or about 345,600 Internet-Based Provider Enrollment, routine medical supply. episodes a year); therefore, the total Chain and Ownership System (PECOS) E. Other annual burden associated with this or by using the paper CMS–855 • Thermometers; and requirement would be 28,800 hours for enrollment application. The estimated • Tongue depressors. CY 2010. burden of completing the entire There are occasions when the B. ICRs Regarding Deactivation of application as a new enrollee is 3 hours. supplies listed in the above examples Medicare Billing Privileges Thus, the estimated annual burden for would be considered non-routine and the approximately 2,000 HHAs that will thus would be considered a billable In the proposed § 424.540(b)(3)(i), an change ownership would be 6,000 supply, i.e., if they are required in HHA whose Medicare billing privileges hours. Second, the provider would need quantity, for recurring need, and are are deactivated under the provisions to undergo a survey (or obtain included in the plan of care. Examples found in 424.540(a) must obtain an accreditation in lieu of a survey) and include, but are not limited to, tape, and initial State survey or accreditation by perform administrative activities 4x4s for major dressings. an approved accreditation organization associated therewith. We estimate that before its Medicare billing privilege can the total hourly burden to the HHA for IV. Collection of Information be reactivated. said activities would be 60 hours, for an Requirements The burden associated with this annual burden of 120,000 hours (2,000 Under the Paperwork Reduction Act requirement would be the time and HHAs × 60 hours). Therefore, we of 1995, we are required to provide 60- effort put forth by the HHA to obtain a estimate that the total annual burden of day notice in the Federal Register and State survey or accreditation. We compliance with § 424.550(b)(1) would solicit public comment before a estimate it would take the prospective be 126,000 hours (120,000 hours + 6,000 collection of information (COI) provider/owner 60 hours to obtain a hours). requirement is submitted to the Office of State survey or accreditation. We Management and Budget (OMB) for estimate that there would be 2,000 such D. ICRs Regarding Patient Assessment review and approval. In order to fairly occurrences annually; therefore, the Data evaluate whether an information total annual burden associated with this Section 484.210 would require an collection should be approved by OMB, requirement would be 120,000 hours. HHA to submit to CMS the OASIS data

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described at § 484.55(b)(1) and (d)(1) in payment rate methodologies described submit the OASIS data. This burden is order for CMS to administer the in §§ 484.215, 484.230 and 484.235. currently accounted for under OMB# The burden associated with this is the 0938–0761. time and effort put forth by the HHA to

Number of Total annual OMB No. Requirements respondents Burden hours burden hours

None ...... 424.22 345,600 1/12 28,800 None ...... 424.540(a)(3)(i) 2,000 60 120,000 None ...... 424.550(b)(1) 2,000 63 126,000 0938–0761 ...... 484.210 N/A N/A N/A

If you comment on these information approximately 7,000 HHAs would be analysis (RIA) must be prepared for collection and recordkeeping submitting this data annually. Based on rules with economically significant requirements, please do either of the that number, the burden associated with effects ($100 million or more in any 1 following: the first month is estimated at 35,000 year). We estimate that this rulemaking 1. Submit your comments hours. The burden would decrease to is ‘‘economically significant’’ as electronically as specified in the 2,100 for subsequent months. Therefore, measured by the $100 million threshold ADDRESSES section of this proposed rule; the total annual burden for the first year and hence also a major rule under the or would total 58,100. Congressional Review Act. Accordingly, 2. Submit your comments to the The burden associated with the home we have prepared a Regulatory Impact Office of Information and Regulatory health patient’s submission of the Analysis, that to the best of our ability, Affairs, Office of Management and HHCAHPS survey is currently pending presents the costs and benefits of the Budget, Attention: CMS Desk Officer, OMB approval (CMS–10275/OMB# rulemaking. CMS–1560–P. Fax: (202) 395–6974; or 0938–NEW). Once OMB approval has 1. HHA Provisions Regarding Co- E-mail: [email protected]. been obtained, CMS will revise the package to include the burden on the Mingling, Ownership Changes, and E. ICRs Regarding Annual Update of the HHAs as discussed above. Reactivation of Billing Privileges Unadjusted National Prospective 60- V. Response to Comments We believe that our proposals Day Episode Payment Rate regarding: (1) The prohibition against Section 484.225(i) requires the Because of the large number of public co-mingling, (2) HHA changes of submission of quality measures as comments we normally receive on ownership, and (3) the reactivation of specified by the Secretary. As part of Federal Register documents, we are not HHA billing privileges would have this requirement, each HHA sponsoring able to acknowledge or respond to them minimal budgetary impact, as the total a Home Health Care CAHPS individually. We will consider all number of entities that will be effected (HHCAHPS) Survey must prepare and comments we receive by the date and each year would be small. Moreover, we submit to its survey vendor a file time specified in the DATES section of believe that these changes are necessary containing patient data on patients this preamble, and, when we proceed to ensure that currently enrolled and served the preceding month that will be with a subsequent document, we will prospective HHAs are billing for the used by the survey vendor to select the respond to the comments in the services provided and are in compliance sample and field the survey. This file preamble to that document. with the conditions of participation in (essentially the sampling frame) for VI. Regulatory Impact Analysis 42 CFR part 484, and all other Medicare most home health agencies can be requirements. generated from existing databases with A. Overall Impact As for the issue of beneficiary access, minimal effort. For some small HHAs, We have examined the impacts of this the number of affected HHAs is such preparation of a monthly sample frame proposed rule as required by Executive that we do not believe that beneficiaries may require more time. However, data Order 12866 on Regulatory Planning would be adversely impacted by the elements needed on the sample frame and Review (September 30, 1993 as proposed provisions. To the contrary, will be kept at a minimum to reduce the further amended) the Regulatory any reduction in the number of enrolled burden on all HHAs. Flexibility Act (RFA) (September 19, HHAs that would result from the The burden associated with this 1980, Pub. L. 96–354), section 1102(b) of implementation of these proposed requirement is the time and effort put the Social Security Act, section 202 of provisions would be more than offset by forth by the HHA to prepare and submit the Unfunded Mandates Reform Act of the assurance that those HHAs that the file containing patient data on 1995 (Pub. L. 104–4), Executive Order cannot meet Medicare requirements and patients. The survey instrument and 13132 on Federalism (August 4, 1999) quality standards are no longer in the procedures for completing the and the Congressional Review Act (5 program. instrument are designed to minimize U.S.C. 804(2)). We are unable to determine the exact burden on all respondents. No Executive Order 12866(as amended by extent to which currently enrolled and significant burden is expected for small Executive Order 13258) directs agencies prospective HHAs would be able to agencies beyond providing their to assess all costs and benefits of meet the requirements outlined in the contracted vendor with a monthly file of available regulatory alternatives and, if proposed provisions. In addition, as a patients served. regulation is necessary, to select result of a dearth of quantifiable data, Initially, we estimate it would take regulatory approaches that maximize we cannot effectively derive an estimate one HHA 5 hours for the first month to net benefits (including potential of the monetary impacts of these meet this requirement. The subsequent economic, environmental, public health provisions. Accordingly, we are seeking monthly burden is estimated to be 30 and safety effects, distributive impacts, public comment so that the public may minutes per HHA. We estimate and equity). A regulatory impact provide any data available that provides

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a calculable impact or any alternative to year. For the purposes of the RFA, proposed in this rule. We use the latest the proposed provisions. approximately 75 percent of HHAs are data and best analysis available, but we considered to small businesses do not make adjustments for future 1. CY 2010 Update according to the Small Business changes in such variables as number of The update set forth in this proposed Administration’s size standards with visits or case-mix. rule applies to Medicare payments total revenues of $13.5 million or less in This analysis incorporates the latest under HH PPS in CY 2010. Accordingly, any 1 year. Individuals and States are estimates of growth in service use and the following analysis describes the not included in the definition of a small payments under the Medicare home impact in CY 2010 only. We estimate entity. Excluding HHAs in areas of the health benefit, based on Medicare that the net impact of the proposals in country where high and suspect outlier claims from 2007. We note that certain this rule, including a 2.75 percent payments exist, this proposed rule is events may combine to limit the scope reduction to the national standardized estimated to have an overall positive or accuracy of our impact analysis, 60-day episode payment rates and the effect upon small entities (see section because such an analysis is future- NRS conversion factor to account for the IB.B ‘‘Anticipated Effects’’, of this oriented and, thus, susceptible to errors case-mix change adjustment, is proposed rule, for supporting analysis). resulting from other changes in the approximately $100 million in CY 2010 In addition, section 1102(b) of the Act impact time period assessed. Some savings. The estimated $100 million requires us to prepare a regulatory examples of such possible events are impact reflects the distributional effects impact analysis, if a rule may have a newly-legislated general Medicare of an updated wage index (¥$10 significant impact on the operations of program funding changes made by the million) as well as the 2.2 percent home a substantial number of small rural Congress, or changes specifically related health market basket increase (an hospitals. This analysis must conform to to HHAs. In addition, changes to the additional $390 million in CY 2010 the provisions of section 603 of the Medicare program may continue to be expenditures attributable only to the CY RFA. For purposes of section 1102(b) of made as a result of the BBA, the BBRA, 2010 home health market basket), and the Act, we define a small rural hospital the Medicare, Medicaid, and SCHIP the 2.75 percent decrease (¥$480 as a hospital that is located outside of Benefits Improvement and Protection million for the third year of a 4-year a Metropolitan Statistical Area and has Act of 2000, the MMA, the DRA, or new phase-in) to the HH PPS national fewer than 100 beds. This proposed rule statutory provisions. Although these standardized 60-day episode rate to applies to home health agencies. changes may not be specific to the HH account for the case-mix change Therefore, the Secretary has determined PPS, the nature of the Medicare program adjustment under the HH PPS. The $100 that this proposed rule will not have a is such that the changes may interact, million is reflected in column 5 of Table significant economic impact on the and the complexity of the interaction of 8 as a 0.86 percent decrease in operations of a substantial number of these changes could make it difficult to expenditures when comparing the small rural hospitals. predict accurately the full scope of the current CY 2009 system to the CY 2010 Section 202 of the Unfunded impact upon HHAs. system. If the Secretary were to impose Mandates Reform Act of 1995 also Table 8 represents how home health a 6.89 percent decrease to the national requires that agencies assess anticipated agency revenues are likely to be affected standardized 60-day episode rates and costs and benefits before issuing any by the policy changes described in this the NRS conversion factor in CY 2010, rule whose mandates require spending rule. For this analysis, we used linked to account for the increase in nominal in any 1 year of about $100 million or home health claims and OASIS case-mix, the impact would be an more in 1995 dollars, updated for assessments; the claims represented a estimated decrease in payments to inflation. That threshold is currently 20-percent sample of 60-day episodes HHAs of 4.9 percent (column 3 of Table approximately $133 million in 2009. occurring in CY 2007. Column one of 8) or $1,220 million. Similarly, if the This proposed rule is not anticipated to this table classifies HHAs according to Secretary were to impose a 3.51 percent have an effect on State, local, or tribal a number of characteristics including decrease to the national standardized governments, in the aggregate, or by the provider type, geographic region, and 60-day episode rates and the NRS private sector, of $133 million or more. urban versus rural location. conversion factor in CY 2010, to account Executive Order 13132 established For the purposes of analyzing impacts for the increase in nominal case-mix, certain requirements that an agency on payments, we performed three the impact would be an estimated must meet when it promulgates a simulations and compared them to each decrease in payments to HHAs of 1.6 proposed rule (and subsequent final other. Based on our assumption that percent (column 4 of table 8) or $590 rule) that imposes substantial direct outliers, as a percentage of total HH PPS million. For comparison purposes, requirement costs on State and local payments, will be no more than 5 estimated impacts that take these governments, preempts State law, or percent in CY 2009, the 2009 baseline, alternative percentage reductions (6.89 otherwise has Federalism implications. for the purposes of these simulations, percent and 3.51 percent) into account We have reviewed this proposed rule we assumed that the full 5 percent can be found in columns 3 and 4 of under the threshold criteria of Executive outlay for outliers will be paid under Table 8 in Section VI.B. of this rule. Order 13132, Federalism, and have our policy in 2009 of a 0.89 FDL ratio. The RFA requires agencies to analyze determined that it would not have As described in section III.A. of this options for regulatory relief of small substantial direct effects on the rights, proposed rule, given our proposed entities, if a rule has a significant impact roles, and responsibilities of States, policies of a 0.67 FDL ratio and a 10 on a substantial number of small local, or tribal governments. percent cap on outlier payments, we entities. For purposes of the RFA, small would return 2.5 percent back into the entities include small businesses, B. Anticipated Effects national standardized 60-day episode nonprofit organizations, and small This proposed rule sets forth updates payment rates, the national per-visit governmental jurisdictions. Most to the HH PPS rates contained in the CY rates, the LUPA add-on payment hospitals and most other providers and 2009 notice (73 FR 65351, November 3, amount, and the NRS conversion factor, suppliers are small entities, either by 2008). The impact analysis of this and then estimate outlier payments to nonprofit status or by having revenues proposed rule presents the estimated be approximately 2.5 percent of total of $7 million to $34.5 million in any 1 expenditure effects of policy changes HH PPS payments in CY 2010. All three

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simulations use a CBSA-based wage column of Table 8 shows the percent South and West regions of the country index reported on the 2007 claims to change due to the combined effects of are estimated to experience decreases in determine the appropriate wage index. the 2010 wage index, our maintaining of the percentage change in estimated total The first simulation estimates CY a 2.75 percent reductions to the rates to payments from CY 2009 to CY 2010 of 2009 payments under the current account for the increase in nominal 4.01 percent and 1.52 percent. We system (to include the 2009 wage case-mix, the 2.2 percent home health believe that the major contributors to index). The second simulation estimates market basket update, the 2.5 percent the estimated decreases in payments in CY 2009 payments under the current increase to the HH PPS rates to account these areas of the country are those with system, but with the 2010 wage index. for an approximate 2.5 percent target for high and suspect outlier payments. The second simulation produces an outliers as a percentage of total HH PPS Breaking this down even further, it is estimate of what total payments using payments, a 0.67 FDL ratio, and a 10 estimated that New England, Mid the sample data would have been in CY percent outlier cap. Atlantic, East South Central, East North 2009 without any of the proposed The overall percentage change, for all Central, and West North Central area provisions in this rule, except for that of HHAs, in estimated total payments from HHAs are all expected to experience the 2010 wage index. The third CY 2009 to CY 2010 is a decrease of increases in their payments in CY 2010 simulation estimates CY 2010 payments approximately 0.86 percent. Rural ranging from just over 2 percent to with the 2010 wage index, incorporating HHAs, however, are estimated to see an almost 5 percent. Conversely, South our maintaining of the 2.75 percent increase in payments from CY 2009 to Atlantic and Pacific HHAs are expected reduction to the HH PPS rates, as well CY 2010 of about 3.45 percent. On the to experience decreases, 11.68 percent as all the proposed provisions of this other hand, urban HHAs are expected to and 2.90 percent respectively, in the rule. see a decrease of approximately 1.64 percentage change in estimated total These simulations demonstrate the percent in payments from CY 2009 to payments from CY 2009 to CY 2010. effects of: A new 2010 wage index, a CY 2010. Again, we believe that the major 2.75 percent reduction to account for Voluntary non-profit HHAs (3.52 contributors to the estimated decreases the increase in nominal case-mix, a 2.2 percent), facility-based HHAs (3.90 in payments in these areas of the percent market basket update, a 2.5 percent), and government owned HHAs country are those with high and suspect percent increase to account for a new (3.11 percent) are estimated to see an outlier payments. outlier target of 2.5 percent, a 0.67 FDL increase in the percentage change in Larger HHAs (those with 200 or more ratio, and a 10 percent cap on outlier estimated total payments from CY 2009 Medicare home health initial episodes payments. Specifically, the second to CY 2010. Proprietary and per year) are estimated to experience an column of Table 8 shows the percent freestanding HHAs, on the other hand, increase in payments from CY 2009 to change due to the effects of the 2010 are estimated to see decreases of 3.14 CY 2010 of approximately 2.44 percent. wage index. The third and fourth percent and 1.73 percent, respectively, Mid-size to small agencies are expected columns are for comparison purposes, in estimated total payments from CY to see a decrease in their payments in and show the percent change due to the 2009 to CY 2010. Freestanding HHAs, CY 2010, ranging from 1.77 percent to combined effects of the 2010 wage broken out, show that voluntary non- 15.93 percent. However, we believe that index, an alternative 6.89 percent profit and governmental HHAs are the major contributors to the estimated reduction (column 3) or an alternative estimated to see increases of 3.22 decreases in payments for mid-size to 3.51 percent reduction (column 4) to the percent and 2.63 percent, respectively, small agencies are those agencies in rates to account for the increase in in estimated total payments from CY areas of the country with high and nominal case-mix, the 2.2 percent home 2009 to CY 2010. suspect outlier payments. Consequently, health market basket update, the 2.5 HHAs in the North and Midwest we have provided a more detailed percent increase to the HH PPS rates to regions are expected to experience a discussion, and analysis in Table 9 account for an approximate 2.5 percent percentage change increase in the below, that demonstrates where, in the target for outliers as a percentage of total estimated total payments from CY 2009 country, these estimated large decreases HH PPS payments, a 0.67 FDL ratio, and to CY 2010 of 3.79 percent and 3.67 for mid-size to small agencies are a 10 percent outlier cap. The fifth percent, respectively. HHAs in the occurring.

TABLE 8—IMPACT BY AGENCY TYPE

Comparisons (For comparison purposes) (For comparison purposes) Impact of CY 2010 Percent change Impact of CY 2010 proposed policies 1 proposed policies 1 Impact of CY Group due to the effects (w/alternative 6.89 (w/alternative 3.51 2010 proposed of the updated percent reduction in percent reduction in policies 1 wage index only place of the proposed place of the proposed (percent) (percent) 2.75 percent reduction) 2.75 percent reduction) (percent) (percent)

Type of Facility: Free-Standing/Other Vol/NP ...... ¥0.01 ¥0.89 2.47 3.22 Free-Standing/Other Proprietary ...... ¥0.05 ¥7.25 ¥4.00 ¥3.27 Free-Standing/Other Government ...... ¥0.32 ¥1.49 1.88 2.63 Facility-Based Vol/NP ...... ¥0.12 ¥0.22 3.19 3.96 Facility-Based Proprietary ...... ¥0.22 ¥0.57 2.89 3.66 Facility-Based Government ...... ¥0.27 ¥0.56 2.88 3.65 Subtotal: Freestanding ...... ¥0.05 ¥5.74 ¥2.46 ¥1.73 Subtotal: Facility-based ...... ¥0.15 ¥0.29 3.13 3.90 Subtotal: Vol/PNP ...... ¥0.06 ¥0.62 2.76 3.52

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TABLE 8—IMPACT BY AGENCY TYPE—Continued

Comparisons (For comparison purposes) (For comparison purposes) Impact of CY 2010 Percent change Impact of CY 2010 proposed policies 1 proposed policies 1 Impact of CY Group due to the effects (w/alternative 6.89 (w/alternative 3.51 2010 proposed of the updated percent reduction in percent reduction in policies 1 wage index only place of the proposed place of the proposed (percent) (percent) 2.75 percent reduction) 2.75 percent reduction) (percent) (percent)

Subtotal: Proprietary ...... ¥0.05 ¥7.12 ¥3.87 ¥3.14 Subtotal: Government ...... ¥0.30 ¥1.05 2.35 3.11

Total ...... ¥0.06 ¥4.90 ¥1.60 ¥0.86

Type of Facility: (Rural * Only) Free-Standing/Other Vol/NP ...... ¥0.50 ¥0.61 2.83 3.60 Free-Standing/Other Proprietary ...... ¥0.14 ¥0.98 2.51 3.29 Free-Standing/Other Government ...... ¥0.58 ¥0.52 2.88 3.63 Facility-Based Vol/NP ...... ¥0.44 ¥0.52 2.91 3.68 Facility-Based Proprietary ...... ¥0.62 ¥1.30 2.16 2.93 Facility-Based Government ...... ¥0.42 ¥0.47 2.97 3.74 Type of Facility: (Urban * Only) Free-Standing/Other Vol/NP ...... 0.06 ¥0.93 2.41 3.16 Free-Standing/Other Proprietary ...... ¥0.03 ¥8.11 ¥4.89 ¥4.17 Free-Standing/Other Government ...... ¥0.04 ¥2.58 0.76 1.51 Facility-Based Vol/NP ...... ¥0.04 ¥0.14 3.27 4.03 Facility-Based Proprietary ...... 0.03 ¥0.10 3.35 4.13 Facility-Based Government ...... ¥0.03 ¥0.71 2.75 3.52 Type of Facility: (Urban* or Rural*) Rural ...... ¥0.31 ¥0.79 2.67 3.45 Urban ...... ¥0.02 ¥5.64 ¥2.37 ¥1.64

Total ...... ¥0.06 ¥4.90 ¥1.60 ¥0.86

Facility Location: Region* North ...... 0.05 ¥0.30 3.04 3.79 South ...... ¥0.05 ¥7.95 ¥4.73 ¥4.01 Midwest ...... ¥0.23 ¥0.57 2.89 3.67 West ...... ¥0.08 ¥5.55 ¥2.26 ¥1.52 Outlying ...... 0.37 0.21 3.68 4.46

Total ...... ¥0.06 ¥4.90 ¥1.60 ¥0.86

Facility Location: Area of the Country New England ...... 0.53 0.75 4.13 4.88 Mid Atlantic ...... ¥0.21 ¥0.87 2.44 3.19 South Atlantic ...... 0.27 ¥15.29 ¥12.34 ¥11.68 East South Central ...... ¥0.23 ¥0.57 2.94 3.72 West South Central ...... ¥0.29 ¥3.71 ¥0.34 0.41 East North Central ...... ¥0.27 ¥0.62 2.85 3.62 West North Central ...... ¥0.07 ¥0.37 3.08 3.85 Mountain ...... 0.33 ¥2.05 1.33 2.09 Pacific ...... ¥0.23 ¥6.88 ¥3.63 ¥2.90 Outlying ...... 0.37 0.21 3.68 4.46

Total ...... ¥0.06 ¥4.90 ¥1.60 ¥0.86

Facility Size: (Number of First Episodes) < 19 ...... 0.12 ¥19.43 ¥16.57 ¥15.93 20 to 49 ...... 0.03 ¥15.28 ¥12.29 ¥11.62 50 to 99 ...... ¥0.04 ¥12.79 ¥9.72 ¥9.04 100 to 199 ...... ¥0.13 ¥5.79 ¥2.51 ¥1.77 200 or More ...... ¥0.07 ¥1.70 1.69 2.44

Total ...... ¥0.06 ¥4.90 ¥1.60 ¥0.86 Note: Based on a 20% sample of CY 2007 claims linked to OASIS assessments. *Urban/rural status, for the purposes of these simulations, is based on the wage index on which episode payment is based. The wage index is based on the site of service of the beneficiary. Region Key: New England = Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont; Middle Atlantic = Pennsylvania, New Jersey, New York; South Atlantic = Delaware, District of Columbia, Florida, Georgia, Maryland, North Carolina, South Carolina, Virginia, West Virginia; East North Central = Illinois, Indiana, Michigan, Ohio, Wisconsin; East South Central = Alabama, Kentucky, Mississippi, Tennessee; West North Central = Iowa, Kansas, Minnesota, Missouri, Nebraska, North Dakota, South Dakota; West South Central = Arkansas, Louisiana, Oklahoma, Texas; Mountain = Arizona, Colorado, Idaho, Montana, Nevada, New Mexico, Utah, Wyoming; Pacific = Alaska, California, Hawaii, Oregon, Washington; Outlying = Guam, Puerto Rico, Virgin Islands.

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1 Percent change due to the effects of the update wage index, the 2.2% home health market basket update, the 2.75% reduction to the na- tional standardized episode rates, the national per-visit rates, the LUPA add-on payment amount, and the NRS conversion factor for nominal in- crease in case-mix, the 2.5% increase in the rates due to the new approximate 2.5% target for outliers as a percentage of total HH PPS pay- ments, a 0.67 FDL ratio, and a 10% outlier cap.

Given the overall large negative occurring in areas of the country (such Conversely, small HHAs in most other impact observed by smaller agencies, we as the South and South Atlantic) where parts of the country are estimated to see performed more detailed analysis there exist high and suspect outlier increases in payments in CY 2010, targeted at identifying where the large payments. Specifically, in columns 3, 4, ranging from 0.20 percent to almost 4.5 negative impacts were occurring. Table and 5 of Table 9, for the South Atlantic percent. Consequently, we believe that 9 below presents the results of the area of the country (which includes small HHAs without high and suspect regional analysis for small agencies. Miami-Dade, Florida), the negative outlier payments, on average, will see a Column 1, of Table 9, shows the percentage impacts in payment ranging positive impact on their payments in CY regional and agency size classifications from around 40 percent to just over 53 2010. We do not believe there would be similar to those in Table 8. In column percent are evidence that it is the high any significant impact on beneficiaries, 2 we repeat the overall impacts (from and suspect outlier payments in areas as a result of the provisions of this rule. Table 8) for those classifications. In such as this, that are skewing the results Areas where negative impacts have been columns 3 through 7, we drill down in of the overall impact analysis. Estimated our analysis, looking at those impacts for small agencies in the South estimated for HHAs, are primarily classifications by the size of the agency (negative impacts ranging around 15 urban, and thus we believe that (as defined by the number of first percent to 22 percent) and the Pacific beneficiaries have a reasonable pool of episodes). It is clear from this analysis (negative impacts ranging from around HHAs from which to receive home that, for smaller agencies, the vast 11 percent to 17 percent) areas of the health services. majority of the negative impact is country, reflect similar results.

TABLE 9—SMALL AGENCY IMPACTS

Comparison of 2009–2010 Changes Group < 20 20–49 50–99 100–199 200 or more Overall episodes episodes episodes episodes episodes (percent) (percent) (percent) (percent) (percent) (percent)

Facility Location: Region of the Country

North ...... 3.79 0.20 3.05 3.06 3.70 3.83 South ...... ¥4.01 ¥21.93 ¥17.44 ¥14.71 ¥3.67 1.29 Midwest ...... 3.67 2.63 3.45 3.52 3.79 3.75 West ...... ¥1.52 ¥5.67 ¥10.21 ¥9.16 ¥3.78 1.98 Outlying ...... 4.46 4.48 4.41 4.86 4.40 4.44

Total ...... ¥0.86 ¥15.93 ¥11.62 ¥9.04 ¥1.77 2.44

Facility Location: Region of the Country (Census Region)

New England ...... 4.88 ¥3.21 3.53 4.79 4.05 5.04 Mid Atlantic...... 3.19 3.94 2.59 1.42 3.30 3.21 South Atlantic ...... ¥11.68 ¥53.28 ¥45.86 ¥40.50 ¥16.47 ¥0.59 East South Central ...... 3.72 4.11 2.30 3.90 3.24 3.79 West South Central ...... 0.41 ¥5.64 ¥2.55 ¥1.26 1.67 2.27 East North Central ...... 3.62 2.45 3.21 3.61 3.88 3.69 West North Central ...... 3.85 4.05 4.69 3.17 3.46 3.99 Mountain ...... 2.09 1.59 ¥1.38 1.52 1.80 2.99 Pacific ...... ¥2.90 ¥11.37 ¥16.68 ¥13.11 ¥6.55 1.65 Outlying ...... 4.46 4.48 4.41 4.86 4.40 4.44

Total ...... ¥0.86 ¥15.93 ¥11.62 ¥9.04 ¥1.77 2.44

Facility Size (Number of First Episodes)

< 19 episodes ...... ¥15.93 ¥15.93 ...... 20 to 49 ...... ¥11.62 ...... ¥11.62 ...... 50 to 99 ...... ¥9.04 ...... ¥9.04 ...... 100 to 199 ...... ¥1.77 ...... ¥1.77 ...... 200 or More ...... 2.44 ...... 2.44

Total ...... ¥0.86 ¥15.93 ¥11.62 ¥9.04 ¥1.77 2.44 Region Key: New England = Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont; Middle Atlantic = Pennsylvania, New Jersey, New York; South Atlantic = Delaware, District of Columbia, Florida, Georgia, Maryland, North Carolina, South Carolina, Virginia, West Virginia; East North Central = Illinois, Indiana, Michigan, Ohio, Wisconsin; East South Central = Alabama, Kentucky, Mississippi, Ten- nessee; West North Central = Iowa, Kansas, Minnesota, Missouri, Nebraska, North Dakota, South Dakota; West South Central = Arkansas, Lou- isiana, Oklahoma, Texas; Mountain = Arizona, Colorado, Idaho, Montana, Nevada, New Mexico, Utah, Wyoming; Pacific = Alaska, California, Hawaii, Oregon, Washington; Outlying = Guam, Puerto Rico, Virgin Islands

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C. Accounting Statement and Table classification of the expenditures of the changes presented in this associated with the provisions of this proposed rule based on the best Whenever a rule is considered a proposed rule. available data. The expenditures are significant rule under Executive Order Table 10, below provides our best classified as a transfer to the Federal 12866, we are required to develop an estimate of the decrease in Medicare Government of $100 million. Accounting Statement showing the payments under the HH PPS as a result

TABLE 10—ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED EXPENDITURES, FROM THE 2009 HH PPS CALENDAR YEAR TO THE 2010 HH PPS CALENDAR YEAR

Category Transfers

Annualized Monetized Transfers ...... Negative transfer—Estimated decrease in expenditures: $100 million. From Whom To Whom ...... Federal Government to HH Providers.

D. Conclusion PART 409—HOSPITAL INSURANCE cause a service that would originally be In conclusion, we estimate that the BENEFITS considered unskilled to be considered a net impact of the proposals in this rule, skilled nursing service. This would 1. The authority citation for part 409 occur when the patient’s underlying including a 2.75 percent reduction to continues to read as follows: the national standardized 60-day condition or complication requires that episode rates and the NRS conversion Authority: Secs. 1102 and 1871 of the only a registered nurse can ensure that factor to account for the case-mix Social Security Act (42 U.S.C. 1302 and essential non-skilled care is achieving 1395hh). change adjustment, is approximately its purpose. The registered nurse is $100 million in CY 2010 savings. The 2. Section 409.42 is amended as ensuring that service is safely and $100 million impact reflects the follows: effectively performed. However, a distributional effects of an updated A. Revising paragraph (c)(1). service is not considered a skilled wage index (¥$10 million) as well as B. Adding paragraph (c)(1)(i) and nursing service merely because it is the 2.2 percent home health market (c)(1)(ii) performed by or under the supervision basket increase (an additional $390 The revisions and additions read as of a licensed nurse. Where a service can million in CY 2010 expenditures follows: be safely and effectively performed (or attributable only to the CY 2010 home self administered) by non-licensed staff § 409.42 Beneficiary qualifications for without the direct supervision of a health market basket), and the 2.75 coverage of services. percent decrease (¥$480 million for the nurse, the service cannot be regarded as * * * * * third year of a 4-year phase-in) to the a skilled service even if a nurse actually (c) * * * national standardized 60-day episode provides the service. (1) Intermittent skilled nursing rates and the NRS conversion factor to (ii) In the home health setting, skilled services that meet the criteria for skilled account for the case-mix change education services are no longer needed services and the need for skilled adjustment under the HH PPS. This if it becomes apparent, after a services found in § 409.32. (Also see analysis above, together with the reasonable period of time, that the § 409.33(a) and (b) for a description of remainder of this preamble, provides a patient, family, or caregiver could not or examples of skilled nursing and Regulatory Impact Analysis. would not be trained. Further teaching In accordance with the provisions of rehabilitation services.) These criteria and training would cease to be Executive Order 12866, this regulation are subject to the following limitations reasonable and necessary in this case, was reviewed by the Office of in the home health setting: and would cease to be considered a Management and Budget. (i) In the home health setting, skilled service. Notwithstanding that the management and evaluation of a patient teaching or training was unsuccessful, List of Subjects care plan is considered a reasonable and the services for teaching and training 42 CFR Part 409 necessary skilled service only when would be considered to be reasonable underlying conditions or complications Health facilities, Medicare. and necessary prior to the point that it are such that only a registered nurse can became apparent that the teaching or 42 CFR Part 424 ensure that essential non-skilled care is training was unsuccessful, as long as achieving its purpose. To be considered Emergency medical services, Health such services were appropriate to the a skilled service, the complexity of the facilities, Health professions, Medicare, patient’s illness, functional loss, or necessary unskilled services that are a Reporting and recordkeeping. injury. necessary part of the medical treatment requirements * * * * * must require the involvement of 3. Section 409.43 is amended by 42 CFR Part 484 licensed nurses to promote the patient’s revising paragraph (e)(1)(ii) to read as Health facilities, Health professions, recovery and medical safety in view of follows: Medicare, Reporting and recordkeeping the overall condition. Where nursing requirements. visits are not needed to observe and § 409.43 Plan of care requirements. assess the effects of the non-skilled * * * * * 42 CFR Part 489 services being provided to treat the (e) * * * Health facilities, Medicare, Reporting illness or injury, skilled nursing care (1) * * * and recordkeeping requirements. would not be considered reasonable and (ii) Significant change in condition; or For the reasons set forth in the necessary, and the management and * * * * * preamble, the Centers for Medicare & evaluation of the care plan would not be 4. Section 409.44 is amended by Medicaid Services proposes to amend considered a skilled service. In some revising the introductory paragraph of 42 CFR chapter IV as set forth below: cases, the condition of the patient may (b)(1) to read as follows:

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§ 409.44 Skilled services requirements. include a written narrative describing stock transfers), transfers or relinquishes * * * * * the clinical justification of this need. ownership of the HHA within 36 (b) * * * * * * * * months after the effective date of the (1) Skilled nursing care consists of 7. Section 424.530 is amended by HHA’s enrollment in Medicare, the those services that must, under State adding paragraph (a)(8) to read as provider agreement and Medicare law, be performed by a registered nurse, follows: billing privileges do not convey to the or practical (vocational) nurse, as new owner. The prospective provider/ defined in § 484.4 of this chapter, meet § 424.530 Denial of enrollment in the owner of the HHA must instead: Medicare program. the criteria for skilled nursing services (i) Enroll in the Medicare program as specified in § 409.32, and meet the (a) * * * a new HHA under the provisions of qualifications for coverage of skilled (8) A prospective HHA is determined, § 424.510, and services specified in § 409.42(c). See under 42 CFR § 489.19, to be sharing, (ii) Obtain a State survey or an § 409.33(a) and (b) for a description of leasing, or subleasing its practice accreditation from an approved skilled nursing services and examples of location or base of operations identified accreditation organization. them. in Section 4 of its Medicare provider (2) [Reserved] * * * * * enrollment application with or to another Medicare-enrolled HHA or * * * * * PART 424—CONDITIONS FOR supplier. PART 484—HOME HEALTH SERVICES MEDICARE PAYMENT * * * * * 8. Section 424.535 is amended by 5. The authority citation for part 424 11. The authority citation for part 484 adding paragraph (a)(11) to read as continues to read as follows: continues to read as follows: follows: Authority: Secs. 1102 and 1871 of the Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and § 424.535 Revocation of enrollment and Social Security Act (42 U.S.C. 1302 and 1395hh). billing privileges in the Medicare program. 1395(hh)). (a) * * * 6. Section 424.22 is amended as Subpart C—Furnishing of Services follows: (11) An HHA is determined, under 42 CFR § 489.19, to be sharing, leasing, or A. Revising paragraph (a)(1)(i); 12. Section 484.55 is amended by subleasing its practice location or base B. Revising paragraph (b)(2). revising paragraph (d)(1)(ii) to read as of operations identified in Section 4 of follows: § 424.22 Requirements for home health its Medicare provider enrollment services. application with or to another Medicare- § 484.55 Condition of participation: (a) * * * enrolled HHA or supplier. Comprehensive assessment of patients. (1) * * * (i) The individual needs or needed * * * * * * * * * * intermittent skilled nursing care, or 9. Section 424.540 is amended by (d) * * * physical or speech therapy, or (for the revising paragraph (1) * * * (b)(3) to read as follows: period from July through November 30, (ii) Significant change in condition; or 1981) occupational therapy. If a § 424.540 Deactivation of Medicare billing * * * * * patient’s underlying condition or privileges. complication requires a registered nurse * * * * * Subpart E—Prospective Payment to ensure that essential non-skilled care (b) * * * System for Home Health Agencies is achieving its purpose, and (3) With the exception of home health necessitates a registered nurse be agencies, reactivation of Medicare 13. Section 484.210 is amended by involved in the development, billing privileges does not require a new revising paragraph (e) to read as follows: management, and evaluation of a certification of the provider or supplier patient’s care plan, the physician will § 484.210 Data used for the calculation of by the State survey agency or the the national prospective 60-day episode include a written narrative describing establishment of a new provider payment. the clinical justification of this need. agreement. * * * * * * * * * * (i) An HHA whose Medicare billing (b) * * * privileges are deactivated under the (e) OASIS assessment data and other (2) Content and basis of provisions found at 42 CFR 424.540(a) data that account for the relative recertification. The recertification must obtain an initial State survey or resource utilization for different HHA statement must indicate the continuing accreditation by an approved Medicare patient case-mix. An HHA need for services and estimate how accreditation organization before its must submit to CMS the OASIS data much longer the services will be Medicare billing privileges can be described at § 484.55(b)(1) and (d)(1) in required. Need for occupational therapy reactivated. order for CMS to administer the may be the basis for continuing services (ii) [Reserved] payment rate methodologies described in §§ 484.215, 484.230 and 484.235. that were initiated because the * * * * * individual needed skilled nursing care 10. Section 424.550 is amended by 14. Revising § 484.250 to read as or physical therapy or speech therapy. adding paragraphs (b)(1) and (2) to read follows: If a patient’s underlying condition or as follows: complication requires a registered nurse § 484.250 Patient assessment data. to ensure that essential non-skilled care § 424.550 Prohibitions on the sale or An HHA must submit to CMS the is achieving its purpose, and transfer of billing privileges. OASIS data described at § 484.55(b)(1) necessitates a registered nurse be * * * * * and (d)(1) in order for CMS to involved in the development, (b) * * * administer the payment rate management, and evaluation of a (1) If an owner of a home health methodologies described in §§ 484.215, patient’s care plan, the physician will agency sells (including asset sales or 484.230, and 484.235.

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PART 489—PROVIDER AGREEMENTS to another Medicare enrolled HHA or enrollment application to another AND SUPPLIER APPROVAL supplier in violation of the HHA space Medicare-enrolled HHA or supplier. sharing prohibition set forth in § 489.19. 15. The authority citation for part 489 Authority: (Catalog of Federal Domestic continues to read as follows: * * * * * Assistance Program No. 93.773, Medicare— 17. Adding a new § 489.19 to read as Hospital Insurance; and Program No. 93.774, Authority: Secs. 1102, 1819, 1820(e), 1861, follows: Medicare—Supplementary Medical 1864(m), 1866, 1869, and 1871 of the Social Insurance Program) Security Act (42 U.S.C. 1302, 1395i–3, 1395x, § 489.19 Prohibition on Space Sharing. 1395aa(m), 1395cc, 1395ff, and 1395hh). Dated: May 28, 2009. An HHA is prohibited from engaging 16. Section 489.12 is amended by Charlene Frizzera, in the following space sharing and/or adding paragraph (a)(5) to read as Acting Administrator, Centers for Medicare follows: leasing arrangements: (a) Sharing its practice location or & Medicaid Services. § 489.12 Decision to deny an agreement. base of operations identified in Section Approved: July 17, 2009. (a) * * * 4 of its Medicare provider enrollment Kathleen Sebelius, (5) A prospective HHA is determined application with another Medicare- Secretary. to be sharing, leasing, or subleasing its enrolled HHA or supplier; or practice location or base of operations (b) Leasing or subleasing its practice Note: The following addenda will not be identified in Section 4 of its Medicare location or base of operations identified published in the Code of Federal Regulations. provider enrollment application with or in Section 4 of its Medicare provider BILLING CODE 13–01–00–D

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[FR Doc. E9–18587 Filed 7–30–09; 4:15 pm] published at pages 39436 to 39496 in the This document, along with the correct tables, is being republished in its entirety. Editorial Note: Federal Register proposed issue of Thursday, August 6, 2009, included rule document E9–18587, originally incorrect tables from pages 39471 to 39496. [FR Doc. R9–18587 Filed 8–12–09; 8:45 am] BILLING CODE 13–01–00–C

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Part IV

Department of the Interior Fish and Wildlife Service

50 CFR Part 20 Migratory Bird Hunting; Proposed Framework for Late-Season Migratory Bird Hunting Regulations; Proposed Rule

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DEPARTMENT OF THE INTERIOR regulations process, and dealt with the addition, new proposals for certain late- establishment of seasons, limits, and season regulations are provided for Fish and Wildlife Service other regulations for hunting migratory public comment. The comment period game birds under ’’20.101 through is specified above under DATES. We 50 CFR Part 20 20.107, 20.109, and 20.110 of subpart K. will publish final regulatory frameworks Major steps in the 2009–10 regulatory for late-season migratory game bird [FWS-R9-MB-2008-0124; 91200-1231-9BPP- L2] cycle relating to open public meetings hunting in the Federal Register on or and Federal Register notifications were around September 22, 2009. RIN 1018-AW31 also identified in the April 10 proposed Population Status and Harvest rule. Further, we explained that all Migratory Bird Hunting; Proposed sections of subsequent documents The following paragraphs provide a Frameworks for Late-Season Migratory outlining hunting frameworks and brief summary of information on the Bird Hunting Regulations guidelines were organized under status and harvest of waterfowl numbered headings. excerpted from various reports. For AGENCY: Fish and Wildlife Service, On May 27, 2009, we published in the more detailed information on Interior. Federal Register (74 FR 25209) a second methodologies and results, you may ACTION: Proposed rule; supplemental. document providing supplemental obtain complete copies of the various proposals for early- and late-season reports at the address indicated under SUMMARY: The Fish and Wildlife Service migratory bird hunting regulations. The FOR FURTHER INFORMATION CONTACT or (hereinafter Service or we) is proposing May 27 supplement also provided from our website http://www.fws.gov/ to establish the 2009–10 late-season detailed information on the 2009–10 migratorybirds/ hunting regulations for certain regulatory schedule and announced the NewsPublicationsReports.html. migratory game birds. We annually Service Migratory Bird Regulation Status of Ducks prescribe frameworks, or outer limits, Committee (SRC) and Flyway Council for dates and times when hunting may meetings. Federal, provincial, and State occur and the number of birds that may On June 24 and 25, 2009, we held agencies conduct surveys each spring to be taken and possessed in late seasons. open meetings with the Flyway Council estimate the size of breeding These frameworks are necessary to Consultants at which the participants populations and to evaluate the allow State selections of seasons and reviewed information on the current conditions of the habitats. These limits and to allow recreational harvest status of migratory shore and upland surveys are conducted using fixed-wing at levels compatible with population game birds and developed aircraft and helicopters and encompass and habitat conditions. recommendations for the 2009–10 principal breeding areas of North DATES: You must submit comments on regulations for these species plus America, and cover over 2.0 million the proposed migratory bird hunting regulations for migratory game birds in square miles. The Traditional survey late-season frameworks by August 24, Alaska, Puerto Rico, and the Virgin area comprises Alaska, Canada, and the 2009. Islands, special September waterfowl northcentral United States, and includes approximately 1.3 million square miles. ADDRESSES: You may submit comments seasons in designated States, special sea The Eastern survey area includes parts on the proposals by one of the following duck seasons in the Atlantic Flyway, of Ontario, Quebec, Labrador, methods: and extended falconry seasons. In Newfoundland, Nova Scotia, Prince • Federal eRulemaking Portal: http:// addition, we reviewed and discussed Edward Island, New Brunswick, New www.regulations.gov. Follow the preliminary information on the status of York, and Maine, an area of instructions for submitting comments. waterfowl as it relates to the development and selection of the approximately 0.7 million square miles. • U.S. mail or hand-delivery: Public regulatory packages for the 2009–10 Comments Processing, Attn: FWS–R9– Breeding Ground Conditions regular waterfowl seasons. On July 24, MB–2008–0124; Division of Policy and 2009, we published in the Federal Habitat conditions during the 2009 Directives Management; U.S. Fish and Register (74 FR 36870) a third document Waterfowl Breeding Population and Wildlife Service; 4401 N. Fairfax Drive, specifically dealing with the proposed Habitat Survey were characterized by Suite 222; Arlington, VA 22203. frameworks for early-season regulations. above-average moisture across the We will not accept e-mail or faxes. We In late August 2009, we will publish a southern portions of the traditional will post all comments on http:// rulemaking establishing final survey area, good habitat in the eastern www.regulations.gov. This generally frameworks for early-season migratory survey area, and late spring conditions means that we will post any personal bird hunting regulations for the 2009–10 across northern survey areas. The total information you provide us (see the season. pond estimate (prairie Canada and U.S. Public Comments section below for On July 29–30, 2009, we held open combined) was 6.4 ± 0.2 million. This more information). meetings with the Flyway Council was 45 percent above last year’s FOR FURTHER INFORMATION CONTACT: Ron Consultants, at which the participants estimate of 4.4 ± 0.2 million ponds and W. Kokel, U.S. Fish and Wildlife reviewed the status of waterfowl and 31 percent above the long-term average Service, Department of the Interior, MS developed recommendations for the of 4.9 ± 0.03 million ponds. The 2009 MBSP-4107-ARLSQ, 1849 C Street, NW, 2009–10 regulations for these species. estimate of ponds in prairie Canada was Washington, DC 20240; (703) 358-1714. This document deals specifically with 3.6 ± 0.1 million. This was a 17 percent SUPPLEMENTARY INFORMATION: proposed frameworks for the late-season increase from last year’s estimate (3.1 ± migratory bird hunting regulations. It 0.1 million) and was similar to the long- Regulations Schedule for 2009 will lead to final frameworks from term average (3.4 ± 0.03 million). The On April 10, 2009, we published in which States may select season dates, 2009 pond estimate for the northcentral the Federal Register (74 FR 16339) a shooting hours, areas, and limits. U.S. of 2.9 ± 0.1 million was 108 percent proposal to amend 50 CFR part 20. The We have considered all pertinent above last year’s estimate (1.4 ± 0.07 proposal provided a background and comments received through August 1, million) and 87 percent above the long- overview of the migratory bird hunting 2009, in developing this document. In term average (1.5 ± 0.02 million).

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Breeding population status Fall Flight Estimate Waterfowl Harvest and Hunter Activity In the Waterfowl Breeding Population The mid-continent mallard National surveys of migratory bird and Habitat Survey traditional survey population is composed of mallards hunters were conducted during the 2007 area (strata 1–18, 20–50, and 75–77), the from the traditional survey area (revised and 2008 hunting seasons. About 1.2 total duck population estimate was 42.0 in 2008 to exclude Alaska mallards), million waterfowl hunters harvested ± 14,578,900 (±4%) ducks and 3,666,100 0.7 [SE] million birds. This estimate Michigan, Minnesota, and Wisconsin, ± ± ( 6%) geese in 2007, and harvested represents a 13 percent increase over and was estimated to be 10.3 0.9 ± last year’s estimate of 37.3 ± 0.6 million 13,635,700 ( 4%) ducks and 3,792,600 million in 2009. This was similar to the (±5%) geese in 2008. Mallard, green- birds and was 25 percent above the 2008 estimate of 9.2 ± 0.8 million. long-term average (1955–2008). winged teal, gadwall, wood duck (Aix See section 1.A. Harvest Strategy Estimated mallard (Anas platyrhynchos) sponsa), and American wigeon were the Considerations for further discussion of abundance was 8.5 ± 0.2 million birds, 5 most-harvested duck species in the which was a 10 percent increase over the implications of this information for United States, and Canada goose was last year’s estimate of 7.7 ± 0.3 million this year’s selection of the appropriate the predominant goose species in the goose harvest. Coot hunters (about birds and 13 percent above the long- hunting regulations. 33,700 in 2007 and 31,100 in 2008) term average. Estimated abundance of Status of Geese and Swans harvested 198,300 (±29%) coots in 2007 gadwall (A. strepera; 3.1 ± 0.2 million) and 275,900 (+43%) in 2008. was similar to the 2008 estimate and 73 We provide information on the percent above the long-term average. population status and productivity of Review of Public Comments and Estimated American wigeon abundance North American Canada geese (Branta Flyway Council Recommendations ± (A. americana; 2.5 0.1 million) was canadensis), brant (B. bernicla), snow The preliminary proposed similar to 2008 and the long-term geese (Chen caerulescens), Ross’ geese rulemaking, which appeared in the average. Estimated abundances of green- (C. rossii ), emperor geese (C. canagica), April 10, 2009, Federal Register, winged teal (A. crecca; 3.4 ± 0.2 million) white-fronted geese (Anser albifrons), ± opened the public comment period for and blue-winged teal (A. discors; 7.4 and tundra swans (Cygnus migratory game bird hunting 0.4 million) were similar to last year’s columbianus). In May of 2009, regulations. The supplemental proposed estimates and well above their long-term temperatures were 1–5 degrees Celsius rule, which appeared in the May 27, averages (+79 percent and +60 percent, colder than average throughout the 2009, Federal Register, discussed the respectively). Northern shovelers (A. central region of subarctic and Arctic ± regulatory alternatives for the 2009–10 clypeata; 4.4 0.2 million) were 25 Canada. In some locales harsh spring duck hunting season. Late-season percent above the 2008 estimate and conditions persisted into June. In areas comments are summarized below and remain well above their long-term near Hudson Bay and the Queen Maud numbered in the order used in the April average (+92 percent). The estimate for ± Gulf, goose and swan nesting activities 10 and May 27 Federal Register northern pintails (A. acuta) was 3.2 were delayed by 1 to 3 weeks. In documents. We have included only the 0.2 million, which was 23 percent above ± contrast, nesting conditions were numbered items pertaining to late- the 2008 estimate of 2.6 0.1 million, favorable near Wrangel Island, Alaska’s season issues for which we received and 20 percent below the long-term North Slope and eastern interior written comments. Consequently, the average. Estimated abundance of regions, parts of the Canadian high issues do not follow in successive redheads (Aythya americana; 1.0 ± 0.1 Arctic, and Newfoundland. Improved numerical or alphabetical order. million) was similar to last year and 62 wetland abundance in the Canadian and We received recommendations from percent above the long-term average. all four Flyway Councils. Some The canvasback estimate (A. valisineria; U.S. prairies, and other temperate ± regions, will likely improve the recommendations supported 0.7 0.06 million) was 35 percent above continuation of last year’s frameworks. the 2008 estimate (0.5 ± 0.05 million) production of Canada geese that nest at southern latitudes. Primary abundance Due to the comprehensive nature of the and similar to the long-term average. annual review of the frameworks The scaup estimate (A. affinis and A. indices decreased for 15 goose ± populations and increased for 10 goose performed by the Councils, support for marila combined; 4.2 0.2 million) was continuation of last year’s frameworks is similar to that of 2008 and 18 percent populations in 2009 compared to 2008. ± Primary abundance indices for both assumed for items for which no below the long-term average of 5.1 recommendations were received. 0.05 million. populations of tundra swans increased in 2009 from 2008 levels. The following Council recommendations for changes The eastern survey area was in the frameworks are summarized populations displayed significant restratified in 2005 and is now below. positive trends during the most recent composed of strata 51-72. Estimates of We seek additional information and 10–year period (P < 0.05); Mississippi mallards, scaup, scoters (black comments on the recommendations in Flyway Giant, Aleutian, Atlantic, and [Melanitta nigra], white-winged [M. this supplemental proposed rule. New fusca], and surf [M. perspicillata]), Eastern Prairie Canada geese; Greater, proposals and modifications to green-winged teal, American wigeon, Western Arctic/Wrangel Island, and previously described proposals are bufflehead (Bucephala albeola), Western Central Flyway light geese; and discussed below. Wherever possible, American black duck (Anas rubripes), Pacific white-fronted geese. No they are discussed under headings ring-necked duck (Aythya collaris), populations showed a significant corresponding to the numbered items in mergansers (red-breasted [Mergus negative 10–year trend. The forecast for the April 10 and May 27, 2009, Federal serrator], common [M. merganser], and the production of geese and swans in Register documents. hooded [Lophodytes cucullatus]), and North America for 2009 is regionally goldeneye (common [B. clangula] and variable, but production for many General Barrow’s [B. islandica]) all were similar populations will be reduced this year Written Comments: An individual to their 2008 estimates and long-term due to harsh spring conditions in much commenter protested the entire averages. of central Canada. migratory bird hunting regulations

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process, the killing of all migratory choice for the Mississippi and Central below the long-term average breeding birds, and the Flyway Council process. Flyways should depend on the status of population by 15 percent or more. The Service Response: Our long-term the recently redefined mid-continent strategy is designed to share the black objectives continue to include providing mallard stock. We also recommend that duck harvest equally between the two opportunities to harvest portions of the regulatory choice for the Atlantic countries; however, recognizing certain migratory game bird populations Flyway continue to depend on the incomplete control of harvest through and to limit annual harvests to levels status of eastern mallards. regulations, it will allow realized compatible with each population’s For the 2009 hunting season, we are harvest in either country to vary ability to maintain healthy, viable continuing to consider the same between 40 and 60 percent. numbers. Having taken into account the regulatory alternatives as those used last Each year in November, Canada zones of temperature and the year. The nature of the ‘‘restrictive,’’ publishes its proposed migratory bird distribution, abundance, economic ‘‘moderate,’’ and ‘‘liberal’’ alternatives hunting regulations for the upcoming value, breeding habits, and times and has remained essentially unchanged hunting season. Thus, last fall the lines of flight of migratory birds, we since 1997, except that extended Canadian Wildlife Service (CWS) used believe that the hunting seasons framework dates have been offered in the interim strategy to establish its provided herein are compatible with the the ‘‘moderate’’ and ‘‘liberal’’ regulatory proposed black duck regulations for the current status of migratory bird alternatives since 2002. Also, in 2003, 2009–10 season based on the most populations and long-term population we agreed to place a constraint on current data available at that time: goals. Additionally, we are obligated to, closed seasons in the western three breeding population estimates for 2006, and do, give serious consideration to all Flyways whenever the midcontinent 2007, and 2008, and an assessment of information received as public mallard breeding-population size (as parity based on harvest estimates for the comment. While there are problems defined prior to 2008; traditional survey 2003–07 hunting seasons. Although inherent with any type of representative area plus Minnesota, Michigan, and updates of both breeding population management of public-trust resources, Wisconsin) was ≥5.5 million. estimates and harvest estimates are now we believe that the Flyway Council Optimal AHM strategies for the 2009– available, the United States will base its system of migratory bird management 10 hunting season were calculated 2009–10 black duck regulations on the has been a long-standing example of using: (1) Harvest-management same data CWS used, to ensure State-Federal cooperative management objectives specific to each mallard comparable application of the strategy. since its establishment in 1952. stock; (2) the 2009 regulatory The long-term (1998–2007) breeding However, as always, we continue to alternatives; and (3) current population population mean estimate is 713,800 explore new ways to streamline and models and associated weights for and the 2006–08 3–year running mean improve the process. midcontinent, western, and eastern estimate is 721,600. Based on these estimates, no restriction or liberalization 1. Ducks mallards. Based on this year’s survey results of 8.71 million midcontinent of black duck harvest is warranted. The Categories used to discuss issues mallards (traditional survey area minus average proportion of the harvest during related to duck harvest management are: Alaska plus Minnesota, Wisconsin, and the 5–year period 2003–2007 was 0.56 (A) Harvest Strategy Considerations, (B) Michigan), 3.57 million ponds in Prairie in the United States and 0.44 in Canada, Regulatory Alternatives, (C) Zones and Canada, 884,000 western mallards and this falls within the established Split Seasons, and (D) Special Seasons/ (381,000 and 503,000 respectively in parity bounds of 40 and 60 percent. Species Management. The categories California-Oregon and Alaska), and correspond to previously published iv. Canvasbacks 908,000 eastern mallards, the prescribed issues/discussion, and only those Council Recommendations: The regulatory choice for all four Flyways is containing substantial recommendations Atlantic, Central, and Pacific Flyway the ‘‘liberal’’ alternative. are discussed below. Councils recommended a full season for Therefore, we concur with the canvasbacks with a 1-bird daily bag A. Harvest Strategy Considerations recommendations of the Atlantic, limit. Season lengths would be 60 days Council Recommendations: The Mississippi, Central, and Pacific Flyway in the Atlantic Flyway, 74 days in the Atlantic, Central, and Pacific Flyway Councils regarding selection of the Central Flyway, and 107 days in the Councils and the Upper- and Lower- ‘‘liberal’’ regulatory alternative and Pacific Flyway. Region Regulations Committees of the propose to adopt the liberal regulatory The Upper- and Lower-Region Mississippi Flyway Council alternative, as described in the July 24, Regulations Committees of the recommended the adoption of the 2009 Federal Register. Mississippi Flyway Council ‘‘liberal’’ regulatory alternative. D. Special Seasons/Species recommended use of their alternative Service Response: We are continuing Management canvasback harvest management development of an Adaptive Harvest strategy that uses threshold levels based iii. Black Ducks Management (AHM) protocol that on breeding population size in order to would allow hunting regulations to vary In 2008, U.S. and Canadian waterfowl determine bag limits (detailed in the among Flyways in a manner that managers developed an interim harvest June 18, 2008, Federal Register (73 FR recognizes each Flyway’s unique strategy that will be employed by both 34692)). Their strategy results in a breeding-ground derivation of mallards. countries until a formal strategy based Council recommendation for a 1-bird Last year, we described and adopted a on the principles of AHM is completed. daily bag limit and a 60–day season in protocol for regulatory decision-making We detailed this interim strategy in the the Mississippi Flyway. for the newly defined stock of western July 24, 2008, Federal Register (73 FR Service Response: Since 1994, we mallards (73 FR 43290). For the 2009 43290). The interim harvest strategy is have followed a canvasback harvest hunting season, we continue to believe prescriptive, in that it calls for no strategy that if canvasback population that the prescribed regulatory choice for substantive changes in hunting status and production are sufficient to the Pacific Flyway should be based on regulations unless the black duck permit a harvest of one canvasback per the status of this western mallard breeding population, averaged over the day nationwide for the entire length of breeding stock, while the regulatory most recent 3 years, exceeds or falls the regular duck season, while still

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attaining a projected spring population projected fall flight of 5.13 million Further opportunity to revise these objective of 500,000 birds, the season on pintails, the pintail harvest strategy packages was afforded prior to the canvasbacks should be opened. A prescribes a full season and a 1-bird 2009–10 season and modifications that partial season would be permitted if the daily bag limit in the Atlantic, were recommended by the Mississippi estimated allowable harvest was within Mississippi, and Central Flyways. In the and Central Flyway Councils were the projected harvest for a shortened Pacific Flyway a 2-bird daily bag limit endorsed by the Service in June 2009 season. If neither of these conditions and a full season is prescribed. Under (74 FR 36870). These packages will can be met, the harvest strategy calls for the ‘‘liberal’’ season length, this remain in effect for at least 3 years prior a closed season on canvasbacks regulation is expected to result in a to their re-evaluation. nationwide. Last year (73 FR 43290), we harvest of 643,388 pintails and an The 2009 breeding population announced our decision to modify the expected breeding population estimate estimate for scaup is 4.17 million, up 12 Canvasback Harvest Strategy to (corrected scale) of 4.02 million in 2010. percent from, but similar to, the 2008 incorporate the option for a 2-bird daily Regarding the Mississippi Flyway estimate of 3.74 million. Total estimated bag limit for canvasbacks when the Council’s recommendation to evaluate scaup harvest for the 2008–09 season predicted breeding population the the performance of the prescribed was 229,000 birds. Based on updated subsequent year exceeds 725,000 birds. strategy for managing harvest of model parameter estimates, the optimal This year’s spring survey resulted in northern pintails, we have previously regulatory choice for scaup is the an estimate of 662,000 canvasbacks. provided such information and remain ‘‘moderate’’ package recommended by This was 35 percent above the 2008 committed to implementation of a the Councils in all four Flyways. estimate of 489,000 canvasbacks and 16 derived strategy for pintail harvest vii. Mottled Ducks percent above the 1955–2008 average. management next year. This strategy The estimate of ponds in Prairie Canada would replace the current prescriptive Council Recommendations: The was 3.6 million, which was 17 percent strategy that has been used for pintails Upper- and Lower-Region Regulations above last year and 5 percent above the since 1997. In order for the Committees of the Mississippi Flyway long-term average. The canvasback implementation of the new derived Council recommended reducing the harvest strategy predicts a 2010 strategy to be successful, the Service daily bag limit for mottled ducks from canvasback population of 602,000 birds and Flyway Councils must reach 3 to 1 bird per day. under a ‘‘liberal’’ duck season with a 1- agreement on several key issues. These The Central Flyway Council initially bird daily bag limit and 565,000 with a issues include: (1) determination of the recommended that no further harvest 2-bird daily bag limit. Because the harvest management objective, (2) reductions were warranted. However, at predicted 2010 population under the 1- identification of any constraints that the July SRC meeting, they subsequently bird daily bag limit is greater than would be included in the strategy (e.g., amended their Council recommendation 500,000, while the prediction under the closure constraint), and (3) a decision by agreeing to delay the opening of the 2-bird daily bag limit is less than regarding specific inclusion of a harvest mottled duck season for the first 5 days 725,000, the canvasback harvest strategy allocation process. We will make of the regular duck season. stipulates a full canvasback season with technical information regarding these Service Response: For many years, we a 1-bird daily bag limit for the upcoming three aspects of the derived strategy have expressed concern about the long- season. available at the December 2009 AHM term status of mottled ducks, especially the Western Gulf Coast Population. v. Pintails Working Group Meeting, with additional discussion at the 2010 After consideration of long-term trends Council Recommendations: The February SRC meeting in Denver, for this population, recent harvest Atlantic, Central and Pacific Flyway followed by Flyway Council levels, and this year’s breeding habitat Councils and the Upper- and Lower- consideration at their 2010 winter conditions, we believe that a reduction Region Regulations Committees of the meetings. in harvest levels for this population is Mississippi Flyway Council necessary. recommended a full season for pintails vi. Scaup The Mississippi Flyway Council’s consisting of a 1-bird daily bag limit and Council Recommendations: The recommendation to reduce the daily bag a 60–day season in the Atlantic and Atlantic Flyway Council and the Upper- limit of mottled ducks to one bird is Mississippi Flyways and a 74–day and Lower-Region Regulations projected to result in a harvest reduction season in the Central Flyway, and a 2- Committees of the Mississippi Flyway of about 20 percent. The Central Flyway bird daily bag limit with a 107–day Council recommended use of the Council’s amended recommendation to season in the Pacific Flyway. ‘‘moderate’’ regulation package delay the opening of the mottled duck The Upper- and Lower-Region consisting of a 60–day season with a 2- season is expected to result in a similar Regulations Committees of the bird daily bag. harvest reduction. We believe that this Mississippi Flyway Council also The Central Flyway Council level of reduction is necessary across recommended that the Service evaluate recommended use of the ‘‘moderate’’ the entire range of Western Gulf Coast the performance of the prescribed regulation package consisting of a 74– Population this year. Accordingly, we strategy for managing harvest of day season with a 2-bird daily bag limit. support the Mississippi Flyway northern pintails and explain the The Pacific Flyway Council Council’s recommendation and the reasons for implementing the derived recommended the adoption of the Central Flyway Council’s amended strategy despite a Council ‘‘moderate’’ regulation package for the recommendation with the goal of recommendation to continue using the Pacific Flyway consisting of an 86–day achieving approximately a 20 percent prescribed strategy. season with a 3-bird daily bag limit. reduction in mottled duck harvest. Service Response: Based on the Service Response: Last year, we We also urge that an assessment be current strategy last modified in 2007, adopted and implemented a new scaup conducted of whether desired along with an observed spring breeding harvest strategy (73 FR 43290 and 73 FR reductions in harvest are achieved as a population of 3.22 million, an 51124). Initial ‘‘restrictive,’’ ‘‘moderate,’’ result of the proposed restrictions. overflight-bias-corrected breeding and ‘‘liberal’’ regulatory packages were Furthermore, the status of mottled population of 3.73 million and a adopted for each Flyway in 2008. ducks and their breeding habitat should

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be closely monitored and a Mississippi Flyway Council River Delta is 6,709, a decrease from the determination made whether further recommended that the season length in previous year’s index of 9,152. The 3– restrictions are warranted. Should Louisiana be extended from 16 to 44 year average index is 8,682. This decline additional restrictions be needed, we days and that the daily bag limit of 1 per triggers implementation of further will consider all regulatory options, day be included in an aggregate dark measures of protection for this including the potential for a closed goose bag of 2 per day, with no more population as described under Action season. than 1 Canada goose. The Committees level 2 in the management plan. Based also recommended extending the goose on the harvest strategy in the viii. Wood Ducks season in Ohio from 70 to 74 days. management plan, we support the Council Recommendations: The The Pacific Flyway Council Council recommendations to further Atlantic and Central Flyway Councils recommended reducing quotas for reduce the quotas assigned to and the Upper- and Lower-Region dusky Canada geese in Washington to Washington (to 45) and Oregon (to 90) Regulations Committees of the 45 (from 85) and in Oregon to 90 (from and institution of the other management Mississippi Flyway Council 165) and lengthening the season in actions identified for Action level 2. We recommended that the Service’s California’s Sacramento Valley Special note that the status of dusky Canada timetable for implementing a wood Management Area (West) to allow it to geese continues to be a matter of duck harvest strategy in the Atlantic, begin concurrently with the general concern, which has resulted in harvest Mississippi, and Central Flyways be goose season and change the name by restrictions throughout their range in extended to allow additional data removing the ‘‘(West)’’. recent years. However, we continue to collection and evaluation of wood duck Service Response: We support the support the harvest strategy described in harvest rates from seasons with a 3-bird Atlantic Flyway’s recommendations for the 2008 management plan for this daily limit. operational Canada goose seasons in population. Service Response: Last year, we Back Bay, Virginia, and the Northeast We also concur with the Pacific indicated that we would like the Goose Zone in North Carolina. Although Flyway Council’s recommendation Flyways to develop a wood duck results of the recent experimental regarding the Sacramento Valley Special harvest strategy for implementation seasons show that migrant goose harvest Management Area (West) in California. during the 2010–11 hunting season (73 was greater than 10 percent, we Created in 1975, the zone was a closure FR 55602). However, upon further recognize that both of those area for Canada geese to protect the review, this date will only allow experimental seasons were within the then-endangered Aleutian Canada information from two hunting seasons existing frameworks for AP, North goose. Over the decades, the boundaries (2008–09 and 2009–10) to be considered Atlantic Population (NAP), and and specifics of the zone evolved to for any assessment of wood duck Southern James Bay Population (SJBP) manage harvest of cackling Canada harvest rates and other parameters goose regular seasons. We also recognize geese and Pacific white-fronted geese useful in making management decisions that these proposed seasons, and the when those populations were at low under a wood duck harvest strategy. harvest expected to result from them, levels. Given the current status of Further, we would not have any wood are allowable under the current hunt Aleutian and cackling Canada geese and duck recovery information available plan guidelines established in the Pacific white-fronted geese, we view from this year’s hunting season. We Flyway Management Plans for AP, NAP, this change as relatively minor and believe that an additional year(s) would SJBP, and resident Canada geese. administrative in nature and do not We also support the Mississippi provide more information for assessing expect the proposed change to impact Flyway Council’s proposals to lengthen the effect of the 3-bird bag limit and populations (see further discussion the season in Louisiana and Ohio. With incorporation of this information into under 5. White-fronted Geese). regard to the goose population involved the harvest strategy development in Louisiana, the 2009 mid-winter 5. White-fronted Geese process. Thus, we agree with the estimate for the Tall Grass Prairie Council Recommendations: The Councils and support such an Population (TGPP) was 310,000, which, Pacific Flyway Council recommended extension. although much lower than previous increasing the overall daily bag limit for 4. Canada Geese years, remains above the 250,000 geese in the Klamath County Zone of population objective. We note that Oregon in the portion of the season after B. Regular Seasons harvest rate on this population is the last Sunday in January from 4 to 6 Council Recommendations: The relatively low and Louisiana harvest is geese per day. Specific to white-fronted Atlantic Flyway Council forwarded two very small, averaging 1,710 in 1999- geese, the Council recommended recommendations concerning Canada 2005 during 9–day seasons and 1,480 in increasing the daily bag limit from 1 to geese. First, the Council recommended 2006-08 during 16–day seasons. 2 per day within the proposed overall the establishment of an operational Louisiana further estimates that goose daily bag limit of 6 birds In season in Back Bay, Virginia. The extending the season length to 44 days California’s Sacramento Valley Special season frameworks would be aligned will likely increase the harvest to Management Area (West), the Council with the harvest regulations in the possibly twice current levels. However, also recommended lengthening the adjacent Atlantic Population (AP) Zone while the extended season would allow season to allow it to begin concurrently (currently a 45–day season with a 2-bird increased opportunity to take Canada with the general goose season and daily bag limit). The Council also geese, Louisiana believes that changing the name by removing the recommended that the Service allow a aggregating the daily bag limit with ‘‘(West).’’ 7–day season with a 1-bird daily bag white-fronted geese would moderate the Service Response: We concur with the limit in the Northeast Goose Zone of increased harvest of Canada geese and Pacific Flyway Council’s recommended North Carolina with framework dates of possibly reduce the harvest pressure on changes in the Oregon’s Klamath the Saturday prior to December 25 to white-fronted geese. County Zone and California’s January 31. Regarding dusky Canada geese, the Sacramento Valley Special Management The Upper- and Lower-Region annual population index based on the Area (West). In the Klamath County Regulations Committees of the breeding pair survey on the Copper Zone, of the five recognized goose

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populations affected by this proposal, management plan goals. In some areas during the comment period and respond all three light goose and Pacific greater of the Pacific Flyway, these goose to them after the closing date in any white-fronted geese are currently above populations are leading to increasing final rules. identified management plan objectives. depredation complaints. In addition, NEPA Consideration Additionally, Tule goose population numbers of light geese breeding on estimates have remained stable over the Wrangel Island, Russia, a colony that NEPA considerations are covered by last 6 years at nearly 12,000 geese. has been of concern in the past, has the programmatic document ‘‘Final Increasing the white-fronted goose daily recovered to near record levels in the Supplemental Environmental Impact bag limit from 1 to 2 is expected to past few years. We support efforts to Statement: Issuance of Annual increase white-fronted goose harvest to increase harvest of these geese to limit Regulations Permitting the Sport levels observed during late-winter hunts further population growth and perhaps Hunting of Migratory Birds (FSES 88- in 2007 and 2008 and the proposed the overabundance problems associated 14),’’ filed with the Environmental change is not expected to appreciably with the species that have been Protection Agency on June 9, 1988. We increase Tule goose harvest beyond that documented in several of the mid- published a notice of availability in the currently occurring in other areas of continent regions. Federal Register on June 16, 1988 (53 California and Oregon. FR 22582). We published our record of Public Comments decision on August 18, 1988 (53 FR 6. Brant The Department of the Interior’s 31341). In addition, an August 1985 Council Recommendations: The policy is, whenever practicable, to environmental assessment entitled Atlantic Flyway Council recommended afford the public an opportunity to ‘‘Guidelines for Migratory Bird Hunting a 50–day season with a 2-bird daily bag participate in the rulemaking process. Regulations on Federal Indian limit for Atlantic brant. Accordingly, we invite interested Reservations and Ceded Lands’’ is Service Response: We concur with the persons to submit written comments, available from the address indicated Atlantic Flyway Council’s suggestions, or recommendations under the caption FOR FURTHER recommendation. The 2009 Mid-Winter regarding the proposed regulations. INFORMATION CONTACT. Index (MWI) for Atlantic brant Before promulgation of final migratory In a notice published in the decreased to 151,300 from 160,618 brant game bird hunting regulations, we will September 8, 2005, Federal Register (70 in 2008. While the Brant Management take into consideration all comments FR 53376), we announced our intent to Plan prescribes the continuation of a received. Such comments, and any develop a new Supplemental 60–day season with a 3-bird daily bag additional information received, may Environmental Impact Statement for the limit when the MWI estimate is above lead to final regulations that differ from migratory bird hunting program. Public 150,000, we note that spring was 2-3 these proposals. scoping meetings were held in the weeks later than normal in portions of You may submit your comments and spring of 2006, as detailed in a March Atlantic brant staging and breeding materials concerning this proposed rule 9, 2006, Federal Register (71 FR 12216). areas this year and these conditions by one of the methods listed in the We have prepared a scoping report have usually resulted in poor brant ADDRESSES section. We will not summarizing the scoping comments and production in the past. Thus, we agree consider comments sent by e-mail or fax scoping meetings. The report is with the Council that a decrease of 10 or to an address not listed in the available by either writing to the days with the associated daily bag limit ADDRESSES section. Finally, we will not address indicated under FOR FURTHER decrease is the proper approach for the consider hand-delivered comments that INFORMATION CONTACT or by viewing on upcoming season. we do not receive, or mailed comments our website at http://www.fws.gov/ that are not postmarked, by the date 7. Snow and Ross’s (Light) Geese migratorybirds/. specified in the DATES section. Council Recommendations: The We will post your entire comment— Endangered Species Act Consideration Pacific Flyway Council recommended including your personal identifying Prior to issuance of the 2009–10 increasing the overall daily bag limit for information—on http:// migratory game bird hunting geese in the Klamath County Zone of www.regulations.gov. If you provide regulations, we will comply with Oregon in the portion of the season after personal identifying information in your provisions of the Endangered Species the last Sunday in January from 4 to 6 comment, you may request at the top of Act of 1973, as amended (16 U.S.C. geese per day. Specific to light geese, your document that we withhold this 1531-1543; hereinafter, the Act), to the Council recommended increasing information from public review. ensure that hunting is not likely to the daily bag limit from 3 to 4 per day However, we cannot guarantee that we jeopardize the continued existence of within the proposed overall goose daily will be able to do so. any species designated as endangered or bag limit of 6 birds. In California’s Comments and materials we receive, threatened, or modify or destroy its Sacramento Valley Special Management as well as supporting documentation we critical habitat, and is consistent with Area (West), the Council also used in preparing this proposed rule, conservation programs for those species. recommended lengthening the season to will be available for public inspection Consultations under section 7 of the Act allow it to begin concurrently with the on http://www.regulations.gov, or by may cause us to change proposals in general goose season and changing the appointment, during normal business this and future supplemental name by removing the ‘‘(West).’’ hours, at the U.S. Fish and Wildlife rulemaking documents. Service Response: We support the Service, Division of Migratory Bird proposed changes for light geese in the Management, Room 4107, 4501 North Executive Order 12866 Pacific Flyway. In 2007, the Flyway’s Fairfax Drive, Arlington, VA 22203. The Office of Management and Budget December goose count exceeded 1 For each series of proposed has determined that this rule is million for the first time, representing a rulemakings, we will establish specific significant and has reviewed this rule doubling of this index since 1999. Light comment periods. We will consider, but under Executive Order 12866. A goose indices (Snow and Ross’ geese possibly may not respond in detail to, regulatory cost-benefit analysis has been combined) indicate that all recognized each comment. As in the past, we will prepared and is available at http:// populations currently exceed summarize all comments received www.fws.gov/migratorybirds/

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NewReportsPublications/SpecialTopics/ The 2008 Analysis was based on the regulatory action’’ under the Unfunded SpecialTopics.html#HuntingRegs or at 2006 National Hunting and Fishing Mandates Reform Act. http://www.regulations.gov. OMB bases Survey and the U.S. Department of Civil Justice Reform—Executive Order its determination of regulatory Commerce’s County Business Patterns, 12988 significance upon the following four from which it was estimated that criteria: migratory bird hunters would spend The Department, in promulgating this (a) Whether the rule will have an approximately $1.2 billion at small proposed rule, has determined that this annual effect of $100 million or more on businesses in 2008. proposed rule will not unduly burden the economy or adversely affect an Copies of the Analysis are available the judicial system and that it meets the economic sector, productivity, jobs, the upon request from the address indicated requirements of sections 3(a) and 3(b)(2) environment, or other units of the under FOR FURTHER INFORMATION of Executive Order 12988. government. CONTACT or from our website at http:// Takings Implication Assessment (b) Whether the rule will create www.fws.gov/migratorybirds/ inconsistencies with other Federal NewReportsPublications/SpecialTopics/ In accordance with Executive Order agencies’ actions. SpecialTopics.html#HuntingRegs or at 12630, this proposed rule, authorized by (c) Whether the rule will materially http://www.regulations.gov. the Migratory Bird Treaty Act, does not affect entitlements, grants, user fees, have significant takings implications loan programs, or the rights and Small Business Regulatory Enforcement and does not affect any constitutionally obligations of their recipients. Fairness Act protected property rights. This rule will (d) Whether the rule raises novel legal This rule is a major rule under 5 not result in the physical occupancy of or policy issues. U.S.C. 804(2), the Small Business property, the physical invasion of Regulatory Enforcement Fairness Act. property, or the regulatory taking of any Clarity of the Rule For the reasons outlined above, this rule property. In fact, these rules allow We are required by Executive Orders has an annual effect on the economy of hunters to exercise otherwise 12866 and 12988 and by the $100 million or more. unavailable privileges and, therefore, Presidential Memorandum of June 1, reduce restrictions on the use of private 1998, to write all rules in plain Paperwork Reduction Act and public property. language. This means that each rule we We examined these regulations under Energy Effects—Executive Order 13211 publish must: the Paperwork Reduction Act of 1995 (a) Be logically organized; (44 U.S.C. 3501 et seq.). The various Executive Order 13211 requires (b) Use the active voice to address recordkeeping and reporting agencies to prepare Statements of readers directly; requirements imposed under regulations Energy Effects when undertaking certain (c) Use clear language rather than established in 50 CFR part 20, subpart actions. While this proposed rule is a jargon; K, are utilized in the formulation of significant regulatory action under (d) Be divided into short sections and migratory game bird hunting Executive Order 12866, it is not sentences; and regulations. expected to adversely affect energy (e) Use lists and tables wherever Specifically, OMB has approved the supplies, distribution, or use. Therefore, possible. information collection requirements of this action is not a significant energy If you feel that we have not met these our Migratory Bird Surveys and action and no Statement of Energy requirements, send us comments by one assigned control number 1018–0023 Effects is required. of the methods listed in the ADDRESSES (expires 2/28/2011). This information is Government-to-Government section. To better help us revise the used to provide a sampling frame for Relationship with Tribes rule, your comments should be as voluntary national surveys to improve specific as possible. For example, you our harvest estimates for all migratory In accordance with the President’s should tell us the numbers of the game birds in order to better manage memorandum of April 29, 1994, sections or paragraphs that are unclearly these populations. ‘‘Government-to-Government Relations written, which sections or sentences are OMB has also approved the with Native American Tribal too long, the sections where you feel information collection requirements of Governments’’ (59 FR 22951), Executive lists or tables would be useful, etc. the Alaska Subsistence Household Order 13175, and 512 DM 2, we have evaluated possible effects on Federally- Regulatory Flexibility Act Survey, an associated voluntary annual household survey used to determine recognized Indian tribes and have The regulations have a significant levels of subsistence take in Alaska, and determined that there are no effects on economic impact on substantial assigned control number 1018–0124 Indian trust resources. However, in the numbers of small entities under the (expires 1/31/2010). April 10 Federal Register, we solicited Regulatory Flexibility Act (5 U.S.C. 601 A Federal agency may not conduct or proposals for special migratory bird et seq.). We analyzed the economic sponsor and a person is not required to hunting regulations for certain Tribes on impacts of the annual hunting respond to a collection of information Federal Indian reservations, off- regulations on small business entities in unless it displays a currently valid OMB reservation trust lands, and ceded lands detail as part of the 1981 cost-benefit control number. for the 2009–10 migratory bird hunting analysis. This analysis was revised season. The resulting proposals will be Unfunded Mandates Reform Act annually from 1990–95. In 1995, the contained in a separate proposed rule. Service issued a Small Entity Flexibility We have determined and certify, in By virtue of these actions, we have Analysis (Analysis), which was compliance with the requirements of the consulted with Tribes affected by this subsequently updated in 1996, 1998, Unfunded Mandates Reform Act, 2 rule. 2004, and 2008. The primary source of U.S.C. 1502 et seq., that this rulemaking information about hunter expenditures will not impose a cost of $100 million Federalism Effects for migratory game bird hunting is the or more in any given year on local or Due to the migratory nature of certain National Hunting and Fishing Survey, State government or private entities. species of birds, the Federal which is conducted at 5–year intervals. Therefore, this rule is not a ‘‘significant Government has been given

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responsibility over these species by the Possession Limits: Unless otherwise Waterfowl Seasons in the Atlantic Migratory Bird Treaty Act. We annually specified, possession limits are twice Flyway prescribe frameworks from which the the daily bag limit. In the Atlantic Flyway States of States make selections regarding the Flyways and Management Units Connecticut, Delaware, Maine, hunting of migratory birds, and we Maryland, Massachusetts, New Jersey, employ guidelines to establish special Waterfowl Flyways: North Carolina, Pennsylvania, and regulations on Federal Indian Virginia, where Sunday hunting is reservations and ceded lands. This Atlantic Flyway—includes Connecticut, Delaware, Florida, Georgia, prohibited statewide by State law, all process preserves the ability of the Sundays are closed to all take of States and Tribes to determine which Maine, Maryland, Massachusetts, New Hampshire, New Jersey, New York, migratory waterfowl (including seasons meet their individual needs. mergansers and coots). Any State or Indian Tribe may be more North Carolina, Pennsylvania, Rhode restrictive than the Federal frameworks Island, South Carolina, Vermont, Special Youth Waterfowl Hunting Days Virginia, and West Virginia. at any time. The frameworks are Outside Dates: States may select 2 developed in a cooperative process with Mississippi Flyway—includes consecutive days (hunting days in the States and the Flyway Councils. Alabama, Arkansas, Illinois, Indiana, Atlantic Flyway States with This process allows States to participate Iowa, Kentucky, Louisiana, Michigan, compensatory days) per duck-hunting in the development of frameworks from Minnesota, Mississippi, Missouri, Ohio, zone, designated as ‘‘Youth Waterfowl which they will make selections, Tennessee, and Wisconsin. Hunting Days,’’ in addition to their thereby having an influence on their Central Flyway—includes Colorado regular duck seasons. The days must be own regulations. These rules do not (east of the Continental Divide), Kansas, held outside any regular duck season on have a substantial direct effect on fiscal Montana (Counties of Blaine, Carbon, a weekend, holiday, or other non-school capacity, change the roles or Fergus, Judith Basin, Stillwater, day when youth hunters would have the responsibilities of Federal or State Sweetgrass, Wheatland, and all counties maximum opportunity to participate. governments, or intrude on State policy east thereof), Nebraska, New Mexico The days may be held up to 14 days or administration. Therefore, in (east of the Continental Divide except before or after any regular duck-season accordance with Executive Order 13132, the Jicarilla Apache Indian Reservation), frameworks or within any split of a these regulations do not have significant North Dakota, Oklahoma, South Dakota, regular duck season, or within any other federalism effects and do not have Texas, and Wyoming (east of the open season on migratory birds. sufficient federalism implications to Continental Divide). Daily Bag Limits: The daily bag limits warrant the preparation of a Federalism may include ducks, geese, tundra Pacific Flyway—includes Alaska, Assessment. swans, mergansers, coots, moorhens, Arizona, California, Idaho, Nevada, and gallinules and would be the same List of Subjects in 50 CFR Part 20 Oregon, Utah, Washington, and those as those allowed in the regular season. portions of Colorado, Montana, New Exports, Hunting, Imports, Reporting Flyway species and area restrictions Mexico, and Wyoming not included in and recordkeeping requirements, would remain in effect. Transportation, Wildlife. the Central Flyway. Shooting Hours: One-half hour before Management Units: sunrise to sunset. The rules that eventually will be Participation Restrictions: Youth promulgated for the 2009–10 hunting High Plains Mallard Management hunters must be 15 years of age or season are authorized under 16 U.S.C. Unit—roughly defined as that portion of younger. In addition, an adult at least 18 703-712 and 16 U.S.C. 742 a-j. the Central Flyway that lies west of the years of age must accompany the youth Dated: August 5, 2009 100th meridian. hunter into the field. This adult may not Jane Lyder Definitions: duck hunt but may participate in other Deputy Assistant Secretary for Fish and seasons that are open on the special Wildlife and Parks. For the purpose of hunting youth day. Tundra swans may only be regulations listed below, the collective taken by participants possessing applicable tundra swan permits. Proposed Regulations Frameworks for terms ‘‘dark’’ and ‘‘light’’ geese include 2009–10 Late Hunting Seasons on the following species: Atlantic Flyway Certain Migratory Game Birds Dark geese: Canada geese, white- fronted geese, brant (except in Ducks, Mergansers, and Coots Pursuant to the Migratory Bird Treaty California, Oregon, Washington, and the Outside Dates: Between the Saturday Act and delegated authorities, the Atlantic Flyway), and all other goose nearest September 24 (September 26) Department has approved frameworks species except light geese. and the last Sunday in January (January for season lengths, shooting hours, bag 31). and possession limits, and outside dates Light geese: snow (including blue) geese and Ross’ geese. Hunting Seasons and Duck Limits: 60 within which States may select seasons days. The daily bag limit is 6 ducks, for hunting waterfowl and coots Area, Zone, and Unit Descriptions: including no more than 4 mallards (2 between the dates of September 1, 2009, hens), 1 black duck, 1 pintail, 1 mottled and March 10, 2010. Geographic descriptions related to duck, 1 fulvous whistling duck, 3 wood late-season regulations are contained in General ducks, 2 redheads, 2 scaup, 1 a later portion of this document. canvasback, and 4 scoters. Dates: All outside dates noted below Area-Specific Provisions: Closures: The season on harlequin are inclusive. ducks is closed. Shooting and Hawking (taking by Frameworks for open seasons, season Sea Ducks: Within the special sea falconry) Hours: Unless otherwise lengths, bag and possession limits, and duck areas, during the regular duck specified, from one-half hour before other special provisions are listed below season in the Atlantic Flyway, States sunrise to sunset daily. by Flyway. may choose to allow the above sea duck

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limits in addition to the limits applying Delaware: A 45–day season may be Western Long Island RP Zone: An 80– to other ducks during the regular duck held between November 15 and January day season may be held between season. In all other areas, sea ducks may 31, with a 2-bird daily bag limit. October 1 and February 15, with a 5- be taken only during the regular open Florida: An 80–day season may be bird daily bag limit. The season may be season for ducks and are part of the held between November 15 and split into 3 segments. regular duck season daily bag (not to February 15, with a 5-bird daily bag Rest of State RP Zone: An 80–day exceed 4 scoters) and possession limits. limit. The season may be split into 3 season may be held between the fourth Merganser Limits: The daily bag limit segments. Saturday in October (October 24) and of mergansers is 5, only 2 of which may Georgia: In specific areas, an 80–day March 10, with a 5-bird daily bag limit. be hooded mergansers. In States that season may be held between November The season may be split into 3 include mergansers in the duck bag 15 and February 15, with a 5-bird daily segments. limit, the daily limit is the same as the bag limit. The season may be split into North Carolina: duck bag limit, only two of which may 3 segments. SJBP Zone: A 70–day season may be be hooded mergansers. Maine: A 60–day season may be held held between October 1 and December Coot Limits: The daily bag limit is 15 Statewide between October 1 and 31, with a 5-bird daily bag limit. coots. January 31, with a 2-bird daily bag limit. RP Zone: An 80–day season may be Lake Champlain Zone, New York: The Maryland: held between October 1 and March 10, waterfowl seasons, limits, and shooting RP Zone: An 80–day season may be with a 5-bird daily bag limit. The season hours shall be the same as those held between November 15 and March may be split into 3 segments. selected for the Lake Champlain Zone of 10, with a 5-bird daily bag limit. The Northeast Hunt Unit: A 7–day season Vermont. season may be split into 3 segments. may be held between the Saturday prior Connecticut River Zone, Vermont: AP Zone: A 45–day season may be to December 25 (December 19) and The waterfowl seasons, limits, and held between November 15 and January January 31, with a 1-bird daily bag limit. shooting hours shall be the same as 31, with a 2-bird daily bag limit. Pennsylvania: Massachusetts: those selected for the Inland Zone of SJBP Zone: A 70–day season may be NAP Zone: A 60–day season may be New Hampshire. held between the second Saturday in held between October 1 and January 31, Zoning and Split Seasons: Delaware, October (October 10) and February 15, with a 2-bird daily bag limit. Florida, Georgia, Maryland, North with a 3-bird daily bag limit. Additionally, a special season may be Carolina, Rhode Island, South Carolina, RP Zone: An 80–day season may be held from January 15 to February 15, and Virginia may split their seasons into held between the fourth Saturday in with a 5-bird daily bag limit. October (October 24) and March 10, three segments; Connecticut, Maine, AP Zone: A 45–day season may be with a 5-bird daily bag limit. The season Massachusetts, New Hampshire, New held between October 20 and January Jersey, New York, Pennsylvania, 31, with a 3-bird daily bag limit. may be split into 3 segments. Vermont, and West Virginia may select New Hampshire: A 60–day season AP Zone: A 45–day season may be hunting seasons by zones and may split may be held statewide between October held between the fourth Saturday in their seasons into two segments in each 1 and January 31, with a 2-bird daily bag October (October 24) and January 31, zone. limit. with a 3-bird daily bag limit. Rhode Island: A 60–day season may Canada Geese New Jersey: Statewide: A 45–day season may be be held between October 1 and January Season Lengths, Outside Dates, and held between the fourth Saturday in 31, with a 2-bird daily bag limit. An Limits: Specific regulations for Canada October (October 24) and January 31, experimental season may be held in geese are shown below by State. These with a 3-bird daily bag limit. designated areas from January 15 to seasons also include white-fronted Special Late Goose Season Area: An February 15, with a 5-bird daily bag geese. Unless specified otherwise, experimental season may be held in limit. seasons may be split into two segments. designated areas of North and South South Carolina: In designated areas, In areas within States where the New Jersey from January 15 to February an 80–day season may be held during framework closing date for Atlantic 15, with a 5-bird daily bag limit. November 15 to February 15, with a 5- Population (AP) goose seasons overlaps New York: bird daily bag limit. The season may be with special late-season frameworks for NAP Zone: Between October 1 and split into 3 segments. resident geese, the framework closing January 31, a 60–day season may be Vermont: A 45–day season may be date for AP goose seasons is January 14. held, with a 2-bird daily bag limit in the held between the fourth Saturday in Connecticut: High Harvest areas; and between October (October 24), except in the Lake North Atlantic Population (NAP) October 1 and February 15, a 70–day Champlain Zone and Interior Zone Zone: Between October 1 and January season may be held, with a 3-bird daily where the opening date is October 20, 31, a 60–day season may be held with bag limit in the Low Harvest areas. and January 31, with a 3-bird daily bag a 2-bird daily bag limit. Special Late Goose Season Area: An limit. Atlantic Population (AP) Zone: A 45– experimental season may be held Virginia: day season may be held between the between January 15 and February 15, SJBP Zone: A 40–day season may be fourth Saturday in October (October 24) with a 5-bird daily bag limit in held between November 15 and January and January 31, with a 3-bird daily bag designated areas of Chemung, Delaware, 14, with a 3-bird daily bag limit. limit. Tioga, Broome, Sullivan, Westchester, Additionally, an experimental season South Zone: A special season may be Nassau, Suffolk, Orange, Dutchess, may be held between January 15 and held between January 15 and February Putnam, and Rockland Counties. February 15, with a 5-bird daily bag 15, with a 5-bird daily bag limit. AP Zone: A 45–day season may be limit. Resident Population (RP) Zone: An held between the fourth Saturday in AP Zone: A 45–day season may be 80–day season may be held between October (October 24), except in the Lake held between November 15 and January October 1 and February 15, with a 5- Champlain Area where the opening date 31, with a 2-bird daily bag limit. bird daily bag limit. The season may be is October 20, and January 31, with a 3- RP Zone: An 80–day season may be split into 3 segments. bird daily bag limit. held between November 15 and March

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10, with a 5-bird daily bag limit. The nearest September 24 (September 26) extend for 45 days. The daily bag limit season may be split into 3 segments. and March 10; for white-fronted geese is 2 Canada geese. West Virginia: An 80–day season may not to exceed 72 days with 2 geese daily (b) Middle Zone – The framework be held between October 1 and January or 86 days with 1 goose daily between opening date for all geese is September 31, with a 5-bird daily bag limit. The the Saturday nearest September 24 16 and the season for Canada geese may season may be split into 2 segments in (September 26) and the Sunday nearest extend for 45 days. The daily bag limit each zone. February 15 (February 14); and for brant is 2 Canada geese. not to exceed 70 days, with 2 brant daily (c) South Zone – The framework Light Geese or 107 days with 1 brant daily between opening date for all geese is September Season Lengths, Outside Dates, and the Saturday nearest September 24 16 and the season for Canada geese may Limits: States may select a 107–day (September 26) and January 31. There is extend for 45 days. The daily bag limit season between October 1 and March no possession limit for light geese. is 2 Canada geese. 10, with a 15-bird daily bag limit and no Specific regulations for Canada geese (1) Allegan County and Muskegon possession limit. States may split their and exceptions to the above general Wastewater GMU - The framework seasons into three segments. provisions are shown below by State. opening date for all geese is September Brant Except as noted below, the outside dates 16 and the season for Canada geese may Season Lengths, Outside Dates, and for Canada geese are the Saturday extend for 45 days. The daily bag limit Limits: States may select a 50–day nearest September 24 (September 26) is 2 Canada geese. (2) Saginaw County and Tuscola/ season between the Saturday nearest and January 31. Huron GMUs - The framework opening September 24 (September 26) and Alabama: In the SJBP Goose Zone, the date for all geese is September 16 and January 31, with a 2-bird daily bag limit. season for Canada geese may not exceed the season for Canada geese may extend States may split their seasons into two 70 days. Elsewhere, the season for for 45 days through December 30 and an segments. Canada geese may extend for 70 days in additional 30 days may be held between the respective duck-hunting zones. The Mississippi Flyway December 31 and February 7. The daily daily bag limit is 2 Canada geese. Ducks, Mergansers, and Coots bag limit is 2 Canada geese. Arkansas: In the Northwest Zone, the (d) Southern Michigan Late Season Outside Dates: Between the Saturday season for Canada geese may extend for Canada Goose Zone—A 30–day special nearest September 24 (September 26) 50 days. In the remainder of the State, Canada goose season may be held and the last Sunday in January (January the season may not exceed 40 days. The between December 31 and February 7. 31). season may extend to February 15. The The daily bag limit may not exceed 5 Hunting Seasons and Duck Limits: daily bag limit is 2 Canada geese. Canada geese. The season may not exceed 60 days, Illinois: The season for Canada geese Minnesota: with a daily bag limit of 6 ducks, may extend for 85 days in the North and (a) West Zone including no more than 4 mallards (no Central Zones and 66 days in the South (1) West Central Zone—The season for more than 2 of which may be females), Zone. The daily bag limit is 2 Canada Canada geese may extend for 41 days. 1 mottled duck, 1 black duck, 1 pintail, geese. The daily bag limit is 2 Canada geese. 3 wood ducks, 1 canvasback, 2 scaup, Indiana: The season for Canada geese (2) Remainder of West Zone—The and 2 redheads. may extend for 74 days. The daily bag season for Canada geese may extend for Merganser Limits: The daily bag limit limit is 2 Canada geese. 60 days. The daily bag limit is 2 Canada is 5, only 2 of which may be hooded Late Canada Goose Season Zone — an geese. mergansers. In States that include experimental special Canada goose (b) Remainder of the State—The mergansers in the duck bag limit, the season of up to 15 days may be held season for Canada geese may extend for daily limit is the same as the duck bag during February 1–15. During this 70 days. The daily bag limit is 2 Canada limit, only 2 of which may be hooded special season the daily bag limit cannot geese. (c) Special Late Canada Goose mergansers. exceed 5 Canada geese. Season—A special Canada goose season Coot Limits: The daily bag limit is 15 Iowa: The season for Canada geese of up to 10 days may be held in coots. may extend for 90 days. The daily bag limit is 2 Canada geese. December, except in the West Central Zoning and Split Seasons: Alabama, Goose zone. During the special season, Illinois, Indiana, Iowa, Kentucky, Kentucky: (a) Western Zone—The season for the daily bag limit is 5 Canada geese, Louisiana, Michigan, Minnesota, except in the Southeast Goose Zone, Missouri, Ohio, Tennessee, and Canada geese may extend for 70 days (85 days in Fulton County). The season where the daily bag limit is 2. Wisconsin may select hunting seasons Mississippi: The season for Canada in Fulton County may extend to by zones. geese may extend for 70 days. The daily February 15. The daily bag limit is 2 In Alabama, Indiana, Iowa, Kentucky, bag limit is 3 Canada geese. Louisiana, Michigan, Minnesota, Ohio, Canada geese. Missouri: The season for Canada geese Tennessee, and Wisconsin, the season (b) Pennyroyal/Coalfield Zone—The may extend for 79 days and may be split may be split into two segments in each season may extend for 70 days. The into 3 segments provided that at least 1 zone. daily bag limit is 2 Canada geese. segment of at least 9 days occurs prior In Arkansas and Mississippi, the (c) Remainder of the State—The to October 16. The daily bag limit is 3 season may be split into three segments. season may extend for 70 days. The Canada geese through October 15 and 2 daily bag limit is 2 Canada geese. Geese Canada geese thereafter. Louisiana: The season for Canada Ohio: Split Seasons: Seasons for geese may geese may extend for 44 days. The daily (a) Lake Erie Zone–The season may be split into three segments. bag limit is 1 Canada goose. extend for 74 days. The daily bag limit Season Lengths, Outside Dates, and Michigan: is 2 Canada geese. Limits: States may select seasons for (a) North Zone – The framework (b) North Zone–The season may light geese not to exceed 107 days, with opening date for all geese is September extend for 74 days. The daily bag limit 20 geese daily between the Saturday 16 and the season for Canada geese may is 2 Canada geese.

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(c) South Zone – The season may hooded mergansers. In States that In Montana, New Mexico and extend for 74 days. The daily bag limit include mergansers in the duck daily Wyoming, States may select seasons not is 2 Canada geese. bag limit, the daily limit may be the to exceed 107 days. The daily bag limit Tennessee: same as the duck bag limit, only two of for dark geese is 5 in the aggregate. (a) Northwest Zone—The season for which may be hooded mergansers. In Colorado, the season may not Canada geese may not exceed 72 days, Coot Limits: The daily bag limit is 15 exceed 107 days. The daily bag limit is and may extend to February 15. The coots. 4 dark geese in the aggregate. daily bag limit is 2 Canada geese. Zoning and Split Seasons: Kansas In the Western Goose Zone of Texas, (b) Southwest Zone—The season for (Low Plains portion), Montana, the season may not exceed 95 days. The Canada geese may extend for 72 days. Nebraska (Low Plains portion), New daily bag limit for Canada geese (or any The daily bag limit is 2 Canada geese. Mexico, Oklahoma (Low Plains portion), other dark goose species except white- (c) Kentucky/Barkley Lakes Zone— South Dakota (Low Plains portion), fronted geese) is 4. The daily bag limit The season for Canada geese may extend Texas (Low Plains portion), and for white-fronted geese is 1. for 72 days. The daily bag limit is 2 Wyoming may select hunting seasons by Pacific Flyway Canada geese. zones. (d) Remainder of the State—The Ducks, Mergansers, Coots, Common In Kansas, Montana, Nebraska, New season for Canada geese may extend for Moorhens, and Purple Gallinules Mexico, North Dakota, Oklahoma, South 72 days. The daily bag limit is 2 Canada Dakota, Texas, and Wyoming, the Hunting Seasons and Duck Limits: geese. Concurrent 107 days. The daily bag Wisconsin: regular season may be split into two (a) Horicon Zone—The framework segments. limit is 7 ducks and mergansers, opening date for all geese is September In Colorado, the season may be split including no more than 2 female 16. The season may not exceed 92 days. into three segments. mallards, 2 pintails, 3 scaup, 1 canvasback, and 2 redheads. For scaup, All Canada geese harvested must be Geese tagged. The season limit will be 6 the season length would be 86 days, Canada geese per permittee. Split Seasons: Seasons for geese may which may be split according to (b) Collins Zone—The framework be split into three segments. Three-way applicable zones/split duck hunting opening date for all geese is September split seasons for Canada geese require configurations approved for each State. The season on coots and common 16. The season may not exceed 70 days. Central Flyway Council and U.S. Fish moorhens may be between the outside All Canada geese harvested must be and Wildlife Service approval, and a 3– dates for the season on ducks, but not tagged. The season limit will be 6 year evaluation by each participating to exceed 107 days. Canada geese per permittee. State. Coot, Common Moorhen, and Purple (c) Exterior Zone—The framework Outside Dates: For dark geese, seasons Gallinule Limits: The daily bag and opening date for all geese is September may be selected between the outside possession limits of coots, common 16. The season may not exceed 85 days. dates of the Saturday nearest September moorhens, and purple gallinules are 25, The daily bag limit is 2 Canada geese. 24 (September 26) and the Sunday Additional Limits: In addition to the nearest February 15 (February 14). For singly or in the aggregate. Outside Dates: Between the Saturday harvest limits stated for the respective light geese, outside dates for seasons nearest September 24 (September 26) zones above, an additional 4,500 Canada may be selected between the Saturday and the last Sunday in January (January geese may be taken in the Horicon Zone nearest September 24 (September 26) and March 10. In the Rainwater Basin 31). under special agricultural permits. Zoning and Split Seasons: Arizona, Light Goose Area (East and West) of California, Idaho, Nevada, Oregon, Utah, Central Flyway Nebraska, temporal and spatial Washington, and Wyoming may select restrictions that are consistent with the Ducks, Mergansers, and Coots hunting seasons by zones. Arizona, late-winter snow goose hunting strategy Outside Dates: Between the Saturday California, Idaho, Nevada, Oregon, Utah, cooperatively developed by the Central nearest September 24 (September 26) Washington, and Wyoming may split Flyway Council and the Service are and the last Sunday in January (January their seasons into two segments. 31). required. Colorado, Montana, and New Mexico may split their seasons into three Hunting Seasons: Season Lengths and Limits: segments. (1) High Plains Mallard Management Light Geese: States may select a light Colorado River Zone, California: Unit (roughly defined as that portion of goose season not to exceed 107 days. Seasons and limits shall be the same as the Central Flyway which lies west of The daily bag limit for light geese is 20 seasons and limits selected in the the 100th meridian): 97 days. The last with no possession limit. adjacent portion of Arizona (South 23 days may start no earlier than the Dark Geese: In Kansas, Nebraska, Zone). Saturday nearest December 10 North Dakota, Oklahoma, South Dakota, (December 12). and the Eastern Goose Zone of Texas, Geese (2) Remainder of the Central Flyway: States may select a season for Canada Season Lengths, Outside Dates, and 74 days. geese (or any other dark goose species Limits: Bag Limits: The daily bag limit is 6 except white-fronted geese) not to ducks, with species and sex restrictions exceed 107 days with a daily bag limit California, Oregon, and Washington: as follows: 5 mallards (no more than 2 of 3. Additionally, in the Eastern Goose Dark geese: Except as subsequently of which may be females), 2 redheads, Zone of Texas, an alternative season of noted, 100–day seasons may be selected, 2 scaup, 3 wood ducks, 1 pintail, 1 107 days with a daily bag limit of 1 with outside dates between the Saturday mottled duck (except for the first 5 days Canada goose may be selected. For nearest October 1 (October 3), and the of the season when it is closed), and 1 white-fronted geese, these States may last Sunday in January (January 31). The canvasback. select either a season of 72 days with a basic daily bag limit is 4 dark geese, Merganser Limits: The daily bag limit bag limit of 2 or an 86–day season with except the dark goose bag limit does not is 5 mergansers, only 2 of which may be a bag limit of 1. include brant.

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Light geese: Except as subsequently New Mexico: The daily bag limit for Quota Zones noted, 107–day seasons may be selected, dark geese is 3. Seasons on geese must end upon with outside dates between the Saturday Oregon: attainment of individual quotas of Except as subsequently noted, the nearest October 1 (October 3), and dusky geese allotted to the designated dark goose daily bag limit is 4, March 10. The daily bag limit is 6 light areas of Oregon (90) and Washington including not more than 1 cackling or geese. (45). The September Canada goose Aleutian goose. Arizona, Colorado, Idaho, Montana, season, the regular goose season, any Nevada, New Mexico, Utah, and Harney, Lake, and Malheur County Zone: For Lake County only, the daily special late dark goose season, and any Wyoming: extended falconry season, combined, Dark geese: Except as subsequently dark goose bag limit may not include more than 1 white-fronted goose. must not exceed 107 days, and the noted, 107–day seasons may be selected, established quota of dusky geese must with outside dates between the Saturday Klamath County Zone: A 107–day season may be selected, with outside not be exceeded. Hunting of geese in nearest September 24 (September 26), those designated areas will only be by and the last Sunday in January (January dates between the Saturday nearest October 1 (October 3), and March 10. A hunters possessing a State-issued permit 31). The basic daily bag limit is 4 dark authorizing them to do so. In a Service- geese. 3-way split season may be selected. The daily goose bag limit is 4 dark geese and approved investigation, the State must Light geese: Except as subsequently obtain quantitative information on noted, 107–day seasons may be selected, 4 white geese except for hunting days that occur after the last Sunday in hunter compliance of those regulations with outside dates between the Saturday aimed at reducing the take of dusky nearest September 24 (September 26), January when only light geese and white-fronted geese may be taken. The geese. If the monitoring program cannot and March 10. The basic daily bag limit be conducted, for any reason, the season is 10 light geese. daily bag limit of geese is 6 of which only 4 may be light geese and only 2 must immediately close. In the Split Seasons: Unless otherwise designated areas of the Washington specified, seasons for geese may be split may be white-fronted geese. Northwest Special Permit Zone: Southwest Quota Zone, a special late into up to 3 segments. Three-way split goose season may be held between the seasons for Canada geese and white- Outside dates are between the Saturday nearest October 1 (October 3), and the Saturday following the close of the fronted geese require Pacific Flyway general goose season and March 10. In Council and U.S. Fish and Wildlife Sunday closest to March 1 (February 28). The daily bag limit of dark geese is the Northwest Special Permit Zone of Service approval and a 3–year Oregon, the framework closing date is evaluation by each participating State. 4 including not more than 2 cackling or Aleutian geese and daily bag limit of extended to the Sunday closest to March Brant Season light geese is 4. In those designated 1 (February 28). Regular goose seasons areas of Tillamook County open to may be split into 3 segments within the Oregon may select a 16–day season, Oregon and Washington quota zones. Washington a 16–day season, and hunting, the daily bag limit of dark California a 30–day season. Days must geese is 2. Swans be consecutive. Washington and South Coast Zone: The daily dark goose bag limit is 4 including cackling In portions of the Pacific Flyway California may select hunting seasons (Montana, Nevada, and Utah), an open by up to two zones. The daily bag limit and Aleutian geese. In Oregon’s South Coast Zone 107–day seasons may be season for taking a limited number of is 2 brant and is in addition to dark swans may be selected. Permits will be goose limits. In Oregon and California, selected, with outside dates between the Saturday nearest October 1 (October 3) issued by the State and will authorize the brant season must end no later than each permittee to take no more than 1 December 15. and March 10. Hunting days that occur after the last Sunday in January shall be swan per season with each permit. Arizona: The daily bag limit for dark concurrent with California’s North Coast Nevada may issue up to 2 permits per geese is 3. Special Management Area. A 3-way hunter. Montana and Utah may only California: split season may be selected. issue 1 permit per hunter. Each State’s Northeastern Zone: The daily bag Southwest Zone: The daily dark goose season may open no earlier than the limit is 6 dark geese and may include no bag limit is 4 including cackling and Saturday nearest October 1 (October 3). more than 1 cackling Canada goose or 1 Aleutian geese. These seasons are also subject to the Aleutian Canada goose. Utah: The daily bag limit for dark following conditions: Balance-of-the-State Zone: Limits may geese is 3. Montana: No more than 500 permits not include more than 6 dark geese per Washington: The daily bag limit is 4 may be issued. The season must end no day. In the Sacramento Valley Special geese. later than December 1. The State must Management Area, the season on white- Area 1: Outside dates are between the implement a harvest-monitoring fronted geese must end on or before Saturday nearest October 1 (October 3), program to measure the species December 14, and the daily bag limit and the last Sunday in January (January composition of the swan harvest and shall contain no more than 2 white- 31). should use appropriate measures to fronted geese. In the North Coast Special Areas 2A and 2B (Southwest Quota maximize hunter compliance in Management Area, 107–day seasons Zone): Except for designated areas, there reporting bill measurement and color may be selected, with outside dates will be no open season on Canada geese. information. between the Saturday nearest October 1 See section on quota zones. In this area, Utah: No more than 2,000 permits (October 3) and March 10. Hunting days the daily bag limit may include 2 may be issued. During the swan season, that occur after the last Sunday in cackling geese. In Southwest Quota no more than 10 trumpeter swans may January shall be concurrent with Zone Area 2B (Pacific County), the daily be taken. The season must end no later Oregon’s South Coast Zone. bag limit may include 1 Aleutian goose. than the second Sunday in December Colorado: The daily bag limit for dark Areas 4 and 5: A 107–day season may (December 13) or upon attainment of 10 geese is 3 geese. be selected for dark geese. trumpeter swans in the harvest, Nevada: The daily bag limit for dark Wyoming: The daily bag limit for dark whichever occurs earliest. The Utah geese is 3. geese is 3. season remains subject to the terms of

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the Memorandum of Agreement entered —In the Central Flyway portion of (New Hampshire Turnpike) in into with the Service in August 2001, Montana, no more than 500 permits may Hampton, and south along I–95 to the regarding harvest monitoring, season be issued. Massachusetts State line. closure procedures, and education —In North Dakota, no more than Inland Zone: That portion of the State requirements to minimize the take of 2,200 permits may be issued. north and west of the above boundary trumpeter swans during the swan —In South Dakota, no more than and along the Massachusetts State line season. 1,300 permits may be issued. crossing the Connecticut River to Nevada: No more than 650 permits Interstate 91 and northward in Vermont Area, Unit, and Zone Descriptions may be issued. During the swan season, to Route 2, east to 102, northward to the no more than 5 trumpeter swans may be Ducks (Including Mergansers) and Canadian border. taken. The season must end no later Coots New Jersey Coastal Zone: That portion of the than the Sunday following January 1 Atlantic Flyway (January 3) or upon attainment of 5 State seaward of a line beginning at the trumpeter swans in the harvest, Connecticut New York State line in Raritan Bay and whichever occurs earliest. North Zone: That portion of the State extending west along the New York In addition, the States of Utah and north of I–95. State line to NJ 440 at Perth Amboy; Nevada must implement a harvest- South Zone: Remainder of the State. west on NJ 440 to the Garden State monitoring program to measure the Maine Parkway; south on the Garden State species composition of the swan North Zone: That portion north of the Parkway to the shoreline at Cape May harvest. The harvest-monitoring line extending east along Maine State and continuing to the Delaware State program must require that all harvested Highway 110 from the New Hampshire line in Delaware Bay. swans or their species-determinant parts and Maine State line to the intersection North Zone: That portion of the State be examined by either State or Federal of Maine State Highway 11 in Newfield; west of the Coastal Zone and north of biologists for the purpose of species then north and east along Route 11 to a line extending west from the Garden classification. The States should use the intersection of U.S. Route 202 in State Parkway on NJ 70 to the New appropriate measures to maximize Auburn; then north and east on Route Jersey Turnpike, north on the turnpike hunter compliance in providing bagged 202 to the intersection of Interstate to U.S. 206, north on U.S. 206 to U.S. swans for examination. Further, the Highway 95 in Augusta; then north and 1 at Trenton, west on U.S. 1 to the States of Montana, Nevada, and Utah east along I–95 to Route 15 in Bangor; Pennsylvania State line in the Delaware must achieve at least an 80-percent then east along Route 15 to Route 9; River. compliance rate, or subsequent permits then east along Route 9 to Stony Brook South Zone: That portion of the State will be reduced by 10 percent. All three in Baileyville; then east along Stony not within the North Zone or the Coastal States must provide to the Service by Brook to the United States border. Zone. South Zone: Remainder of the State. June 30, 2010, a report detailing harvest, New York Massachusetts hunter participation, reporting Lake Champlain Zone: The U.S. Western Zone: That portion of the compliance, and monitoring of swan portion of Lake Champlain and that area State west of a line extending south populations in the designated hunt east and north of a line extending along from the Vermont State line on I–91 to areas. NY 9B from the Canadian border to U.S. MA 9, west on MA 9 to MA 10, south 9, south along U.S. 9 to NY 22 south of Tundra Swans on MA 10 to U.S. 202, south on U.S. 202 Keesville; south along NY 22 to the west In portions of the Atlantic Flyway to the Connecticut State line. shore of South Bay, along and around (North Carolina and Virginia) and the Central Zone: That portion of the the shoreline of South Bay to NY 22 on Central Flyway (North Dakota, South State east of the Berkshire Zone and the east shore of South Bay; southeast Dakota [east of the Missouri River], and west of a line extending south from the along NY 22 to U.S. 4, northeast along that portion of Montana in the Central New Hampshire State line on I–95 to U.S. 4 to the Vermont State line. Flyway), an open season for taking a U.S. 1, south on U.S. 1 to I–93, south on Long Island Zone: That area limited number of tundra swans may be I–93 to MA 3, south on MA 3 to U.S. consisting of Nassau County, Suffolk selected. Permits will be issued by the 6, west on U.S. 6 to MA 28, west on MA County, that area of Westchester County States that authorize the take of no more 28 to I–195, west to the Rhode Island southeast of I–95, and their tidal waters. than 1 tundra swan per permit. A State line; except the waters, and the Western Zone: That area west of a line second permit may be issued to hunters lands 150 yards inland from the high- extending from Lake Ontario east along from unused permits remaining after the water mark, of the Assonet River the north shore of the Salmon River to first drawing. The States must obtain upstream to the MA 24 bridge, and the I–81, and south along I–81 to the harvest and hunter participation data. Taunton River upstream to the Center Pennsylvania State line. These seasons are also subject to the St.Elm St. bridge shall be in the Coastal Northeastern Zone: That area north of following conditions: Zone. a line extending from Lake Ontario east Coastal Zone: That portion of along the north shore of the Salmon In the Atlantic Flyway: Massachusetts east and south of the River to I–81 to NY 31, east along NY —The season may be 90 days, from Central Zone. 31 to NY 13, north along NY 13 to NY October 1 to January 31. New Hampshire 49, east along NY 49 to NY 365, east —In North Carolina, no more than Coastal Zone: That portion of the along NY 365 to NY 28, east along NY 5,000 permits may be issued. State east of a line extending west from 28 to NY 29, east along NY 29 to I–87, —In Virginia, no more than 600 the Maine State line in Rollinsford on north along I–87 to U.S. 9 (at Exit 20), permits may be issued. NH 4 to the city of Dover, south to NH north along U.S. 9 to NY 149, east along 108, south along NH 108 through NY 149 to U.S. 4, north along U.S. 4 to In the Central Flyway: Madbury, Durham, and Newmarket to the Vermont State line, exclusive of the —The season may be 107 days, from NH 85 in Newfields, south to NH 101 Lake Champlain Zone. the Saturday nearest October 1 (October in Exeter, east to NH 51 (Exeter– Southeastern Zone: The remaining 3) to January 31. Hampton Expressway), east to I–95 portion of New York.

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Pennsylvania northwest along New River Road to East Zone: The remainder of Lake Erie Zone: The Lake Erie waters Interstate Highway 55, south along I-55 Kentucky. of Pennsylvania and a shoreline margin to Pine Bluff-Lorenzo Road, west along Louisiana along Lake Erie from New York on the Pine Bluff - Lorenzo Road to Illinois West Zone: That portion of the State east to Ohio on the west extending 150 Route 47, north along Illinois Route 47 west and south of a line extending south yards inland, but including all of to I-80, west along I-80 to I-39, south from the Arkansas State line along Presque Isle Peninsula. along I-39 to Illinois Route 18, west Louisiana Highway 3 to Bossier City, Northwest Zone: The area bounded on along Illinois Route 18 to Illinois Route east along Interstate Highway 20 to the north by the Lake Erie Zone and 29, south along Illinois Route 29 to Minden, south along Louisiana 7 to including all of Erie and Crawford Illinois Route 17, west along Illinois Ringgold, east along Louisiana 4 to Counties and those portions of Mercer Route 17 to the Mississippi River, and Jonesboro, south along U.S. Highway and Venango Counties north of I–80. due south across the Mississippi River 167 to Lafayette, southeast along U.S. 90 North Zone: That portion of the State to the Iowa border. to the Mississippi State line. east of the Northwest Zone and north of Central Zone: That portion of the East Zone: The remainder of a line extending east on I–80 to U.S. State south of the North Zone to a line Louisiana. 220, Route 220 to I–180, I–180 to I–80, extending west from the Indiana border Michigan and I–80 to the Delaware River. along Interstate Highway 70 to Illinois North Zone: The Upper Peninsula. South Zone: The remaining portion of Route 4, south along Illinois Route 4 to Middle Zone: That portion of the Pennsylvania. Illinois Route 161, west along Illinois Lower Peninsula north of a line Vermont Route 161 to Illinois Route 158, south beginning at the Wisconsin State line in Lake Champlain Zone: The U.S. and west along Illinois Route 158 to Lake Michigan due west of the mouth of portion of Lake Champlain and that area Illinois Route 159, south along Illinois Stony Creek in Oceana County; then due north and west of the line extending Route 159 to Illinois Route 156, west east to, and easterly and southerly along from the New York State line along U.S. along Illinois Route 156 to A Road, the south shore of Stony Creek to Scenic 4 to VT 22A at Fair Haven; VT 22A to north and west on A Road to Levee Drive, easterly and southerly along U.S. 7 at Vergennes; U.S. 7 to the Road, north on Levee Road to the south Scenic Drive to Stony Lake Road, Canadian border. shore of New Fountain Creek, west easterly along Stony Lake and Garfield Interior Zone: That portion of along the south shore of New Fountain Roads to Michigan Highway 20, east Vermont west of the Lake Champlain Creek to the Mississippi River, and due along Michigan 20 to U.S. Highway 10 Zone and eastward of a line extending west across the Mississippi River to the Business Route (BR) in the city of from the Massachusetts State line at Missouri border. Midland, easterly along U.S. 10 BR to Interstate 91; north along Interstate 91 to South Zone: The remainder of Illinois. U.S. 10, easterly along U.S. 10 to US 2; east along US 2 to VT 102; north Indiana Interstate Highway 75/U.S. Highway 23, along VT 102 to VT 253; north along VT North Zone: That portion of the State northerly along I–75/U.S. 23 to the U.S. 253 to the Canadian border. north of a line extending east from the 23 exit at Standish, easterly along U.S. Connecticut River Zone: The Illinois State line along State Road 18 to 23 to the centerline of the Au Gres remaining portion of Vermont east of U.S. Highway 31, north along U.S. 31 to River, then southerly along the the Interior Zone. U.S. 24, east along U.S. 24 to centerline of the Au Gres River to West Virginia Huntington, then southeast along U.S. Saginaw Bay, then on a line directly east Zone 1: That portion outside the 224 to the Ohio State line. 10 miles into Saginaw Bay, and from boundaries in Zone 2. Ohio River Zone: That portion of the that point on a line directly northeast to Zone 2 (Allegheny Mountain Upland): State south of a line extending east from the Canadian border. That area bounded by a line extending the Illinois State line along Interstate South Zone: The remainder of south along U.S. 220 through Keyser to Highway 64 to New Albany, east along Michigan. U.S. 50; U.S. 50 to WV 93; WV 93 south State Road 62 to State Road 56, east Minnesota to WV 42; WV 42 south to Petersburg; along State Road 56 to Vevay, east and North Duck Zone: That portion of the WV 28 south to Minnehaha Springs; WV north on State 156 along the Ohio River State north of a line extending east from 39 west to U.S. 219; U.S. 219 south to to North Landing, north along State 56 the North Dakota State line along State I–64; I–64 west to U.S. 60; U.S. 60 west to U.S. Highway 50, then northeast Highway 210 to State Highway 23, east to U.S. 19; U.S. 19 north to I–79, I–79 along U.S. 50 to the Ohio State line. along State Highway 23 to State north to I–68; I–68 east to the Maryland South Zone: That portion of the State Highway 39, then east along State State line; and along the State line to the between the North and Ohio River Zone Highway 39 to the Wisconsin State line point of beginning. boundaries. at the Oliver Bridge. Iowa South Duck Zone: The remainder of Mississippi Flyway North Zone: That portion of the State Minnesota. Alabama north of a line extending east from the Missouri South Zone: Mobile and Baldwin Nebraska border along State Highway North Zone: That portion of Missouri Counties. 175 to State Highway 37, southeast north of a line running west from the North Zone: The remainder of along State Highway 37 to State Illinois State line (Lock and Dam 25) on Alabama. Highway 183, northeast along State Lincoln County Highway N to Missouri Illinois Highway 183 to State Highway 141, east Highway 79; south on Missouri North Zone: That portion of the State along State Highway 141 to U.S. Highway 79 to Missouri Highway 47; north of a line extending west from the Highway 30, then east along U.S. west on Missouri Highway 47 to Indiana border along Peotone-Beecher Highway 30 to the Illinois border. Interstate 70; west on Interstate 70 to the Road to Illinois Route 50, south along South Zone: The remainder of Iowa. Kansas State line. Illinois Route 50 to Wilmington-Peotone Kentucky South Zone: That portion of Missouri Road, west along Wilmington-Peotone West Zone: All counties west of and south of a line running west from the Road to Illinois Route 53, north along including Butler, Daviess, Ohio, Illinois State line on Missouri Highway Illinois Route 53 to New River Road, Simpson, and Warren Counties. 34 to Interstate 55; south on Interstate

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55 to U.S. Highway 62; west on U.S. High Plains Zone: That portion of the U.S. 136 and the Steamboat Trace Highway 62 to Missouri Highway 53; State west of U.S. 283. (Trace); north along the Trace to the north on Missouri Highway 53 to Low Plains Early Zone: That area of intersection with Federal Levee R-562; Missouri Highway 51; north on Missouri Kansas east of U.S. 283, and generally north along Federal Levee R-562 to the Highway 51 to U.S. Highway 60; west west of a line beginning at the Junction intersection with the Trace; north along on U.S. Highway 60 to Missouri of the Nebraska border and KS 28; south the Trace/Burlington Northern Railroad Highway 21; north on Missouri on KS 28 to U.S. 36; east on U.S. 36 to right-of-way to NE 2; west to U.S. 75; Highway 21 to Missouri Highway 72; KS 199; south on KS 199 to Republic north to NE 2; west to NE 43; north to west on Missouri Highway 72 to Co. Road 563; south on Republic Co. U.S. 34; east to NE 63; north and west Missouri Highway 32; west on Missouri Road 563 to KS 148; east on KS 148 to to U.S. 77; north to NE 92; west to U.S. Highway 32 to U.S. Highway 65; north Republic Co. Road 138; south on 81; south to NE 66; west to NE 14; south on U.S. Highway 65 to U.S. Highway 54; Republic Co. Road 138 to Cloud Co. to County Road 22 (Hamilton County); west on U.S. Highway 54 to the Kansas Road 765; south on Cloud Co. Road 765 west to County Road M; south to County State line. to KS 9; west on KS 9 to U.S. 24; west Road 21; west to County Road K; south Middle Zone: The remainder of on U.S. 24 to U.S. 281; north on U.S. U.S. 34; west to NE 2; south to U.S. I- Missouri. 281 to U.S. 36; west on U.S. 36 to U.S. 80; west to Gunbarrel Road (Hall/ Ohio 183; south on U.S. 183 to U.S. 24; west Hamilton county line); south to Giltner North Zone: That portion of the State on U.S. 24 to KS 18; southeast on KS 18 Road; west to U.S. 281; south to U.S. 34; north of a line extending east from the to U.S. 183; south on U.S. 183 to KS 4; west to NE 10; north to County Road Indiana State line along U.S. Highway east on KS 4 to I-135; south on I-135 to ‘‘R’’ (Kearney County) and County Road 33 to State Route 127, south along SR KS 61; southwest on KS 61 to KS 96; #742 (Phelps County); west to County 127 to SR 703, south along SR 703 to SR northwest on KS 96 to U.S. 56; Road #438 (Gosper County line); south 219, east along SR 219 to SR 364, north southwest on U.S. 56 to KS 19; east on along County Road #438 (Gosper County along SR 364 to SR 703, east along SR KS 19 to U.S. 281; south on U.S. 281 to line) to County Road #726 (Furnas 703 to SR 66, north along SR 66 to U.S. U.S. 54; west on U.S. 54 to U.S. 183; County line); east to County Road #438 33, east along U.S. 33 to SR 385, east north on U.S. 183 to U.S. 56; southwest (Harlan County line); south to U.S. 34; along SR 385 to SR 117, south along SR on U.S. 56 to Ford Co. Road 126; south south and west to U.S. 136; east to NE 117 to SR 273, east along SR 273 to SR on Ford Co. Road 126 to U.S. 400; 14; south to the Kansas-Nebraska 31, south along SR 31 to SR 739, east northwest on U.S. 400 to U.S. 283. border; west to U.S. 283; north to NE 23; along SR 739 to SR 4, north along SR Low Plains Late Zone: The remainder west to NE 47; north to U.S. 30; east to 4 to SR 95, east along SR 95 to SR 13, of Kansas. NE 14; north to NE 52; west and north southeast along SR 13 to SR 3, northeast Montana (Central Flyway Portion) to NE 91 to U.S. 281; south to NE 22; along SR 3 to SR 60, north along SR 60 Zone 1: The Counties of Blaine, west to NE 11; northwest to NE 91; west to U.S. 30, east along U.S. 30 to SR 3, Carbon, Carter, Daniels, Dawson, Fallon, to Loup County Line; north to Loup- south along SR 3 to SR 226, south along Fergus, Garfield, Golden Valley, Judith Brown County line; east along northern SR 226 to SR 514, southwest along SR Basin, McCone, Musselshell, Petroleum, boundaries of Loup, Garfield, and 514 to SR 754, south along SR 754 to SR Phillips, Powder River, Richland, Wheeler Counties; south on the 39/60, east along SR 39/60 to SR 241, Roosevelt, Sheridan, Stillwater, Sweet Wheeler-Antelope county line to NE 70; north along SR 241 to U.S. 30, east along Grass, Valley, Wheatland, Wibaux, and east to NE 14; south to NE 39; southeast U.S.30 to SR 39, east along SR 39 to the Yellowstone. to NE 22; east to U.S. 81; southeast to Pennsylvania State line. Zone 2: The remainder of Montana. U.S. 30; east to U.S. 75; north to the South Zone: The remainder of Ohio. Nebraska High Plains Zone: That portion of Washington County line; east to the Tennessee Iowa-Nebraska border; south along the Reelfoot Zone: All or portions of Lake Nebraska lying west of a line beginning at the South Dakota-Nebraska border on Iowa-Nebraska border; to the beginning and Obion Counties. at U.S. 75 and the Kansas-Nebraska State Zone: The remainder of U.S. 183, south on U.S. 183 to U.S. 20, west on U.S. 20 to NE 7, south on NE border. Tennessee. Low Plains Zone 3: The area east of 7 to NE 91, southwest on NE 91 to NE Wisconsin the High Plains Zone, excluding Low 2, southeast on NE 2 to NE 92, west on North Zone: That portion of the State Plains Zone 1, north of Low Plains Zone NE 92 to NE 40, south on NE 40 to NE north of a line extending east from the 2. Minnesota State line along U.S. 47, south on NE 47 to NE 23, east on NE Low Plains Zone 4: The area east of Highway 10 to U.S. Highway 41, then 23 to U.S. 283 and south on U.S. 283 to the High Plains Zone and south of Zone north on U.S. Highway 41 to the the Kansas-Nebraska border. 2. Michigan State line. Low Plains Zone 1: That portion of New Mexico (Central Flyway Portion) South Zone: The remainder of Dixon County west of NE 26E Spur and North Zone: That portion of the State Wisconsin. north of NE 12; those portions of Cedar north of I–40 and U.S. 54. County north of NE 12; those portions South Zone: The remainder of New Central Flyway of Knox County north of NE 12 to Mexico. Colorado (Central Flyway Portion) intersection of Niobrara River; all of North Dakota Eastern Plains Zone: That portion of Boyd County; Keya Paha County east of High Plains Unit: That portion of the the State east of Interstate 25, and all of U.S. 183. Both banks of the Niobrara State south and west of a line from the El Paso, Pueblo, Heurfano, and Las River in Keya Paha, Boyd, and Knox South Dakota State line along U.S. 83 Animas Counties. Counties east of U.S. 183 shall be and I–94 to ND 41, north to U.S. 2, west Mountain/Foothills Zone: That included in Zone 1. to the Williams/Divide County line, portion of the State west of Interstate 25 Low Plains Zone 2: Area bounded by then north along the County line to the and east of the Continental Divide, designated Federal and State highways Canadian border. except El Paso, Pueblo, Heurfano, and and political boundaries beginning at Low Plains Unit: The remainder of Las Animas Counties. the Kansas-Nebraska border on U.S. 75 North Dakota. Kansas to U.S. 136; east to the intersection of Oklahoma

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High Plains Zone: The Counties of Wyoming (Central Flyway Portion) south on a road known as ‘‘Aqueduct Beaver, Cimarron, and Texas. Zone 1: The Counties of Converse, Road’’ in San Bernardino County Low Plains Zone 1: That portion of Goshen, Hot Springs, Natrona, Platte, through the town of Rice to the San the State east of the High Plains Zone and Washakie; and the portion of Park Bernardino–Riverside County line; and north of a line extending east from County east of the Shoshone National south on a road known in Riverside the Texas State line along OK 33 to OK Forest boundary and south of a line County as the ‘‘Desert Center to Rice 47, east along OK 47 to U.S. 183, south beginning where the Shoshone National Road’’ to the town of Desert Center; east along U.S.183 to I-40, east along I-40 to Forest boundary meets Park County 31 miles on I–10 to the Wiley Well U.S. 177, north along U.S. 177 to OK 33, Road 8VC, east along Park County Road Road; south on this road to Wiley Well; east along OK 33 to OK 18, north along 8VC to Park County Road 1AB, southeast along the Army–Milpitas OK 18 to OK 51, west along OK 51 to continuing east along Park County Road Road to the Blythe, Brawley, Davis Lake I-35, north along I-35 to U.S. 412, west 1AB to Wyoming Highway 120, north intersections; south on the Blythe– along U.S. 412 to OK 132, then north along WY Highway 120 to WY Highway Brawley paved road to the Ogilby and along OK 132 to the Kansas State line. 294, south along WY Highway 294 to Tumco Mine Road; south on this road Low Plains Zone 2: The remainder of Lane 9, east along Lane 9 to Powel and to U.S. 80; east 7 miles on U.S. 80 to the Oklahoma. WY Highway 14A, and finally east along Andrade–Algodones Road; south on this South Dakota WY Highway 14A to the Park County paved road to the Mexican border at High Plains Zone: That portion of the and Big Horn County line. Algodones, Mexico. State west of a line beginning at the Zone 2: The remainder of Wyoming. Southern Zone: That portion of North Dakota State line and extending southern California (but excluding the south along U.S. 83 to U.S.14, east on Pacific Flyway Colorado River Zone) south and east of U.S.14 to Blunt, south on the Blunt- Arizona a line extending from the Pacific Ocean Canning road to SD 34, east and south Game Management Units (GMU) as east along the Santa Maria River to CA on SD 34 to SD 50 at Lee’s Corner, south follows: 166 near the City of Santa Maria; east on on SD 50 to I-90, east on I-90 to SD 50, South Zone: Those portions of GMUs CA 166 to CA 99; south on CA 99 to the south on SD 50 to SD 44, west on SD 6 and 8 in Yavapai County, and GMUs crest of the Tehachapi Mountains at 44 across the Platte-Winner bridge to SD 10 and 12B–45. Tejon Pass; east and north along the 47, south on SD 47 to U.S.18, east on North Zone: GMUs 1–5, those crest of the Tehachapi Mountains to CA U.S. 18 to SD 47, south on SD 47 to the portions of GMUs 6 and 8 within 178 at Walker Pass; east on CA 178 to Nebraska State line. Coconino County, and GMUs 7, 9, 12A. U.S. 395 at the town of Inyokern; south North Zone: That portion of California on U.S. 395 to CA 58; east on CA 58 to northeastern South Dakota east of the Northeastern Zone: In that portion of I–15; east on I–15 to CA 127; north on High Plains Unit and north of a line California lying east and north of a line CA 127 to the Nevada State line. extending east along U.S. 212 to the beginning at the intersection of Southern San Joaquin Valley Minnesota State line. Interstate 5 with the California–Oregon Temporary Zone: All of Kings and South Zone: That portion of Gregory line; south along Interstate 5 to its Tulare Counties and that portion of County east of SD 47 and south of SD junction with Walters Lane south of the Kern County north of the Southern 44; Charles Mix County south of SD 44 town or Yreka; west along Walters Lane Zone. to the Douglas County line; south on SD to its junction with Easy Street; south Balance-of-the-State Zone: The 50 to Geddes; east on the Geddes along Easy Street to the junction with remainder of California not included in Highway to U.S. 281; south on U.S. 281 Old Highway 99; south along Old the Northeastern, Southern, and and U.S. 18 to SD 50; south and east on Highway 99 to the point of intersection Colorado River Zones, and the Southern SD 50 to the Bon Homme County line; with Interstate 5 north of the town of San Joaquin Valley Temporary Zone. the Counties of Bon Homme, Yankton, Weed; south along Interstate 5 to its Idaho and Clay south of SD 50; and Union junction with Highway 89; east and County south and west of SD 50 and I- south along Highway 89 to Main Street Zone 1: Includes all lands and waters 29. Greenville; north and east to its junction within the Fort Hall Indian Reservation, Middle Zone: The remainder of South with North Valley Road; south to its including private inholdings; Bannock Dakota. junction of Diamond Mountain Road; County; Bingham County, except that Texas north and east to its junction with North portion within the Blackfoot Reservoir High Plains Zone: That portion of the Arm Road; south and west to the drainage; and Power County east of ID State west of a line extending south junction of North Valley Road; south to 37 and ID 39. from the Oklahoma State line along U.S. the junction with Arlington Road (A22); Zone 2: Includes the following 183 to Vernon, south along U.S. 283 to west to the junction of Highway 89; Counties or portions of Counties: Albany, south along TX 6 to TX 351 to south and west to the junction of Adams; Bear Lake; Benewah; Bingham Abilene, south along U.S. 277 to Del Highway 70; east on Highway 70 to within the Blackfoot Reservoir drainage; Rio, then south along the Del Rio Highway 395; south and east on Blaine; Bonner; Bonneville; Boundary; International Toll Bridge access road to Highway 395 to the point of intersection Butte; Camas; Caribou except the Fort the Mexico border. with the California–Nevada State line; Hall Indian Reservation; Cassia within Low Plains North Zone: That portion north along the California–Nevada State the Minidoka National Wildlife Refuge; of northeastern Texas east of the High line to the junction of the California– Clark; Clearwater; Custer; Elmore within Plains Zone and north of a line Nevada–Oregon State lines; west along the Camas Creek drainage; Franklin; beginning at the International Toll the California–Oregon State line to the Fremont; Idaho; Jefferson; Kootenai; Bridge south of Del Rio, then extending point of origin. Latah; Lemhi; Lewis; Madison; Nez east on U.S. 90 to San Antonio, then Colorado River Zone: Those portions Perce; Oneida; Power within the continuing east on I–10 to the Louisiana of San Bernardino, Riverside, and Minidoka National Wildlife Refuge; State line at Orange, Texas. Imperial Counties east of a line Shoshone; Teton; and Valley Counties. Low Plains South Zone: The extending from the Nevada State line Zone 3: Includes the following remainder of Texas. south along U.S. 95 to Vidal Junction; Counties or portions of Counties: Ada;

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Boise; Canyon; Cassia except within the along Route 159 to its intersection with Road); then south along Route 553 to Minidoka National Wildlife Refuge; Route 91 in Hartford, and then Route 40; then east along Route 40 to Elmore except the Camas Creek extending south along Route 91 to its route 55; then south along Route 55 to drainage; Gem; Gooding; Jerome; intersection with the Hartford/ Route 552 (Sherman Avenue); then west Lincoln; Minidoka; Owyhee; Payette; Middlesex County line. along Route 552 to Carmel Road; then Power west of ID 37 and ID 39 except AFRP Unit: Starting at the south along Carmel Road to Route 49; that portion within the Minidoka intersection of I-95 and the Quinnipiac then east along Route 49 to Route 555; National Wildlife Refuge; Twin Falls; River, north on the Quinnipiac River to then south along Route 555 to Route and Washington Counties. its intersection with I-91, north on I-91 553; then east along Route 553 to Route Nevada to I-691, west on I-691 to the Hartford 649; then north along Route 649 to Lincoln and Clark County Zone: All of County line, and encompassing the rest Route 670; then east along Route 670 to Clark and Lincoln Counties. of New Haven County and Fairfield Route 47; then north along Route 47 to Remainder-of-the-State Zone: The County in its entirety. Route 548; then east along Route 548 to remainder of Nevada. NAP H-Unit: All of the rest of the Route 49; then east along Route 49 to Oregon State not included in the AP or AFRP Route 50; then south along Route 50 to Zone 1: Clatsop, Tillamook, Lincoln, descriptions above. Route 9; then south along Route 9 to Lane, Douglas, Coos, Curry, Josephine, South Zone: Same as for ducks. Route 625 (Sea Isle City Boulevard); Jackson, Linn, Benton, Polk, Marion, North Zone: Same as for ducks. then east along Route 625 to the Atlantic Yamhill, Washington, Columbia, Maryland Ocean; then north to the beginning Multnomah, Clackamas, Hood River, Resident Population (RP) Zone: point. Wasco, Sherman, Gilliam, Morrow and Garrett, Allegany, Washington, New York Umatilla Counties. Frederick, and Montgomery Counties; Lake Champlain Goose Area: That Columbia Basin Mallard Management that portion of Prince George’s County area of New York State lying east and Unit: Gilliam, Morrow, and Umatilla west of Route 3 and Route 301; that north of a continuous line extending Counties. portion of Charles County west of Route along Route 11 from the New York- Zone 2: The remainder of the State. 301 to the Virginia State line; and that Canada International boundary south to Utah portion of Carroll County west of Route Route 9B, south along Route 9B to Route Zone 1: All of Box Elder, Cache, 31 to the intersection of Route 97, and 9, south along Route 9 to Route 22 south Daggett, Davis, Duchesne, Morgan, Rich, west of Route 97 to the Pennsylvania of Keeseville, south along Route 22 to Salt Lake, Summit, Unitah, Utah, line. the west shore of South Bay along and Wasatch, and Weber Counties, and that AP Zone: Remainder of the State. around the shoreline of South Bay to part of Toole County north of I–80. Massachusetts Route 22 on the east shore of South Bay, Zone 2: The remainder of Utah. NAP Zone: Central and Coastal Zones southeast along Route 22 to Route 4, Washington (see duck zones). northeast along Route 4 to the New East Zone: All areas east of the Pacific AP Zone: The Western Zone (see duck York-Vermont boundary. Northeast Goose Area: The same as Crest Trail and east of the Big White zones). the Northeastern Waterfowl Hunting Salmon River in Klickitat County. Special Late Season Area: The Central Zone, which is that area of New York Columbia Basin Mallard Management Zone and that portion of the Coastal State lying north of a continuous line Unit: Same as East Zone. Zone (see duck zones) that lies north of extending from Lake Ontario east along West Zone: All areas to the west of the the Cape Cod Canal, north to the New the north shore of the Salmon River to East Zone. Hampshire line. New Hampshire Interstate 81, south along Interstate Wyoming Same zones as for ducks. Route 81 to Route 31, east along Route Snake River Zone: Beginning at the New Jersey 31 to Route 13, north along Route 13 to south boundary of Yellowstone National North: That portion of the State Route 49, east along Route 49 to Route Park and the Continental Divide; south within a continuous line that runs east 365, east along Route 365 to Route 28, along the Continental Divide to Union along the New York State boundary line east along Route 28 to Route 29, east Pass and the Union Pass Road (U.S.F.S. to the Hudson River; then south along along Route 29 to Interstate Route 87, Road 600); west and south along the the New York State boundary to its north along Interstate Route 87 to Route Union Pass Road to U.S. F.S. Road 605; intersection with Route 440 at Perth 9 (at Exit 20), north along Route 9 to south along U.S.F.S. Road 605 to the Amboy; then west on Route 440 to its Route 149, east along Route 149 to Bridger-Teton National Forest boundary; intersection with Route 287; then west Route 4, north along Route 4 to the New along the national forest boundary to the along Route 287 to its intersection with York-Vermont boundary, exclusive of Idaho State line; north along the Idaho Route 206 in Bedminster (Exit 18); then the Lake Champlain Zone. State line to the south boundary of north along Route 206 to its intersection East Central Goose Area: That area of Yellowstone National Park; east along with Route 94: then west along Route 94 New York State lying inside of a the Yellowstone National Park boundary to the tollbridge in Columbia; then north continuous line extending from to the Continental Divide. along the Pennsylvania State boundary Interstate Route 81 in Cicero, east along Balance of Flyway Zone: Balance of in the Delaware River to the beginning Route 31 to Route 13, north along Route the Pacific Flyway in Wyoming outside point. 13 to Route 49, east along Route 49 to the Snake River Zone. South: That portion of the State Route 365, east along Route 365 to Geese within a continuous line that runs west Route 28, east along Route 28 to Route from the Atlantic Ocean at Ship Bottom 29, east along Route 29 to Route 147 at Atlantic Flyway along Route 72 to Route 70; then west Kimball Corners, south along Route 147 Connecticut along Route 70 to Route 206; then south to Schenectady County Route 40 (West AP Unit: Litchfield County and the along Route 206 to Route 536; then west Glenville Road), west along Route 40 to portion of Hartford County west of a along Route 536 to Route 322; then west Touareuna Road, south along Touareuna line beginning at the Massachusetts along Route 322 to Route 55; then south Road to Schenectady County Route 59, border in Suffield and extending south along Route 55 to Route 553 (Buck south along Route 59 to State Route 5,

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east along Route 5 to the Lock 9 bridge, southwest along Route 18 to Yates to Route 85, south along Route 85 to southwest along the Lock 9 bridge to County Route 34, east along Route 34 to Route 443, southeast along Route 443 to Route 5S, southeast along Route 5S to Yates County Route 32, south along Albany County Route 301 at Clarksville, Schenectady County Route 58, Route 32 to Steuben County Route 122, southeast along Route 301 to Route 32, southwest along Route 58 to the NYS south along Route 122 to Route 53, south along Route 32 to Route 23 at Thruway, south along the Thruway to south along Route 53 to Steuben County Cairo, west along Route 23 to Joseph Route 7, southwest along Route 7 to Route 74, east along Route 74 to Route Chadderdon Road, southeast along Schenectady County Route 103, south 54A (near Pulteney), south along Route Joseph Chadderdon Road to Hearts along Route 103 to Route 406, east along 54A to Steuben County Route 87, east Content Road (Greene County Route 31), Route 406 to Schenectady County Route along Route 87 to Steuben County Route southeast along Route 31 to Route 32, 99 (Windy Hill Road), south along Route 96, east along Route 96 to Steuben south along Route 32 to Greene County 99 to Dunnsville Road, south along County Route 114, east along Route 114 Route 23A, east along Route 23A to Dunnsville Road to Route 397, to Schuyler County Route 23, east and Interstate Route 87 (the NYS Thruway), southwest along Route 397 to Route 146 southeast along Route 23 to Schuyler south along Route 87 to Route 28 (Exit at Altamont, west along Route 146 to County Route 28, southeast along Route 19) near Kingston, northwest on Route Albany County Route 252, northwest 28 to Route 409 at Watkins Glen, south 28 to Route 209, southwest on Route along Route 252 to Schenectady County along Route 409 to Route 14, south 209 to the New York–Pennsylvania Route 131, north along Route 131 to along Route 14 to Route 224 at Montour boundary, southeast along the New Route 7, west along Route 7 to Route 10 Falls, east along Route 224 to Route 228 York–Pennsylvania boundary to the at Richmondville, south on Route 10 to in Odessa, north along Route 228 to New York–New Jersey boundary, Route 23 at Stamford, west along Route Route 79 in Mecklenburg, east along southeast along the New York–New 23 to the south bank of the Susquehanna Route 79 to Route 366 in Ithaca, Jersey boundary to Route 210 near River, southwest along the south bank of northeast along Route 366 to Route 13, Greenwood Lake, northeast along Route the Susquehanna River to Interstate northeast along Route 13 to Interstate 210 to Orange County Route 5, northeast Route 88 near Harpursville, west along Route 81 in Cortland, north along Route along Orange County Route 5 to Route Route 88 to Route 79, northwest along 81 to the north shore of the Salmon 105 in the Village of Monroe, east and Route 79 to Route 26 in Whitney Point, River to shore of Lake Ontario, north along Route 105 to Route 32, southwest along Route 26 to Interstate extending generally northwest in a northeast along Route 32 to Orange Route 81, north along Route 81 to the straight line to the nearest point of the County Route 107 (Quaker Avenue), east point of beginning. International boundary with Canada, along Route 107 to Route 9W, north south and west along the International West Central Goose Area: That area of along Route 9W to the south bank of boundary to the point of beginning. New York State lying within a Moodna Creek, southeast along the continuous line beginning at the point Hudson Valley Goose Area: That area south bank of Moodna Creek to the New where the northerly extension of Route of New York State lying within a Windsor–Cornwall town boundary, 269 (County Line Road on the Niagara- continuous line extending from Route 4 northeast along the New Windsor- Orleans County boundary) meets the at the New York-Vermont boundary, Cornwall town boundary to the Orange– International boundary with Canada, west and south along Route 4 to Route Dutchess County boundary (middle of south to the shore of Lake Ontario at the 149 at Fort Ann, west on Route 149 to the Hudson River), north along the eastern boundary of Golden Hill State Route 9, south along Route 9 to county boundary to Interstate Route 84, Park, south along the extension of Route Interstate Route 87 (at Exit 20 in Glens east along Route 84 to the Dutchess– 269 and Route 269 to Route 104 at Falls), south along Route 87 to Route 29, Putnam County boundary, east along the Jeddo, west along Route 104 to Niagara west along Route 29 to Route 147 at county boundary to the New York- County Route 271, south along Route Kimball Corners, south along Route 147 Connecticut boundary, north along the 271 to Route 31E at Middleport, south to Schenectady County Route 40 (West New York–Connecticut boundary to the along Route 31E to Route 31, west along Glenville Road), west along Route 40 to New York–Massachusetts boundary, Route 31 to Griswold Street, south along Touareuna Road, south along Touareuna north along the New York– Griswold Street to Ditch Road, south Road to Schenectady County Route 59, Massachusetts boundary to the New along Ditch Road to Foot Road, south south along Route 59 to State Route 5, York–Vermont boundary, north to the along Foot Road to the north bank of east along Route 5 to the Lock 9 bridge, point of beginning. Tonawanda Creek, west along the north southwest along the Lock 9 bridge to bank of Tonawanda Creek to Route 93, Route 5S, southeast along Route 5S to Eastern Long Island Goose Area (NAP south along Route 93 to Route 5, east Schenectady County Route 58, High Harvest Area): That area of Suffolk along Route 5 to Crittenden-Murrays southwest along Route 58 to the NYS County lying east of a continuous line Corners Road, south on Crittenden- Thruway, south along the Thruway to extending due south from the New Murrays Corners Road to the NYS Route 7, southwest along Route 7 to York-Connecticut boundary to the Thruway, east along the Thruway 90 to Schenectady County Route 103, south northernmost end of Roanoke Avenue in Route 98 (at Thruway Exit 48) in along Route 103 to Route 406, east along the Town of Riverhead; then south on Batavia, south along Route 98 to Route Route 406 to Schenectady County Route Roanoke Avenue (which becomes 20, east along Route 20 to Route 19 in 99 (Windy Hill Road), south along Route County Route 73) to State Route 25; then Pavilion Center, south along Route 19 to 99 to Dunnsville Road, south along west on Route 25 to Peconic Avenue; Route 63, southeast along Route 63 to Dunnsville Road to Route 397, then south on Peconic Avenue to Route 246, south along Route 246 to southwest along Route 397 to Route 146 County Route (CR) 104 (Riverleigh Route 39 in Perry, northeast along Route at Altamont, southeast along Route 146 Avenue); then south on CR 104 to CR 31 39 to Route 20A, northeast along Route to Main Street in Altamont, west along (Old Riverhead Road); then south on CR 20A to Route 20, east along Route 20 to Main Street to Route 156, southeast 31 to Oak Street; then south on Oak Route 364 (near Canandaigua), south along Route 156 to Albany County Street to Potunk Lane; then west on and east along Route 364 to Yates Route 307, southeast along Route 307 to Stevens Lane; then south on Jessup County Route 18 (Italy Valley Road), Route 85A, southwest along Route 85A Avenue (in Westhampton Beach) to

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Dune Road (CR 89); then due south to Pender, Person, Pitt, Polk, Randolph, then Route 460 (SE) to City of Suffolk, international waters. Richmond (all of the county with then south along Route 32 to the North Western Long Island Goose Area (RP exception of that portion that is south of Carolina line. Area): That area of Westchester County NC 73 and west of US 220 and north of SJBP Zone: The area to the west of the and its tidal waters southeast of US 74), Robeson, Rockingham, AP Zone boundary and east of the Interstate Route 95 and that area of Rutherford, Sampson, Scotland, Stokes, following line: the ‘‘Blue Ridge’’ Nassau and Suffolk Counties lying west Surry, Swain, Transylvania, Vance, (mountain spine) at the West Virginia– of a continuous line extending due Warren, Watauga, Wayne, Wilkes, Virginia Border (Loudoun County– south from the New York-Connecticut Wilson, Yadkin, and Yancey. Clarke County line) south to Interstate boundary to the northernmost end of the Northeast Hunt Unit: Includes the 64 (the Blue Ridge line follows county Sunken Meadow State Parkway; then following Counties or portions of borders along the western edge of south on the Sunken Meadow Parkway Counties: Bertie (that portion north and Loudoun–Fauquier–Rappahannock– to the Sagtikos State Parkway; then east of a line formed by NC 45 at the Madison–Greene–Albemarle and into south on the Sagtikos Parkway to the Washington County line to US 17 in Nelson Counties), then east along Robert Moses State Parkway; then south Midway, US 17 in Midway to US 13 in Interstate Rt. 64 to Route 15, then south on the Robert Moses Parkway to its Windsor, US 13 in Windsor to the along Rt. 15 to the North Carolina line. southernmost end; then due south to Hertford Co. line), Camden, Chowan, RP Zone: The remainder of the State international waters. Currituck, Dare, Hyde, Pasquotank, west of the SJBP Zone. Central Long Island Goose Area (NAP Perquimans, Tyrrell, and Washington. West Virginia Low Harvest Area): That area of Suffolk Pennsylvania Same zones as for ducks. County lying between the Western and Resident Canada Goose Zone: All of Mississippi Flyway Eastern Long Island Goose Areas, as Pennsylvania except for SJBP Zone and defined above. the area east of route SR 97 from the Alabama South Goose Area: The remainder of Maryland State Line to the intersection Same zones as for ducks, but in New York State, excluding New York of SR 194, east of SR 194 to intersection addition: City. of US Route 30, south of US Route 30 SJBP Zone: That portion of Morgan Special Late Canada Goose Area: That to SR 441, east of SR 441 to SR 743, east County east of U.S. Highway 31, north area of the Central Long Island Goose of SR 743 to intersection of I–81, east of of State Highway 36, and west of U.S. Area lying north of State Route 25A and I–81 to intersection of I–80, and south 231; that portion of Limestone County west of a continuous line extending of I–80 to the New Jersey State line. south of U.S. 72; and that portion of northward from State Route 25A along SJBP Zone: The area north of I-80 and Madison County south of Swancott Randall Road (near Shoreham) to North west of I-79 including in the city of Erie Road and west of Triana Road. Country Road, then east to Sound Road west of Bay Front Parkway to and Arkansas and then north to Long Island Sound including the Lake Erie Duck zone (Lake Northwest Zone: Baxter, Benton, and then due north to the New York- Erie, Presque Isle, and the area within Boone, Carroll, Conway, Crawford, Connecticut boundary. 150 yards of the Lake Erie Shoreline). Faulkner, Franklin, Johnson, Logan, North Carolina AP Zone: The area east of route SR 97 Madison, Marion, Newton, Perry, Pope, SJBP Hunt Zone: Includes the from Maryland State Line to the Pulaski, Searcy, Sebastian, Scott, Van following Counties or portions of intersection of SR 194, east of SR 194 to Buren, Washington, and Yell Counties. Counties: Anson, Cabarrus, Chatham, intersection of US Route 30, south of US Illinois Davidson, Durham, Halifax (that portion Route 30 to SR 441, east of SR 441 to Same zones as for ducks. east of NC 903), Montgomery (that SR 743, east of SR 743 to intersection of Indiana portion west of NC 109), Northampton, I–81, east of I–81 to intersection of I–80, Same zones as for ducks but in Richmond (that portion south of NC 73 south of I–80 to New Jersey State line. addition: and west of US 220 and north of US 74), Rhode Island Special Canada Goose Seasons Rowan, Stanly, Union, and Wake. Special Area for Canada Geese: Kent RP Hunt Zone: Includes the following and Providence Counties and portions Indiana Late Canada Goose Season Counties or portions of Counties: of the towns of Exeter and North Zone: That part of the state Alamance, Alleghany, Alexander, Ashe, Kingston within Washington County encompassed by the following Counties: Avery, Beaufort, Bertie (that portion (see State regulations for detailed Steuben, Lagrange, Elkhart, St. Joseph, south and west of a line formed by NC descriptions). La Porte, Starke, Marshall, Kosciusko, 45 at the Washington Co. line to US 17 South Carolina Noble, De Kalb, Allen, Whitley, in Midway, US 17 in Midway to US 13 Canada Goose Area: Statewide except Huntington, Wells, Adams, Boone, in Windsor, US 13 in Windsor to the for Clarendon County, that portion of Hamilton, Madison, Hendricks, Marion, Hertford Co. line), Bladen, Brunswick, Orangeburg County north of SC Hancock, Morgan, Johnson, Shelby, Buncombe, Burke, Caldwell, Carteret, Highway 6, and that portion of Berkeley Vermillion, Parke, Vigo, Clay, Sullivan, Caswell, Catawba, Cherokee, Clay, County north of SC Highway 45 from and Greene. Cleveland, Columbus, Craven, the Orangeburg County line to the Iowa Cumberland, Davie, Duplin, Edgecombe, junction of SC Highway 45 and State North Zone: That portion of the State Forsyth, Franklin, Gaston, Gates, Road S-8-31 and that portion west of the north of U.S. Highway 20. Graham, Granville, Greene, Guilford, Santee Dam. South Zone: The remainder of Iowa. Halifax (that portion west of NC 903), Vermont Kentucky Harnett, Haywood, Henderson, Hertford, Same zones as for ducks. Western Zone: That portion of the Hoke, Iredell, Jackson, Johnston, Jones, Virginia State west of a line beginning at the Lee, Lenoir, Lincoln, McDowell, Macon, AP Zone: The area east and south of Tennessee State line at Fulton and Madison, Martin, Mecklenburg, the following line the Stafford County extending north along the Purchase Mitchell, Montgomery (that portion that line from the Potomac River west to Parkway to Interstate Highway 24, east is east of NC 109), Moore, Nash, New Interstate 95 at Fredericksburg, then along I–24 to U.S. Highway 641, north Hanover, Onslow, Orange, Pamlico, south along Interstate 95 to Petersburg, along U.S. 641 to U.S. 60, northeast

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along U.S. 60 to the Henderson County boundaries of the Muskegon County U.S. Highway 63 to the south boundary line, then south, east, and northerly wastewater system, east of the of the State; thence along the south and along the Henderson County line to the Muskegon State Game Area, in sections east boundaries of the State to the south Indiana State line. 5, 6, 7, 8, 17, 18, 19, 20, 29, 30, and 32, boundary of the Twin Cities Metro Ballard Reporting Area: That area T10N R14W, and sections 1, 2, 10, 11, Canada Goose Zone; thence along said encompassed by a line beginning at the 12, 13, 14, 24, and 25, T10N R15W, as boundary to the point of beginning. northwest city limits of Wickliffe in posted. Missouri Ballard County and extending westward Same zones as for ducks but in Special Canada Goose Seasons to the middle of the Mississippi River, addition: north along the Mississippi River and Southern Michigan Late Season Middle Zone along the low-water mark of the Ohio Canada Goose Zone: Same as the South River on the Illinois shore to the Duck Zone excluding Tuscola/Huron Southeast Zone: That portion of the Ballard-McCracken County line, south Goose Management Unit (GMU), State encompassed by a line beginning along the county line to Kentucky Allegan County GMU, Saginaw County at the intersection of Missouri Highway Highway 358, south along Kentucky 358 GMU, and Muskegon Wastewater GMU. (MO) 34 and Interstate 55 and extending to U.S. Highway 60 at LaCenter, then Minnesota south along I–55 to U.S. Highway 62, southwest along U.S. 60 to the northeast West Zone: That portion of the State west along U.S. 62 to MO 53, north city limits of Wickliffe. encompassed by a line beginning at the along MO 53 to MO 51, north along MO Henderson-Union Reporting Area: junction of State Trunk Highway (STH) 51 to U.S. 60, west along U.S. 60 to MO Henderson County and that portion of 60 and the Iowa State line, then north 21, north along MO 21 to MO 72, east Union County within the Western Zone. and east along STH 60 to U.S. Highway along MO 72 to MO 34, then east along Pennyroyal/Coalfield Zone: Butler, 71, north along U.S. 71 to Interstate MO 34 to I–55. Daviess, Ohio, Simpson, and Warren Highway 94, then north and west along Ohio Counties and all counties lying west to I–94 to the North Dakota State line. Same zones as for ducks but in the boundary of the Western Goose West Central Zone: That area addition: encompassed by a line beginning at the Zone. North Zone Michigan intersection of State Trunk Highway (a) North Zone – Same as North duck (STH) 29 and U.S. Highway 212 and Lake Erie Zone: That portion of the zone. extending west along U.S. 212 to U.S. North Duck Zone encompassed by and (b) Middle Zone – Same as Middle 59, south along U.S. 59 to STH 67, west north and east of a line beginning in duck zone. along STH 67 to U.S. 75, north along Lucas County at the Michigan State line (c) South Zone – Same as South duck U.S. 75 to County State Aid Highway on I–75, and extending south along I–75 zone. (CSAH) 30 in Lac qui Parle County, west to I–280, south along I–280 to I–80, and Tuscola/Huron Goose Management along CSAH 30 to the western boundary east along I– 80 to the Pennsylvania Unit (GMU): Those portions of Tuscola of the State, north along the western State line in Trumbull County. and Huron Counties bounded on the boundary of the State to a point due Tennessee south by Michigan Highway 138 and south of the intersection of STH 7 and Southwest Zone: That portion of the Bay City Road, on the east by Colwood CSAH 7 in Big Stone County, and State south of State Highways 20 and and Bay Port Roads, on the north by continuing due north to said 104, and west of U.S. Highways 45 and Kilmanagh Road and a line extending intersection, then north along CSAH 7 45W. directly west off the end of Kilmanagh to CSAH 6 in Big Stone County, east Northwest Zone: Lake, Obion, and Road into Saginaw Bay to the west along CSAH 6 to CSAH 21 in Big Stone Weakley Counties and those portions of boundary, and on the west by the County, south along CSAH 21 to CSAH Gibson and Dyer Counties not included Tuscola-Bay County line and a line 10 in Big Stone County, east along in the Southwest Tennessee Zone. extending directly north off the end of CSAH 10 to CSAH 22 in Swift County, Kentucky/Barkley Lakes Zone: That the Tuscola-Bay County line into east along CSAH 22 to CSAH 5 in Swift portion of the State bounded on the Saginaw Bay to the north boundary. County, south along CSAH 5 to U.S. 12, west by the eastern boundaries of the Allegan County GMU: That area east along U.S. 12 to CSAH 17 in Swift Northwest and Southwest Zones and on encompassed by a line beginning at the County, south along CSAH 17 to CSAH the east by State Highway 13 from the junction of 136th Avenue and Interstate 9 in Chippewa County, south along Alabama State line to Clarksville and Highway 196 in Lake Town Township CSAH 9 to STH 40, east along STH 40 U.S. Highway 79 from Clarksville to the and extending easterly along 136th to STH 29, then south along STH 29 to Kentucky State line. Avenue to Michigan Highway 40, the point of beginning. Wisconsin southerly along Michigan 40 through Same zones as for ducks but in Special Canada Goose Seasons the city of Allegan to 108th Avenue in addition: Trowbridge Township, westerly along Southeast Zone: That part of the State Horicon Zone: That area encompassed 108th Avenue to 46th Street, northerly within the following described by a line beginning at the intersection of along 46th Street to 109th Avenue, boundaries: beginning at the State Highway 21 and the Fox River in westerly along 109th Avenue to I–196 in intersection of U.S. Highway 52 and the Winnebago County and extending Casco Township, then northerly along south boundary of the Twin Cities westerly along State 21 to the west I–196 to the point of beginning. Metro Canada Goose Zone; thence along boundary of Winnebago County, Saginaw County GMU: That portion the U.S. Highway 52 to State Trunk southerly along the west boundary of of Saginaw County bounded by Highway (STH) 57; thence along STH 57 Winnebago County to the north Michigan Highway 46 on the north; to the municipal boundary of Kasson; boundary of Green Lake County, Michigan 52 on the west; Michigan 57 thence along the municipal boundary of westerly along the north boundaries of on the south; and Michigan 13 on the Kasson County State Aid Highway Green Lake and Marquette Counties to east. (CSAH) 13, Dodge County; thence along State 22, southerly along State 22 to Muskegon Wastewater GMU: That CSAH 13 to STH 30; thence along STH State 33, westerly along State 33 to portion of Muskegon County within the 30 to U.S. Highway 63; thence along Interstate Highway 39, southerly along

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Interstate Highway 39 to Interstate Central Flyway 2, west along NE 2 to the corner formed Highway 90/94, southerly along I–90/94 Colorado (Central Flyway Portion) by Garden—Grant—Sheridan Counties, to State 60, easterly along State 60 to Northern Front Range Area: All areas west along the north border of Garden, State 83, northerly along State 83 to in Boulder, Larimer and Weld Counties Morrill, and Scotts Bluff Counties to the State 175, northerly along State 175 to from the Continental Divide east along intersection of the Interstate Canal, west State 33, easterly along State 33 to U.S. the Wyoming border to U.S. 85, south to Wyoming State line. Highway 45, northerly along U.S. 45 to on U.S. 85 to the Adams County line, North–Central Unit: The remainder of the east shore of the Fond Du Lac River, and all lands in Adams, Arapahoe, the State. northerly along the east shore of the Broomfield, Clear Creek, Denver, Light Geese Fond Du Lac River to Lake Winnebago, Douglas, Gilpin, and Jefferson Counties. northerly along the western shoreline of Rainwater Basin Light Goose Area North Park Area: Jackson County. Lake Winnebago to the Fox River, then (West): The area bounded by the South Park and San Luis Valley Area: westerly along the Fox River to State 21. junction of U.S. 283 and U.S. 30 at All of Alamosa, Chaffee, Conejos, Collins Zone: That area encompassed Lexington, east on U.S. 30 to U.S. 281, Costilla, Custer, Fremont, Lake, Park, by a line beginning at the intersection of south on U.S. 281 to NE 4, west on NE Rio Grande and Teller Counties, and Hilltop Road and Collins Marsh Road in 4 to U.S. 34, continue west on U.S. 34 those portions of Saguache, Mineral and Manitowoc County and extending to U.S. 283, then north on U.S. 283 to Hinsdale Counties east of the westerly along Hilltop Road to Humpty the beginning. Dumpty Road, southerly along Humpty Continental Divide. Rainwater Basin Light Goose Area Dumpty Road to Poplar Grove Road, Remainder: Remainder of the Central (East): The area bounded by the junction easterly along Poplar Grove Road to Flyway portion of Colorado. of U.S. 281 and U.S. 30 at Grand Island, Rockea Road, southerly along Rockea Eastern Colorado Late Light Goose north and east on U.S. 30 to NE 14, Road to County Highway JJ, Area: That portion of the State east of south to NE 66, east to US 81, north to southeasterly along County JJ to Collins Interstate Highway 25. NE 92, east on NE 92 to NE 15, south Road, southerly along Collins Road to Nebraska on NE 15 to NE 4, west on NE 4 to U.S. the Manitowoc River, southeasterly Dark Geese 281, north on U.S. 281 to the beginning. along the Manitowoc River to Quarry Remainder of State: The remainder Niobrara Unit: That area contained Road, northerly along Quarry Road to portion of Nebraska. within and bounded by the intersection Einberger Road, northerly along New Mexico (Central Flyway Portion) Einberger Road to Moschel Road, of the South Dakota State line and the westerly along Moschel Road to Collins Cherry County line, south along the Dark Geese Marsh Road, northerly along Collins Cherry County line to the Niobrara Middle Rio Grande Valley Unit: Marsh Road to Hilltop Road. River, east to the Norden Road, south on Sierra, Socorro, and Valencia Counties. Exterior Zone: That portion of the the Norden Road to U.S. Hwy 20, east Remainder: The remainder of the State not included in the Horicon or along U.S. Hwy 20 to NE Hwy 137, Central Flyway portion of New Mexico. Collins Zones. north along NE Hwy 137 to the Niobrara North Dakota Mississippi River Subzone: That area River, east along the Niobrara River to Missouri River Canada Goose Zone: encompassed by a line beginning at the the Boyd County line, north along the The area within and bounded by a line intersection of the Burlington Northern Boyd County line to the South Dakota starting where ND Hwy 6 crosses the & Santa Fe Railway and the Illinois State line. Where the Niobrara River South Dakota border; thence north on State line in Grant County and forms the boundary, both banks of the ND Hwy 6 to I-94; thence west on I-94 extending northerly along the river are included in the Niobrara Unit. to ND Hwy 49; thence north on ND Hwy Burlington Northern & Santa Fe Railway East Unit: That area north and east of 49 to ND Hwy 200; thence north on to the city limit of Prescott in Pierce U.S. 281 at the Kansas–Nebraska State Mercer County Rd. 21 to the section line County, then west along the Prescott line, north to Giltner Road (near between sections 8 and 9 (T146N- city limit to the Minnesota State line. Doniphan), east to NE 14, north to NE R87W); thence north on that section line Rock Prairie Subzone: That area 66, east to U.S. 81, north to NE 22, west to the southern shoreline to Lake encompassed by a line beginning at the to NE 14 north to NE 91, east to U.S. Sakakawea; thence east along the intersection of the Illinois State line and 275, south to U.S. 77, south to NE 91, southern shoreline (including Mallard Interstate Highway 90 and extending east to U.S. 30, east to Nebraska–Iowa Island) of Lake Sakakawea to US Hwy north along I–90 to County Highway A, State line. 83; thence south on US Hwy 83 to ND east along County A to U.S. Highway 12, Platte River Unit: That area south and Hwy 200; thence east on ND Hwy 200 southeast along U.S. 12 to State west of U.S. 281 at the Kansas— to ND Hwy 41; thence south on ND Hwy Highway 50, west along State 50 to State Nebraska State line, north to Giltner 41 to US Hwy 83; thence south on US 120, then south along 120 to the Illinois Road (near Doniphan), east to NE 14, Hwy 83 to I-94; thence east on I-94 to State line. north to NE 66, east to U.S. 81, north to US Hwy 83; thence south on US Hwy Brown County Subzone: That area NE 22, west to NE 14 north to NE 91, 83 to the South Dakota border; thence encompassed by a line beginning at the west along NE 91 to NE 11, north to the west along the South Dakota border to intersection of the Fox River with Green Holt County line, west along the ND Hwy 6. Bay in Brown County and extending northern border of Garfield, Loup, Rest of State: Remainder of North southerly along the Fox River to State Blaine and Thomas Counties to the Dakota. Highway 29, northwesterly along State Hooker County line, south along the South Dakota 29 to the Brown County line, south, Thomas-Hooker County lines to the east, and north along the Brown County McPherson County line, east along the Canada Geese line to Green Bay, due west to the south border of Thomas County to the Unit 1: Remainder of South Dakota. midpoint of the Green Bay Ship western line of Custer County, south Unit 2: Bon Homme, Brule, Buffalo, Channel, then southwesterly along the along the Custer—Logan County line to Charles Mix, Custer east of SD Hwy 79 Green Bay Ship Channel to the Fox NE 92, west to U.S. 83, north to NE 92, and south of French Creek, Dewey south River. west to NE 61, north along NE 61 to NE of US Hwy 212, Fall River east of SD

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Hwy 71 and US Hwy 385, Gregory, North Zone: Game Management Units east along the Santa Maria River to CA Hughes, Hyde south of US Hwy 14, 1-5, those portions of Game 166 near the City of Santa Maria; east on Lyman, Perkins, Potter west of US Hwy Management Units 6 and 8 within CA 166 to CA 99; south on CA 99 to the 83, Stanley, and Sully Counties. Coconino County, and Game crest of the Tehachapi Mountains at Unit 3: Bennett County. Management Units 7, 9, and 12A. Tejon Pass; east and north along the Texas South Zone: Those portions of Game crest of the Tehachapi Mountains to CA Northeast Goose Zone: That portion of Management Units 6 and 8 in Yavapai 178 at Walker Pass; east on CA 178 to Texas lying east and north of a line County, and Game Management Units U.S. 395 at the town of Inyokern; south beginning at the Texas–Oklahoma 10 and 12B-45. on U.S. 395 to CA 58; east on CA 58 to border at U.S. 81, then continuing south California I-15; east on I-15 to CA 127; north on CA to Bowie and then southeasterly along Northeastern Zone: In that portion of 127 to the Nevada border. U.S. 81 and U.S. 287 to I–35W and I– California lying east and north of a line Imperial County Special Management beginning at the intersection of 35 to the juncture with I–10 in San Area: The area bounded by a line Interstate 5 with the California-Oregon Antonio, then east on I–10 to the Texas– beginning at Highway 86 and the Navy line; south along Interstate 5 to its Louisiana border. Test Base Road; south on Highway 86 to junction with Walters Lane south of the Southeast Goose Zone: That portion of the town of Westmoreland; continue town of Yreka; west along Walters Lane Texas lying east and south of a line through the town of Westmoreland to to its junction with Easy Street; south Route S26; east on Route S26 to beginning at the International Toll along Easy Street to the junction with Bridge at Laredo, then continuing north Highway 115; north on Highway 115 to Old Highway 99; south along Old Weist Rd.; north on Weist Rd. to following I–35 to the juncture with I–10 Highway 99 to the point of intersection in San Antonio, then easterly along I– Flowing Wells Rd.; northeast on with Interstate 5 north of the town of Flowing Wells Rd. to the Coachella 10 to the Texas–Louisiana border. Weed; south along Interstate 5 to its West Goose Zone: The remainder of Canal; northwest on the Coachella Canal junction with Highway 89; east and to Drop 18; a straight line from Drop 18 the State. south along Highway 89 to main street Wyoming (Central Flyway Portion) to Frink Rd.; south on Frink Rd. to Greenville; north and east to its junction Highway 111; north on Highway 111 to Dark Geese with North Valley Road; south to its Niland Marina Rd.; southwest on Niland junction of Diamond Mountain Road; Area 1: Converse, Hot Springs, Marina Rd. to the old Imperial County north and east to its junction with North boat ramp and the water line of the Natrona, and Washakie Counties, and Arm Road; south and west to the the portion of Park County east of the Salton Sea; from the water line of the junction of North Valley Road; south to Salton Sea, a straight line across the Shoshone National Forest boundary and the junction with Arlington Road (A22); south of a line beginning where the Salton Sea to the Salinity Control west to the junction of Highway 89; Research Facility and the Navy Test Shoshone National Forest boundary south and west to the junction of Base Road; southwest on the Navy Test crosses Park County Road 8VC, easterly Highway 70; east on Highway 70 to Base Road to the point of beginning. along said road to Park County Road Highway 395; south and east on 1AB, easterly along said road to Balance-of-the-State Zone: The Highway 395 to the point of intersection remainder of California not included in Wyoming Highway 120, northerly along with the California-Nevada State line; said highway to Wyoming Highway 294, the Northeastern, Southern, and the north along the California-Nevada State Colorado River Zones. southeasterly along said highway to line to the junction of the California- Lane 9, easterly along said lane to the North Coast Special Management Nevada-Oregon State lines west along Area: The Counties of Del Norte and town of Powel and Wyoming Highway the California-Oregon State line to the 14A, easterly along said highway to the Humboldt. point of origin. Sacramento Valley Special Park County and Big Horn County Line. Colorado River Zone: Those portions Management Area: That area bounded Area 2: Albany, Campbell, Crook, of San Bernardino, Riverside, and by a line beginning at Willows south on Johnson, Laramie, Niobrara, Sheridan, Imperial Counties east of a line I-5 to Hahn Road; easterly on Hahn and Weston Counties, and that portion extending from the Nevada border south Road and the Grimes-Arbuckle Road to of Carbon County east of the Continental along U.S. 95 to Vidal Junction; south Grimes; northerly on CA 45 to the Divide; that portion of Park County west on a road known as ‘‘Aqueduct Road’’ junction with CA 162; northerly on CA of the Shoshone National Forest in San Bernardino County through the 45/162 to Glenn; and westerly on CA boundary, and that portion of Park town of Rice to the San Bernardino- 162 to the point of beginning in County north of a line beginning where Riverside County line; south on a road Willows. the Shoshone National Forest boundary known in Riverside County as the Colorado (Pacific Flyway Portion) crosses Park County Road 8VC, easterly ‘‘Desert Center to Rice Road’’ to the West Central Area: Archuleta, Delta, along said road to Park County Road town of Desert Center; east 31 miles on Dolores, Gunnison, LaPlata, 1AB, easterly along said road to I-10 to the Wiley Well Road; south on Montezuma, Montrose, Ouray, San Juan, Wyoming Highway 120, northerly along this road to Wiley Well; southeast along and San Miguel Counties and those said highway to Wyoming Highway 294, the Army-Milpitas Road to the Blythe, portions of Hinsdale, Mineral, and southeasterly along said highway to Brawley, Davis Lake intersections; south Saguache Counties west of the Lane 9, easterly along said lane to the on the Blythe-Brawley paved road to the Continental Divide. town of Powel and Wyoming Highway Ogilby and Tumco Mine Road; south on State Area: The remainder of the 14A, easterly along said highway to the this road to U.S. 80; east 7 miles on U.S. Pacific-Flyway Portion of Colorado. Park County and Big Horn County Line. 80 to the Andrade-Algodones Road; Idaho Area 3: Goshen and Platte Counties. south on this paved road to the Mexican Zone 1: Adams, Benewah, Bonner, Area 4: Big Horn and Fremont border at Algodones, Mexico. Boundary, Clearwater, Idaho, Kootenai, Counties. Southern Zone: That portion of Latah, Lewis, Nez Perce, Shoshone, and southern California (but excluding the Valley Counties. Pacific Flyway Colorado River Zone) south and east of Zone 2: The Counties of Ada; Boise; Arizona a line extending from the Pacific Ocean Canyon; those portions of Elmore north

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and east of I-84, and south and west of intersection of the Benton and Lincoln northeast along the boundary to the I-84, west of ID 51, except the Camas County line; then north along the Perry access road; east on the Perry Creek drainage; Gem; Owyhee west of western boundary of Benton and Polk access road to I-15; south on I-15 to the ID 51; Payette; and Washington. Counties to the southern boundary of Weber-Box Elder County line. Zone 3: The Counties of Cassia except Tillamook County; then west along the Remainder-of-the-State Zone: The the Minidoka National Wildlife Refuge; Tillamook County boundary to the remainder of Utah. those portions of Elmore south of I-84 Pacific Coast. Washington east of ID 51, and within the Camas Lower Columbia/N. Willamette Valley Area 1: Skagit, Island, and Snohomish Creek drainage; Gooding; Jerome; Management Area: Those portions of Counties. Lincoln; Minidoka; Owyhee east of ID Clatsop, Columbia, Multnomah, and Area 2A (SW Quota Zone): Clark 51; and Twin Falls. Washington Counties within the County, except portions south of the Zone 4: The Counties of Bear Lake; Northwest Special Permit Zone. Washougal River; Cowlitz County; and Bingham within the Blackfoot Reservoir Tillamook County Management Area: Wahkiakum County. drainage; Blaine; Bonneville, Butte; All of Tillamook County is open to Area 2B (SW Quota Zone): Pacific Camas; Caribou except the Fort Hall goose hunting except for the following County. Indian Reservation; Cassia within the area—beginning in Cloverdale at Hwy Area 3: All areas west of the Pacific Minidoka National Wildlife Refuge; 101, west on Old Woods Rd to Sand Crest Trail and west of the Big White Clark; Custer; Franklin; Fremont; Lake Rd at Woods, north on Sand Lake Salmon River that are not included in Jefferson; Lemhi; Madison; Oneida; and Rd to the intersection with McPhillips Areas 1, 2A, and 2B. Teton. Dr, due west (~200 yards) from the Area 4: Adams, Benton, Chelan, Zone 5: All lands and waters within intersection to the Pacific coastline, Douglas, Franklin, Grant, Kittitas, the Fort Hall Indian Reservation, south on the Pacific coastline to Lincoln, Okanogan, Spokane, and Walla including private inholdings; Bannock Neskowin Creek, east along the north Walla Counties. County; Bingham County, except that shores of Neskowin Creeks and then Area 5: All areas east of the Pacific portion within the Blackfoot Reservoir Hawk Creeks to Salem Ave, east on Crest Trail and east of the Big White drainage; and Power County. Salem Ave in Neskowin to Hawk Ave, Salmon River that are not included in Montana (Pacific Flyway Portion) east on Hawk Ave to Hwy 101, north on Area 4. East of the Divide Zone: The Pacific Hwy 101 at Cloverdale, to the point of Flyway portion of the State located east beginning. Brant of the Continental Divide. Northwest Zone: Those portions of Pacific Flyway Clackamas, Lane, Linn, Marion, West of the Divide Zone: The California Multnomah, and Washington Counties remainder of the Pacific Flyway portion North Coast Zone: Del Norte, outside of the Northwest Special Permit of Montana. Humboldt and Mendocino Counties. Zone and all of Lincoln County. Nevada South Coast Zone: Balance of the Lincoln Clark County Zone: All of Eastern Zone: Hood River, Wasco, State. Lincoln and Clark Counties. Sherman, Gilliam, Morrow, Umatilla, Washington Remainder-of-the-State Zone: The Deschutes, Jefferson, Crook, Wheeler, Puget Sound Zone: Skagit County. remainder of Nevada. Grant, Baker, Union, and Wallowa Coastal Zone: Pacific County. New Mexico (Pacific Flyway Portion) Counties. North Zone: The Pacific Flyway Harney, Lake, and Malheur County Swans portion of New Mexico located north of Zone: All of Harney, Lake, and Malheur Central Flyway I-40. Counties. South Zone: The Pacific Flyway Klamath County Zone: All of Klamath South Dakota: Aurora, Beadle, portion of New Mexico located south of County. Brookings, Brown, Brule, Buffalo, I-40. Utah Campbell, Clark, Codington, Davison, Oregon Northern Utah Zone: All of Cache and Deuel, Day, Edmunds, Faulk, Grant, Southwest Zone: Those portions of Rich Counties, and that portion of Box Hamlin, Hand, Hanson, Hughes, Hyde, Douglas, Coos, and Curry Counties east Elder County beginning at I-15 and the Jerauld, Kingsbury, Lake, Marshall, of Highway 101, and Josephine and Weber-Box Elder County line; east and McCook, McPherson, Miner, Jackson Counties. north along this line to the Weber-Cache Minnehaha, Moody, Potter, Roberts, South Coast Zone: Those portions of County line; east along this line to the Sanborn, Spink, Sully, and Walworth Douglas, Coos, and Curry Counties west Cache-Rich County line; east and south Counties. of Highway 101. along the Rich County line to the Utah- Northwest Special Permit Zone: That Wyoming State line; north along this Pacific Flyway portion of western Oregon west and line to the Utah-Idaho State line; west Montana (Pacific Flyway Portion) north of a line running south from the on this line to Stone, Idaho-Snowville, Open Area: Cascade, Chouteau, Hill, Columbia River in Portland along I-5 to Utah road; southwest on this road to Liberty, and Toole Counties and those OR 22 at Salem; then east on OR 22 to Locomotive Springs Wildlife portions of Pondera and Teton Counties the Stayton Cutoff; then south on the Management Area; east on the county lying east of U.S. 287–89. Stayton Cutoff to Stayton and due south road, past Monument Point and across Nevada to the Santiam River; then west along Salt Wells Flat, to the intersection with Open Area: Churchill, Lyon, and the north shore of the Santiam River to Promontory Road; south on Promontory Pershing Counties. I-5; then south on I-5 to OR 126 at Road to a point directly west of the Utah Eugene; then west on OR 126 to northwest corner of the Bear River Open Area: Those portions of Box Greenhill Road; then south on Greenhill Migratory Bird Refuge boundary; east Elder, Weber, Davis, Salt Lake, and Road to Crow Road; then west on Crow along an imaginary line to the northwest Toole Counties lying west of I–15, north Road to Territorial Hwy; then west on corner of the Refuge boundary; south of I–80, and south of a line beginning Territorial Hwy to OR 126; then west on and east along the Refuge boundary to from the Forest Street exit to the Bear OR 126 to Milepost 19; then north to the the southeast corner of the boundary; River National Wildlife Refuge

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boundary; then north and west along the Promontory Road to the intersection of Nevada–Utah State line; then south on Bear River National Wildlife Refuge SR 83; then north on SR 83 to I–84; then the Nevada–Utah State line to I–80. boundary to the farthest west boundary north and west on I–84 to State Hwy 30; [FR Doc. E9–19432 Filed 8–12–09; 8:45 am] of the Refuge; then west along a line to then west on State Hwy 30 to the BILLING CODE 4310–55–S Promontory Road; then north on

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Reader Aids Federal Register Vol. 74, No. 155 Thursday, August 13, 2009

CUSTOMER SERVICE AND INFORMATION CFR PARTS AFFECTED DURING AUGUST

Federal Register/Code of Federal Regulations At the end of each month, the Office of the Federal Register General Information, indexes and other finding 202–741–6000 publishes separately a List of CFR Sections Affected (LSA), which aids lists parts and sections affected by documents published since Laws 741–6000 the revision date of each title. 1229...... 38508 Presidential Documents 3 CFR 1282...... 39873 Executive orders and proclamations 741–6000 Administrative Orders: 1291...... 38514 The United States Government Manual 741–6000 Memorandums: Proposed Rules: Memorandum of July Other Services 914...... 38559 30, 2009 ...... 38885 985...... 38564 Electronic and on-line services (voice) 741–6020 Memorandum of 989...... 38564 Privacy Act Compilation 741–6064 August 5, 2009...... 39871 1235...... 38559 Public Laws Update Service (numbers, dates, etc.) 741–6043 Memorandum of 1273...... 38564 TTY for the deaf-and-hard-of-hearing 741–6086 August 6, 2009...... 40055 1274...... 38564 1282...... 38572 4 CFR ELECTRONIC RESEARCH 1732...... 38559 202...... 38503 World Wide Web Proposed Rules: 14 CFR Full text of the daily Federal Register, CFR and other publications 200...... 38363 25 ...... 38328, 40479, 40482 is located at: http://www.gpoaccess.gov/nara/index.html 201...... 38366 39 ...... 38340, 38894, 38896, Federal Register information and research tools, including Public 38899, 38901, 38903, 38905, 5 CFR Inspection List, indexes, and links to GPO Access are located at: 38910, 38912, 40061, 40484 http://www.archives.gov/federallregister 300...... 40057 71 ...... 40065, 40066, 40067 315...... 40471 E-mail 95...... 40488 316...... 40471 97...... 40719, 40721 FEDREGTOC-L (Federal Register Table of Contents LISTSERV) is 135...... 38522 6 CFR an open e-mail service that provides subscribers with a digital Proposed Rules: form of the Federal Register Table of Contents. The digital form 5...... 38887 21...... 39242 of the Federal Register Table of Contents includes HTML and 39 ...... 38381, 38988, 38991, PDF links to the full text of each document. 7 CFR 38993, 38995, 38999, 39243, To join or leave, go to http://listserv.access.gpo.gov and select 210...... 38889 39582, 40525, 40527, 40529, Online mailing list archives, FEDREGTOC-L, Join or leave the list 925...... 38323 40776, 40778, 40781 (or change settings); then follow the instructions. 932...... 38324 71 ...... 39001, 39002, 39908, 944...... 38323 40534, 40535 PENS (Public Law Electronic Notification Service) is an e-mail 948...... 38504 service that notifies subscribers of recently enacted laws. 959...... 38505 15 CFR To subscribe, go to http://listserv.gsa.gov/archives/publaws-l.html 1205...... 39211 30...... 38914 and select Join or leave the list (or change settings); then follow Proposed Rules: Proposed Rules: the instructions. 761...... 39565 742...... 40117 FEDREGTOC-L and PENS are mailing lists only. We cannot 766...... 39565 774...... 40117 respond to specific inquiries. 983...... 39230 1493...... 39240 16 CFR Reference questions. Send questions and comments about the Federal Register system to: [email protected] 317...... 40686 9 CFR 1500...... 39535 The Federal Register staff cannot interpret specific documents or 145...... 38326 Proposed Rules: regulations. 425...... 40121 Reminders. Effective January 1, 2009, the Reminders, including 10 CFR 1112...... 40784 Rules Going Into Effect and Comments Due Next Week, no longer 26...... 38326 appear in the Reader Aids section of the Federal Register. This 50...... 38890 17 CFR information can be found online at http://www.regulations.gov. 72...... 40060 7...... 39211 CFR Checklist. Effective January 1, 2009, the CFR Checklist no Proposed Rules: 200...... 40068 longer appears in the Federal Register. This information can be 31...... 38372 232...... 38523 found online at http://bookstore.gpo.gov/. 50 ...... 38987, 40006, 40765 248...... 40398 52...... 40006 Proposed Rules: 609...... 39569 190...... 40794 FEDERAL REGISTER PAGES AND DATE, AUGUST 275...... 39840 11 CFR 38323–38502...... 3 20 CFR 38503–38884...... 4 111...... 39535 38885–39210...... 5 Proposed Rules: 12 CFR 618...... 39198 39211–39534...... 6 226...... 40477 39535–39870...... 7 308...... 40478 21 CFR 39871–40056...... 10 363...... 40478 2...... 40069 40057–40470...... 11 619...... 40060 312...... 40872, 40900 40471–40718...... 12 620...... 40060 316...... 40900 40719–41032...... 13 621...... 40060 510...... 38341

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524...... 38341 602...... 39498 271...... 40539 7...... 40459 558...... 40723 300...... 40123 15...... 40463 872...... 38686 36 CFR 22...... 40460, 40461 223...... 40736 42 CFR 25...... 40461, 40463 22 CFR 405...... 39384 28...... 40466 37 CFR 123...... 38342, 39212 412...... 39762 30...... 40467 124...... 38342 201...... 39900 418...... 39384 32...... 40468 126...... 38342 351...... 38532 483...... 40288 52 ...... 40460, 40461, 40463, 129...... 38342 Proposed Rules: 40466, 40467, 40468 38 CFR 409...... 39436, 40948 502...... 39563 26 CFR Proposed Rules: 410...... 39032 Proposed Rules: 1...... 38830 1...... 39589 411...... 39032 2...... 39262, 40131 31...... 38830 4...... 39591 414...... 39032 4...... 39262, 40131 415...... 39032 602...... 38830 39 CFR 12...... 40131 Proposed Rules: 424...... 39436, 40948 15...... 39262 301...... 39003 3020 ...... 38921, 40708, 40714 484...... 39436, 40948 25...... 39597 Proposed Rules: 485...... 39032 39...... 40131 29 CFR 111...... 38383 489...... 39436, 40948 42...... 39262 1910...... 40442 3020...... 38533 45...... 39262 3050...... 39909 44 CFR Proposed Rules: 52...... 39262, 40131 64...... 38358 471...... 38488 40 CFR 1910...... 40450 Proposed Rules: 50...... 40074 67...... 38386 49 CFR 30 CFR 51...... 40074 206...... 40124 89...... 40521 52 ...... 38536, 40083, 40745, 571...... 40760 250...... 40069 40747, 40750 46 CFR 251...... 40726 599...... 38974 55...... 40498 10...... 39218 Proposed Rules: 62...... 38344, 38346 11...... 39218 926...... 40537, 40799 141...... 38348 50 CFR 174...... 39540 47 CFR 17...... 40132 33 CFR 180 ...... 38924, 38935, 38945, 1...... 39219, 40089 20...... 40138 100 ...... 38524, 39213, 40731 38952, 38956, 38962, 38970, 63...... 39551 226...... 39903 147...... 38524 39543, 39545, 40503, 40509, 73...... 39228 300...... 38544 165 ...... 38524, 38530, 38916, 40513, 40753 Proposed Rules: 648...... 39229 38918, 39216, 40734 271...... 40518 2...... 39249 679 ...... 38558, 38985, 40523 Proposed Rules: 300...... 40085 73 ...... 38388, 38389, 39529, Proposed Rules: 117...... 40802 Proposed Rules: 39260, 39261, 40806 17 ...... 39268, 40540, 40650 165...... 39247, 39584 52 ...... 39007, 39592, 40122, 95...... 39249 20...... 39598, 41008 40123, 40804, 40805 229...... 39910, 39914 34 CFR 62...... 38384, 38385 48 CFR 218...... 40560 371...... 40495 63...... 39013 Ch. 1...... 40458, 40468 300...... 39032, 39269 Proposed Rules: 96...... 39592 4...... 40463 600...... 39914 600...... 39498 211...... 39150 5...... 40459 635...... 39032, 39914

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Superintendent of Documents, patent operations in order to U.S. Government Printing avoid furloughs and LIST OF PUBLIC LAWS Office, Washington, DC 20402 reductions-in-force, and for Public Laws Electronic (phone, 202–512–1808). The other purposes. (Aug. 7, 2009; Notification Service This is a continuing list of text will also be made 123 Stat. 1968) (PENS) public bills from the current available on the Internet from session of Congress which GPO Access at http:// H.R. 3357/P.L. 111–46 have become Federal laws. It www.gpoaccess.gov/plaws/ To restore sums to the PENS is a free electronic mail may be used in conjunction index.html. Some laws may Highway Trust Fund and for notification service of newly with ‘‘P L U S’’ (Public Laws not yet be available. other purposes. (Aug. 7, 2009; enacted public laws. To Update Service) on 202–741– subscribe, go to http:// H.R. 2245/P.L. 111–44 123 Stat. 1970) 6043. This list is also listserv.gsa.gov/archives/ available online at http:// New Frontier Congressional H.R. 3435/P.L. 111–47 publaws-l.html Gold Medal Act (Aug. 7, 2009; www.archives.gov/federal- Making supplemental 123 Stat. 1966) Note: This service is strictly register/laws.html. appropriations for fiscal year H.R. 3114/P.L. 111–45 for E-mail notification of new 2009 for the Consumer The text of laws is not To authorize the Director of laws. The text of laws is not Assistance to Recycle and published in the Federal the United States Patent and available through this service. Save Program. (Aug. 7, 2009; Register but may be ordered Trademark Office to use funds PENS cannot respond to 123 Stat. 1972) in ‘‘slip law’’ (individual made available under the specific inquiries sent to this pamphlet) form from the Trademark Act of 1946 for Last List August 4, 2009 address.t to this address.

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