4–15–10 Thursday Vol. 75 No. 72 Apr. 15, 2010

Pages 19533–19872

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Contents Federal Register Vol. 75, No. 72

Thursday, April 15, 2010

Agriculture Department Executive Office of the President See Forest Service See Management and Budget Office See Presidential Documents Arts and Humanities, National Foundation See Trade Representative, Office of United States See National Foundation on the Arts and the Humanities Federal Aviation Administration Centers for Medicare & Medicaid Services RULES RULES Standard Instrument Approach Procedures, and Takeoff Medicare Program: Minimums and Obstacle Departure Procedures; Policy and Technical Changes to the Medicare Advantage Miscellaneous Amendments, 19539–19542 and the Medicare Prescription Drug Benefit PROPOSED RULES Programs, 19678–19826 Airworthiness Directives: Boeing Co. Model 737–200, –200C, –300, –400, and –500 Coast Guard Series Airplanes, 19564–19567 RULES NOTICES Inland Navigation Rules, 19544–19555 Petition for Exemption; Summary of Petition Received, 19672–19673 Commerce Department See Foreign-Trade Zones Board See International Trade Administration Federal Communications Commission See National Oceanic and Atmospheric Administration RULES See Patent and Trademark Office Public Safety and Homeland Security Bureau Seeks Informal Comment: Commodity Trading Commission Revisions to the Federal Communication Commissions NOTICES Rules Governing the Emergency Alert System Request for Comment on Proposal to Exempt Trading and Pending Adoption of the Common Alerting Protocol Clearing of Certain Products: by the Federal Emergency Management Agency, ETFS Physical Swiss Gold Shares and ETFS Physical 19559–19561 Silver Shares, 19619–19622 Federal Election Commission Consumer Product Safety Commission NOTICES NOTICES Meetings; Sunshine Act, 19647 Meetings; Sunshine Act, 19622

Defense Department Federal Energy Regulatory Commission See Navy Department NOTICES NOTICES Agency Information Collection Activities; Proposals, Privacy Act; Systems of Records, 19622–19626 Submissions, and Approvals, 19630–19632 Applications: Department of Transportation San Diego County Water Authority, 19632–19633 See Pipeline and Hazardous Materials Safety Combined Filings, 19633–19641 Administration Environmental Assessments; Availability, etc.: Empire Pipeline, Inc., Tioga County Extension Project, Drug Enforcement Administration 19641–19643 NOTICES Filings: Agency Information Collection Activities; Proposals, Sagebrush, a California Partnership, 19643 Submissions, and Approvals: Initial Market-Based Rate Filings: National Clandestine Laboratory Seizure Report, 19658– Crestwood Energy LP, 19643 19659 West Oaks Energy LP, 19643–19644 West Oaks Energy NY/NE, LP, 19644 Energy Department Meetings: See Federal Energy Regulatory Commission Entergy Regional State Committee; FERC Staff NOTICES Attendance, 19644–19645 Charter Renewals: Petition for Rate Approval: Environmental Management Site-Specific Advisory Enterprise Texas Pipeline LLC, 19645 Board, 19630 Request for Approval of Plan for Conducting an Open Season: Environmental Protection Agency Denali – The Alaska Gas Pipeline LLC, 19645–19646 PROPOSED RULES Request Under Blanket Authorization: Prevention of Significant Deterioration and Nonattainment Cheniere Creole Trail Pipeline, L.P., 19646 New Source Review: Revocation of Market-Based Rate Tarriff: Aggregation; Reconsideration, 19567–19575 Electric Quarterly Reports et al., 19646–19647

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Federal Highway Administration Health Resources and Services Administration NOTICES NOTICES Environmental Impact Statements; Availability, etc.: Agency Information Collection Activities; Proposals, Record of Decision for the I–65 to US 31W Access Submissions, and Approvals, 19649–19651 Improvement, 19670 Meetings: Final Federal Agency Actions: National Advisory Council on Migrant Health, 19652 Proposed New Road Connecting I–65 and US 31W in Privacy Act; Systems of Records, 19652–19654 Kentucky, 19670–19671 Homeland Security Department Federal Motor Carrier Safety Administration See Coast Guard NOTICES See U.S. Customs and Border Protection Qualification of Drivers; Exemption Applications; Vision, 19674–19675 Interior Department Qualification of Drivers; Exemption Renewals; Vision, See Fish and Wildlife Service 19676 See Land Management Bureau RULES Federal Reserve System Acquisition Regulation Rewrite, 19828–19863 NOTICES Federal Open Market Committee; Domestic Policy Directive International Trade Administration (March 16, 2010), 19647 NOTICES Preliminary Results of the Antidumping Duty Federal Trade Commission Administrative Review: NOTICES First Administrative Review of Sodium Agency Information Collection Activities; Proposals, Hexametaphosphate from the People’s Republic of Submissions, and Approvals, 19647–19649 China, 19613–19618 Solid Urea From the Russian Federation, 19610–19613 Fish and Wildlife Service PROPOSED RULES International Trade Commission Endangered and Threatened Wildlife and Plants: NOTICES 12-Month Finding on a Petition to List the Wyoming Investigations: Pocket Gopher as Endangered or Threatened with Barium Chloride from China, 19657 Critical Habitat, 19592–19607 Preserved Mushrooms from Chile, China, India, and Initiation of Status Review of the North American Indonesia, 19658 Wolverine in the Contiguous United States, 19591– Meetings; Sunshine Act, 19658 19592 Revised Critical Habitat for Navarretia fossalis (Spreading Justice Department Navarretia), 19575–19590 See Drug Enforcement Administration NOTICES See Justice Programs Office Receipt of Applications for Permit, 19656–19657 Justice Programs Office Food and Drug Administration NOTICES NOTICES Agency Information Collection Activities; Proposals, Agency Information Collection Activities; Proposals, Submissions, and Approvals: Submissions, and Approvals: Federal Law Enforcement Officers Congressional Badge of Export of Medical Devices–Foreign Letters of Approval, Bravery, 19659 19651–19652 Labor Department Foreign-Trade Zones Board NOTICES NOTICES Request for Information: Grant of Authority For Subzone Status: Business Practices to Reduce Likelihood of Forced Labor CNH America, LLC (Agricultural Equipment and or Child Labor in Production of Goods, 19659–19661 Component Parts), Racine, WI, 19610 Land Management Bureau Forest Service NOTICES NOTICES Filing of Plats of Survey: Call for Nominations: Nevada, 19656 Recreation Resource Advisory Committees, 19608 Newspapers Used for Publication of Legal Notices: Management and Budget Office Southwestern Region, which includes Arizona, New NOTICES Mexico, and parts of Oklahoma and Texas, 19609– Determination of Benchmark Compensation Amount for 19610 Certain Executives, 19661

Health and Human Services Department Maritime Administration See Centers for Medicare & Medicaid Services NOTICES See Food and Drug Administration Applications: See Health Resources and Services Administration Marine Highway Projects, 19670

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National Aeronautics and Administration Pipeline and Hazardous Materials Safety Administration NOTICES NOTICES Meetings: Meetings: Aerospace Safety Advisory Panel, 19662 International Standards on the Transport of Dangerous NASA Advisory Council; Science Committee; Planetary Goods, 19671–19672 Protection Subcommittee, 19661–19662 Presidential Documents National Archives and Records Administration PROCLAMATIONS RULES Special Observances: NARA Facility Locations and , 19555–19558 Honoring the Victims of the Mine Disaster in Montcoal, NOTICES WV (Proc. 8497), 19865–19867 Meetings: ADMINISTRATIVE ORDERS Advisory Committee on Presidential Libraries, 19662– Enhanced Partnership with Pakistan Act of 2009; 19663 Delegation of Authority (Memorandum of April 7, Records Schedules: 2010), 19533 Availability and Request for Comments, 19663–19664 Palestine Liberation Organization; Waiver of Statutory Provisions (Presidential Determination) National Foundation on the Arts and the Humanities No. 2010–05 of April 7, 2010, 19537 NOTICES Palestinian Authority; Waiver of Restriction on Providing Meetings: Funds (Presidential Determination) Arts Advisory Panel, 19664–19665 No. 2010–06 of 4/7/2010, 19535

National Highway Traffic Safety Administration Securities and Exchange Commission NOTICES NOTICES Petitions for Exemption from the Vehicle Theft Prevention Self-Regulatory Organizations; Proposed Rule Changes: Standard: Depository Trust Co., 19667–19668 Saab, 19673–19674 Small Business Administration National Oceanic and Atmospheric Administration NOTICES RULES Action Subject to Intergovernmental Review Under Fisheries of Economic Exclusive Zone Off Alaska: Executive Order 12372, 19665–19666 Pacific Cod in Bering Sea and Aleutian Islands, 19561 Disaster Declarations: Fisheries of the Exclusive Economic Zone Off Alaska: Oklahoma, 19667 Pollock in Statistical Area 610 in the Gulf of Alaska, Rhode Island, 19666–19667 19562–19563 Reallocation of Pacific Cod in the Bering Sea and State Department Aleutian Islands Management Area, 19562 NOTICES Culturally Significant Objects Imported for Exhibition Navy Department Determinations: NOTICES From Xanadu to Dadu: The World of Khubilai Khan, Intents to Grant Exclusive Patent Licenses: 19668–19669 SciTech Medical Inc., 19626–19627 Meetings: Trade Representative, Office of United States Chief of Naval Operations (CNO) Executive Panel, 19627 NOTICES Privacy Act; Systems of Records, 19627–19630 Andean Trade Preference Act, as Amended: Request for Public Comments Regarding Beneficiary Nuclear Regulatory Commission Countries, 19669–19670 NOTICES Final Regulatory Guide; Issuance, Availability, 19665 Transportation Department See Federal Aviation Administration Office of Management and Budget See Federal Highway Administration See Management and Budget Office See Federal Motor Carrier Safety Administration See Maritime Administration Office of United States Trade Representative See National Highway Traffic Safety Administration See Trade Representative, Office of United States See Pipeline and Hazardous Materials Safety Administration Patent and Trademark Office RULES U.S. Customs and Border Protection Cancellation of Rule of Practice 41.200(b) before Board of NOTICES Patent Appeals and Interferences in Interference Agency Information Collection Activities; Proposals, Proceedings, 19558–19559 Submissions, and Approvals: Customs–Trade Partnership against Terrorism, 19654– Pension Benefit Guaranty Corporation 19655 RULES Meetings: Benefits Payable in Terminated Single-Employer Plans: Advisory Committee on Commercial Operations of Interest Assumptions for Valuing and Paying Benefits, Customs and Border Protection, 19655–19656 19542–19544

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Separate Parts In This Issue Reader Aids Consult the Reader Aids section at the end of this page for Part II phone numbers, online resources, finding aids, reminders, Health and Human Services Department, Centers for and notice of recently enacted public laws. Medicare & Medicaid Services, 19678–19826 To subscribe to the Federal Register Table of Contents Part III LISTSERV electronic mailing list, go to http:// Interior Department, 19828–19863 listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change Part IV settings); then follow the instructions. Presidential Documents, 19865–19867

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CFR PARTS AFFECTED IN THIS ISSUE

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

3 CFR Proclamations: 8497...... 19867 Executive Orders: 13536...... 19869 3 CFR Administrative Orders: Memorandums: Memorandum of April 7, 2010...... 19533 Presidential Determinations: No. 2010–05 of April 7, 2010 ...... 19537 No. 2010–06 of April 7, 2010 ...... 19535 14 CFR 97 (2 documents) ...... 19539, 19541 Proposed Rules: 39...... 19564 29 CFR 4022...... 19542 33 CFR 83...... 19544 36 CFR 1200...... 19555 1253...... 19555 1280...... 19555 37 CFR 41...... 19558 40 CFR Proposed Rules: 51...... 19567 52...... 19567 42 CFR 417...... 19678 422...... 19678 423...... 19678 480...... 19678 47 CFR 11...... 19559 48 CFR Ch. XIV ...... 19828 50 CFR 679 (3 documents) ...... 19561, 19562 Proposed Rules: 17 (3 documents) ...... 19575, 19591, 19592

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Federal Register Presidential Documents Vol. 75, No. 72

Thursday, April 15, 2010

Title 3— Memorandum of April 7, 2010

The President Delegation of a Reporting Authority

Memorandum for the Secretary of State

By the authority vested in me as President by the Constitution and the laws of the United States, including section 301 of title 3, United States Code, I hereby delegate to you the functions and authority conferred upon the President by section 301 of the Enhanced Partnership with Pakistan Act of 2009, Public Law 111–73, to make the specified report to the Congress. You are authorized and directed to notify the appropriate congressional committees and publish this memorandum in the Federal Register.

THE WHITE HOUSE, WASHINGTON, April 7, 2010

[FR Doc. 2010–8789 Filed 4–14–10; 8:45 am] Billing code 4710–10–P

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Presidential Determination No. 2010–06 of April 7, 2010

Waiver of Restriction on Providing Funds to the Palestinian Authority

Memorandum for the Secretary of State

By the authority vested in me as President by the Constitution and the laws of the United States of America, including section 7040(b) of the Department of State, Foreign Operations, and Related Programs Appropria- tions Act, 2010 (Division F, Public Law 111–117) (the ‘‘Act’’), I hereby certify that it is important to the national security interests of the United States to waive the provisions of section 7040(a) of the Act, in order to provide funds appropriated to carry out Chapter 4 of Part II of the Foreign Assistance Act, as amended, to the Palestinian Authority. You are directed to transmit this determination to the Congress, with a report pursuant to section 7040(d) of the Act and to publish the determination in the Federal Register.

THE WHITE HOUSE, WASHINGTON, April 7, 2010

[FR Doc. 2010–8793 Filed 4–14–10; 8:45 am] Billing code 4710–10–P

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Presidential Determination No. 2010–05 of April 7, 2010

Waiver of and Certification of Statutory Provisions Regarding the Palestine Liberation Organization Office

Memorandum for the Secretary of State

Pursuant to the authority and conditions contained in section 7034(b) of the Department of State, Foreign Operations, and Related Programs Appro- priations Act, 2010 (Division F, Public Law 111–117), I hereby determine and certify that it is important to the national security interests of the United States to waive the provisions of section 1003 of the Anti-Terrorism Act of 1987, Public Law 100–204. This waiver shall be effective for a period of 6 . You are hereby authorized and directed to transmit this determination to the Congress and to publish it in the Federal Register.

THE WHITE HOUSE, WASHINGTON, April 7, 2010

[FR Doc. 2010–8791 Filed 4–14–10; 8:45 am] Billing code 4710–10–P

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Rules and Regulations Federal Register Vol. 75, No. 72

Thursday, April 15, 2010

This section of the FEDERAL REGISTER Independence Avenue, SW., by reference are realized and contains regulatory documents having general Washington, DC 20591; publication of the complete description applicability and legal effect, most of which 2. The FAA Regional Office of the of each SIAP contained in FAA form are keyed to and codified in the Code of region in which the affected airport is documents is unnecessary. This Federal Regulations, which is published under located; amendment provides the affected CFR 50 titles pursuant to 44 U.S.C. 1510. 3. The National Flight Procedures sections and specifies the types of SIAP The Code of Federal Regulations is sold by Office, 6500 South MacArthur Blvd., and the corresponding effective dates. the Superintendent of Documents. Prices of Oklahoma City, OK 73169 or, This amendment also identifies the new books are listed in the first FEDERAL 4. The National Archives and Records airport and its location, the procedure REGISTER issue of each . Administration (NARA). For and the amendment number. information on the availability of this material at NARA, call 202–741–6030, The Rule DEPARTMENT OF TRANSPORTATION or go to: http://www.archives.gov/ This amendment to 14 CFR part 97 is federal_register/ effective upon publication of each 14 CFR Part 97 code_of_federal_regulations/ separate SIAP as amended in the ibr_locations.html. transmittal. For safety and timeliness of [Docket No. 30717; Amdt. No. 3367] Availability—All SIAPs are available change considerations, this amendment online free of charge. Visit nfdc.faa.gov incorporates only specific changes Standard Instrument Approach to register. Additionally, individual contained for each SIAP as modified by Procedures, and Takeoff Minimums SIAP and Takeoff Minimums and ODP FDC/P–NOTAMs. and Obstacle Departure Procedures; copies may be obtained from: The SIAPs, as modified by FDC/P– Miscellaneous Amendments 1. FAA Public Inquiry Center (APA– NOTAM, and contained in this 200), FAA Headquarters Building, 800 amendment are based on the criteria AGENCY: Federal Aviation Independence Avenue, SW., contained in the U.S. Standard for Administration (FAA), DOT. Washington, DC 20591; or Terminal Instrument Procedures ACTION: Final rule. 2. The FAA Regional Office of the (TERPS). In developing these changes to region in which the affected airport is SIAPs, the TERPS criteria were applied SUMMARY: This rule establishes, amends, located. only to specific conditions existing at suspends, or revokes Standard the affected airports. All SIAP FOR FURTHER INFORMATION CONTACT: Instrument Approach Procedures amendments in this rule have been Harry J. Hodges, Flight Procedure (SIAPs) and associated Takeoff previously issued by the FAA in a FDC Standards Branch (AFS–420) Flight Minimums and Obstacle Departure NOTAM as an emergency action of Technologies and Programs Division, Procedures for operations at certain immediate flight safety relating directly Flight Standards Service, Federal airports. These regulatory actions are to published aeronautical charts. The Aviation Administration, Mike needed because of the adoption of new circumstances which created the need Monroney Aeronautical Center, 6500 or revised criteria, or because of changes for all these SIAP amendments requires South MacArthur Blvd., Oklahoma City, occurring in the National Airspace making them effective in less than 30 OK 73169 (Mail Address: P.O. Box System, such as the commissioning of days. new navigational facilities, adding new 25082 Oklahoma City, OK 73125) Because of the close and immediate obstacles, or changing air traffic telephone: (405) 954–4164. relationship between these SIAPs and requirements. These changes are SUPPLEMENTARY INFORMATION: This rule safety in air commerce, I find that notice designed to provide safe and efficient amends Title 14, Code of Federal and public procedure before adopting use of the navigable airspace and to Regulations, Part 97 (14 CFR part 97) by these SIAPs are impracticable and promote safe flight operations under amending the referenced SIAPs. The contrary to the public interest and, instrument flight rules at the affected complete regulatory description of each where applicable, that good cause exists airports. SIAP is listed on the appropriate FAA for making these SIAPs effective in less Form 8260, as modified by the National DATES: This rule is effective April 15, than 30 days. Flight Data Center (FDC)/Permanent 2010. The compliance date for each Notice to Airmen (P–NOTAM), and is Conclusion SIAP, associated Takeoff Minimums, incorporated by reference in the The FAA has determined that this and ODP is specified in the amendatory amendment under 5 U.S.C. 552(a), 1 regulation only involves an established provisions. CFR part 51, and § 97.20 of Title 14 of body of technical regulations for which The incorporation by reference of the Code of Federal Regulations. frequent and routine amendments are certain publications listed in the The large number of SIAPs, their necessary to keep them operationally regulations is approved by the Director complex nature, and the need for a current. It, therefore—(1) is not a of the Federal Register as of April 15, special format make their verbatim ‘‘significant regulatory action’’ under 2010. publication in the Federal Register Executive Order 12866; (2) is not a ADDRESSES: Availability of matter expensive and impractical. Further, ‘‘significant rule’’ under DOT regulatory incorporated by reference in the airmen do not use the regulatory text of Policies and Procedures (44 FR 11034; amendment is as follows: the SIAPs, but refer to their graphic February 26, 1979); and (3) does not For Examination— depiction on charts printed by warrant preparation of a regulatory 1. FAA Rules Docket, FAA publishers of aeronautical materials. evaluation as the anticipated impact is Headquarters Building, 800 Thus, the advantages of incorporation so minimal. For the same reason, the

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FAA certifies that this amendment will Federal Regulations, Part 97, 14 CFR or TACAN; § 97.25 LOC, LOC/DME, not have a significant economic impact part 97, is amended by amending LDA, LDA/DME, SDF, SDF/DME; on a substantial number of small entities Standard Instrument Approach § 97.27 NDB, NDB/DME; § 97.29 ILS, under the criteria of the Regulatory Procedures, effective at 0901 UTC on ILS/DME, MLS, MLS/DME, MLS/RNAV; Flexibility Act. the dates specified, as follows: § 97.31 RADAR SIAPs; § 97.33 RNAV SIAPs; and § 97.35 COPTER SIAPs, List of Subjects in 14 CFR Part 97 PART 97—STANDARD INSTRUMENT Identified as follows: Air traffic control, Airports, APPROACH PROCEDURES Incorporation by reference, and * * * Effective Upon Publication Navigation (Air). ■ 1. The authority citation for part 97 continues to read as follows: Issued in Washington, DC, on March 19, 2010. Authority: 49 U.S.C. 106(g), 40103, 40106, John M. Allen, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721–44722. Director, Flight Standards Service. ■ 2. Part 97 is amended to read as Adoption of the Amendment follows: ■ Accordingly, pursuant to the authority By amending: § 97.23 VOR, VOR/ delegated to me, Title 14, Code of DME, VOR or TACAN, and VOR/DME

AIRAC date State City Airport FDC No. FDC date Subject

6–May–10 IN Muncie ...... Delaware County-Johnson Field .... 0/0115 3/17/10 VOR RWY 32, AMDT 15. 6–May–10 IN Muncie ...... Delaware County-Johnson Field .... 0/0116 3/17/10 RNAV (GPS) RWY 14, ORIG. 6-May–10 IN Muncie ...... Delaware County-Johnson Field .... 0/0117 3/17/10 ILS RWY 32, AMDT 9A. 6–May–10 MI Ontonagon ...... Ontonagon County–Schuster Field 0/0147 3/17/10 NDB OR GPS A, AMDT 4. 6–May–10 MI Port Huron ...... St Clair County Intl ...... 0/0149 3/17/10 ILS RWY 4, AMDT 3A. 6–May–10 MI Port Huron ...... St Clair County Intl ...... 0/0151 3/17/10 VOR/DME OR GPS A, AMDT 7A. 6–May–10 MI Sturgis ...... Kirsch Muni ...... 0/0152 3/17/10 RNAV (GPS) RWY 18, ORIG. 6–May–10 MI Sturgis ...... Kirsch Muni ...... 0/0153 3/17/10 NDB RWY 24, AMDT 10B. 6–May–10 MI Sturgis ...... Kirsch Muni ...... 0/0154 3/17/10 NDB RWY 18, AMDT 5B. 6–May–10 VT Rutland ...... Rutland–Southern Vermont Rgnl ... 0/0457 3/17/10 LOC Z RWY 19, AMDT 1A. 6–May–10 MD Clinton ...... Washington Executive/Hyde Field 0/4187 3/4/10 TAKEOFF MINIMUMS AND OB- STACLE DP, ORIG. 6–May–10 MI Davison ...... Athelone Williams Memorial ...... 0/7577 2/25/10 VOR RWY 8, ORIG–B. 6–May–10 OH Youngstown/ Youngstown/Warren Rgnl ...... 0/7635 2/25/10 RADAR–1, AMDT 13. Warren. 6–May–10 ND Minot ...... Minot Intl ...... 0/7667 2/25/10 RNAV (GPS) RWY 13, AMDT 1B. 6–May–10 KS Liberal ...... Liberal Mid-America Rgnl ...... 0/8350 3/4/10 RNAV (GPS) RWY 22, ORIG. 6–May–10 MA Westfield/Spring- Barnes Muni ...... 0/8385 3/4/10 VOR OR TACAN RWY 2, AMDT field. 4C. 6–May–10 IA Guthrie Center ... Guthrie County Rgnl ...... 0/8435 3/4/10 NDB RWY 18, ORIG. 6–May–10 GA Carrollton ...... West Georgia Regional-O V Gray 0/8726 3/3/10 RNAV (GPS) RWY 17, ORIG. Field. 6–May–10 IL Galesburg ...... Galesburg Muni ...... 0/8790 3/11/10 ILS RWY 3, AMDT 9A. 6–May–10 IL Galesburg ...... Galesburg Muni...... 0/8792 3/11/10 VOR OR GPS RWY 21, AMDT 6C. 6–May–10 IL Galesburg ...... Galesburg Muni ...... 0/8793 3/11/10 VOR OR GPS RWY 3, AMDT 6A. 6–May–10 KY Lewisport ...... Hancock Co-Ron Lewis Field ...... 0/8830 3/8/10 RNAV (GPS) RWY 5, ORIG. 6–May–10 KY Lewisport ...... Hancock Co-Ron Lewis Field ...... 0/8831 3/8/10 RNAV (GPS) RWY 23, ORIG. 6–May–10 SC Georgetown ...... Georgetown County ...... 0/9026 3/8/10 NDB OR GPS RWY 5, AMDT 5A. 6–May–10 GA Canton ...... Cherokee County ...... 0/9072 3/8/10 RNAV (GPS) RWY 22, ORIG. 6–May–10 SC Conway ...... Conway-Horry County ...... 0/9131 3/8/10 RNAV (GPS) RWY 4, ORIG. 6–May–10 SC Conway ...... Conway-Horry County ...... 0/9132 3/8/10 NDB RWY 4, ORIG. 6–May–10 SC Conway ...... Conway-Horry County ...... 0/9133 3/8/10 NDB RWY 22, ORIG. 6–May–10 GA Douglas ...... Douglas Muni ...... 0/9144 3/8/10 RNAV (GPS) RWY 22, ORIG. 6–May–10 GA Douglas ...... Douglas Muni ...... 0/9146 3/8/10 RNAV (GPS) RWY 4, ORIG. 6–May–10 GA Douglas ...... Douglas Muni ...... 0/9147 3/8/10 ILS OR LOC RWY 4, AMDT 1. 6–May–10 OH Lorain/Elyria ...... Lorain County Regional ...... 0/9306 3/8/10 ILS OR LOC RWY 7, AMDT 6B. 6–May–10 MI Tecumseh ...... Meyers-Diver’s ...... 0/9316 3/11/10 VOR OR GPS A, AMDT 7. 6–May–10 GA Blakely ...... Early County ...... 0/9322 3/8/10 RNAV (GPS) RWY 5, AMDT 1. 6–May–10 GA Blakely ...... Early County ...... 0/9323 3/8/10 LOC/NDB RWY 23, AMDT 1. 6–May–10 GA Blakely ...... Early County ...... 0/9324 3/8/10 RNAV (GPS) RWY 23, AMDT 1. 6–May–10 SC Orangeburg ...... Orangeburg Muni ...... 0/9338 3/8/10 TAKEOFF MINIMUMS AND OB- STACLE DP, AMDT 3. 6–May–10 MN Windom ...... Windom Muni ...... 0/9400 3/11/10 NDB RWY 17, AMDT 5. 6–May–10 MN Brainerd ...... Brainerd Lakes Rgnl ...... 0/9579 3/11/10 TAKEOFF MINIMUMS AND OB- STACLE DP, AMDT 5. 6–May–10 MI New Hudson ...... Oakland Southwest ...... 0/9583 3/17/10 VOR OR GPS A, AMDT 3A. 6–May–10 MI Cadillac ...... Wexford County ...... 0/9586 3/17/10 NDB RWY 7, AMDT 2. 6–May–10 MI Cadillac ...... Wexford County ...... 0/9587 3/17/10 RNAV (GPS) RWY 7, ORIG. 6–May–10 MI Cadillac ...... Wexford County ...... 0/9588 3/17/10 ILS OR LOC RWY 7, ORIG–A. 6–May–10 MI Detroit ...... Detroit Metropolitan Wayne County 0/9684 3/17/10 ILS OR LOC RWY 27R, AMDT 11A.

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AIRAC date State City Airport FDC No. FDC date Subject

6–May–10 ME Caribou ...... Caribou Muni ...... 0/9838 3/17/10 RNAV (GPS) RWY 19, ORIG. 6–May–10 FL Tampa ...... Tampa Intl ...... 0/9917 3/17/10 ILS OR LOC RWY 18R, AMDT 4B.

[FR Doc. 2010–6654 Filed 4–14–10; 8:45 am] 3. The National Flight Procedures refer to their depiction on charts printed BILLING CODE 4910–13–P Office, 6500 South MacArthur Blvd., by publishers of aeronautical materials. Oklahoma City, OK 73169 or, The advantages of incorporation by 4. The National Archives and Records reference are realized and publication of DEPARTMENT OF TRANSPORTATION Administration (NARA). For the complete description of each SIAP, information on the availability of this Takeoff Minimums and ODP listed on Federal Aviation Administration material at NARA, call 202–741–6030, FAA forms is unnecessary. This or go to: http://www.archives.gov/ amendment provides the affected CFR 14 CFR Part 97 federal_register/ sections and specifies the types of SIAPs _ _ _ [Docket No. 30716; Amdt. No. 3366] code of federal regulations/ and the effective dates of the, associated ibr_locations.html. Takeoff Minimums and ODPs. This Standard Instrument Approach Availability—All SIAPs and Takeoff amendment also identifies the airport Procedures, and Takeoff Minimums Minimums and ODPs are available and its location, the procedure, and the and Obstacle Departure Procedures; online free of charge. Visit http:// amendment number. Miscellaneous Amendments www.nfdc.faa.gov to register. The Rule Additionally, individual SIAP and AGENCY: Federal Aviation Takeoff Minimums and ODP copies may This amendment to 14 CFR part 97 is Administration (FAA), DOT. be obtained from: effective upon publication of each ACTION: Final rule. 1. FAA Public Inquiry Center (APA– separate SIAP, Takeoff Minimums and 200), FAA Headquarters Building, 800 ODP as contained in the transmittal. SUMMARY: This establishes, amends, Independence Avenue, SW., Some SIAP and Takeoff Minimums and suspends, or revokes Standard Washington, DC 20591; or textual ODP amendments may have Instrument Approach Procedures 2. The FAA Regional Office of the been issued previously by the FAA in a (SIAPs) and associated Takeoff region in which the affected airport is Flight Data Center (FDC) Notice to Minimums and Obstacle Departure located. Airmen (NOTAM) as an emergency Procedures for operations at certain action of immediate flight safety relating FOR FURTHER INFORMATION CONTACT: airports. These regulatory actions are directly to published aeronautical needed because of the adoption of new Harry J. Hodges, Flight Procedure charts. The circumstances which or revised criteria, or because of changes Standards Branch (AFS–420), Flight created the need for some SIAP and occurring in the National Airspace Technologies and Programs Divisions, Takeoff Minimums and ODP System, such as the commissioning of Flight Standards Service, Federal amendments may require making them new navigational facilities, adding new Aviation Administration, Mike effective in less than 30 days. For the obstacles, or changing air traffic Monroney Aeronautical Center, 6500 remaining SIAPS and Takeoff requirements. These changes are South MacArthur Blvd., Oklahoma City, Minimums and ODPS, an effective date designed to provide safe and efficient OK 73169 (Mail Address: P.O. Box at least 30 days after publication is use of the navigable airspace and to 25082, Oklahoma City, OK 73125) provided. promote safe flight operations under Telephone: (405) 954–4164. Further, the SIAPs and Takeoff instrument flight rules at the affected SUPPLEMENTARY INFORMATION: This rule Minimums and ODPS contained in this airports. amends Title 14 of the Code of Federal amendment are based on the criteria Regulations, Part 97 (14 CFR part 97), by DATES: contained in the U.S. Standard for This rule is effective April 15, establishing, amending, suspending, or 2010. The compliance date for each Terminal Instrument Procedures revoking SIAPS, Takeoff Minimums (TERPS). In developing these SIAPS and SIAP, associated Takeoff Minimums, and/or ODPS. The complete regulators and ODP is specified in the amendatory Takeoff Minimums and ODPs, the description of each SIAP and its TERPS criteria were applied to the provisions. associated Takeoff Minimums or ODP The incorporation by reference of conditions existing or anticipated at the for an identified airport is listed on FAA affected airports. Because of the close certain publications listed in the form documents which are incorporated regulations is approved by the Director and immediate relationship between by reference in this amendment under 5 these SIAPs, Takeoff Minimums and of the Federal Register as of April 15, U.S.C. 552(a), 1 CFR part 51, and 14 2010. ODPs, and safety in air commerce, I find CFR part 97.20. The applicable FAA that notice and public procedures before ADDRESSES: Availability of matters Forms are FAA Forms 8260–3, 8260–4, adopting these SIAPS, Takeoff incorporated by reference in the 8260–5, 8260–15A, and 8260–15B when Minimums and ODPs are impracticable amendment is as follows: required by an entry on 8260–15A. and contrary to the public interest and, For Examination— The large number of SIAPs, Takeoff where applicable, that good cause exists 1. FAA Rules Docket, FAA Minimums and ODPs, in addition to for making some SIAPs effective in less Headquarters Building, 800 their complex nature and the need for than 30 days. Independence Avenue, SW., a special format make publication in the Washington, DC 20591; Federal Register expensive and Conclusion 2. The FAA Regional Office of the impractical. Furthermore, airmen do not The FAA has determined that this region in which the affected airport is use the regulatory text of the SIAPs, regulation only involves an established located; Takeoff Minimums or ODPs, but instead body of technical regulations for which

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frequent and routine amendments are Mattoon/Charleston, IL, Coles County Panama City, FL, Panama City-Bay County necessary to keep them operationally Memorial, ILS OR LOC RWY 29, Amdt 6A Intl, VOR OR TACAN RWY 14, Amdt 16, current. It, therefore—(1) is not a Mount Carmel, IL, Mount Carmel Muni, NDB CANCELLED ‘‘significant regulatory action’’ under OR GPS RWY 4, Amdt 5, CANCELLED Panama City, FL, Panama City-Bay County Mount Carmel, IL, Mount Carmel Muni, VOR Intl, VOR OR TACAN RWY 32, Amdt 11, Executive Order 12866; (2) is not a CANCELLED ‘‘significant rule’’ under DOT Regulatory RWY 22, Amdt 10 Leonardtown, MD, St. Mary’s County Rgnl, Panama City, FL, Panama City-Bay County Policies and Procedures (44 FR 11034; VOR OR GPS RWY 29, Amdt 6A, Intl, VOR OR TACAN–A, Amdt 14, February 26, 1979); and (3) does not CANCELLED CANCELLED warrant preparation of a regulatory Flint, MI, Bishop Intl, ILS OR LOC RWY 9, Moultrie, GA, Moultrie Muni, NDB–A, Orig- evaluation as the anticipated impact is Amdt 22A A so minimal. For the same reason, the Flint, MI, Bishop Intl, ILS OR LOC RWY 27, Ames, IA, Ames Muni, Takeoff Minimums FAA certifies that this amendment will Amdt 5 and Obstacle DP, Amdt 4 Sparta, MI, Paul C. Miller-Sparta, Takeoff Chicago/Romeoville, IL, Lewis University, not have a significant economic impact Takeoff Minimums and Obstacle DP, Amdt on a substantial number of small entities Minimums and Obstacle DP, Amdt 2 Alexandria, MN, Chandler Field, RNAV 1 under the criteria of the Regulatory Goshen, IN, Goshen Muni, VOR RWY 27, Flexibility Act. (GPS) RWY 22, Orig Bemidji, MN, Bemidji Rgnl, RNAV (GPS) Amdt 7A Hettinger, ND, Hettinger Muni, Takeoff RWY 25, Orig List of Subjects in 14 CFR Part 97 Minimums and Obstacle DP, Amdt 2 Granite Falls, MN, Granite Falls Muni/ Air traffic control, Airports, Reno, NV, Reno/Tahoe Intl, LOC/DME BC Lenzen-Roe Meml Fld, Takeoff Minimums RWY 34L, Amdt 1C, CANCELLED Incorporation by reference, and and Obstacle DP, Orig Fostoria, OH, Fostoria Metropolitan, Takeoff Navigation (air). Long Prairie, MN, Todd Field, RNAV (GPS) Minimums and Obstacle DP, Amdt 1 RWY 34, Amdt 1 Issued in Washington, DC on March 19, Kutztown, PA, Kutztown, RNAV (GPS)-A, Minneapolis, MN, Anoka County-Blaine Arpt 2010. Orig, CANCELLED (Janes Field), Takeoff Minimums and John M. Allen, Kutztown, PA, Kutztown, Takeoff Minimums Obstacle DP, Amdt 5A Director, Flight Standards Service. and Obstacle DP, Orig, CANCELLED Ainsworth, NE, Ainsworth Muni, RNAV Kutztown, PA, Kutztown, VOR–B, Amdt 1B, Adoption of the Amendment (GPS) RWY 17, Amdt 2 CANCELLED Ainsworth, NE, Ainsworth Muni, RNAV Blanding, UT, Blanding Muni, RNAV (GPS) ■ Accordingly, pursuant to the authority (GPS) RWY 35, Amdt 2 delegated to me, Title 14, Code of RWY 35, Amdt 1 Newark, NJ, Newark Liberty Intl, ILS OR LOC Brigham City, UT, Brigham City, NDB–A, Federal Regulations, Part 97 (14 CFR RWY 22L; ILS RWY 22L (CAT II), Amdt 12 Amdt 1 part 97) is amended by establishing, Ashland, OH, Ashland County, Takeoff Brigham City, UT, Brigham City, RNAV amending, suspending, or revoking Minimums and Obstacle DP, Amdt 3 (GPS) RWY 35, Amdt 1 Standard Instrument Approach Loris, SC, Twin City, Takeoff Minimums and Brigham City, UT, Brigham City, Takeoff Procedures and/or Takeoff Minimums Obstacle DP, Orig Minimums and Obstacle DP, Amdt 6 and/or Obstacle Departure Procedures Bridgewater, VA, Bridgewater Airpark, Danville, VA, Danville Rgnl, GPS RWY 20, Takeoff Minimums and Obstacle DP, Amdt Orig-A, CANCELLED effective at 0902 UTC on the dates 2 specified, as follows: Danville, VA, Danville Rgnl, RNAV (GPS) * * * Effective 3 Jun 2010 RWY 2, Orig Danville, VA, Danville Rgnl, RNAV (GPS) PART 97—STANDARD INSTRUMENT Talkeetna, AK, Talkeetna, GPS RWY 36, Orig, APPROACH PROCEDURES RWY 20, Orig CANCELLED Farmville, VA, Farmville Rgnl, GPS RWY 21, ■ 1. The authority citation for part 97 Talkeetna, AK, Talkeetna, NDB RWY 36, Orig, CANCELLED Amdt 2 continues to read as follows: Farmville, VA, Farmville Rgnl, NDB RWY 3, Talkeetna, AK, Talkeetna, RNAV (GPS) RWY Amdt 6 Authority: 49 U.S.C. 106(g), 40103, 40106, 36, Orig Farmville, VA, Farmville Rgnl, RNAV (GPS) 40113, 40114, 40120, 44502, 44514, 44701, Talkeetna, AK, Talkeetna, Takeoff Minimums RWY 3, Orig 44719, 44721–44722. and Obstacle DP, Amdt 2 Farmville, VA, Farmville Rgnl, RNAV (GPS) Talkeetna, AK, Talkeetna, VOR–A, Amdt 10 ■ RWY 21, Orig 2. Part 97 is amended to read as Talkeetna, AK, Talkeetna, VOR/DME RWY Manitowish Waters, WI, Manitowish Waters, follows: 36, Amdt 2 Takeoff Minimums and Obstacle DP, Orig Palmdale, CA, Palmdale Rgnl/USAF Plant 42, * * * Effective 8 Apr 2010 Casper, WY, Casper/Natrona County Intl, Takeoff Minimums and Obstacle DP, Amdt VOR/DME RWY 3, Amdt 5 Clinton, MD, Washington Executive/Hyde 2 Rock Springs, WY, Rock Springs-Sweetwater Field, VOR/DME RWY 5, Orig, Panama City, FL, Panama City-Bay County County, VOR–B, Amdt 4A, CANCELLED CANCELLED Intl, ILS RWY 14, Amdt 16, CANCELLED [FR Doc. 2010–7663 Filed 4–14–10; 8:45 am] * * * Effective 6 May 2010 Panama City, FL, Panama City-Bay County Intl, NDB RWY 14, Amdt 5, CANCELLED BILLING CODE 4910–13–P West Palm Beach, FL, Palm Beach Intl, Panama City, FL, Panama City-Bay County RNAV (RNP) Z RWY 10L, Orig-A West Palm Beach, FL, Palm Beach Intl, Intl, RNAV (GPS) RWY 5, ORIG–A, RNAV (RNP) Z RWY 14, Orig-A CANCELLED PENSION BENEFIT GUARANTY West Palm Beach, FL, Palm Beach Intl, Panama City, FL, Panama City-Bay County CORPORATION RNAV (RNP) Z RWY 28R, Orig-A Intl, RNAV (GPS) RWY 14, Amdt 1, West Palm Beach, FL, Palm Beach Intl, CANCELLED 29 CFR Part 4022 RNAV (RNP) Z RWY 32, Orig-A Panama City, FL, Panama City-Bay County Clinton, IA, Clinton Muni, Takeoff Intl, RNAV (GPS) RWY 23, Orig, Benefits Payable in Terminated Single- Minimums and Obstacle DP, Amdt 1 CANCELLED Employer Plans; Interest Assumptions Guthrie Center, IA, Guthrie County Rgnl, Panama City, FL, Panama City-Bay County for Valuing and Paying Benefits Takeoff Minimums and Obstacle DP, Orig Intl, RNAV (GPS) RWY 32, Amdt 1, Red Oak, IA, Red Oak Muni, NDB RWY 17, CANCELLED AGENCY: Pension Benefit Guaranty Amdt 9 Panama City, FL, Panama City-Bay County Corporation. Flora, IL, Flora Muni, RNAV (GPS) RWY 21, Intl, Takeoff Minimums and Obstacle DP, ACTION: Final rule. Amdt 1A Amdt 1, CANCELLED

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SUMMARY: Pension Benefit Guaranty Two sets of interest assumptions are interest assumptions promptly so that Corporation’s regulation on Benefits prescribed under the benefit payments the assumptions can reflect current Payable in Terminated Single-Employer regulation: (1) A set for PBGC to use to market conditions as accurately as Plans prescribes interest assumptions determine whether a benefit is payable possible. for valuing and paying certain benefits as a lump sum and to determine lump- Because of the need to provide under terminating single-employer sum amounts to be paid by PBGC (found immediate guidance for the valuation plans. This final rule amends the benefit in Appendix B to part 4022), and (2) a and payment of benefits in plans with payments regulation to adopt interest set for private-sector pension valuation dates during May 2010, PBGC assumptions for plans with valuation practitioners to refer to if they wish to finds that good cause exists for making dates in May 2010. Interest assumptions use lump-sum interest rates determined the assumptions set forth in this are also published on PBGC’s Web site using PBGC’s historical methodology amendment effective less than 30 days (http://www.pbgc.gov). (found in Appendix C to part 4022). after publication. DATES: Effective May 1, 2010. This amendment (1) adds to PBGC has determined that this action Appendix B to part 4022 the interest FOR FURTHER INFORMATION CONTACT: is not a ‘‘significant regulatory action’’ assumptions for PBGC to use for its own Catherine B. Klion, Manager, Regulatory under the criteria set forth in Executive lump-sum payments in plans with and Policy Division, Legislative and Order 12866. Regulatory Department, Pension Benefit valuation dates during May 2010, and Guaranty Corporation, 1200 K Street, (2) adds to Appendix C to part 4022 the Because no general notice of proposed NW., Washington, DC 20005, 202–326– interest assumptions for private-sector rulemaking is required for this 4024. (TTY/TDD users may call the pension practitioners to refer to if they amendment, the Regulatory Flexibility Federal relay service toll-free at 1–800– wish to use lump-sum interest rates Act of 1980 does not apply. See 5 U.S.C. 877–8339 and ask to be connected to determined using PBGC’s historical 601(2). 202–326–4024.) methodology for valuation dates during List of Subjects in 29 CFR Part 4022 SUPPLEMENTARY INFORMATION: PBGC’s May 2010. regulations prescribe actuarial The interest assumptions that PBGC Employee benefit plans, Pension assumptions—including interest will use for its own lump-sum payments insurance, Pensions, Reporting and assumptions—for valuing and paying (set forth in Appendix B to part 4022) recordkeeping requirements. plan benefits of terminating single- will be 3.00 percent for the period ■ In consideration of the foregoing, 29 employer plans covered by title IV of during which a benefit is in pay status CFR part 4022 is amended as follows: the Employee Retirement Income and 4.00 percent during any Security Act of 1974. The interest preceding the benefit’s placement in pay PART 4022—BENEFITS PAYABLE IN assumptions are intended to reflect status. In comparison with the interest TERMINATED SINGLE-EMPLOYER current conditions in the financial and assumptions in effect for April 2010, PLANS annuity markets. these interest assumptions represent an These interest assumptions are found increase of 0.25 percent in the ■ 1. The authority citation for part 4022 in two PBGC regulations: The regulation immediate annuity rate and are continues to read as follows: on Benefits Payable in Terminated otherwise unchanged. For private-sector Authority: 29 U.S.C. 1302, 1322, 1322b, Single-Employer Plans (29 CFR part payments, the interest assumptions (set 1341(c)(3)(D), and 1344. 4022) and the regulation on Allocation forth in Appendix C to part 4022) will of Assets in Single-Employer Plans (29 be the same as those used by PBGC for ■ 2. In appendix B to part 4022, Rate Set CFR part 4044). Assumptions under the determining and paying lump sums (set 199, as set forth below, is added to the asset allocation regulation are updated forth in Appendix B to part 4022). table. quarterly; assumptions under the benefit PBGC has determined that notice and payments regulation are updated public comment on this amendment are APPENDIX B TO PART 4022—LUMP monthly. This final rule updates only impracticable and contrary to the public SUM INTEREST RATES FOR PBGC the assumptions under the benefit interest. This finding is based on the PAYMENTS payments regulation. need to determine and issue new * * * * *

For plans with a valuation date Immediate Deferred annuities (percent) Rate set annuity rate On or after Before (percent) i1 i2 i3 n1 n2

******* 199 ...... 5–1–10 6–1–10 3.00 4.00 4.00 4.00 7 8

■ 3. In appendix C to part 4022, Rate Set APPENDIX C TO PART 4022—LUMP 199, as set forth below, is added to the SUM INTEREST RATES FOR table. PRIVATE-SECTOR PAYMENTS * * * * *

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For plans with a valuation date Immediate Deferred annuities Rate set annuity rate (percent) On or after Before (percent) i1 i2 i3 n1 n2

******* 199 ...... 5–1–10 6–1–10 3.00 4.00 4.00 4.00 7 8

Issued in Washington, DC, on this 6th day Internet by going to http:// contain requirements for all vessels of April 2010. www.regulations.gov, inserting USCG– navigating on U.S. inland waters and Vincent K. Snowbarger, 2009–0948 in the ‘‘Keyword’’ box, and include rules for: Acting Director, Pension Benefit Guaranty then clicking ‘‘Search.’’ • Navigation lights; • Corporation. FOR FURTHER INFORMATION CONTACT: If Day shapes; [FR Doc. 2010–8680 Filed 4–14–10; 8:45 am] you have questions on this rule, call or • Whistle signals; • BILLING CODE 7709–01–P e-mail Lieutenant Scott Medeiros, Office Conduct of vessels in restricted of Vessel Activities (CG–54133), visibility; and telephone (202) 372–1565, e-mail • Conduct of vessels in sight of each DEPARTMENT OF HOMELAND [email protected]. If you have other. SECURITY questions on viewing the docket, call These regulations are commonly Renee V. Wright, Program Manager, known as the ‘‘inland rules of the road.’’ Coast Guard Docket Operations, telephone (202) Congress also amended Section 3 of 366–9826. the Inland Navigation Rules Act of 1980 33 CFR Part 83 SUPPLEMENTARY INFORMATION: to grant the Secretary of Homeland Security authority to issue inland [Docket No. USCG–2009–0948] Table of Contents for Preamble navigation regulations. In doing so, RIN 1625–AB43 I. Abbreviations Congress specified that repeal of Section II. Basis and Purpose 2 (the inland navigation rules then in Inland Navigation Rules III. Discussion of Rule effect) would not be effective until the IV. Regulatory Analyses effective date of regulations for the AGENCY: Coast Guard, DHS. A. Administrative Procedure Act inland navigation rules. This guaranteed ACTION: Final rule. B. Regulatory Planning and Review there would be no gap in application of (Executive Order 12866) the inland navigation rules between SUMMARY: By this final rule, the Coast C. Small Entities being removed from the United States D. Assistance for Small Entities Guard is placing the Inland Navigation Code and being added to the Code of Rules into the Code of Federal E. Collection of Information F. Federalism Federal Regulations (CFR). Regulations. This move is in accordance The Secretary of Homeland Security with the Coast Guard and Maritime G. Unfunded Mandates Reform Act H. Taking of Private Property has delegated authority to develop and Transportation Act of 2004, which I. Civil Justice Reform enforce navigation safety regulations to repeals the Inland Navigation Rules as J. Protection of Children the Commandant of the Coast Guard of the effective date of these regulations. K. Indian Tribal Governments through Department of Homeland updates of the Inland Navigation L. Energy Effects Security Delegation 0170.1, Delegation Rules will be accomplished through M. Technical Standards to the Commandant of the Coast Guard. N. Environment rulemaking rather than legislation. The Coast Guard has decided to use the DATES: This final rule is effective May I. Abbreviations authority granted by Congress and 17, 2010. DHS Department of Homeland Security delegated by the Secretary to move the ADDRESSES: Documents mentioned in CFR Code of Federal Regulations inland navigation rules to a new Part 83 this preamble as being available in the NPRM Notice of proposed rulemaking of Title 33, Code of Federal Regulations. docket are part of docket USCG–2009– U.S.C. United States Code This is the most logical place for the 0948 and are available for inspection or inland navigation rules, as 33 CFR parts copying at the Docket Management II. Basis and Purpose 84 through 90 also contain requirements Facility (M–30), U.S. Department of In section 303 of the Coast Guard and for inland navigation rules as shown in Transportation, West Building Ground Maritime Transportation Authorization table 1. Moving the main body of the Floor, Room W12–140, 1200 New Jersey Act of 2004 (Pub. L. 108–293), Congress inland navigation rules to a new part 83 Avenue, SE., Washington, DC 20590, repealed Section 2 of the Inland is consistent with the intent of Congress between 9 a.m. and 5 p.m., Monday Navigation Rules Act of 1980, found in and puts all of the inland navigation through Friday, except Federal holidays. sections 2001–2038 of Title 33 of the rules in one place in the Code of Federal You may also find this docket on the United States Code. These sections Regulations.

TABLE 1—EXISTING INLAND NAVIGATION RULES IN 33 CFR

33 CFR part 84 ...... Annex I: Positioning and technical details of lights and shapes. 33 CFR part 85 ...... Annex II: Additional signals for fishing vessels fishing in close proximity. 33 CFR part 86 ...... Annex III: Technical details of sound and signal appliances. 33 CFR part 87 ...... Annex IV: Distress signals. 33 CFR part 88 ...... Annex V: Pilot rules. 33 CFR part 89 ...... Inland navigation rules: Implementing rules. 33 CFR part 90 ...... Inland rules: Interpretive rules.

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In addition to having all of the inland based on 14 of these statutes or require an assessment of potential costs navigation rules in one location, moving executive orders. and benefits under section 6(a)(3) of that the inland navigation rules from the Order. The Office of Management and A. Administrative Procedure Act United States Code to the CFR will Budget has not reviewed it under that make it easier for the Coast Guard to The Coast Guard did not publish a Order. update or revise the rules, and improve notice of proposed rulemaking (NPRM) By this final rule, the Coast Guard the public’s opportunity for input for this regulation. Under 5 U.S.C. moves the Inland Navigation Rules in regarding changes to the rules. Future 553(b)(B), the Coast Guard finds that their entirety from Title 33 U.S.C. to updates to the inland navigation rules good cause exists for not publishing an Title 33 CFR part 83. This final rule will be accomplished through NPRM. contains requirements for all vessels rulemaking rather than legislation, and Under the Administrative Procedure navigating on U.S. inland waters, interested persons will be able to Act (APA) ‘‘good cause’’ exception at 5 including commercial, recreational, and participate as required by law through U.S.C. 553(b)(B), an agency may government vessels. We expect no the notice and comment process. dispense with notice and comment additional costs to the public or procedures if the agency finds that industry from this final rule because all III. Discussion of Rule following these APA requirements vessels that operate in the United States Through this final rule, the Coast would be ‘‘impracticable, unnecessary, are currently required by statute to Guard moves the inland navigation or contrary to the public interest.’’ See follow the inland navigation rules. This rules in their entirety from 33 U.S.C. Jeffrey L. Lubbers, A Guide to Federal rule will not change the current 2001–2038 to new 33 CFR part 83, Agency Rulemaking (4th ed.) 105–109 obligations and responsibilities of Inland Navigation Rules. (2006) for a discussion of agency mariners. findings of good cause in lieu of notice Although the substance of the Inland This final rule allows the Coast Guard and comment procedures. Navigation Rules has not changed, a to make more timely changes to the ‘‘Unnecessary’’ for the purpose of the number of conforming changes were regulations, easing the burden of good cause exceptions to the made to maintain clarity in the Final revising the rules. In this case, the Coast requirements of the APA, refers to ‘‘the Rule: Guard would use the rulemaking issuance of a minor rule in which the process rather than seeking legislation. The subparagraphs of each rule were public is not particularly interested.’’ renumbered as necessary to conform to United States Department of Justice, C. Small Entities the CFR standard paragraph structure. Attorney General’s Manual on the Under the Regulatory Flexibility Act To conform to CFR standard paragraph Administrative Procedure Act at 31 (5 U.S.C. 601–612), we have considered structure, -level (level ‘‘(i)’’) and (1947). Its use should be ‘‘confined to whether this rule would have a third-level (level ‘‘(1)’’) subparagraphs those situations in which the significant economic impact on a were renumbered to conform to the CFR administrative rule is a routine substantial number of small entities. standard (now designated as determination, insignificant in nature The term ‘‘small entities’’ comprises subparagraphs ‘‘(1)’’ and ‘‘(i)’’, and impact, and inconsequential to the small businesses, not-for-profit respectively). For example, Rule 38 industry and to the public.’’ Utility Solid organizations that are independently paragraph (d)(iv)(2) was renumbered to Waste Activities Group v. EPA, 236 F.3d owned and operated and are not become Rule 38 paragraph (d)(4)(ii). 749, 755 (DC Cir. 2001), citing South dominant in their fields, and In § 83.185 Exemptions (Rule 38), Carolina v. Block, 558 F.Supp. 1004, governmental jurisdictions with paragraphs (a)–(c), references to 1016 (D.S.C. 1983). populations of less than 50,000. ‘‘chapters 3, 4, and 5 of this title’’ were This rulemaking makes no change to A Regulatory Flexibility Act (RFA) changed to the names of the Acts which the substance of the Inland Navigation analysis is not required when the were codified in the referenced chapter. Rules; the only changes are to which agency finds good cause that notice and Also in § 83.185 Exemptions (Rule branch of the Federal government public procedure thereon are 38), in paragraph (d), references to ‘‘the manages the Inland Navigation Rules impracticable, unnecessary, or contrary effective date of these Rules’’ were (the Executive, through the Department to the public interest. The Coast Guard changed to ‘‘the effective date of the of Homeland Security and the U.S. determined that this rule is exempt from Inland Navigation Rules Act of 1980 Coast Guard, instead of Congress) and notice and comment procedures (Pub. L. 96–591). This change avoids the where those rules are written (the CFR pursuant to 5 U.S.C. 553(b)(B). ambiguous term ‘‘these Rules’’ which in instead of the U.S.C.). There will be no Therefore, an RFA analysis is not the old text referred to the statute, not impact on the mariner or the public, required for this final rule. See the the new regulations at 33 CFR part 83, with the exception that a mariner who ‘‘Administrative Procedure Act’’ section and avoids inadvertently resetting seeks a change in the inland rules will of this rule for additional details on this compliance deadlines for vessels built have the option of requesting a determination. before the effective date of this final regulatory change under 33 CFR 1.05–20 D. Assistance for Small Entities rule. instead of being required to petition Note that most of the statutes referred Congress for a legislative change. The Under section 213(a) of the Small to in § 83.185 Exemptions (Rule 38) APA’s good cause exception thus Business Regulatory Enforcement have been repealed. The Coast Guard applies to the notice and comment Fairness Act of 1996 (Pub. L. 104–121), intends to address the necessity of requirement, as that requirement is we offer to assist small entities in maintaining these exemptions through a unnecessary for this rulemaking. understanding the rule so that they can future rulemaking. better evaluate its effects on them and B. Regulatory Planning and Review participate in the rulemaking. If the rule IV. Regulatory Analyses (Executive Order 12866) will affect your small business, We developed this rule after This rule is not a significant organization, or governmental considering numerous statutes and regulatory action under section 3(f) of jurisdiction and you have questions executive orders related to rulemaking. Executive Order 12866, Regulatory concerning its provisions or options for Below, we summarize our analyses Planning and Review, and does not compliance, please consult Lieutenant

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Scott Medeiros, Office of Waterways J. Protection of Children Management Directive 023–01 and Management by telephone at 202–372– We have analyzed this rule under Commandant Instruction M16475.lD, 1565. The Coast Guard will not retaliate Executive Order 13045, Protection of which guide the Coast Guard in against small entities that question or Children from Environmental Health complying with the National complain about this rule or any policy Risks and Safety Risks. This rule is not Environmental Policy Act of 1969 or action of the Coast Guard. an economically significant rule and (NEPA) (42 U.S.C. 4321–4370f), and Small businesses may send comments does not create an environmental risk to have concluded that this action is one on the actions of Federal employees health or risk to safety that may of a category of actions which do not who enforce or otherwise determine disproportionately affect children. individually or cumulatively have a compliance with Federal regulations to significant effect on the human the Small Business and Agriculture K. Indian Tribal Governments environment. This rule is categorically Regulatory Enforcement Ombudsman This rule does not have Tribal excluded under section 2.B.2, figure 2– and the Regional Small Business implications under Executive Order 1, paragraphs (34)(a) and (34)(i) of the Regulatory Fairness Boards. The 13175, Consultation and Coordination Instruction. This rule involves Ombudsman evaluates these actions with Indian Tribal Governments, regulations which are editorial or annually and rates each agency’s because it does not have a substantial procedural, such as those updating responsiveness to small business. If you direct effect on one or more Indian addresses or establishing application wish to comment on actions by Tribes, on the relationship between the procedures, and also involves employees of the Coast Guard, call 1– Federal Government and Indian Tribes, regulations in aid of navigation. An 888–REG–FAIR (1–888–734–3247). or on the distribution of power and environmental analysis checklist and a responsibilities between the Federal categorical exclusion determination are E. Collection of Information Government and Indian Tribes. available in the docket where indicated This rule calls for no new collection L. Energy Effects under ADDRESSES. of information under the Paperwork List of Subjects in 33 CFR Part 83 Reduction Act of 1995 (44 U.S.C. 3501– We have analyzed this rule under 3520). Executive Order 13211, Actions Fishing vessels, Navigation (water), Concerning Regulations That Waterways. F. Federalism Significantly Affect Energy Supply, ■ For the reasons discussed in the Distribution, or Use. We have A rule has implications for federalism preamble, the Coast Guard adds part 83 determined that it is not a ‘‘significant under Executive Order 13132, to 33 CFR Subchapter E of Chapter I to energy action’’ under that order because Federalism, if it has a substantial direct read as follows: it is not a ‘‘significant regulatory action’’ effect on State or local governments and under Executive Order 12866 and is not SUBCHAPTER E—INLAND NAVIGATION would either preempt State law or RULES likely to have a significant adverse effect impose a substantial direct cost of on the supply, distribution, or use of compliance on them. We have analyzed PART 83—RULES energy. The Administrator of the Office this rule under that Order and have of Information and Regulatory Affairs Subpart A—General determined that it does not have has not designated it as a significant implications for federalism. Sec. energy action. Therefore, it does not 83.01 Application (Rule 1). G. Unfunded Mandates Reform Act require a Statement of Energy Effects 83.02 Responsibility (Rule 2). under Executive Order 13211. 83.03 Definitions (Rule 3). The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531–1538) requires M. Technical Standards Subpart B—Steering and Sailing Rules Federal agencies to assess the effects of The National Technology Transfer Conduct of Vessels in Any Condition of their discretionary regulatory actions. In and Advancement Act (NTTAA) (15 Visibility particular, the Act addresses actions U.S.C. 272 note) directs agencies to use 83.04 Application (Rule 4). that may result in the expenditure by a voluntary consensus standards in their 83.05 Look-out (Rule 5). State, local, or Tribal government, in the regulatory activities unless the agency 83.06 Safe speed (Rule 6). aggregate, or by the private sector of 83.07 Risk of collision (Rule 7). provides Congress, through the Office of 83.08 Action to avoid collision (Rule 8). $100,000,000 or more (adjusted for Management and Budget (OMB), with inflation) in any one . Though this 83.09 Narrow channels (Rule 9). an explanation of why using these 83.10 Traffic separation schemes (Rule 10). rule will not result in such an standards would be inconsistent with expenditure, we do discuss the effects of applicable law or otherwise impractical. Conduct of Vessels in Sight of One Another this rule elsewhere in this preamble. Voluntary consensus standards are 83.11 Application (Rule 11). 83.12 Sailing vessels (Rule 12). H. Taking of Private Property technical standards (e.g., specifications of materials, performance, design, or 83.13 Overtaking (Rule 13). 83.14 Head-on situation (Rule 14). This rule will not cause a taking of operation; test methods; sampling private property or otherwise have 83.15 Crossing situation (Rule 15). procedures; and related management 83.16 Action by give-way vessel (Rule 16). taking implications under Executive systems practices) that are developed or 83.17 Action by stand-on vessel (Rule 17). Order 12630, Governmental Actions and adopted by voluntary consensus 83.18 Responsibilities between vessels Interference with Constitutionally standards bodies. (Rule 18). Protected Property Rights. This rule does not use technical Conduct of Vessels in Restricted Visibility I. Civil Justice Reform standards. Therefore, we did not consider the use of voluntary consensus 83.19 Conduct of vessels in restricted visibility (Rule 19). This rule meets applicable standards standards. in sections 3(a) and 3(b)(2) of Executive Subpart C—Lights and Shapes N. Environment Order 12988, Civil Justice Reform, to 83.20 Application (Rule 20). minimize litigation, eliminate We have analyzed this rule under 83.21 Definitions (Rule 21). ambiguity, and reduce burden. Department of Homeland Security 83.22 Visibility of lights (Rule 22).

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83.23 Power-driven vessels underway (Rule they shall have effect as if they were a (a) Vessel includes every description 23). part of these Rules. of water craft, including 83.24 Towing and pushing (Rule 24). (d) Traffic regulation schemes; vessel nondisplacement craft and seaplanes, 83.25 Sailing vessels underway and vessels used or capable of being used as a under oars (Rule 25). traffic service regulations. Traffic 83.26 Fishing vessels (Rule 26). separation schemes may be established means of transportation on water; 83.27 Vessels not under command or for the purpose of these Rules. Vessel (b) Power-driven vessel means any restricted in their ability to maneuver traffic service regulations may be in vessel propelled by machinery; (Rule 27). effect in certain areas. (c) Sailing vessel means any vessel 83.28 [Reserved](Rule 28). (e) Alternative compliance. Whenever under sail provided that propelling 83.29 Pilot vessels (Rule 29). the Secretary determines that a vessel or machinery, if fitted, is not being used; 83.30 Anchored vessels and vessels class of vessels of special construction (d) Vessel engaged in fishing means aground (Rule 30). any vessel fishing with nets, lines, 83.31 Seaplanes (Rule 31). or purpose cannot comply fully with the provisions of any of these Rules with trawls, or other fishing apparatus which Subpart D—Sound and Light Signals respect to the number, position, range, restricts maneuverability, but does not 83.32 Definitions (Rule 32). or arc of visibility of lights or shapes, as include a vessel fishing with trolling 83.33 Equipment for sound signals (Rule well as to the disposition and lines or other fishing apparatus which 33). characteristics of sound-signaling do not restrict maneuverability; 83.34 Maneuvering and warning signals appliances, the vessel shall comply with (e) Seaplane includes any aircraft (Rule 34). such other provisions in regard to the designed to maneuver on the water; 83.35 Sound signals in restricted visibility (f) Vessel not under command means (Rule 35). number, position, range, or arc of visibility of lights or shapes, as well as a vessel which, through some 83.36 Signals to attract attention (Rule 36). exceptional circumstance, is unable to 83.37 Distress signals (Rule 37). to the disposition and characteristics of sound-signaling appliances, as the maneuver as required by these Rules Subpart E—Exemptions Secretary shall have determined to be and is therefore unable to keep out of 83.38 Exemptions (Rule 38). the closest possible compliance with the way of another vessel; (g) Vessel restricted in her ability to Authority: Sec. 303, Pub. L. 108–293, 118 these Rules. The Secretary may issue a maneuver means a vessel which, from Stat. 1028 (33 U.S.C. 2001); Department of certificate of alternative compliance for the nature of her work, is restricted in Homeland Security Delegation No. 0170.1. a vessel or class of vessels specifying the her ability to maneuver as required by closest possible compliance with these these Rules and is therefore unable to Subpart A—General Rules. The Secretary of the Navy shall keep out of the way of another vessel; make these determinations and issue § 83.01 Application (Rule 1). vessels restricted in their ability to certificates of alternative compliance for (a) United States inland waters and maneuver include, but are not limited vessels of the Navy. Canadian waters of the Great Lakes. to: These Rules apply to all vessels upon (f) Acceptance of certificates of (1) A vessel engaged in laying, the inland waters of the United States, alternative compliance from contracting servicing, or picking up a navigation and to vessels of the United States on parties to International Regulations. The mark, submarine cable, or pipeline; the Canadian waters of the Great Lakes Secretary may accept a certificate of (2) A vessel engaged in dredging, to the extent that there is no conflict alternative compliance issued by a surveying, or underwater operations; with Canadian law. contracting party to the International (3) A vessel engaged in replenishment (b) International Regulations. Regulations if he determines that the or transferring persons, provisions, or (1) These Rules constitute special alternative compliance standards of the cargo while underway; rules made by an appropriate authority contracting party are substantially the (4) A vessel engaged in the launching within the meaning of Rule 1(b) of the same as those of the United States. or recovery of aircraft; International Regulations. § 83.02 Responsibility (Rule 2). (5) A vessel engaged in mineclearance (2) All vessels complying with the operations; and construction and equipment (a) Exoneration. Nothing in these (6) A vessel engaged in a towing requirements of the International Rules shall exonerate any vessel, or the operation such as severely restricts the Regulations are considered to be in owner, master, or crew thereof, from the towing vessel and her tow in their compliance with these Rules. consequences of any neglect to comply ability to deviate from their course. (c) Special rules. Nothing in these with these Rules or of the neglect of any (h) Underway means that a vessel is Rules shall interfere with the operation precaution which may be required by not at anchor, or of any special rules made by the the ordinary practice of seamen, or by made fast to the shore, or aground; Secretary of the Navy with respect to the special circumstances of the case. (i) Length and breadth of a vessel additional station or signal lights and (b) Departure from rules when mean her length overall and greatest shapes or whistle signals for ships of necessary to avoid immediate danger. In breadth; war and vessels proceeding under construing and complying with these (j) Vessels shall be deemed to be in convoy, or by the Secretary with respect Rules due regard shall be had to all sight of one another only when one can to additional station or signal lights and dangers of navigation and collision and be observed visually from the other; shapes for fishing vessels engaged in to any special circumstances, including (k) Restricted visibility means any fishing as a fleet. These additional the limitations of the vessels involved, condition in which visibility is station or signal lights and shapes or which may make a departure from these restricted by fog, mist, falling snow, whistle signals shall, so far as possible, Rules necessary to avoid immediate heavy rainstorms, sandstorms, or any be such that they cannot be mistaken for danger. other similar causes; any light, shape, or signal authorized (l) Western Rivers means the elsewhere under these Rules. Notice of § 83.03 Definitions (Rule 3). Mississippi River, its tributaries, South such special rules shall be published in For the purpose of these Rules and Pass, and Southwest Pass, to the the Federal Register and, after the this chapter, except where the context navigational demarcation lines dividing effective date specified in such notice, otherwise requires: the high seas from harbors, rivers, and

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other inland waters of the United States, (2) The traffic density including § 83.08 Action to avoid collision (Rule 8). and the Port Allen-Morgan City concentration of fishing vessels or any (a) General characteristics of action Alternate Route, and that part of the other vessels; taken to avoid collision. Any action Atchafalaya River above its junction (3) The maneuverability of the vessel taken to avoid collision shall, if the with the Port Allen-Morgan City with special reference to stopping circumstances of the case admit, be Alternate Route including the Old River distance and turning ability in the positive, made in ample time and with and the Red River; prevailing conditions; due regard to the observance of good (m) Great Lakes means the Great (4) At night the presence of seamanship. Lakes and their connecting and tributary background light such as from shores (b) Readily apparent alterations in waters including the Calumet River as lights or from back scatter of her own course or speed. Any alteration of far as the Thomas J. O’Brien Lock and lights; course or speed to avoid collision shall, Controlling Works (between mile 326 (5) The state of wind, sea, and current, if the circumstances of the case admit, and 327), the Chicago River as far as the and the proximity of navigational be large enough to be readily apparent east side of the Ashland Avenue Bridge hazards; to another vessel observing visually or (between mile 321 and 322), and the (6) The draft in relation to the by radar; a succession of small Saint Lawrence River as far east as the available depth of water. alterations of course or speed should be (b) Additionally, by vessels with lower exit of Saint Lambert Lock; avoided. (n) Secretary means the Secretary of operational radar: (c) Alteration of course to avoid close- (1) The characteristics, efficiency and the Department in which the Coast quarters situation. If there is sufficient limitations of the radar equipment; Guard is Operating; (2) Any constraints imposed by the sea room, alteration of course alone may (o) Inland Waters means the navigable radar range scale in use; be the most effective action to avoid a waters of the United States shoreward of (3) The effect on radar detection of the close-quarters situation provided that it the navigational demarcation lines sea state, weather, and other sources of is made in good time, is substantial and dividing the high seas from harbors, interference; does not result in another close-quarters rivers, and other inland waters of the (4) The possibility that small vessels, situation. United States and the waters of the ice and other floating objects may not be (d) Action to result in passing at safe Great Lakes on the United States side of detected by radar at an adequate range; distance. Action taken to avoid collision the International Boundary; (5) The number, location, and with another vessel shall be such as to (p) Inland Rules or Rules mean the movement of vessels detected by radar; result in passing at a safe distance. The Inland Navigational Rules and the and effectiveness of the action shall be annexes thereto, which govern the (6) The more exact assessment of the carefully checked until the other vessel conduct of vessels and specify the visibility that may be possible when is finally and clear. lights, shapes, and sound signals that radar is used to determine the range of (e) Slackening of vessel speed; apply on inland waters; and vessels or other objects in the vicinity. stopping or reversing means of (q) International Regulations means propulsion. If necessary to avoid the International Regulations for § 83.07 Risk of collision (Rule 7). collision or allow more time to assess Preventing Collisions at Sea, 1972, (a) Determination if risk exists. Every the situation, a vessel shall slacken her including annexes currently in force for vessel shall use all available means speed or take all way off by stopping or the United States. appropriate to the prevailing reversing her means of propulsion. circumstances and conditions to (f) Early action to allow room for safe Subpart B—Steering and Sailing Rules determine if risk of collision exists. If passage: there is any doubt such risk shall be (1) A vessel which, by any of these Conduct of Vessels in Any Condition of deemed to exist. Rules, is required not to impede the Visibility (b) Radar. Proper use shall be made of passage or safe passage of another vessel § 83.04 Application (Rule 4). radar equipment if fitted and shall, when required by the Rules in this subpart apply in any operational, including long-range circumstances of the case, take early condition of visibility. scanning to obtain early warning of risk action to allow sufficient sea room for of collision and radar plotting or the safe passage of the other vessel. § 83.05 Look-out (Rule 5). equivalent systematic observation of (2) A vessel required not to impede Every vessel shall at all detected objects. the passage or safe passage of another maintain a proper look-out by sight and (c) Scanty information. Assumptions vessel is not relieved of this obligation hearing as well as by all available means shall not be made on the basis of scanty if approaching the other vessel so as to appropriate in the prevailing information, especially scanty radar involve risk of collision and shall, when circumstances and conditions so as to information. taking action, have full regard to the make a full appraisal of the situation (d) Considerations taken into account action which may be required by the and of the risk of collision. in determining if risk exists. In Rules of this part. determining if risk of collision exists the (3) A vessel the passage of which is § 83.06 Safe speed (Rule 6). following considerations shall be among not to be impeded remains fully obliged Every vessel shall at all times proceed those taken into account: to comply with the Rules of this part at a safe speed so that she can take (1) Such risk shall be deemed to exist when the two vessels are approaching proper and effective action to avoid if the compass bearing of an one another so as to involve risk of collision and be stopped within a approaching vessel does not appreciably collision. distance appropriate to the prevailing change; and circumstances and conditions. (2) Such risk may sometimes exist § 83.09 Narrow channels (Rule 9). In determining a safe speed the even when an appreciable bearing (a) Keeping near to outer limit of following factors shall be among those change is evident, particularly when channel or fairway which lies on taken into account: approaching a very large vessel or a tow vessel’s starboard side; exception. (a) By all vessels: or when approaching a vessel at close (1) A vessel proceeding along the (1) The state of visibility; range. course of a narrow channel or fairway

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shall keep as near to the outer limit of § 83.10 Traffic separation schemes (Rule (j) Power-driven vessels. A vessel of the channel or fairway which lies on her 10). less than twenty meters in length or a starboard side as is safe and practicable. (a) Obligations under other Rules sailing vessel shall not impede the safe (2) Notwithstanding paragraph (a)(1) unaffected. This Rule applies to traffic passage of a power-driven vessel and Rule 14(a), a power-driven vessel separation schemes and does not relieve following a traffic lane. operating in narrow channels or any vessel of her obligation under any (k) Exemption; maintenance of safety fairways on the Great Lakes, Western other Rule. of navigation. A vessel restricted in her Rivers, or waters specified by the (b) Duties for vessel using scheme. A ability to maneuver when engaged in an Secretary, and proceeding downbound vessel using a traffic separation scheme operation for the maintenance of safety with a following current shall have the shall: of navigation in a traffic separation right-of-way over an upbound vessel, (1) Proceed in the appropriate traffic scheme is exempted from complying shall propose the manner and place of lane in the general direction of traffic with this Rule to the extent necessary to passage, and shall initiate the flow for that lane; carry out the operation. maneuvering signals prescribed by Rule (2) So far as practicable keep clear of (l) Exemption; laying, servicing, or 34(a)(1), as appropriate. The vessel a traffic separation line or separation picking up submarine cable. zone; proceeding upbound against the current A vessel restricted in her ability to (3) Normally join or leave a traffic shall hold as necessary to permit safe maneuver when engaged in an operation lane at the termination of the lane, but for the laying, servicing, or picking up passing. when joining or leaving from either side (b) Vessels of less than 20 meters in of a submarine cable, within a traffic shall do so at as small an angle to the separation scheme, is exempted from length; sailing vessels. A vessel of less general direction of traffic flow as than 20 meters in length or a sailing complying with this Rule to the extent practicable. necessary to carry out the operation. vessel shall not impede the passage of (c) Crossing traffic lanes. A vessel a vessel that can safely navigate only shall, so far as practicable, avoid Conduct of Vessels in Sight of One within a narrow channel or fairway. crossing traffic lanes but if obliged to do Another (c) Vessels engaged in fishing. A so shall cross on a heading as nearly as vessel engaged in fishing shall not practicable at right angles to the general § 83.11 Application (Rule 11). impede the passage of any other vessel direction of traffic flow. Rules in this subpart apply to vessels navigating within a narrow channel or (d) Use of inshore traffic lane. in sight of one another. fairway. (1) A vessel shall not use an inshore § 83.12 Sailing vessels (Rule 12). (d) Crossing narrow channels or traffic zone when she can safely use the fairways. A vessel shall not cross a appropriate traffic lane within the (a) Keeping out of the way. When two narrow channel or fairway if such adjacent traffic separation scheme. sailing vessels are approaching one crossing impedes the passage of a vessel However, vessels of less than twenty another, so as to involve risk of which can safely navigate only within meters in length, sailing vessels, and collision, one of them shall keep out of that channel or fairway. The latter vessels engaged in fishing may use the the way of the other as follows: vessel shall use the danger signal inshore traffic zone. (1) When each has the wind on a prescribed in Rule 34(d) if in doubt as (2) Notwithstanding subparagraph different side, the vessel which has the to the intention of the crossing vessel. (d)(1), a vessel may use an inshore wind on the port side shall keep out of (e) Overtaking vessels. traffic zone when en route to or from a the way of the other; (2) When both have the wind on the (1) In a narrow channel or fairway port, offshore installation or structure, same side, the vessel which is to when overtaking, the power-driven pilot station, or any other place situated windward shall keep out of the way of vessel intending to overtake another within the inshore traffic zone, or to the vessel which is to leeward; and power-driven vessel shall indicate her avoid immediate danger. (e) Entering separation zone or (3) If a vessel with the wind on the intention by sounding the appropriate port side sees a vessel to windward and signal prescribed in Rule 34(c) and take crossing separation line. A vessel other than a crossing vessel or a vessel joining cannot determine with certainty steps to permit safe passing. The power- whether the other vessel has the wind driven vessel being overtaken, if in or leaving a lane shall not normally enter a separation zone or cross a on the port or on the starboard side, she agreement, shall sound the same signal shall keep out of the way of the other. and may, if specifically agreed to, take separation line except: (1) In cases of emergency to avoid (b) Windward side. For the purpose of steps to permit safe passing. If in doubt this Rule the windward side shall be she shall sound the danger signal immediate danger; or (2) To engage in fishing within a deemed to be the side opposite to that prescribed in Rule 34(d). separation zone. on which the mainsail is carried or, in (2) This Rule does not relieve the (f) Caution in areas near termination the case of a square-rigged vessel, the overtaking vessel of her obligation of scheme. A vessel navigating in areas side opposite to that on which the under Rule 13. near the terminations of traffic largest fore-and-aft sail is carried. (f) Areas of obscured visibility due to separation schemes shall do so with intervening obstructions. A vessel particular caution. § 83.13 Overtaking (Rule 13). nearing a bend or an area of a narrow (g) Anchoring. A vessel shall so far as (a) Overtaking vessel to keep out of channel or fairway where other vessels practicable avoid anchoring in a traffic the overtaken vessel’s way. may be obscured by an intervening separation scheme or in areas near its Notwithstanding anything contained in obstruction shall navigate with terminations. Rules 4 through 18, any vessel particular alertness and caution and (h) Avoidance of scheme. A vessel not overtaking any other shall keep out of shall sound the appropriate signal using a traffic separation scheme shall the way of the vessel being overtaken. prescribed in Rule 34(e). avoid it by as wide a margin as is (b) Overtaking vessel defined. A (g) Avoidance of anchoring in narrow practicable. vessel shall be deemed to be overtaking channels. Every vessel shall, if the (i) Fishing vessels. A vessel engaged when coming up with another vessel circumstances of the case admit, avoid in fishing shall not impede the passage from a direction more than 22.5 degrees anchoring in a narrow channel. of any vessel following a traffic lane. abaft her beam; that is, in such a

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position with reference to the vessel she Great Lakes, Western Rivers, or water (c) Vessels engaged in fishing when is overtaking, that at night she would be specified by the Secretary, a power- underway. A vessel engaged in fishing able to see only the sternlight of that driven vessel crossing a river shall keep when underway shall, so far as possible, vessel but neither of her sidelights. out of the way of a power-driven vessel keep out of the way of: (c) Assumption that vessel is ascending or descending the river. (1) A vessel not under command; and overtaking another in cases of doubt. When a vessel is in any doubt as to § 83.16 Action by give-way vessel (Rule (2) A vessel restricted in her ability to 16). whether she is overtaking another, she maneuver. shall assume that this is the case and act Every vessel which is directed to keep (d) Seaplanes on the water. A accordingly. out of the way of another vessel shall, seaplane on the water shall, in general, (d) Overtaking vessel to become so far as possible, take early and keep well clear of all vessels and avoid substantial action to keep well clear. crossing vessel only when finally past impeding their navigation. In and clear. Any subsequent alteration of § 83.17 Action by stand-on vessel (Rule circumstances, however, where risk of the bearing between the two vessels 17). collision exists, she shall comply with shall not make the overtaking vessel a (a) Stand-on vessel to keep course and the Rules of this part. crossing vessel within the meaning of speed; action allowed when give-way Conduct of Vessels in Restricted these Rules or relieve her of the duty of vessel fails to take appropriate action. Visibility keeping clear of the overtaken vessel (1) Where one of two vessels is to until she is finally past and clear. keep out of the way, the other shall keep § 83.19 Conduct of vessels in restricted § 83.14 Head-on situation (Rule 14). her course and speed. visibility (Rule 19). (2) The latter vessel may, however, (a) Course alterations to starboard; take action to avoid collision by her (a) Vessels to which rule applies. This port side passage. Unless otherwise maneuver alone, as soon as it becomes Rule applies to vessels not in sight of agreed, when two power-driven vessels apparent to her that the vessel required one another when navigating in or near are meeting on reciprocal or nearly to keep out of the way is not taking an area of restricted visibility. reciprocal courses so as to involve risk appropriate action in compliance with of collision each shall alter her course (b) Safe speed; engines ready for these Rules. to starboard so that each shall pass on immediate maneuver. Every vessel shall (b) Action by stand-on vessel allowed proceed at a safe speed adapted to the the port side of the other. when action by give-way vessel alone (b) Existence of head-on situation. prevailing circumstances and conditions cannot avoid collision. When, from any Such a situation shall be deemed to of restricted visibility. A power-driven cause, the vessel required to keep her exist when a vessel sees the other ahead vessel shall have her engines ready for course and speed finds herself so close or nearly ahead and by night she could immediate maneuver. that collision cannot be avoided by the see the masthead lights of the other in (c) Due regard to prevailing action of the give-way vessel alone, she a line or nearly in a line or both circumstances and conditions. Every shall take such action as will best aid to sidelights and by day she observes the avoid collision. vessel shall have due regard to the corresponding aspect of the other vessel. (c) Crossing situations. A power- prevailing circumstances and conditions (c) Assumption that head-on situation driven vessel which takes action in a of restricted visibility when complying exists in cases of doubt. When a vessel crossing situation in accordance with with Rules 4 through 10. is in any doubt as to whether such a subparagraph (a)(2) of this Rule to avoid (d) Detection of vessel by radar alone. situation exists she shall assume that it collision with another power-driven A vessel which detects by radar alone does exist and act accordingly. vessel shall, if the circumstances of the the presence of another vessel shall (d) Vessel operating on Great Lakes, case admit, not alter course to port for determine if a close-quarters situation is Western Rivers, or other specified a vessel on her own port side. developing or risk of collision exists. If waters, and proceeding downbound (d) Give-way vessel not relieved of so, she shall take avoiding action in with following current. Notwithstanding obligation to keep out of the way. This paragraph (a) of this Rule, a power- ample time, provided that when such Rule does not relieve the give-way driven vessel operating on the Great action consists of an alteration of vessel of her obligation to keep out of Lakes, Western Rivers, or waters course, so far as possible the following the way. specified by the Secretary, and shall be avoided: proceeding downbound with a § 83.18 Responsibilities between vessels (1) An alteration of course to port for following current shall have the right-of- (Rule 18). a vessel forward of the beam, other than way over an upbound vessel, shall Except where Rules 9, 10, and 13 for a vessel being overtaken; and propose the manner of passage, and otherwise require: (2) An alteration of course toward a shall initiate the maneuvering signals (a) Power-driven vessels underway. A vessel abeam or abaft the beam. prescribed by Rule 34(a)(1), as power-driven vessel underway shall (e) Reduction of speed to minimum. appropriate. keep out of the way of: Except where it has been determined (1) A vessel not under command; § 83.15 Crossing situation (Rule 15). (2) A vessel restricted in her ability to that a risk of collision does not exist, (a) Vessel which must keep out of the maneuver; every vessel which hears apparently other vessel’s way. When two power- (3) A vessel engaged in fishing; and forward of her beam the fog signal of driven vessels are crossing so as to (4) A sailing vessel. another vessel, or which cannot avoid a involve risk of collision, the vessel (b) Sailing vessels underway. A sailing close-quarters situation with another which has the other on her starboard vessel underway shall keep out of the vessel forward of her beam, shall reduce side shall keep out of the way and shall, way of: her speed to the minimum at which she if the circumstances of the case admit, (1) A vessel not under command; can be kept on course. She shall if avoid crossing ahead of the other vessel. (2) A vessel restricted in her ability to necessary take all her way off and, in (b) Vessels crossing river. maneuver; and any , navigate with extreme Notwithstanding paragraph (a), on the (3) A vessel engaged in fishing. caution until danger of collision is over.

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Subpart C—Lights and Shapes (d) Towing light means a yellow light (1) A white all-round light, 3 miles. having the same characteristics as the § 83.20 Application (Rule 20). ’’sternlight’’ defined in paragraph (c) of § 83.23 Power-driven vessels underway (Rule 23). (a) Compliance in all weathers. Rules this Rule. in this part shall be complied with in all (e) All-round light means a light (a) Lights exhibited by power-driven weathers. showing an unbroken light over an arc vessels underway. A power-driven (b) Rules concerning lights complied of the horizon of 360 degrees. vessel underway shall exhibit: with from sunset to sunrise; other lights. (f) Flashing light means a light (1) A masthead light forward; The Rules concerning lights shall be flashing at regular intervals at a (2) A second masthead light abaft of complied with from sunset to sunrise, frequency of 120 flashes or more per and higher than the forward one; except and during such times no other lights . that a vessel of less than 50 meters in shall be exhibited, except such lights as (g) Special flashing light means a length shall not be obliged to exhibit cannot be mistaken for the lights yellow light flashing at regular intervals such light but may do so; specified in these Rules or do not impair at a frequency of 50 to 70 flashes per (3) Sidelights; and their visibility or distinctive character, minute, placed as far forward and as (4) A sternlight. (b) Air-cushion vessels. An air- or interfere with the keeping of a proper nearly as practicable on the fore and aft cushion vessel when operating in the lookout. centerline of the tow and showing an nondisplacement mode shall, in (c) Lights during daylight hours in unbroken light over an arc of the addition to the lights prescribed in restricted visibility; other circumstances. horizon of not less than 180 degrees nor paragraph (a) of this Rule, exhibit an all- The lights prescribed by these Rules more than 225 degrees and so fixed as round flashing yellow light where it can shall, if carried, also be exhibited from to show the light from right ahead to best be seen. sunrise to sunset in restricted visibility abeam and no more than 22.5 degrees (c) Alternative lights for power-driven and may be exhibited in all other abaft the beam on either side of the vessels of less than 12 meters in length. circumstances when it is deemed vessel. A power-driven vessel of less than 12 necessary. § 83.22 Visibility of lights (Rule 22). meters in length may, in lieu of the (d) Rules concerning shapes; The lights prescribed in these Rules lights prescribed in paragraph (a) of this compliance by day. The Rules shall have an intensity as specified in Rule, exhibit an all-round white light concerning shapes shall be complied Annex I to these Rules, so as to be and sidelights. with by day. visible at the following minimum (d) Power-driven vessels when (e) Annex. The lights and shapes ranges: operating on Great Lakes. A power- specified in these Rules shall comply (a) Vessel of 50 meters or more in driven vessel when operating on the with the provisions of Annex I of these length. In a vessel of 50 meters or more Great Lakes may carry an all-round Rules. in length: white light in lieu of the second § 83.21 Definitions (Rule 21). (1) A masthead light, 6 miles; masthead light and sternlight prescribed (2) A sidelight, 3 miles; in paragraph (a) of this Rule. The light (a) Masthead light means a white light (3) A sternlight, 3 miles; shall be carried in the position of the placed over the fore and aft centerline (4) A towing light, 3 miles; second masthead light and be visible at of the vessel showing an unbroken light (5) A white, red, green or yellow all- the same minimum range. over an arc of the horizon of 225 degrees round light, 3 miles; and and so fixed as to show the light from (6) A special flashing light, 2 miles. § 83.24 Towing and pushing (Rule 24). right ahead to 22.5 degrees abaft the (b) Vessels of 12 meters or more in (a) A power-driven vessel when towing beam on either side of the vessel, except length but less than 50 meters in length. astern. A power-driven vessel when that on a vessel of less than 12 meters In a vessel of 12 meters or more in towing astern shall exhibit: in length the masthead light shall be length but less than 50 meters in length: (1) Instead of the light prescribed placed as nearly as practicable to the (1) A masthead light, 5 miles; except either in Rule 23(a)(1) or 23(a)(2), two fore and aft centerline of the vessel. that where the length of the vessel is masthead lights in a vertical line. When (b) Sidelights mean a green light on less than 20 meters, 3 miles; the length of the tow, measuring from the starboard side and a red light on the (2) A sidelight, 2 miles; the stern of the towing vessel to the after port side each showing an unbroken (3) A sternlight, 2 miles; end of the tow exceeds 200 meters, three light over an arc of the horizon of 112.5 (4) A towing light, 2 miles; such lights in a vertical line; degrees and so fixed as to show the light (5) A white, red, green or yellow all- (2) Sidelights; from right ahead to 22.5 degrees abaft round light, 2 miles; and (3) A sternlight; the beam on its respective side. On a (6) A special flashing light, 2 miles. (4) A towing light in a vertical line vessel of less than 20 meters in length (c) Vessels of less than 12 meters in above the sternlight; and the side lights may be combined in one length. In a vessel of less than 12 meters (5) When the length of the tow lantern carried on the fore and aft in length: exceeds 200 meters, a diamond shape centerline of the vessel, except that on (1) A masthead light, 2 miles; where it can best be seen. a vessel of less than 12 meters in length (2) A sidelight, 1 mile; (b) Pushing vessel and pushed vessel the sidelights when combined in one (3) A sternlight, 2 miles; rigidly connected in composite unit. lantern shall be placed as nearly as (4) A towing light, 2 miles; When a pushing vessel and a vessel practicable to the fore and aft centerline (5) A white, red, green or yellow all- being pushed ahead are rigidly of the vessel. round light, 2 miles; and connected in a composite unit they shall (c) Sternlight means a white light (6) A special flashing light, 2 miles. be regarded as a power-driven vessel placed as nearly as practicable at the (d) An inconspicuous, partly and exhibit the lights prescribed in Rule stern showing an unbroken light over an submerged vessel or objects being 23. arc of the horizon of 135 degrees and so towed. In an inconspicuous, partly (c) A power-driven vessel when fixed as to show the light 67.5 degrees submerged vessel or objects being pushing ahead or towing alongside. A from right aft on each side of the vessel. towed: power-driven vessel when pushing

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ahead or towing alongside, except as indicate its presence to an approaching paragraph (a) or (b) of this Rule, but if required by paragraphs (b) and (1) of vessel. she does not, she shall have ready at this Rule, shall exhibit: (h) Alternative lighting of vessel or hand an electric torch or lighted lantern (1) Instead of the light prescribed object being towed. Where from any showing a white light which shall be either in Rule 23(a)(1) or 23(a)(2), two sufficient cause it is impracticable for a exhibited in sufficient time to prevent masthead lights in a vertical line; vessel or object being towed to exhibit collision. (2) Sidelights; and the lights prescribed in paragraph (e) or (2) A vessel under oars may exhibit (3) Two towing lights in a vertical (g) of this Rule, all possible measures the lights prescribed in this Rule for line. shall be taken to light the vessel or sailing vessels, but if she does not, she (d) Compliance with other object towed or at least to indicate the shall have ready at hand an electric requirements. A power-driven vessel to presence of the unlighted vessel or torch or lighted lantern showing a white which paragraphs (a) or (c) of this Rule object. light which shall be exhibited in apply shall also comply with Rule (i) Western Rivers or other specified sufficient time to prevent collision. 23(a)(1) and 23(a)(2). waters; exception. Notwithstanding (e) Vessels being towed. A vessel or (e) Vessels proceeding under sail. A paragraph (c), on the Western Rivers vessel proceeding under sail when also object other than those referred to in (except below the Huey P. Long Bridge paragraph (g) of this Rule being towed being propelled by machinery shall on the Mississippi River) and on waters exhibit forward where it can best be shall exhibit: specified by the Secretary, a power- (1) Sidelights; seen a conical shape, apex downward. (2) A sternlight; and driven vessel when pushing ahead or A vessel of less than 12 meters in length (3) When the length of the tow towing alongside, except as paragraph is not required to exhibit this shape, but exceeds 200 meters, a diamond shape (b) applies, shall exhibit: may do so. (1) Sidelights; and where it can best be seen. § 83.26 Fishing vessels (Rule 26). (f) Vessels being towed alongside or (2) Two towing lights in a vertical pushed in a group. Provided that any line. (a) Exhibition of only prescribed lights number of vessels being towed (j) Towing another vessel in distress or and shapes. A vessel engaged in fishing, alongside or pushed in a group shall be otherwise in need of assistance. Where whether underway or at anchor, shall lighted as one vessel, except as provided from any sufficient cause it is exhibit only the lights and shapes in paragraph (3)— impracticable for a vessel not normally prescribed in this Rule. (1) A vessel being pushed ahead, not engaged in towing operations to display (b) Vessels engaged in trawling. A being part of a composite unit, shall the lights prescribed by paragraph (a), vessel when engaged in trawling, by exhibit at the forward end, sidelights (c) or (i) of this Rule, such vessel shall which is meant the dragging through the and a special flashing light; not be required to exhibit those lights water of a dredge net or other apparatus (2) A vessel being towed alongside when engaged in towing another vessel used as a fishing appliance, shall shall exhibit a sternlight and at the in distress or otherwise in need of exhibit: forward end, sidelights and a special assistance. All possible measures shall (1) Two all-round lights in a vertical flashing light; and be taken to indicate the nature of the line, the upper being green and the (3) When vessels are towed alongside relationship between the towing vessel lower white, or a shape consisting of on both sides of the towing vessels a and the vessel being assisted. The two cones with their apexes together in sternlight shall be exhibited on the stern searchlight authorized by Rule 36 may a vertical line one above the other; of the outboard vessel on each side of be used to illuminate the tow. (2) A masthead light abaft of and the towing vessel, and a single set of higher than the all-round green light; a sidelights as far forward and as far § 83.25 Sailing vessels underway and vessels under oars (Rule 25). vessel of less than 50 meters in length outboard as is practicable, and a single (a) Sailing vessels underway. A sailing shall not be obliged to exhibit such a special flashing light. light but may do so; and (g) An inconspicuous, partly vessel underway shall exhibit: (1) Sidelights; and (3) When making way through the submerged vessel or object being towed. water, in addition to the lights An inconspicuous, partly submerged (2) A sternlight. (b) Sailing vessels of less than 20 prescribed in this paragraph, sidelights vessel or object being towed shall and a sternlight. exhibit: meters in length. In a sailing vessel of (1) If it is less than 25 meters in less than 20 meters in length the lights (c)Vessels engaged in fishing other breadth, one all-round white light at or prescribed in paragraph (a) of this Rule than trawling. A vessel engaged in near each end; may be combined in one lantern carried fishing, other than trawling, shall (2) If it is 25 meters or more in at or near the top of the mast where it exhibit: breadth, four all-round white lights to can best be seen. (1) Two all-round lights in a vertical mark its length and breadth; (c) Additional lights. A sailing vessel line, the upper being green and the (3) If it exceeds 100 meters in length, underway may, in addition to the lights lower white, or a shape consisting of additional all-round white lights prescribed in paragraph (a) of this Rule, two cones with their apexes together in between the lights prescribed in exhibit at or near the top of the mast, a vertical line one above the other; subparagraphs (1) and (2) so that the where they can best be seen, two all- (2) A masthead light abaft of and distance between the lights shall not round lights in a vertical line, the upper higher than the all-round green light; a exceed 100 meters: Provided, that any being red and the lower green, but these vessel of less than 50 meters in length vessels or objects being towed alongside lights shall not be exhibited in shall not be obliged to exhibit such a each other shall be lighted as one vessel conjunction with the combined lantern light but may do so; and or object; permitted by paragraph (b) of this Rule. (3) When making way through the (4) A diamond shape at or near the (d) Sailing vessels of less than 7 water, in addition to the lights aftermost extremity of the last vessel or meters in length; vessels under oars. prescribed in this paragraph, sidelights object being towed; and (1) A sailing vessel of less than 7 and a sternlight. (5) The towing vessel may direct a meters in length shall, if practicable, (c) Vessels engaged in fishing other searchlight in the direction of the tow to exhibit the lights prescribed in than trawling. A vessel engaged in

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fishing, other than trawling, shall towing operation which severely assistance. Such signals are contained in exhibit: restricts the towing vessel and her tow Annex IV to these Rules. (1) Two all-round lights in a vertical in their ability to deviate from their line, the upper being red and the lower course shall, in addition to the lights or § 83.28 [Reserved] (Rule 28). white, or a shape consisting of two shapes prescribed in subparagraphs § 83.29 Pilot vessels (Rule 29). cones with apexes together in a vertical (b)(1) and (2) of this Rule, exhibit the (a) Vessels engaged on pilotage duty. line one above the other; lights or shape prescribed in Rule 24. A vessel engaged on pilotage duty shall (2) When there is outlying gear (d) Vessels engaged in dredging or exhibit: extending more than 150 meters underwater operations. A vessel (1) At or near the masthead, two all- horizontally from the vessel, an all- engaged in dredging or underwater round lights in a vertical line, the upper round white light or a cone apex operations, when restricted in her being white and the lower red; upward in the direction of the gear; and ability to maneuver, shall exhibit the (2) When underway, in addition, (3) When making way through the lights and shapes prescribed in sidelights and a sternlight; and water, in addition to the lights subparagraphs (b)(1), (2), and (3) of this (3) When at anchor, in addition to the prescribed in this paragraph, sidelights Rule and shall in addition, when an lights prescribed in subparagraph (1), and a sternlight. obstruction exists, exhibit: (d) Vessels engaged in fishing in close (1) Two all-round red lights or two the anchor light, lights, or shape proximity to other vessels engaged in balls in a vertical line to indicate the prescribed in Rule 30 for anchored fishing. The additional signals described side on which the obstruction exists; vessels. in Annex II to these Rules apply to a (2) Two all-round green lights or two (b) Vessels when not engaged on vessel engaged in fishing in close diamonds in a vertical line to indicate pilotage duty. A pilot vessel when not proximity to other vessels engaged in the side on which another vessel may engaged on pilotage duty shall exhibit fishing. pass; and the lights or shapes prescribed for a (e) Vessels when not engaged in (3) When at anchor, the lights or vessel of her length. fishing. A vessel when not engaged in shape prescribed by this paragraph, § 83.30 Anchored vessels and vessels fishing shall not exhibit the lights or instead of the lights or shapes aground (Rule 30). prescribed in Rule 30 for anchored shapes prescribed in this Rule, but only (a) Vessels at anchor. A vessel at vessels. those prescribed for a vessel of her anchor shall exhibit where it can best be length. (e) Vessels engaged in diving operations. Whenever the size of a seen: § 83.27 Vessels not under command or vessel engaged in diving operations (1) In the fore part, an all-round white restricted in their ability to maneuver (Rule makes it impracticable to exhibit all light or one ball; and 27). lights and shapes prescribed in (2) At or near the stern and at a lower (a) Vessels not under command. A paragraph (d) of this Rule, the following level than the light prescribed in vessel not under command shall exhibit: shall instead be exhibited: subparagraph (1), an all-round white (1) Two all-round red lights in a (1) Three all-round lights in a vertical light. vertical line where they can best be line where they can best be seen. The (b) Vessels of less than 50 meters in seen; highest and lowest of these lights shall length; alternative light. A vessel of less (2) Two balls or similar shapes in a be red and the middle light shall be than 50 meters in length may exhibit an vertical line where they can best be white. all-round white light where it can best seen; and (2) A rigid replica of the international be seen instead of the lights prescribed (iii) When making way through the Code flag ’’A’’ not less than 1 meter in in paragraph (a) of this Rule. water, in addition to the lights height. Measures shall be taken to (c) Illumination of decks. A vessel at prescribed in this paragraph, sidelights insure its all-round visibility. anchor may, and a vessel of 100 meters and a sternlight. (f) Vessels engaged in mineclearance or more in length shall, also use the (b) Vessels restricted in their ability to operations. A vessel engaged in available working or equivalent lights to maneuver. A vessel restricted in her mineclearance operations shall, in illuminate her decks. ability to maneuver, except a vessel addition to the lights prescribed for a (d) Vessels aground. A vessel aground engaged in mineclearance operations, power-driven vessel in Rule 23 or to the shall exhibit the lights prescribed in shall exhibit: lights or shape prescribed for a vessel at paragraph (a) or (b) of this Rule and in (1) Three all-round lights in a vertical anchor in Rule 30, as appropriate, addition, if practicable, where they can line where they can best be seen. The exhibit three all-round green lights or best be seen: highest and lowest of these lights shall three balls. One of these lights or shapes (1) Two all-round red lights in a be red and the middle light shall be shall be exhibited near the foremast vertical line; and white; head and one at each end of the fore (2) Three balls in a vertical line. (2) Three shapes in a vertical line yard. These lights or shapes indicate (e) Vessels of less than 7 meters in where they can best be seen. The that it is dangerous for another vessel to length when at anchor. A vessel of less highest and lowest of these shapes shall approach within 1,000 meters of the than 7 meters in length, when at anchor, be balls and the middle one a diamond; mineclearance vessel. not in or near a narrow channel, (3) When making way through the (g) Vessels of less than 12 meters in fairway, anchorage, or where other water, masthead lights, sidelights and a length. A vessel of less than 12 meters vessels normally navigate, shall not be sternlight, in addition to the lights in length, except when engaged in required to exhibit the lights or shape prescribed in subparagraph (b)(1); and diving operations, is not required to prescribed in paragraphs (a) and (b) of (4) When at anchor, in addition to the exhibit the lights or shapes prescribed this Rule. lights or shapes prescribed in in this Rule. (f) Vessels of less than 12 meters in subparagraphs (b)(1) and (2), the light, (h) Signals of vessels in distress and length when aground. A vessel of less lights or shapes prescribed in Rule 30. requiring assistance. The signals than 12 meters in length when aground (c) Vessels engaged in towing prescribed in this Rule are not signals of shall not be required to exhibit the operations. A vessel engaged in a vessels in distress and requiring lights or shapes prescribed in

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subparagraphs (d)(1) and (2) of this (1) Shall indicate that maneuver by an area of a channel or fairway where Rule. the following signals on her whistle: one other vessels may be obscured by an (g) Vessels of less than 20 meters in short blast to mean ‘‘I intend to leave intervening obstruction shall sound one length while at anchor in special you on my port side’’; two short blasts prolonged blast. This signal shall be anchorage. A vessel of less than 20 to mean ‘‘I intend to leave you on my answered with a prolonged blast by any meters in length, when at anchor in a starboard side’’; and three short blasts to approaching vessel that may be within special anchorage area designated by the mean ‘‘I am operating astern hearing around the bend or behind the Secretary, shall not be required to propulsion’’. intervening obstruction. exhibit the anchor lights and shapes (2) Upon hearing the one or two blast (f) Use of one whistle only on a vessel. required by this Rule. signal of the other shall, if in agreement, If whistles are fitted on a vessel at a sound the same whistle signal and take distance apart of more than 100 meters, § 83.31 Seaplanes (Rule 31). the steps necessary to effect a safe one whistle only shall be used for giving Where it is impracticable for a passing. If, however, from any cause, the maneuvering and warning signals. seaplane to exhibit lights and shapes of vessel doubts the safety of the proposed (g) Power-driven vessels leaving dock the characteristics or in the positions maneuver, she shall sound the danger or berth. When a power-driven vessel is prescribed in the Rules of this part she signal specified in paragraph (d) of this leaving a dock or berth, she shall sound shall exhibit lights and shapes as closely Rule and each vessel shall take one prolonged blast. similar in characteristics and position as appropriate precautionary action until a (h) Agreement between vessels using is possible. safe passing agreement is made. radiotelephone. A vessel that reaches (b) Light signals. A vessel may agreement with another vessel in a Subpart D—Sound and Light Signals supplement the whistle signals head-on, crossing, or overtaking situation, as for example, by using the § 83.32 Definitions (Rule 32). prescribed in paragraph (a) of this Rule by light signals: radiotelephone as prescribed by the (a) Whistle means any sound signaling (1) These signals shall have the Vessel Bridge-to-Bridge Radiotelephone appliance capable of producing the following significance: one flash to Act (85 Stat. 164; 33 U.S.C. 1201 et prescribed blasts and which complies mean ‘‘I intend to leave you on my port seq.), is not obliged to sound the whistle with specifications in Annex III to these side’’; two flashes to mean ‘‘I intend to signals prescribed by this Rule, but may Rules. leave you on my starboard side’’; three do so. If agreement is not reached, then (b) Short blast means a blast of about flashes to mean ‘‘I am operating astern whistle signals shall be exchanged in a 1 second’s . propulsion’’; timely manner and shall prevail. (c) Prolonged blast means a blast of (2) The duration of each flash shall be from 4 to 6 second’s duration. about 1 second; and § 83.35 Sound signals in restricted (3) The light used for this signal shall, visibility (Rule 35). § 83.33 Equipment for sound signals (Rule if fitted, be one all-round white or In or near an area of restricted 33). yellow light, visible at a minimum range visibility, whether by day or night, the (a) Vessels of 12 meters or more in of 2 miles, synchronized with the signals prescribed in this Rule shall be length. A vessel of 12 meters or more in whistle, and shall comply with the used as follows: length shall be provided with a whistle provisions of Annex I to these Rules. (a) Power-driven vessels making way and a bell and a vessel of 100 meters or (c) Overtaking situations. When in through the water. A power-driven more in length shall, in addition, be sight of one another: vessel making way through the water provided with a gong, the tone and (1) A power-driven vessel intending shall sound at intervals of not more than sound of which cannot be confused to overtake another power-driven vessel 2 one prolonged blast. with that of the bell. The whistle, bell shall indicate her intention by the (b) Power-driven vessels underway but and gong shall comply with the following signals on her whistle: one stopped and making no way through the specifications in Annex III to these short blast to mean ‘‘I intend to overtake water. A power-driven vessel underway Rules. The bell or gong or both may be you on your starboard side’’; two short but stopped and making no way through replaced by other equipment having the blasts to mean ‘‘I intend to overtake you the water shall sound at intervals of not same respective sound characteristics, on your port side’’; and more than 2 minutes two prolonged provided that manual sounding of the (2) The power-driven vessel about to blasts in succession with an interval of prescribed signals shall always be be overtaken shall, if in agreement, about 2 between them. possible. sound a similar sound signal. If in doubt (c) Vessels not under command; (b) Vessels of less than 12 meters in she shall sound the danger signal vessels restricted in ability to maneuver; length. A vessel of less than 12 meters prescribed in paragraph (d). sailing vessels; vessels engaged in in length shall not be obliged to carry (d) Doubts or failure to understand fishing; vessels engaged in towing or the sound signaling appliances signals. When vessels in sight of one pushing. A vessel not under command; prescribed in paragraph (a) of this Rule another are approaching each other and a vessel restricted in her ability to but if she does not, she shall be from any cause either vessel fails to maneuver, whether underway or at provided with some other means of understand the intentions or actions of anchor; a sailing vessel; a vessel making an efficient sound signal. the other, or is in doubt whether engaged in fishing, whether underway sufficient action is being taken by the or at anchor; and a vessel engaged in § 83.34 Maneuvering and warning signals other to avoid collision, the vessel in towing or pushing another vessel shall, (Rule 34). doubt shall immediately indicate such instead of the signals prescribed in (a) Whistle signals. When power- doubt by giving at least five short and paragraphs (a) or (b) of this Rule, sound driven vessels are in sight of one rapid blasts on the whistle. This signal at intervals of not more than 2 minutes, another and meeting or crossing at a may be supplemented by a light signal three blasts in succession; namely, one distance within half a mile of each of at least five short and rapid flashes. prolonged followed by two short blasts. other, each vessel underway, when (e) Vessels in areas of obscured (d) Vessels towed. A vessel towed or maneuvering as authorized or required visibility due to intervening if more than one vessel is towed the last by these Rules: obstructions. A vessel nearing a bend or vessel of the tow, if manned, shall at

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intervals of not more than 2 minutes elsewhere in these Rules, or may direct effective date of the Inland Navigational sound four blasts in succession; namely, the beam of her searchlight in the Rules Act of 1980 (Pub. L. 96–591); one prolonged followed by three short direction of the danger, in such a way (6) Power-driven vessels of 12 meters blasts. When practicable, this signal as not to embarrass any vessel. or more but less than 20 meters in shall be made immediately after the length are permanently exempt from the signal made by the towing vessel. § 83.37 Distress signals (Rule 37). provisions of Rule 23(a)(1) and 23(a)(4) (e) Pushing and pushed vessels When a vessel is in distress and provided that, in place of these lights, connected in composite unit. When a requires assistance she shall use or the vessel exhibits a white light aft pushing vessel and a vessel being exhibit the signals described in Annex visible all round the horizon; and pushed ahead are rigidly connected in IV to these Rules. (7) The requirements for sound signal a composite unit they shall be regarded appliances prescribed in Annex III to Subpart E—Exemptions as a power-driven vessel and shall give these Rules, until 9 years after the the signals prescribed in paragraphs (a) § 83.38 Exemptions (Rule 38). effective date of the Inland Navigational or (b) of this Rule. Any vessel or class of vessels, the keel Rules Act of 1980 (Pub. L. 96–591). (f) Vessels at anchor. A vessel at of which is laid or which is at a Dated: March 31, 2010. anchor shall at intervals of not more corresponding stage of construction Kevin S. Cook, than 1 minute ring the bell rapidly for before December 24, 1980, provided that about 5 seconds. In a vessel of 100 Rear Admiral, U.S. Coast Guard, Director of she complies with the requirements of— Prevention Policy. meters or more in length the bell shall (a) The Act of June 7, 1897, (30 Stat. be sounded in the forepart of the vessel [FR Doc. 2010–8532 Filed 4–14–10; 8:45 am] 96), as amended (33 U.S.C. 154–232) for and immediately after the ringing of the BILLING CODE 9110–04–P vessels navigating the waters subject to bell the gong shall be sounded rapidly that statute; for about 5 seconds in the after part of (b) Section 4233 of the Revised NATIONAL ARCHIVES AND RECORDS the vessel. A vessel at anchor may in Statutes (33 U.S.C. 301–356) for vessels ADMINISTRATION addition sound three blasts in navigating the waters subject to that succession; namely, one short, one statute; 36 CFR Parts 1200, 1253, and 1280 prolonged and one short blast, to give (c) The Act of February 8, 1895 (28 warning of her position and of the Stat. 645), as amended (33 U.S.C. 241– [FDMS Docket NARA–10–0002] possibility of collision to an 295) for vessels navigating the waters approaching vessel. subject to that statute; or RIN 3095–AB66 (g) Vessels aground. A vessel aground (d) Sections 3, 4, and 5 of the Act of shall give the bell signal and if required NARA Facility Locations and Hours April 25, 1940 (54 Stat. 163), as the gong signal prescribed in paragraph amended (46 U.S.C. 526b, c, and d) for AGENCY: National Archives and Records (f) of this Rule and shall, in addition, motorboats navigating the waters subject Administration (NARA). give three separate and distinct strokes to that statute; shall be exempted from on the bell immediately before and after ACTION: Direct final rule. compliance with the technical Annexes the rapid ringing of the bell. A vessel to these Rules as follows: SUMMARY: NARA is amending several of aground may in addition sound an (1) The installation of lights with its regulations; the amendments include appropriate whistle signal. ranges prescribed in Rule 22, until 4 a change to the naming convention for (h) Vessels of less than 12 meters in years after the effective date of the the regional archives, a new logo for length. A vessel of less than 12 meters Inland Navigational Rules Act of 1980 NARA’s regional records service office, in length shall not be obliged to give the (Pub. L. 96–591), except that vessels of and the addition of facility information above-mentioned signals but, if she does less than 20 meters in length are for the locations of two NARA records not, shall make some other efficient permanently exempt; centers. NARA is changing the naming sound signal at intervals of not more (2) The installation of lights with convention for the regional archives, than 2 minutes. currently identified in the regulations (i) Pilot vessels. A pilot vessel when color specifications as prescribed in by a geographic location following the engaged on pilotage duty may in Annex I to these Rules, until 4 years name of the region (e.g. NARA- addition to the signals prescribed in after the effective date of the Inland Northeast Region (Boston)). The Office paragraphs (a), (b) or (f) of this Rule Navigational Rules Act of 1980 (Pub. L. of Regional Records Services has sound an identity signal consisting of 96–591), except that vessels of less than determined that the naming convention four short blasts. 20 meters in length are permanently ‘‘ (j) Vessels anchored in special exempt; The National Archives at [metropolitan ’’ anchorage areas. The following vessels (3) The repositioning of lights as a city name] will better identify to the shall not be required to sound signals as result of conversion to metric units and public the services provided by NARA’s prescribed in paragraph (f) of this Rule rounding off measurement figures, are regional archives located throughout the when anchored in a special anchorage permanently exempt; and U.S. In conjunction with the new area designated by the Secretary: (4) The horizontal repositioning of naming convention, the NARA (1) A vessel of less than 20 meters in masthead lights prescribed by Annex I headquarters office that administers length; and to these Rules: NARA’s regional records services, the (2) A barge, canal boat, scow, or other (i) On vessels of less than 150 meters Office of the Regional Records Services, nondescript craft. in length, permanent exemption. has designed a new logo for the (ii) On vessels of 150 meters or more headquarters office; each of the regional § 83.36 Signals to attract attention (Rule in length, until 9 years after the effective archives will customize the logo by 36). date of the Inland Navigational Rules including their specific city name. The If necessary to attract the attention of Act of 1980 (Pub. L. 96–591). Federal Records Center Program of the another vessel, any vessel may make (5) The restructuring or repositioning Office of the Regional Records Services light or sound signals that cannot be of all lights to meet the prescriptions of has also added two facilities to its list mistaken for any signal authorized Annex I to these, until 9 years after the of locations. Because this rulemaking is

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a direct final rulemaking, the effective archives, the Office of Regional Records facilities or changes of services to the date will be the date of publication. Services has designed a new logo. The public. Moreover, the public benefits DATES: Effective April 15, 2010 without new logo for the headquarters staff for immediately with correct addresses and further action, unless adverse comment the regional archives and corresponding hours for NARA’s facilities and any is received by May 17, 2010. If adverse logos for the individual regional delay in the effective date would be comment is received, NARA will archives will provide the visual contrary to the public interest. The publish a timely withdrawal of the rule connection for the public akin to the adoption of the logo for the Office of in the Federal Register. naming convention. Regional Records Services, as well as The regional archives facilities in FOR FURTHER INFORMATION CONTACT: the facility name changes also assists Boston and Kansas City have modified Laura McCarthy at 301–837–3023. the public in recognizing and locating their hours to increase the public access. NARA facilities outside the Washington, SUPPLEMENTARY INFORMATION: NARA is The new hours in Boston and Kansas DC, area. revising several of its regulations; a City have been changed on the NARA This direct final rule is not a change to the naming convention for the web site and the revisions to the significant regulatory action for the regional archives, addition of a new logo regulations reflect these changes. The purposes of Executive Order 12866 and for the regional archives administered new hours are Monday, Tuesday, has not been reviewed by the Office of by NARA’s Regional Records Service Wednesday, Friday, 7 a.m. to 4:30 p.m., Management and Budget (OMB). As Office, and the addition of facility Thursday, 7 a.m. to 9 p.m., and some required by the Regulatory Flexibility information for the locations of two Saturday hours; previously, the facility Act, it is hereby certified that this rule NARA records centers. hours were 8 a.m. to 4:30 p.m., Monday will not have a significant impact on a The regional archives are currently through Friday. The National Archives substantial number of small entities identified in the regulations by a at Kansas City has changed it hours to because this rule applies to individual geographic location following the name provide greater public access, also. The researchers. This rule does not have any of the region (e.g. NARA-Northeast facility is open from 8 a.m. to 4 p.m. for federalism implications. Region (Boston)). The Office of Regional research and the exhibit area is open Records Services has determined that from 9 a.m. to 5 p.m. List of Subjects the naming convention ‘‘The National The Federal Records Center Program 36 CFR Part 1200 Archives at [metropolitan city name]’’ of the Office of the Regional Records will better connect the public to the Services has added two facilities to its Seals and insignia. services provided by NARA’s regional list of locations. The NARA-Great Lakes 36 CFR Part 1253 archives located throughout the U.S. Region (Dayton-Miamisburg) has been This new name, similar to the name in operation since February 2003, but Archives and records. long used for ‘‘The National Archives at was not added to the list of facilities. 36 CFR Part 1280 College Park,’’ will be used on The second facility, NARA-Great Plains brochures, other outreach materials, and Region (Lenexa), was established in Federal buildings and facilities. signage for better identification by the February 2003 and since it began ■ For the reasons set forth in the public. The names are: operations, it has received records from preamble, NARA amends parts 1200, The National Archives at Anchorage; the Veterans Administration and other 1253, and 1280 of title 36, Code of The National Archives at Atlanta; federal agencies; the records center at Federal Regulations, as follows: The National Archives at Boston; Lenexa also received records formerly The National Archives at Chicago; stored at the NARA records center on PART 1200—OFFICIAL SEALS The National Archives at Denver; Bannister Road in Kansas City before its ■ 1. The authority citation for part 1200 The National Archives at Fort Worth; closure. continues to read as follow: The National Archives at Kansas City; This rule is effective upon publication The National Archives at New York; for ‘‘good’’ cause as permitted by the Authority: 18 U.S.C. 506, 701, and 1017; 44 The National Archives at Administrative Procedure Act (5 U.S.C. U.S.C. 2104(e), 2116(b), 2302. Philadelphia; 553(d)(3)). NARA believes that delaying ■ 2. Amend § 1200.7 by adding The National Archives at Riverside; the effective date for 30 days is paragraph (a)(9) to read as follows: The National Archives at San unnecessary as this rule represents Francisco; minor technical amendments. NARA § 1200.7 What are NARA logos and how The National Archives at Seattle; also believes a comment period are they used? The National Archives at St. Louis, provided by notice of proposed * * * * * National Personnel Records Center. rulemaking (5 U.S.C. 553(b)(B) is (a) * * * In conjunction with the change to the unnecessary as there are no changes to (9) Regional archives: naming convention for the regional the public’s ability to access the (i)

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(ii) Each regional archives has the New York, NY 10014–4811 (the P.O. Box 25307, Denver, CO 80225– same logo design with the geographic entrance is on Houston Street between 0307). The hours are 7:30 a.m. to 3:45 location of the facility added. Varick and Hudson). The hours are 9 p.m., Monday through Friday. The * * * * * a.m. to 5 p.m., Monday through Friday, telephone number is 303–407–5751. and some Saturday hours. The (i) The National Archives at Riverside PART 1253—LOCATION OF RECORDS telephone number is 212–401–1620, and is located at 23123 Cajalco Road, Perris, AND HOURS OF USE toll-free at 1–866–840–1752. CA 92570. The hours are 8 a.m. to 4:30 (c) The National Archives at p.m., Monday through Friday. The ■ 3. The authority citation for part 1253 Philadelphia is located at the Robert telephone number is 951–956–2000. continues to read as follows: N.C. Nix Federal Building, 900 Market (j) The National Archives at San Authority: 44 U.S.C. 2104(a). St., Philadelphia, PA 19107–4292 Francisco is located at 1000 Commodore (Entrance is on Chestnut Street between Dr., San Bruno, CA 94066–2350. The ■ 4. In § 1253.6: 9th and 10th Streets). The hours are 8 hours are 7:30 a.m. to 4 p.m., Monday ■ a. Remove paragraph (g); a.m. to 5 p.m., Monday through Friday, ■ through Friday. The telephone number b. Redesignate paragraph (f) as (g); and some Saturday hours. The is 650–238–3501. ■ c. Redesignate paragraphs (i) through telephone number is 215–606–0100. (k) The National Archives at Seattle is (m) as (j) through (n); and (d) The National Archives at Atlanta ■ located at 6125 Sand Point Way, NE., d. Add paragraphs (f) and (i) as is located at 5780 Jonesboro Road, follows: Seattle, WA 98115–7999. The hours are Morrow, GA 230260. The hours are 8:30 7:45 a.m. to 4:15 p.m., Monday through § 1253.6 Records Centers. a.m. to 5 p.m., Tuesday through Friday, and some Saturday hours. The * * * * * Saturday. The telephone number is 770– telephone number is 206–336–5115. (f) NARA-Great Lakes Region (Dayton- 968–2100. (l) The National Archives at Miamisburg) is located at 8801 (e) The National Archives at Chicago Anchorage is located at 654 West Third Kingsridge Drive, Dayton, OH 45458. is located at 7358 S. Pulaski Rd., Avenue, Anchorage, AK 99501–2145. The hours are 8:30 a.m. to 5 p.m., Chicago, IL 60629–5898. The hours are The hours are 8 a.m. to 4 p.m., Monday Monday through Friday. The telephone 8 a.m. to 4:15 p.m., Monday through through Friday, and some Saturday number is (937) 425–0601. Friday, and some Saturday hours. The hours. The telephone number is 907– (i) NARA-Central Plains Region telephone number is 773–948–9000. 261–7820. (f) The National Archives at Kansas (Lenexa) is located at 17501 W. 98th (m) The National Archives at St. City is located at 400 West Pershing Street, Lenexa, KS 66219. The hours are Louis, the National Personnel Records Road, Kansas City, MO 64108–4306. 8 a.m. to 3:30 p.m., Monday through Center archival research room is located The hours are Tuesday through Friday. The telephone number is 913– at 9700 Page Ave., St. Louis, MO 63132– Saturday: Eexhibits: 9 a.m. to 5 p.m.; 563–7600. 5100. The hours are 10 a.m. to 4 p.m., research rooms: 8 a.m. to 4 p.m. The * * * * * Tuesday through Friday, except Federal telephone number is 816–268–8000. ■ 5. Revise § 1253.7 to read as follows: holidays. (g) The National Archives at Fort § 1253.7 Regional Archives. Worth is located at 1400 John Burgess PART 1280—USE OF NARA (a) The National Archives at Boston is Drive, Fort Worth, TX 76140 (mailing FACILITIES located in the Frederick C. Murphy address: P.O. Box 6216, Fort Worth, TX Federal Center, 380 Trapelo Rd., 76115–0216). The hours are 6:30 a.m. to ■ 6. The authority citation for part 1280 Waltham, MA 02452. Hours are 4 p.m., Monday through Friday. The continues to read as follows: telephone number is 817–551–2051. Monday, Tuesday, Wednesday, Friday, Authority: 44 U.S.C. 2102 notes, 2104(a), 7 a.m. to 4:30 p.m., Thursday, 7 a.m. to (h) The National Archives at Denver: 2112, 2903. 9 p.m., and some Saturday hours. The The Textual Research room is located at telephone number is 781–663–0130. Building 48, Denver Federal Center, ■ 7. Amend § 1280.2 by revising The National Archives at Boston, West 6th Ave. and Kipling Street, paragraph (d) to read as follows: Pittsfield Annex is located at 10 Conte Denver, CO. The hours are 7:30 a.m. to Drive, Pittsfield, MA 01201–8230. The 3:45 p.m., Monday through Friday. The § 1280.2 What property is under the hours are 8 a.m. to 4:30 p.m., Monday telephone number is 303–407–5740. control of the Archivist of the United through Friday. The telephone number The Microfilm Research room is located States? is 413–236–3600. at Building 46, Denver Federal Center, * * * * * (b) The National Archives at New West 6th Ave. and Kipling Street, (d) The National Archives at Atlanta. York City is located at 201 Varick St., Denver, CO. (The mailing address is: The National Archives at Atlanta in

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Morrow, Georgia, as specified in 36 CFR or Board), by telephone at (571) 272– U.S.C. 553 (or any other law), neither a 1253.7(d). 9797, or by mail addressed to: Mail Stop regulatory flexibility analysis nor a * * * * * Interference, Director of the United certification under the Regulatory ■ 8. Amend § 1280.12 by revising States Patent and Trademark Office, Flexibility Act (5 U.S.C. 601 et seq.) is paragraph (c) to read as follows: P.O. Box 1450, Alexandria, VA 22313– required. See 5 U.S.C. 603. 1450, marked to the attention of James C. Executive Order 12866 (Regulatory § 1280.12 Is parking available? T. Moore, at the BPAI. Planning and Review): This rule making * * * * * SUPPLEMENTARY INFORMATION: 37 CFR has been determined to be not (c) Records services facilities. Most 41.200(b) (2004) provides: ‘‘A claim significant for purposes of Executive records services facilities have onsite shall be given its broadest reasonable Order 12866 (Sept. 30, 1993). parking available for researchers. construction in light of the specification D. Executive Order 13132 Parking at these facilities and at the of the application or patent in which it (Federalism): This rule making does not Washington National Records Center is appears.’’ On June 4, 2009, the Federal contain policies with federalism governed by GSA regulations, Circuit in Agilent determined that 37 implications sufficient to warrant Management of Buildings and Grounds, CFR 41.200(b) does not apply in an preparation of a Federalism Assessment found at 41 CFR part 101–20. The interference proceeding in the instance under Executive Order 13132 (Aug. 4, National Archives at Philadelphia on where one party challenges another’s 1999). Market Street (in Philadelphia) and the written description. The Court held: E. Executive Order 13175 (Tribal National Archives at New York City do ‘‘[W]hen a party challenges written Consultation): This rule making will not have onsite parking. However, there description support for an interference not: (1) Have substantial direct effects is ample parking in commercial parking count or the copied claim in an on one or more Indian tribes; (2) impose garages near these facilities. interference, the originating disclosure substantial direct compliance costs on * * * * * provides the meaning of the pertinent Indian tribal governments; or (3) preempt tribal law. Therefore, a tribal Dated: April 7, 2010. claim language.’’ Agilent, 567 F.3d at 1375. The Court also noted that ‘‘[w]hen summary impact statement is not David S. Ferriero, a party challenges a claim’s validity required under Executive Order 13175 Archivist of the United States. under 35 U.S.C. 102 or 103, however, (Nov. 6, 2000). [FR Doc. 2010–8567 Filed 4–14–10; 8:45 am] this court and the Board must interpret F. Executive Order 13211 (Energy BILLING CODE 7515–01–P the claim in light of the specification in Effects): This rule making is not a which it appears.’’ Id. Addressing the significant energy action under issue again in Koninklijke Philips Executive Order 13211 because this rule DEPARTMENT OF COMMERCE Electronics N.V. v. Cardiac Science making is not likely to have a significant Operating Co., 590 F.3d 1326, 1335 adverse effect on the supply, Patent and Trademark Office (Fed. Cir. 2010), the Court stated that distribution, or use of energy. Therefore, ‘‘[A]ny conflict between [Agilent and a Statement of Energy Effects is not 37 CFR Part 41 Rule 200(b)] must be resolved as required under Executive Order 13211 [Docket No. PTO–P–2010–0032] directed in Agilent.’’). Accordingly, the (May 18, 2001). Board in an interference will construe a G. Executive Order 12988 (Civil RIN 0651–AC46 claim in a manner consistent with Justice Reform): This rule making meets Cancellation of Rule of Practice Agilent. applicable standards to minimize litigation, eliminate ambiguity, and 41.200(b) Before the Board of Patent Rulemaking Considerations Appeals and Interferences in reduce burden as set forth in sections Interference Proceedings A. Administrative Procedure Act: The 3(a) and 3(b)(2) of Executive Order change in this final rule merely revises 12988 (Feb. 5, 1996). AGENCY: United States Patent and the USPTO’s rules of practice to H. Executive Order 13045 (Protection Trademark Office, Commerce. eliminate any inconsistency with the of Children): This rule making does not ACTION: Final rule. Federal Circuit’s determination. concern an environmental risk to health Furthermore, this rule change involves or safety that may disproportionately SUMMARY: The United States Court of an interpretive rule or rule of agency affect children under Executive Order Appeals for the Federal Circuit issued a practice and procedure under 5 U.S.C. 13045 (Apr. 21, 1997). decision in Agilent Technologies, Inc. v. 553(b)(A). Accordingly, the change in I. Executive Order 12630 (Taking of Affymetrix, Inc., 567 F.3d 1366 (Fed. this final rule may be adopted without Private Property): This rule making will Cir. 2009). That decision impacted the prior notice and opportunity for public not effect a taking of private property or continuing viability of portions of a comment under 5 U.S.C. 553(b) and (c), otherwise have taking implications patent interference rule. The United or thirty-day advance publication under under Executive Order 12630 (Mar. 15, States Patent and Trademark Office 5 U.S.C. 553(d). See Cooper Techs. Co. 1988). (USPTO or Office) is therefore v. Dudas, 536 F.3d 1330, 1336–37, 87 J. Congressional Review Act: Under cancelling the affected portion of the U.S.P.Q.2d 1705, 1710 (Fed. Cir. 2008) the Congressional Review Act interference rule. (stating that 5 U.S.C. 553, and thus 35 provisions of the Small Business DATES: Effective date: This final rule is U.S.C. 2(b)(2)(B), does not require notice Regulatory Enforcement Fairness Act of effective on April 15, 2010. and comment rule making for 1996 (5 U.S.C. 801 et seq.), prior to Applicability date: This final rule is ‘‘‘interpretative rules, general statements issuing any final rule the USPTO will applicable in interferences declared of policy, or rules of agency submit a report containing the final rule before, on, or after April 15, 2010. organization, procedure, or practice.’’’ and other required information to the FOR FURTHER INFORMATION CONTACT: (quoting 5 U.S.C. 553(b)(A))). United States Senate, the United States James T. Moore, Vice Chief B. Regulatory Flexibility Act: As prior House of Representatives, and the Administrative Patent Judge, Board of notice and an opportunity for public Comptroller General of the Government Patent Appeals and Interferences (BPAI comment are not required pursuant to 5 Accountability Office. However, this

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action is not a major rule as defined by PART 41—PRACTICE BEFORE THE www.fcc.gov/cgb/ecfs/. Follow the 5 U.S.C. 804(2). BOARD OF PATENT APPEALS AND instructions for submitting comments. K. Unfunded Mandates Reform Act of INTERFERENCES • Mail: Filings can be sent by hand or 1995: This rule making does not involve messenger delivery, by commercial a Federal intergovernmental mandate ■ 1. The authority citation for 37 CFR overnight courier, or by first-class or that will result in the expenditure by part 41 continues to read as follows: overnight U.S. Postal Service mail State, local, and tribal governments, in Authority: 35 U.S.C. 2(b)(2), 3(a)(2)(A), 21, (although the Commission continues to the aggregate, of 100 million dollars (as 23, 32, 41, 134, 135. experience delays in receiving U.S. adjusted) or more in any one year, or a Postal Service mail). All filings must be Federal private sector mandate that will Subpart E—Patent Interferences addressed to the Commission’s result in the expenditure by the private § 41.200 [Amended] Secretary, Office of the Secretary, sector of 100 million dollars (as ■ Federal Communications Commission. adjusted) or more in any one year, and 2. In § 41.200, paragraph (b) is • People With Disabilities: Contact will not significantly or uniquely affect removed and reserved. the Commission to request reasonable small governments. Therefore, no Dated: April 10, 2010. accommodations (accessible format actions are necessary under the David J. Kappos, documents, sign language interpreters, provisions of the Unfunded Mandates Under Secretary of Commerce for Intellectual CART, etc.) by e-mail: [email protected] Reform Act of 1995. See 2 U.S.C. 1501 Property and Director of the United States or phone: 202–418–0530 or TTY: 202– et seq. Patent and Trademark Office. 418–0432. L. National Environmental Policy Act: [FR Doc. 2010–8626 Filed 4–14–10; 8:45 am] For detailed instructions for This rule making will not have any BILLING CODE 3510–16–P submitting comments and additional effect on the quality of environment and information on the rulemaking process, is thus categorically excluded from see the SUPPLEMENTARY INFORMATION review under the National FEDERAL COMMUNICATIONS section of this document. Environmental Policy Act of 1969. See COMMISSION Commercial overnight mail (other 42 U.S.C. 4321 et seq. than U.S. Postal Service Express Mail M. National Technology Transfer and 47 CFR Part 11 and Priority Mail) must be sent to 9300 Advancement Act: The requirements of East Hampton Drive, Capitol Heights, section 12(d) of the National [EB Docket No. 04–296; DA 10–500] MD 20743. Technology Transfer and Advancement Public Safety and Homeland Security U.S. Postal Service first-class, Act of 1995 (15 U.S.C. 272 note) are not Express, and Priority mail should be applicable because this rule making Bureau Seeks Informal Comment Regarding Revisions to the Federal addressed to 445 12th Street, SW., does not contain provisions which Washington, DC 20554. involve the use of technical standards. Communication Commission’s Rules Governing the Emergency Alert To request materials in accessible N. Paperwork Reduction Act: This formats for people with disabilities rule making involves information System Pending Adoption of the Common Alerting Protocol by the (Braille, large print, electronic files, collection requirements which are audio format), send an e-mail to subject to review by the Office of Federal Emergency Management Agency [email protected] or call the Consumer & Management and Budget (OMB) under Governmental Affairs Bureau at 202– the Paperwork Reduction Act of 1995 AGENCY: Federal Communications 418–0530 (voice), 202–418–0432 (TTY). (44 U.S.C. 3501 et seq.). The collection Commission. of information involved in this notice FOR FURTHER INFORMATION CONTACT: has been reviewed and approved by ACTION: Request for comments. Gregory M. Cooke, Associate Chief, OMB under OMB control number 0651– Policy Division, Public Safety and SUMMARY: In this document, the Federal Homeland Security Bureau, at (202) 0032. The USPTO is not resubmitting an Communication Commission’s information collection package to OMB 418–2351, or by e-mail at (Commission) Public Safety and [email protected]. for its review and approval because the Homeland Security Bureau (PSHSB) SUPPLEMENTARY INFORMATION: This is a changes in this rule making do not affect seeks informal comment regarding what, summary of the Federal Communication the information collection requirements if any, changes to the Commission’s Commission’s Public Notice in EB associated with the information rules governing the Emergency Alert Docket No. 04–296, DA 10–500, released collection under OMB control number System (EAS) might be necessitated by on March 25, 2010. This document is 0651–0032. the introduction of the Common Notwithstanding any other provision available to the public at http:// Alerting Protocol (CAP), as well as the of law, no person is required to respond hraunfoss.fcc.gov/edocs_public/ Federal Emergency Management to nor shall a person be subject to a attachmatch/DA–10–500A1.doc. Agency’s (FEMA) deployment of its penalty for failure to comply with a Integrated Public Alert and Warning collection of information subject to the Synopsis of the Public Notice System (IPAWS). requirements of the Paperwork 1. CAP is an open, interoperable, data Reduction Act unless that collection of DATES: Comments are due on or before interchange format for collecting and information displays a currently valid May 17, 2010 and reply comments are distributing all-hazard safety OMB control number. due on or before June 14, 2010. notifications and emergency warnings to ADDRESSES: You may submit comments, multiple information networks, public List of Subjects in 37 CFR Part 41 identified by EB Docket No. 04–296 by safety alerting systems, and personal Administrative practice and any of the following methods: communications devices. In conjunction procedure, Inventions and patents, • Federal eRulemaking Portal: http:// with appropriate alert transmission Lawyers. www.regulations.gov. Follow the architectures, CAP will allow FEMA, ■ For the reasons stated in the preamble, instructions for submitting comments. the National Weather Service (NWS), a the Patent and Trademark Office • Federal Communications State Governor, or any other authorized amends 37 CFR part 41 as follows: Commission’s Web site: http:// initiator of a public alert and warning to

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automatically format and geo-target a alerts. In its EAS Second Report and to oral and written presentations are set particular alert simultaneously to the Order, the Commission requires EAS forth in § 1.1206(b) of the Commission’s public over multiple media platforms Participants to configure their networks rules. such as television radio, cable, cell to receive CAP-formatted alerts B. Comment Filing Procedures phones and electronic highway signs. delivered via any new delivery systems, CAP will also allow an alert initiator to whether wireline, internet, satellite, or 8. Pursuant to §§ 1.415 and 1.419 of send alerts specifically formatted for other, within 180 days after the date that the Commission’s rules, 47 CFR 1.415, people with disabilities and for non- FEMA announces the technical 1.419, interested parties may file English speakers. standards for the Next Generation EAS. comments and reply comments on or 2. The Commission, in its Emergency However, the Commission’s rules before the dates indicated on the first Alert System (EAS) Second Report and presently also do not address such alert page of this document. All filings Order and Further Notice of Proposed distribution methods. related to this Notice of Proposed Rulemaking (Second Report and Order), 5. Accordingly, PSHSB also takes this Rulemaking should refer to EB Docket FCC No. 07–109 (adopted May 31, 2007; opportunity to ask commenters to No. 04–296. Comments may be filed released July 12, 2007) mandated that identify specific rule changes or using: (1) The Commission’s Electronic all EAS Participants must accept CAP- additions that they foresee could Comment Filing System (ECFS), (2) the based EAS alerts 180 days after the date advance or facilitate introduction of a Federal Government’s eRulemaking on which FEMA publishes the CAP-based Next Generation EAS Portal, or (3) by filing paper copies. See applicable technical standards for its architecture. In this regard, PSHSB Electronic Filing of Documents in adoption of CAP as the basis for FEMA- seeks comment on the extent to which Rulemaking Proceedings, 63 FR 24121, generated alerts. On July 30, 2008, states already are adopting CAP-based May 1, 1998. FEMA announced its intention to adopt systems for distribution of state and 9. Electronic Filers: Comments may be a version of CAP, and more recently local EAS alerts, and the extent to filed electronically using the Internet by announced that this adoption may occur which any revisions to Part 11 can be accessing the ECFS: http://www.fcc.gov/ as early as the third quarter of 2010. adopted in manner consistent with cgb/ecfs/ or the Federal eRulemaking Such action would trigger the those systems. Again, PSHSB urges Portal: http://www.regulations.gov. Commission’s 180 day requirement. commenters to consider the degree to Filers should follow the instructions 3. The Commission’s EAS rules, 47 which the Commission can and should provided on the Web site for submitting CFR part 11, were not written to implement flexibility into its new rules, comments. 10. For ECFS filers, if multiple docket accommodate a CAP-based EAS and in order to accommodate future changes or rulemaking numbers appear in the will likely require significant revision or to EAS delivery systems without caption of this proceeding, filers must replacement once CAP is adopted and necessitating repeated revisions to Part transmit one electronic copy of the implemented, even if CAP-formatted 11. What factors should the Commission comments for each docket or messages continue to be utilized in weigh in determining whether and-or rulemaking number referenced in the connection with the alert transmission when to implement future rule changes? ‘‘ ’’ caption. In completing the transmittal architectures of the current or legacy Should the structure and content of screen, filers should include their full EAS. In advance of any rulemaking that state EAS Plans covered by § 11.21 of name, U.S. Postal Service mailing may need to be conducted by the the EAS rules be altered to address, and the applicable docket or Commission once FEMA announces its accommodate CAP and, if so, how? adoption of standards for CAP, PSHSB 6. Finally, PSHSB seeks comment on rulemaking number. Parties may also seeks informal comment regarding what, what rules changes, if any, are necessary submit an electronic comment by if any, part 11 changes might be to our Part 11 rules to ensure access to Internet e-mail. To get filing necessitated by the introduction of CAP. a CAP-based EAS by people with instructions, filers should send an e- PSHSB asks commenters to identify, disabilities and those who do not speak mail to [email protected], and include the with specificity, those rules that need to English. We seek comment on how following words in the body of the ‘‘ ’’ be modified or deleted, and to suggest states that have adopted CAP currently message, get form. A sample form and new rules for Part 11—or a new rules address this issue. We also seek directions will be sent in response. framework to replace part 11 rules. 11. Paper Filers: Parties who choose comment on the status of any initiatives Accordingly, commenters should feel to file by paper must file an original and or programs developed by, as well as free to address the entirety of part 11 four copies of each filing. If more than any ongoing discussions among, rules in this regard. For example, one docket or rulemaking number interested stakeholders to address these commenters may address rules for a appears in the caption of this issues. CAP-based EAS system architecture, proceeding, filers must submit two equipment requirements, organization, Procedural Matters additional copies for each additional operations, testing, and access for docket or rulemaking number. A. Ex Parte Presentations people with disabilities and non-English 12. Filings can be sent by hand or speakers. PSHSB also asks commenters 7. This matter shall be treated as a messenger delivery, by commercial to consider the degree to which the ‘‘permit-but-disclose’’ proceeding in overnight courier, or by first-class or Commission can implement flexibility accordance with the Commission’s ex overnight U.S. Postal Service mail into any new rules adopted for part 11, parte rules. Persons making oral ex (although we continue to experience such that future versions of CAP can be parte presentations are reminded that delays in receiving U.S. Postal Service accommodated without further rule memoranda summarizing the mail). All filings must be addressed to changes. presentations must contain summaries the Commission’s Secretary, Office of 4. Further, FEMA’s adoption of CAP of the substance of the presentations the Secretary, Federal Communications anticipates FEMA´s deployment of and not merely a listing of the subjects Commission. IPAWS, which will combine new and discussed. More than a one or two 13. Effective December 28, 2009, all innovative technologies and distribution sentence description of the views and hand-delivered or messenger-delivered systems with greater redundancy and arguments presented is generally paper filings for the Commission’s resiliency for the delivery of emergency required. Other requirements pertaining Secretary must be delivered to FCC

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Headquarters at 445 12th St., SW., Room • Fax: (907) 586–7557. requirement to provide prior notice and TW–A325, Washington, DC 20554. The • Hand delivery to the Federal opportunity for public comment filing hours at this location are 8 a.m. to Building: 709 West 9th Street, Room pursuant to the authority set forth at 5 7 p.m. All hand deliveries must be held 420A, Juneau, AK. U.S.C. 553(b)(B) as such requirement is together with rubber bands or fasteners. All comments received are a part of impracticable and contrary to the public Any envelopes must be disposed of the public record. No comments will be interest. This requirement is before entering the building. Please posted to http://www.regulations.gov for impracticable and contrary to the public Note: The Commission’s former filing public viewing until after the comment interest as it would prevent NMFS from location at 236 Massachusetts Avenue, period has closed. Comment will responding to the most recent fisheries NE., is permanently closed. generally be posted without change. All data in a timely fashion and would Federal Communications Commission. Personal Identifying Information (for delay the opening of the Pacific cod example, name, address, etc.) David L. Furth, fishery by Pacific cod by catcher vessels voluntarily submitted by the commenter Deputy Bureau Chief, Public Safety and less than 60 feet (18.3 meters) length may be publicly accessible. Do not Homeland Security Bureau. submit Confidential Business overall using hook-and-line or pot gear [FR Doc. 2010–8636 Filed 4–14–10; 8:45 am] Information or otherwise sensitive or in the BSAI. Immediate notification is BILLING CODE 6712–01–P protected information. necessary to allow for the orderly NMFS will accept anonymous conduct and efficient operation of this comments (enter N/A in the required fishery, to allow the industry to plan for DEPARTMENT OF COMMERCE fields, if you wish to remain the fishing season, and to avoid anonymous). You may submit potential disruption to the fishing fleet National Oceanic and Atmospheric attachments to electronic comments in and processors. NMFS was unable to Administration Microsoft Word, Excel, WordPerfect, or publish a notice providing time for Adobe PDF file formats only. public comment because the most 50 CFR Part 679 FOR FURTHER INFORMATION CONTACT: recent, relevant data only became [Docket No. 0910131363–0087–02] Mary Furuness, 907–586–7228. available as of April 9, 2010. RIN 0648–XV79 SUPPLEMENTARY INFORMATION: NMFS The AA also finds good cause to manages the groundfish fishery in the waive the 30–day delay in the effective Fisheries of the Economic Exclusive BSAI exclusive economic zone date of this action under 5 U.S.C. Zone Off Alaska; Pacific Cod in the according to the Fishery Management 553(d)(3). This finding is based upon Bering Sea and Aleutian Islands Plan for Groundfish of the Bering Sea the reasons provided above for waiver of and Aleutian Islands Management Area AGENCY: National Marine Fisheries prior notice and opportunity for public (FMP) prepared by the North Pacific Service (NMFS), National Oceanic and comment. Fishery Management Council under Atmospheric Administration (NOAA), Without this inseason adjustment, authority of the Magnuson-Stevens Commerce. Fishery Conservation and Management NMFS could not allow the fishery for ACTION: Temporary rule; modification Act. Regulations governing fishing by Pacific cod by catcher vessels less than of a closure. U.S. vessels in accordance with the FMP 60 feet (18.3 meters) length overall using appear at subpart H of 50 CFR part 600 hook-and-line or pot gear in the BSAI to SUMMARY: NMFS is opening directed and 50 CFR part 679. be harvested in an expedient manner fishing for Pacific cod by catcher vessels NMFS closed directed fishing for and in accordance with the regulatory less than 60 feet (18.3 meters) length Pacific cod by catcher vessels less than schedule. Under § 679.25(c)(2), overall using hook-and-line or pot gear 60 feet (18.3 meters) length overall using interested persons are invited to submit in the Bering Sea and Aleutian Islands hook-and-line or pot gear in the BSAI written comments on this action to the management area (BSAI). This action is under § 679.20(d)(1)(iii) on March 25, above address until April 29, 2010. necessary to fully use the 2010 total 2010 (75 FR 15626, March 26, 2010). allowable catch (TAC) of Pacific cod This action is required by § 679.25 NMFS has determined that as of April specified for the BSAI. and is exempt from review under 9, 2010, approximately 400 metric tons Executive Order 12866. DATES: Effective 1200 hrs, Alaska local of Pacific cod remain in the 2010 Pacific time (A.l.t.), April 30, 2010, through cod apportionment for catcher vessels Authority: 16 U.S.C. 1801 et seq. 2400 hrs, A.l.t., December 31, 2010. less than 60 feet (18.3 meters) length Dated: April 12, 2010. Comments must be received at the overall using hook-and-line or pot gear Emily H. Menashes, following address no later than 4:30 in the BSAI. Therefore, in accordance p.m., A.l.t., April 29, 2010. Acting Director, Office of Sustainable with § 679.25(a)(1)(i), (a)(2)(i)(C), and Fisheries, National Marine Fisheries Service. ADDRESSES: Send comments to Sue (a)(2)(iii)(D), and to fully use the 2010 [FR Doc. 2010–8639 Filed 4–14–10; 8:45 am] Salveson, Assistant Regional TAC of Pacific cod in the BSAI, NMFS Administrator, Sustainable Fisheries is terminating the previous closure and BILLING CODE 3510–22–S Division, Alaska Region, NMFS, Attn: is opening directed fishing for Pacific Ellen Sebastian. You may submit cod by catcher vessels less than 60 feet comments, identified by RIN 0648– (18.3 meters) length overall using hook- XV79, by any one of the following and-line or pot gear in the BSAI. methods: • Electronic Submissions: Submit all Classification electronic public comments via the This action responds to the best Federal eRulemaking Portal http:// available information recently obtained www.regulations.gov. from the fishery. The Assistant • Mail: P.O. Box 21668, Juneau, AK Administrator for Fisheries, NOAA 99802. (AA), finds good cause to waive the

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DEPARTMENT OF COMMERCE 400 mt of Pacific cod from the B season DEPARTMENT OF COMMERCE jig gear apportionment to catcher vessels National Oceanic and Atmospheric less than 60 feet (18.3 meters (m)) LOA National Oceanic and Atmospheric Administration using hook-and-line or pot gear. Administration The harvest specifications for Pacific 50 CFR Part 679 50 CFR Part 679 cod included in the final harvest [Docket No. 0910131363–0087–02] specifications for groundfish in the [Docket No. 0910131362–0087–02] RIN 0648–XV78 BSAI (75 FR 11788, March 12, 2010) are RIN 0648–XV80 revised as follows: 22 mt to the B season Fisheries of the Exclusive Economic apportionment for vessels using jig gear Fisheries of the Exclusive Economic Zone Off Alaska; Reallocation of and 4,598 mt to catcher vessels less than Zone Off Alaska; Pollock in Statistical Pacific Cod in the Bering Sea and 60 feet (18.3 m) LOA using hook-and- Area 610 in the Gulf of Alaska Aleutian Islands Management Area line or pot gear. AGENCY: National Marine Fisheries AGENCY: National Marine Fisheries Classification Service (NMFS), National Oceanic and Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Atmospheric Administration (NOAA), This action responds to the best Commerce. Commerce. available information recently obtained ACTION: Temporary rule; closure. ACTION: Temporary rule; reallocation. from the fishery. The Assistant Administrator for Fisheries, NOAA SUMMARY: NMFS is prohibiting directed SUMMARY: NMFS is reallocating the (AA), finds good cause to waive the fishing for pollock in Statistical Area projected unused amount of Pacific cod requirement to provide prior notice and 610 in the Gulf of Alaska (GOA). This from vessels using jig gear to catcher opportunity for public comment action is necessary to prevent exceeding vessels less than 60 feet (18.3 meters) pursuant to the authority set forth at 5 the B season allowance of the 2010 total length overall (LOA) using hook-and- U.S.C. 553(b)(B) as such requirement is allowable catch (TAC) of pollock for line or pot gear in the Bering Sea and impracticable and contrary to the public Statistical Area 610 in the GOA. Aleutian Islands management area interest. This requirement is DATES: Effective 1200 hrs, Alaska local (BSAI). This action is necessary to allow impracticable and contrary to the public time (A.l.t.), April 12, 2010, through the B season apportionment of the 2010 interest as it would prevent NMFS from 1200 hrs, A.l.t., August 25, 2010. total allowable catch (TAC) of Pacific responding to the most recent fisheries FOR FURTHER INFORMATION CONTACT: Josh cod to be harvested. data in a timely fashion and would Keaton, 907–586–7228. DATES: Effective April 12, 2010, through delay the reallocation of Pacific cod SUPPLEMENTARY INFORMATION: NMFS 2400 hrs, Alaska local time (A.l.t.), specified from jig vessels to catcher manages the groundfish fishery in the December 31, 2010. vessels less than 60 feet (18.3 m) LOA GOA exclusive economic zone FOR FURTHER INFORMATION CONTACT: using hook-and-line or pot gear. Since according to the Fishery Management Obren Davis, 907–586–7228. the fishery is currently open, it is Plan for Groundfish of the Gulf of SUPPLEMENTARY INFORMATION: NMFS important to immediately inform the Alaska (FMP) prepared by the North manages the groundfish fishery in the industry as to the revised allocations. Pacific Fishery Management Council BSAI according to the Fishery Immediate notification is necessary to under authority of the Magnuson- Management Plan for Groundfish of the allow for the orderly conduct and Stevens Fishery Conservation and Bering Sea and Aleutian Islands efficient operation of this fishery, to Management Act. Regulations governing Management Area (FMP) prepared by allow the industry to plan for the fishing fishing by U.S. vessels in accordance the North Pacific Fishery Management season, and to avoid potential with the FMP appear at subpart H of 50 Council under authority of the disruption to the fishing fleet as well as CFR part 600 and 50 CFR part 679. Magnuson-Stevens Fishery processors. NMFS was unable to The B season allowance of the 2010 Conservation and Management Act. publish a notice providing time for TAC of pollock in Statistical Area 610 Regulations governing fishing by U.S. public comment because the most of the GOA is 5,551 metric tons (mt) as vessels in accordance with the FMP recent, relevant data only became established by the final 2010 and 2011 appear at subpart H of 50 CFR part 600 available as of April 9, 2010. harvest specifications for groundfish of and 50 CFR part 679. The AA also finds good cause to the GOA (publication in Federal The B season apportionment of the waive the 30–day delay in the effective Register pending). 2010 Pacific cod TAC specified for date of this action under 5 U.S.C. In accordance with § 679.20(d)(1)(i), vessels using jig gear in the BSAI is 422 553(d)(3). This finding is based upon the Regional Administrator has metric tons (mt) as established by the the reasons provided above for waiver of determined that the B season allowance final 2010 and 2011 harvest prior notice and opportunity for public of the 2010 TAC of pollock in Statistical specifications for groundfish in the comment. Area 610 of the GOA will soon be BSAI (75 FR 11788, March 12, 2010), for reached. Therefore, the Regional the period 1200 hrs, A.l.t., April 30, This action is required by § 679.20 Administrator is establishing a directed 2010, through 1200 hrs, A.l.t., August and is exempt from review under fishing allowance of 5,451 mt, and is 31, 2010. Executive Order 12866. setting aside the remaining 100 mt as The Administrator, Alaska Region, Authority: 16 U.S.C. 1801 et seq. bycatch to support other anticipated NMFS, has determined that jig vessels groundfish fisheries. In accordance with Dated: April 12, 2010. will not be able to harvest 400 mt of the § 679.20(d)(1)(iii), the Regional B season apportionment of the 2010 Emily H. Menashes, Administrator finds that this directed Pacific cod TAC allocated to those Acting Director, Office of Sustainable fishing allowance has been reached. vessels under § 679.20(a)(7)(ii)(A)(1). Fisheries, National Marine Fisheries Service. Consequently, NMFS is prohibiting Therefore, in accordance with [FR Doc. 2010–8637 Filed 4–12–10; 4:15 pm] directed fishing for pollock in Statistical § 679.20(a)(7)(iii)(A), NMFS apportions BILLING CODE 3510–22–S Area 610 of the GOA.

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After the effective date of this closure interest. This requirement is 553(d)(3). This finding is based upon the maximum retainable amounts at impracticable and contrary to the public the reasons provided above for waiver of § 679.20(e) and (f) apply at any time interest as it would prevent NMFS from prior notice and opportunity for public during a trip. responding to the most recent fisheries comment. Classification data in a timely fashion and would This action is required by § 679.20 delay the closure of pollock in and is exempt from review under This action responds to the best Statistical Area 610 of the GOA. NMFS available information recently obtained Executive Order 12866. was unable to publish a notice from the fishery. The Assistant providing time for public comment Authority: 16 U.S.C. 1801 et seq. Administrator for Fisheries, NOAA Dated: April 12, 2010. (AA), finds good cause to waive the because the most recent, relevant data requirement to provide prior notice and only became available as of April 9, Emily H. Menashes, opportunity for public comment 2010. Acting Director, Office of Sustainable pursuant to the authority set forth at 5 The AA also finds good cause to Fisheries, National Marine Fisheries Service. U.S.C. 553(b)(B) as such requirement is waive the 30–day delay in the effective [FR Doc. 2010–8640 Filed 4–12–10; 4:15 pm] impracticable and contrary to the public date of this action under 5 U.S.C. BILLING CODE 3510–22–S

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Proposed Rules Federal Register Vol. 75, No. 72

Thursday, April 15, 2010

This section of the FEDERAL REGISTER W12–140, 1200 New Jersey Avenue SE., consider all comments received by the contains notices to the public of the proposed Washington, DC 20590. closing date and may amend this issuance of rules and regulations. The • Hand Delivery: U.S. Department of proposed AD because of those purpose of these notices is to give interested Transportation, Docket Operations, M– comments. persons an opportunity to participate in the 30, West Building Ground Floor, Room We will post all comments we rule making prior to the adoption of the final receive, without change, to http:// rules. W12–140, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. www.regulations.gov, including any and 5 p.m., Monday through Friday, personal information you provide. We DEPARTMENT OF TRANSPORTATION except Federal holidays. will also post a report summarizing each For service information identified in substantive verbal contact we receive Federal Aviation Administration this proposed AD, contact Boeing about this proposed AD. Commercial Airplanes, Attention: Data Discussion 14 CFR Part 39 & Services Management, P.O. Box 3707, MC 2H–65, Seattle, Washington 98124– We have received reports of cracks of [Docket No. FAA–2010–0036; Directorate the skin and surrounding structure Identifier 2009–NM–077–AD] 2207; telephone 206–544–5000, extension 1; fax 206–766–5680; e-mail under the number 3 (very high RIN 2120–AA64 [email protected]; Internet frequency) VHF antenna on the lower https://www.myboeingfleet.com. You external surface of the airplane at Airworthiness Directives; The Boeing may review copies of the referenced Buttock Line 0.0, aft of the main landing Company Model 737–200, –200C, –300, service information at the FAA, gear wheel well on Model 737–200, –400, and– 500 Series Airplanes Transport Airplane Directorate, 1601 –200C, –300, –400, and– 500 series airplanes. One report indicated there AGENCY: Federal Aviation Lind Avenue SW., Renton, Washington. For information on the availability of was a 15-inch longitudinal crack in the Administration (FAA), DOT. skin near Buttock Line 0.0 just forward ACTION: Notice of proposed rulemaking this material at the FAA, call 425–227– 1221. of the number 3 VHF antenna cutout, (NPRM). running forward. The first 14 inches of Examining the AD Docket SUMMARY: We propose to adopt a new the crack was hidden beneath the airworthiness directive (AD) for certain You may examine the AD docket on number 3 VHF antenna. Five other Model 737–200, –200C, –300, –400, the Internet at http:// reports indicated there were skin cracks and– 500 series airplanes. This www.regulations.gov; or in person at the between 1.5 and 3 inches in length in proposed AD would require repetitive Docket Management Facility between 9 the same area. The reports also indicated that the main antenna support inspections for cracking and corrosion a.m. and 5 p.m., Monday through channel and other support structure of the skin and surrounding structure Friday, except Federal holidays. The AD were cracked. The earliest reported under the number 3 very high frequency docket contains this proposed AD, the cracks were at 18,289 flight cycles. This (VHF) antenna, and corrective actions if regulatory evaluation, any comments condition, if not corrected, could result necessary. Also, for certain airplanes, received, and other information. The in crack growth, possibly leading to this proposed AD would require street address for the Docket Office separation of the antenna from the replacing bonded skin panels with solid (telephone 800–647–5527) is in the airplane, and rapid depressurization of skin panels. This proposed AD results ADDRESSES section. Comments will be the airplane. from reports of cracks in the skin and available in the AD docket shortly after surrounding structure under the number receipt. Relevant Service Information 3 VHF antenna on the lower external FOR FURTHER INFORMATION CONTACT: We have reviewed Boeing Special surface of the airplane at Buttock Line Wayne Lockett, Aerospace Engineer, Attention Service Bulletin 737–53– 0.0, aft of the main landing gear wheel Airframe Branch, ANM–120S, FAA, 1287, dated March 11, 2009. The service well. We are proposing this AD to detect Seattle Aircraft Certification Office, bulletin describes procedures for and correct cracks and corrosion of the 1601 Lind Avenue, SW., Renton, repetitive external detailed and external skin and surrounding structure under Washington 98057–3356; telephone high frequency eddy current (HFEC) the number 3 VHF antenna, which (425) 917–6447; fax (425) 917–6590. inspections for cracking and corrosion could result in separation of the antenna SUPPLEMENTARY INFORMATION: in the skin; and repetitive internal from the airplane, and rapid detailed inspections for cracking and depressurization of the airplane. Comments Invited corrosion in the skin, antenna support DATES: We must receive comments on We invite you to send any written structure, and surrounding frames and this proposed AD by June 1, 2010. relevant data, views, or arguments about stringers; depending on the airplane ADDRESSES: You may send comments by this proposed AD. Send your comments configuration. For Group 1–4, any of the following methods: to an address listed under the configuration 2 airplanes, having a • Federal eRulemaking Portal: Go to ADDRESSES section. Include ‘‘Docket No. cover plate at the number 3 VHF http://www.regulations.gov. Follow the FAA–2010–0036; Directorate Identifier antenna location, accomplishing the instructions for submitting comments. 2009–NM–077–AD’’ at the beginning of HFEC inspection eliminates the need for • Fax: 202–493–2251. your comments. We specifically invite repetitive external detailed inspections. • Mail: U.S. Department of comments on the overall regulatory, Boeing Special Attention Service Transportation, Docket Operations, M– economic, environmental, and energy Bulletin 737–53–1287, dated March 11, 30, West Building Ground Floor, Room aspects of this proposed AD. We will 2009, also specifies contacting Boeing

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for certain inspection instructions, and configuration and inspection type, range Difference Between the Proposed AD for all repair instructions. between 1,100 flight cycles and 18,000 and Service Bulletin The initial compliance time is 15,000 flight cycles. total flight cycles, or within 1,100 or Boeing Special Attention Service Boeing Special Attention Service 6,000 flight cycles (depending on Bulletin 737–53–1287, dated March 11, Bulletin 737–53–1287, dated March 11, configuration and inspection type) from 2009, specifies to contact the 2009, specifies prior or concurrent the date on the service bulletin, manufacturer for instructions on how to whichever occurs later, for the following accomplishment, for certain airplanes, repair certain conditions, but this inspections: of the replacement of bonded skin proposed AD would require repairing • External detailed inspections for panels with solid skin panels in those conditions in one of the following any crack in the skin; accordance with Part 5 of Boeing ways: • External HFEC inspections for any Service Bulletin 737–53A1042, Revision • Using a method that we approve; or crack in the skin; 5, dated October 5, 1984. The actions • • Using data that meet the Internal detailed inspection for any specified in Boeing Service Bulletin certification basis of the airplane, and crack in the skin, antenna support 737–53A1042, Revision 5, dated that have been approved by the Boeing structure, and surrounding frames and October 5, 1984, are necessary to Commercial Airplanes Organization stringers; and comply with AD 90–06–02, Amendment Designation Authorization (ODA) that • Internal detailed inspection for any 39–6489 (55 FR 8372, March 7, 1990). has been authorized by the Manager, crack or corrosion in the skin, antenna Seattle ACO, to make those findings. support structure, and surrounding FAA’s Determination and Requirements frames and stringers. of This Proposed AD Interim Action The initial compliance time is within 18,000 flight cycles (depending on We are proposing this AD because we We consider this proposed AD configuration and inspection type) from evaluated all relevant information and interim action. If final action is later the date on the service bulletin, for the determined the unsafe condition identified, we might consider further following inspections: described previously is likely to exist or rulemaking then. • develop in other products of these same External detailed and HFEC Costs of Compliance inspection for any crack or corrosion in type designs. This proposed AD would the skin; and require accomplishing the actions We estimate that this proposed AD • Internal detailed inspection for any specified in the service information would affect 1,016 airplanes of U.S. crack or corrosion in the skin. described previously, except as registry. The following table provides The repetitive inspection intervals, discussed under ‘‘Difference Between the estimated costs for U.S. operators to which depend on the airplane the Proposed AD and Service Bulletin.’’ comply with this proposed AD.

TABLE—ESTIMATED COSTS

Number of Average U.S.- Action Work hours labor rate Parts Cost per product registered Fleet cost per airplanes

Inspection ...... Between 3 $85 None Between $255 and $765, 629 Between $160,395 and and 9. per inspection cycle. $481,185, per inspec- tion cycle. Concurrent Replacement 2,112 ...... $85 $35,000 $214,520...... 387 $83,019,240. for Group 2 airplanes.1 1 The concurrent modification for Group 2 airplanes required by this AD is already required by AD 90–06–02. AD 90–06–02 mandated the skin replacement per Boeing Service Bulletin 737–53A1042 within 20 years of the manufacture date of the airplane. All group 2 airplanes have ex- ceeded the 20-year threshold.

Authority for This Rulemaking is within the scope of that authority 1. Is not a ‘‘significant regulatory because it addresses an unsafe condition action’’ under Executive Order 12866, Title 49 of the United States Code that is likely to exist or develop on specifies the FAA’s authority to issue 2. Is not a ‘‘significant rule’’ under the products identified in this rulemaking DOT Regulatory Policies and Procedures rules on aviation safety. Subtitle I, action. section 106, describes the authority of (44 FR 11034, February 26, 1979), and the FAA Administrator. ‘‘Subtitle VII: Regulatory Findings 3. Will not have a significant Aviation Programs,’’ describes in more economic impact, positive or negative, We determined that this proposed AD detail the scope of the Agency’s on a substantial number of small entities would not have federalism implications authority. under the criteria of the Regulatory under Executive Order 13132. This We are issuing this rulemaking under Flexibility Act. the authority described in ‘‘Subtitle VII, proposed AD would not have a substantial direct effect on the States, on You can find our regulatory Part A, Subpart III, Section 44701: evaluation and the estimated costs of General requirements.’’ Under that the relationship between the national compliance in the AD Docket. section, Congress charges the FAA with government and the States, or on the promoting safe flight of civil aircraft in distribution of power and List of Subjects in 14 CFR Part 39 air commerce by prescribing regulations responsibilities among the various for practices, methods, and procedures levels of government. Air transportation, Aircraft, Aviation the Administrator finds necessary for For the reasons discussed above, I safety, Incorporation by reference, safety in air commerce. This regulation certify this proposed regulation: Safety.

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The Proposed Amendment the number 3 very high frequency (VHF) exists under the cover plate that extends a antenna on the lower external surface of the minimum of 3 rows of fasteners all around Accordingly, under the authority airplane at Buttock Line 0.0, aft of the main the cover plate: Do the applicable inspections delegated to me by the Administrator, landing gear wheel well. The Federal on the doubler instead of the skin. the FAA proposes to amend 14 CFR part Aviation Administration is issuing this AD to (i) For Group 1–4, configuration 2 airplanes 39 as follows: detect and correct cracks and corrosion of the having a cover plate at the number 3 VHF skin and surrounding structure under the antenna location: Accomplishing the HFEC PART 39—AIRWORTHINESS number 3 VHF antenna, which could result inspection terminates the repetitive external in separation of the antenna from the DIRECTIVES detailed inspections. airplane, and rapid depressurization of the 1. The authority citation for part 39 airplane. Corrective Actions continues to read as follows: Compliance (j) If any cracking or corrosion is found Authority: 49 U.S.C. 106(g), 40113, 44701. (f) You are responsible for having the during any inspection required by this AD, before further flight, repair the crack or § 39.13 [Amended] actions required by this AD performed within the compliance times specified, unless the corrosion using a method approved in 2. The FAA amends § 39.13 by adding actions have already been done. accordance with the procedures specified in the following new AD: paragraph (o) of this AD. Inspections The Boeing Company: Docket No. FAA– Concurrent Requirement 2010–0036; Directorate Identifier 2009– (g) Except as required by paragraphs (m) NM–077–AD. and (n) of this AD, at the applicable time in (k) For Group 2 airplanes, as identified in paragraph 1.E., ‘‘Compliance,’’ of Boeing Boeing Special Attention Service Bulletin Comments Due Date Special Attention Service Bulletin 737–53– 737–53–1287, dated March 11, 2009: Before (a) We must receive comments by June 1, 1287, dated March 11, 2009: Do external or concurrently with accomplishing the 2010. detailed and high frequency eddy current requirements of paragraph (g) of this AD, (HFEC) inspections for cracking in the skin, replace the bonded skin panels with solid Affected ADs and for cracking and corrosion in the skin, skin panels, in accordance with the (b) AD 90–06–02, Amendment 39–6489, as applicable; and an internal detailed Accomplishment Instructions of Boeing affects this AD. inspection for cracking or corrosion in the Service Bulletin 737–53A1042, Revision 9, skin, antenna support structure, and dated July 25, 1991. Applicability surrounding frames and stringers, under the Note 1: The concurrent requirement for (c) This AD applies to The Boeing number 3 VHF antenna, as applicable; in replacement of bonded skin panels with solid Company Model 737–200, –200C, –300, accordance with the Accomplishment skin panels is already required by AD 90–06– –400, and –500 series airplanes, certificated Instructions of Boeing Special Attention 02, Amendment 39–6489. in any category, as identified in Boeing Service Bulletin 737–53–1287, dated March Special Attention Service Bulletin 737–53– 11, 2009, except as provided by paragraph (h) Replacements Accomplished According to 1287, dated March 11, 2009. of this AD. Repeat the inspections, as Previous Issue of Service Bulletin applicable, thereafter at the applicable time Subject specified in paragraph 1.E., ‘‘Compliance,’’ of (l) Replacements accomplished before the (d) Air Transport Association (ATA) of Boeing Special Attention Service Bulletin effective date of this AD in accordance with America Code 53: Fuselage. 737–53–1287, dated March 11, 2009 except the Accomplishment Instructions of the as provided by paragraph (i) of this AD. service bulletins specified in Table 1 of this Unsafe Condition (h) For airplanes on which any external AD are considered acceptable for compliance (e) This AD results from reports of cracks detailed, or external detailed and HFEC with the corresponding action specified in of the skin and surrounding structure under inspection is done, and an external doubler paragraph (k) of this AD.

TABLE 1—PREVIOUSLY ISSUED SERVICE BULLETIN

Document Revision Date

Boeing Service Bulletin 737–53A1042 ...... 5 October 5, 1984. Boeing Service Bulletin 737–53A1042 ...... 6 August 10, 1989. Boeing Service Bulletin 737–53A1042 ...... 7 October 19, 1989. Boeing Service Bulletin 737–53A1042 ...... 8 July 19, 1990.

Exceptions to Service Bulletin Special Attention Service Bulletin 737–53– 39.19. Before using any approved AMOC on (m) Where Boeing Special Attention 1287, dated March 11, 2009. any airplane to which the AMOC applies, Service Bulletin 737–53–1287, dated March Alternative Methods of Compliance notify your principal maintenance inspector 11, 2009, specifies a compliance time after (AMOCs) (PMI) or principal avionics inspector (PAI), the date on that service bulletin, this AD as appropriate, or lacking a principal (o)(1) The Manager, Seattle Aircraft requires compliance after the effective date of inspector, your local Flight Standards District Certification Office (ACO), FAA, has the this AD. Office. The AMOC approval letter must (n) The Compliance Time column of Table authority to approve AMOCs for this AD, if specifically reference this AD. 5 of paragraph 1.E., ‘‘Compliance,’’ of Boeing requested using the procedures found in 14 Special Attention Service Bulletin 737–53– CFR 39.19. Send information to ATTN: (3) An AMOC that provides an acceptable 1287, dated March 11, 2009, is missing the Wayne Lockett, Aerospace Engineer, level of safety may be used for any repair phrase ‘‘(Whichever Occurs Later).’’ Airframe Branch, ANM–120S, FAA, Seattle required by this AD, if it is approved by the Compliance with the actions in the Action Aircraft Certification Office, 1601 Lind Boeing Commercial Airplanes Organization column of Table 5 of paragraph 1.E., Avenue SW., Renton, Washington 98057– Designation Authorization (ODA) that has ‘‘Compliance,’’ of Boeing Special Attention 3356; telephone (425) 917–6447; fax (425) been authorized by the Manager, Seattle Service Bulletin 737–53–1287, dated March 917–6590. Or, e-mail information to 9-ANM- ACO, to make those findings. For a repair 11, 2009, is required by the later of the [email protected]. method to be approved, the repair must meet corresponding times specified in the (2) To request a different method of the certification basis of the airplane, and the Compliance Time column of Table 5 of compliance or a different compliance time approval must specifically refer to this AD. paragraph 1.E., ‘‘Compliance,’’ of Boeing for this AD, follow the procedures in 14 CFR

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Issued in Renton, Washington on April 2, • http://www.regulations.gov. Follow electronically through http:// 2010. the online instructions for submitting www.regulations.gov or in hard copy at Ali Bahrami, comments. the EPA Docket Center, Public Reading Manager, Transport Airplane Directorate, • E-mail: [email protected]. Room, EPA West, Room 3334, 1301 Aircraft Certification Service. • Mail: Air and Radiation Docket, Constitution Ave., NW., Washington, [FR Doc. 2010–8570 Filed 4–14–10; 8:45 am] Environmental Protection Agency, Mail DC, 20460. The Public Reading Room is BILLING CODE 4910–13–P code 6102T, 1200 Pennsylvania Avenue, open from 8:30 a.m. to 4:30 p.m., NW., Washington, DC 20460. Please Monday through Friday, excluding legal include a total of two copies. holidays. The telephone number for the • ENVIRONMENTAL PROTECTION Hand Delivery: EPA Docket Center, Public Reading Room is (202) 566–1742, Public Reading Room, EPA West, Room AGENCY and the telephone number for the Air 3334, 1301 Constitution Ave., NW, Docket is (202) 566–1744. 40 CFR Parts 51 and 52 Washington, DC 20460. Such deliveries Public Hearing. If a public hearing is are only accepted during the Docket’s held, it will be held in Washington, DC. [EPA–HQ–OAR–2003–0064; FRL–9133–7] normal hours of operation, and special FOR FURTHER INFORMATION CONTACT: Mr. RIN 2060–AP80 arrangements should be made for David Svendsgaard, Air Quality Policy deliveries of boxed information. Division (C504–03), U.S. Environmental Instructions: Direct your comments to Prevention of Significant Deterioration Protection Agency, Research Triangle the applicable docket. EPA’s policy is (PSD) and Nonattainment New Source Park, NC 27711, telephone number: that all comments received will be Review (NSR): Aggregation; (919) 541–2380; fax number: (919) 541– Reconsideration included in the public docket without change and may be made available 5509, e-mail address: AGENCY: Environmental Protection online at http://www.regulations.gov, [email protected]. To request a public hearing or Agency (EPA). including any personal information information pertaining to a public ACTION: Proposed rule. provided, unless the comment includes hearing on this document, contact Ms. information claimed to be confidential SUMMARY: Pursuant to a proceeding for Pamela Long, Air Quality Policy business information (CBI) or other reconsideration, the EPA requests Division (C504–03), U.S. Environmental information whose disclosure is Protection Agency, Research Triangle comment on a Clean Air Act (CAA) rule, restricted by statute. Do not submit the New Source Review (NSR) information that you consider to be CBI Park, North Carolina 27711; telephone Aggregation Amendments, which was or otherwise protected through http:// number (919) 541–0641; fax number promulgated on January 15, 2009. The www.regulations.gov or e-mail. The (919) 541–5509; e-mail address: NSR Aggregation Amendments http://www.regulations.gov Web site is [email protected]. established a new interpretation of the an ‘‘anonymous access’’ system, which SUPPLEMENTARY INFORMATION: existing NSR rules governing the means EPA will not know your identity I. General Information modification of major sources by or contact information unless you requiring sources and permitting provide it in the body of your comment. A. Does this sction spply to me? authorities to combine emissions from If you send an e-mail comment directly nominally-separate activities at a major Entities potentially affected by this to EPA without going through http:// action include sources in all industry stationary source only when the www.regulations.gov, your e-mail activities are ‘‘substantially related.’’ groups and state, local, and tribal address will be automatically captured governments. This proposed reconsideration is in and included as part of the comment response to a petition from the Natural that is placed in the public docket and B. How is this preamble organized? Resources Defense Council (NRDC) made available on the Internet. If you The preamble is organized as follows: received on January 30, 2009. EPA submit an electronic comment, EPA requests public comment on all issues I. General Information recommends that you include your A. Does this action apply to me? included in NRDC’s petition. In light of name and other contact information in the legal and policy issues raised in the B. How is this preamble organized? the body of your comment and with any II. Overview petition and in our own review of the disk or CD–ROM you submit. If EPA A. What is ‘‘Aggregation’’? rule, EPA’s preferred option is to revoke cannot read your comment due to B. What events have led to this action? the NSR Aggregation Amendments. EPA technical difficulties and cannot contact III. This Action is also proposing to extend the effective you for clarification, EPA may not be A. What is the standard for date of the stay by an additional 6 able to consider your comment. reconsideration? months, and soliciting comment on a Electronic files should avoid the use of B. What issues are being reconsidered? longer extension of the stay. C. Key Issues Under Reconsideration special characters, any form of 1. Lack of Adequate Opportunity for Notice DATES: Comments. Comments must be encryption, and be free of any defects or and Comment on the Adopted Rule received on or before May 17, 2010. viruses. 2. Rule may be Inconsistent with a Court Public Hearing. If anyone contacts Docket: All documents in the docket of Appeals Decision for Previous NSR EPA requesting the opportunity to speak are listed in the http:// Rule at a public hearing concerning the www.regulations.gov index. Although a. Background for Our Historic Approach proposed regulation by April 26, 2010, listed in the index, some information is b. Our Explanation of Our Authority in the EPA will hold a public hearing on April not publicly available, e.g., CBI or other NSR Aggregation Amendments 30, 2010. If a hearing is held, the record information whose disclosure is c. The CAA Requires Aggregation of for the hearing will remain open until restricted by statute. Certain other Nominally-Separate Changes When They June 1, 2010. Collectively can be Seen as One Change material, such as copyrighted material, 3. Questioning the Need for a Policy ADDRESSES: Submit your comments, is not placed on the Internet and will be Change identified by Docket ID No. EPA–HQ– publicly available only in hard copy 4. State Plan Adoption OAR–2003–0064, by one of the form. Publicly available docket 5. Proposal to Revoke Rule following methods: materials are available either 6. Proposal to Extend Effective Date

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IV. Statutory and Executive Order Reviews time through statutory and regulatory that occur three or more years apart are A. Executive Order 12866: Regulatory interpretation and applicability presumed to not be substantially Planning and Review determinations in response to a need to related. Collectively, this rulemaking is B. Paperwork Reduction Act deter sources from attempting to known as the ‘‘NSR Aggregation C. Regulatory Flexibility Act D. Unfunded Mandates Reform Act expedite construction by permitting Amendments.’’ For further information E. Executive Order 13132: Federalism several changes separately as minor on the NSR Aggregation Amendments, F. Executive Order 13175: Consultation modifications. When related changes are see 74 FR 2376 (January 15, 2009). and Coordination with Indian Tribal evaluated separately, the source may On January 30, 2009, NRDC submitted Governments circumvent the purpose of the NSR a petition for reconsideration of the NSR G. Executive Order 13045: Protection of program by showing a less than Aggregation Amendments as provided Children from Environmental Health and significant emission increase for Step 1 for in CAA section 307(d)(7)(B).4 Under Safety Risks of the applicability analysis, that could that CAA provision, the Administrator I. National Technology Transfer and Advancement Act result in avoiding major NSR permitting may convene a reconsideration 3 J. Executive Order 12898: Federal Actions requirements. This, in turn, could proceeding if the petitioner raises an to Address result in increases of emissions of air objection to a rule that was K. Determination Under Section 307(d) pollutants from the facility that would impracticable to raise during the V. Statutory Authority be higher than the increases would be comment period or if the grounds for the objection arose after the comment II. Overview had the changes been subject to NSR control requirements. The associated period. In either case, the objection A. What is ‘‘Aggregation’’? emissions increases could endanger the must be of central relevance to the When undergoing a physical or air quality health standard and outcome of the rule. operational change, a source determines adversely affect public health. On February 13, 2009, we announced major NSR applicability through a two- Under our longstanding aggregation the convening of a reconsideration step analysis that first considers policy, we evaluate all relevant and proceeding in response to the NRDC whether the increased emissions from a objective criteria specific to a case in petition. See 74 FR 7193. In order to particular proposed change alone are determining if multiple changes at a allow for completion of the significant, followed by a calculation of source should be aggregated as a single reconsideration prior to the NSR the change’s net emissions increase project for NSR purposes. See section Aggregation Amendments becoming considering all contemporaneous III.C.2.a of this notice. Our policy aims effective, we also announced a 90-day increases and decreases at the source to ensure the proper permitting of administrative stay of the rule. See 74 (i.e., source-wide netting calculation) to modifications that involve multiple FR 7284 (Feb. 13, 2009). We determine if a major modification has physical and/or operational changes. subsequently completed a rulemaking further delaying the effective date until occurred. See, for example, 40 CFR B. What events have led to this action? 52.21(b)(2)(i). The term ‘‘aggregation’’ May 18, 2010. See 74 FR 22693 (May 14, On January 15, 2009, we issued a final comes into play in the first step (Step 1), 2009). The extensions enable us to take rule that changed our interpretation of and describes the process of grouping comment on issues that are in question the PSD and nonattainment NSR together multiple, nominally-separate and complete any revisions of the rule regulations relating to the definition of but related physical changes or changes that become necessary as a result of the ‘‘modification’’ in the CAA 111(a)(4). in the method of operation (‘‘nominally- reconsideration process. The new rule addressed when a source separate changes’’) into one physical or must aggregate emissions from III. This Action operational change, or ‘‘project.’’ The nominally-separate changes for the emission increases of the nominally- A. What is the standard for purpose of determining whether they separate but related changes must be reconsideration? are a single project resulting in a combined in Step 1 for purposes of As noted above, pursuant to CAA significant emission increase. The final determining whether a significant 307(d)(7)(B) of the CAA, an individual rule retained the prior rule language emissions increase has occurred from can petition an agency to reconsider a relevant to aggregation, but interpreted the project. See, for example, 40 CFR final rule issued under CAA 307(d)(1) if that rule text to mean that sources and 52.21(b)(40). When undertaking the individual can show that: permitting authorities should combine multiple nominally-separate changes, • It was impracticable to raise the emissions only when nominally- the source must consider whether NSR objection during the public comment separate changes are ‘‘substantially applicability should be determined period on the proposed rule, or the related.’’ We described in the final rule collectively (i.e., ‘‘aggregated’’) or grounds for the objection arose after the whether the emissions from each of preamble the factors that may be public comment period; and these changes should separately considered when evaluating whether • The objection is centrally relevant undergo a Step 1 analysis.1 changes are substantially related, and to the outcome of the rule. Neither the CAA nor current EPA we specifically stated that two As to the first procedural criterion for rules specifically address the basis upon nominally-separate changes are not reconsideration, a petitioner must show which to aggregate nominally-separate substantially related if they are only why the issue could not have been changes for the purpose of making NSR related to the extent that they both presented during the comment period, applicability determinations. Instead, support the plant’s overall basic either because it was impracticable to our 2 aggregation policy developed over purpose. At the same time, we adopted raise the issue during that time or a rebuttable presumption that because the grounds for the issue arose 1 Even if activities are determined to be separate nominally-separate changes at a source after the period for public comment (but and subject to an individual Step 1 analysis, the within 60 days of publication of the emission increases and decreases may still be 3 Of course, if a source has a significant increase final action). Thus, CAA 307(d)(7)(B) included together in the source-wide netting in emissions from a change (or aggregated changes), calculation if the projects occur within a it is not necessarily subject to NSR; rather, not until does not provide a forum to request EPA contemporaneous period. the source also has a ‘‘significant net emission 2 In this notice, the terms ‘‘we,’’ ‘‘us,’’ and ‘‘our’’ increase’’ would it be subject to NSR permitting 4 John Walke, Natural Resources Defense Council, refer to the EPA. requirements. EPA–HQ–OAR–2003–0064–0116.1.

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to reconsider issues that actually were policy issues related to the NSR C. Key Issues Under Reconsideration raised, or could have been raised, prior Aggregation Amendments. We also 1. Lack of Adequate Opportunity for to promulgation of the final rule. acknowledge an interdependence Notice and Comment on the Adopted An agency can deny the among several objections raised in Rule reconsideration of issues when they fail NRDC’s petition, such that granting to meet the procedural test for reconsideration on one issue that meets As noted above, NRDC identifies as reconsideration under CAA the standard for reconsideration may grounds for reconsideration several 307(d)(7)(B). If, however, there are warrant taking comment on a second issues related to the adoption and adequate grounds for the objections issue that may, on its own, not meet the implementation of the ‘‘substantially raised in this petition, the EPA standard for reconsideration. However, related’’ test for aggregating nominally- Administrator must ‘‘* * *convene a the basis for the second issue is at stake separate changes. The proposed rule did proceeding for reconsideration of the depending on what comments are not mention the ‘‘substantially related’’ rule and provide the same procedural received on the first issue. test adopted in the final rule.5 rights as would have been afforded had For example, under CAA 307(d)(3)(C), Additionally, the proposed rule offered the information been available at the EPA is required to for public new regulatory text to clarify the criteria time the rule was proposed.’’ CAA comment ‘‘the major legal for aggregation, while the final rule 307(d)(7)(B). In this case, the final rule interpretations and policy retains the existing text. Our proposed adopted interpretations that were not considerations underlying the proposed rule did not discuss the possibility of described in the proposal and on which rule.’’ We acknowledge through this changing the interpretation of the the public did not have an opportunity reconsideration proceeding that existing text. to offer comment, as described more portions of the legal basis for the NSR A commenter would not have been on specifically below. Aggregation Amendments did not notice of the possibility that we would undergo comment solicitation, and it is adopt the ‘‘substantially related’’ test B. What issues are being reconsidered? necessary to allow the public an without amending the rule text, nor The basis for this reconsideration opportunity to comment fully on the would a commenter have been on notice proceeding is NRDC’s petition of basic authority for the rule. However, as of the need to comment on whether the January 30, 2009, in which NRDC is the case with many rules, the existing text was susceptible to this requested reconsideration of many statutory basis of this rule provides the interpretation. The issue of adopting aspects of the January 15, 2009, final underpinning for most every aspect of this rule in the form and manner we did rule. The reader is directed to the the rule, and could call into question is an issue that arose after the comment petition for an exact explanation of each the legitimacy of other aspects of the period and is of central relevance to the objection raised by NRDC. See Docket rule. Therefore, in addition to granting rulemaking proceeding. EPA–HQ–OAR–2003–0064–0116.1. In reconsideration on the legal basis for the In soliciting comment on the option of summary, NRDC’s main points of rule, we are also taking comment on creating time-based presumptions concern include: other aspects of the final rule that are regarding aggregation, we did not raise • The NSR Aggregation Amendments dependent upon a sound legal basis. For the issue of whether the existing are inconsistent with the DC Circuit instance, although we requested regulatory text could support the Court ruling on the NSR ’’Equipment comment on a 3-year presumption creation of this presumption. We Replacement Provision,’’ by creating an against aggregation through our 2006 ‘‘acknowledge[d] that the establishment illegal exclusion to the broad ‘‘any proposal, in light of the broad legal of a presumption* * * would go physical change’’ provision in the CAA. issue that is currently under beyond the codification of the status • The EPA failed to identify any reconsideration, we believe it is justified quo.’’ See 71 FR 54248. Therefore, we actual problems or inconsistencies with to open for additional comment the did not characterize a time-based longstanding policy. issue of having a presumption against presumption as a clarification. We • The 2006 proposal sought to clarify aggregation because such a presumption recognized it could only apply aggregation rules through proposing would be necessarily dependent on, and prospectively. Nevertheless, the final new rule text, but the 2009 final rule an outgrowth of, the legal basis of our rule announced the 3-year presumption reinterpreted the existing rule text and rule. against aggregation as an interpretation was described as a change in policy. Moreover, a few of the issues raised of the regulatory text despite the • The term ‘‘substantially related’’ is in the NRDC petition demonstrate that regulation’s silence on this issue. vague and undefined, did not appear in there are fundamental components of In context, commenters could not the proposal, retreats from the factors the final rule that elicit confusion, such have been aware that we were used in previous aggregation as whether states with approved suggesting the presumption was an determinations by EPA (e.g., adopting implementation plans must adopt the interpretation of the existing regulatory the 3-year timing presumption against new rule and whether their State text rather than a proposal to add a aggregation), and eliminates Implementation Plans (SIPs) must be presumption to the text. Therefore, consideration of EPA’s policy on amended. Since the aim of the rule was commenters did not have an adequate circumvention by failure to consider a to reduce, not promote, confusion with opportunity to comment on whether the company’s intent. regard to project aggregation, we are existing regulatory text could be • The final rule is silent, and particularly concerned with this interpreted to have a time-based therefore confusing, on whether States comment from the petitioner, and it is presumption. must implement the new rule in their one of the primary reasons for delaying We solicit comment on the change in own programs. the effective date of the rule while we approach from the pre-rule policy on • The EPA violated relevant reconsider issues raised in the petition. executive orders through failure to For these reasons, we invite comment 5 Furthermore, subsumed within the adequately consult with states during on all issues raised by the petitioner. In ‘‘substantially related test’’ is another feature of the final rule that was not introduced as a possible the development of the rule. the sections below, we specifically change in policy at proposal—i.e., to not aggregate Through this notice, we are taking describe several key issues on which we projects when their sole common ground is that comment on a broad range of legal and seek comment. they each support the plant’s overall basic purpose.

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aggregation to the ‘‘substantially related’’ aggregation was completely silent on emission increases, instead of obtaining test set forth in the preamble to the how we interpreted CAA section a permit for the collection of changes January 15, 2009, final rule. We 111(a)(4) to authorize aggregation and that, when examined as a single project, specifically request comment on any provided no analysis of the relevant resulted (or would result) in a rule changes that may be needed to case law. significant emission increase. implement the new test. For example, if Below we set out our understanding We issued several letters since the we were to retain the ‘‘substantially of the statute and case law. We invite early 1980s explaining that we may related’’ test, then must we amend the comment on our understanding and enforce the major source permitting regulatory text for the definition of what we believe would be the result requirements in such cases when a ‘‘project’’ to say that nominally-separate from that understanding—i.e., the source ‘‘circumvents’’ major source NSR changes must be aggregated into a revocation of the NSR Aggregation by dividing one change and its emission project if they are substantially related? Amendments and the reversion to our increase into nominally-separate Must we also add new regulatory text in pre-existing policy on project physical or operational changes.6 Some order to establish a time-based aggregation. of these letters discussed intent to evade NSR, but focused more on objective presumption for or against aggregation? a. Background for our Historic factors such as the closeness in the We also solicit comment on whether we Approach would need new or revised rule timing of nominally-separate changes language to adopt a time-based Under both the nonattainment NSR and the integrated planning of these presumption against aggregation. provisions of the CAA as well as the changes.7 In 1993, we issued a letter Furthermore, we specifically request PSD provisions, a modification of a analyzing a series of minor permit comment on whether ‘‘substantially major stationary source is treated as applications for 3M Company’s research related’’ is the proper measurement to construction of a new source subject to and development facility in apply when determining whether to permitting. Modification is a defined Maplewood, Minnesota.8 This letter has aggregate projects. Or does it, as the term under the statute: ‘‘The term been widely cited for its discussion of petitioner has expressed, add confusion ‘modification’ means any physical objective factors that could support a for sources and permitting authorities change in, or change in the method of conclusion that nominally-separate trying to apply the test? Is there another operation of, a stationary source which changes should be treated as one benchmark that would be more sensible increases the amount of any air project. These factors include the filing to use to determine when the emissions pollutant emitted by such source or of multiple minor source or minor of nominally-separate changes at a which results in the emission of any air modification permits for a single source source should be aggregated for pollutant not previously emitted’’ (CAA within a short period of time, funding evaluating NSR applicability? If we section 111(a)(4)). This definition information indicating one project, decide to retain the substantially related requires analyzing whether a physical or other reporting on consumer demand test or revert to our former test, is the operational change will take (or, post and project levels, other statements from 3-year presumption against aggregation hoc, has taken) place, and whether it the business indicating one project, appropriate? results in an emission increase. As EPA’s assessment of the economic noted above, in situations involving 2. Rule May Be Inconsistent With a realities of the project, as well as the multiple nominally-separate changes at relationship of the changes to the Court of Appeals Decision for Previous a source, EPA’s ‘‘aggregation’’ policy NSR Rule overall basic purpose of the plant. interprets what is the physical or Subsequently, we have issued The NRDC petition identifies our operational change that must be additional letters discussing aggregation assessed for an emission increase. interpretation of the controlling at particular plants in certain statutory term, ‘‘modification,’’ and a key We calculate the emissions increase circumstances.9 Collectively, these case discussing that definition as issues associated with a physical or operational change at a major stationary that were impractical to raise during the 6 Memorandum from John Calcagni, Director, Air comment period and of central source by reference to de minimis Quality Management Division, to William B. relevance to the rule. While NRDC and thresholds (also known as ‘‘significance Hathaway, Director, Air, Pesticides, and Toxics other commenters identified these levels’’). From the earliest days of the Division, EPA Region 6, entitled ‘‘Request for matters as being at issue in their NSR program, we recognized that a Clarification of Policy Regarding the ‘Net Emissions Increase’ ’’ (Sept. 18, 1989). comments, we did not include an party seeking to avoid major source NSR 7 See, e.g., Letter from James Wilburn, Chief, Air explanation in the proposed rule of how might attempt to break up a single Management Branch, EPA Region 4, to Harold the EPA aggregation interpretation was physical or operational change into Hodges, Director, Division of Air Pollution Control, consistent with the statute and the court nominally-separate changes in order to Tennessee Department of Public Health (Aug. 15, 1983); Memorandum from Darryl Tyler, Director, decision. In a sense, the rulemaking make the emission increase associated Control Programs Development Division, EPA process required by CAA 307(d) was with each change appear to be less than Office of Air Quality Planning and Standards inverted: rather than the EPA providing significant. See 45 FR 52702 (Aug. 7, (OAQPS), to David Kee, Director, Air Management a ‘‘statement of basis [summarizing] the 1980). As subsequent case law Division, EPA Region 5, entitled ‘‘Applicability of PSD to Portions of Plan Constructed in Phases major legal confirmed, even a small physical or Without Permits’’ (Oct. 21, 1986); Letter from Don interpretations* * *underlying the operational change may satisfy the first Clay, Acting Assistant Administrator, EPA Office of proposed rule,’’ as required by CAA portion of the definition of Air and Radiation, to John Boston, Vice President, 307(d)(3)(C), the commenters provided modification. State of New York v. EPA, Wisconsin Electric Power Company (Feb. 15, 1989). their views of the law, and we then 443 F.3d 880, 890 (DC Cir. 2006), cert. 8 Memorandum from John Rasnic, Director, Stationary Source Compliance Division, OAQPS, to provided a legal basis in the final rule den. 127 S. Ct. 2127 (2007) (New York George Czerniak, Chief, Air Enforcement Branch, and in the response-to-comment II); Wisconsin Elec. Power Co. v. Reilly, EPA Region 5, entitled ‘‘Applicability of New document. Moreover, the rulemaking 893 F.2d 901, 908 (7th Cir. 1990). We Source Review Circumvention Guidance to 3M– did not simply adopt a theory that was recognized that an owner or operator Maplewood, Minnesota’’ (June 17, 1993). 9 See, e.g., Letter from Doug Cole, Acting a logical outgrowth of the theory or might apply for multiple minor permits Manager, Federal & Delegated Air Programs Unit, theories suggested in the proposal. The for nominally-separate, small changes EPA Region 10, to Grant Cooper et al., Frederickson portion of the proposal discussing that by themselves result in de minimis Power L.P. (Oct. 12, 2001); Letter from Gregg

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letters outline an approach where we interrelationship and dependence. In or indicators, of these changes being one would look at case-specific facts and the NRDC’s view, because the statute covers common aggregate change. As noted relationship between nominally- ‘‘any physical change,’’ and the NSR above, one much-cited example of our separate changes to determine whether Aggregation Amendments would omit analysis of grouping together nominally- they were a single project to be assessed some of these physical changes from separate changes is appropriate is the for an emission increase under Step 1 of NSR permitting by not aggregating them, ‘‘3M-Maplewood’’ memorandum the NSR applicability test. the NSR Aggregation Amendments discussed above and in the notices for impermissibly narrowed the expansive the proposed and final rules. One b. Our Explanation of Our Authority in reading of the statute’s ‘‘any physical concern about the 3M-Maplewood the NSR Aggregation Amendments change’’ required by New York II. See analysis has been that one portion of the The statute itself defines modification NRDC petition at 5–6. analysis suggests that any set of in the singular: ‘‘any physical change in, nominally-separate changes that are c. The CAA Requires Aggregation of or change in the method of operation of, consistent with ‘‘the plant’s overall basic Nominally-Separate Changes When a stationary source’’ that increases purpose’’ can be aggregated.11 emissions. Some have argued that we They Collectively Can Be Seen as One The opinion in New York II further cannot aggregate or accumulate Change clarifies this portion of the 3M- nominally-separate changes to The issue NRDC raises goes to the Maplewood analysis, which remains determine NSR applicability because crux of the NSR Aggregation EPA’s most complete statement of the they can be viewed as multiple changes. Amendments. What must be treated as principles regarding grouping In response to this argument in one physical or operational change nominally-separate changes. As the comments on the NSR Aggregation under the definition of ‘‘modification’’ in Court observed, ‘‘[t]he modifier ‘any’ Amendment proposed rule, we cited the the act is the legal underpinning for our cannot bring an activity that is never recent decision in New York II, which aggregation policy. considered a ‘physical change’ within held that the definition of modification The New York II Court held that we the ambit of NSR.’’ 443 F.3d at 887–888. requires ‘‘EPA [to] apply NSR whenever have limited authority to exempt from Therefore, an important limiting factor a source conducts an emission- NSR those activities that can be in analyzing indicia of whether increasing activity that fits within one of considered a single physical change. nominally-separate changes should be the ordinary meanings of ‘physical Accordingly, ‘‘any physical change’’ grouped into an aggregated, single change.’ ’’ 443 F.3d at 885. Because should encompass any change that change is whether the grouping would ‘‘[s]ubstantially related, nominally- reasonably can be considered an be under one of the ordinary meanings separate changes can be seen as one ordinary meaning of the phrase. As the of physical change or change in the change when viewed as a whole,’’ we Court noted, ‘‘[W]hen Congress places method of operation of a source. viewed ‘‘[a]ggregation of nominally the word ‘any’ before a phrase with If ‘‘substantially related’’ would omit separate changes that are substantially several common meanings, the statutory an ordinary, common meaning of related as ‘fit[ting] within one of the phrase encompasses each of those physical change that would bring an ordinary meanings of physical meanings; the agency may not pick and emission-increasing project under change.’ ’’ 10 Therefore, we viewed choose among them.’’ 443 F.3d at 888. review, then the definition would aggregation as allowed under the statute The logic of New York II applies not eliminate a type of physical change that and the ‘‘substantially related’’ test for only to physical changes but also to Congress intended to cover (i.e., the aggregation as a permissible changes in the method of operation of change that consists of the group of interpretation of the modification a source. nominally-separate changes that definition. Much of the emphasis of New York II comprise a project but do not qualify as Having seen EPA’s analysis of New and other cases has been on whether we ‘‘substantially related’’). In effect, the York II for the first time in the response- could exclude small changes from being interpretation in the NSR Aggregation to-comment document supporting the considered potential modifications as Amendments is unreasonable because it NSR Aggregation Amendments, NRDC defined in the Act. However, the New would create a carve-out from the scope expressed the view that the foregoing York II Court’s reasoning also applies to of the statutory definition of analysis of that case ‘‘utterly misses the a rule that would split apart one change modification. point.’’ NRDC’s petition acknowledges into separate changes in order to limit It is our view that New York II that aggregation of nominally-separate the applicability of NSR. The Court requires EPA to aggregate any group of changes that are substantially related is concludes, ‘‘[a]lthough the phrase small changes that are sufficiently one of the ordinary meanings of ‘‘physical change’’ is susceptible to related to ‘‘fit[] within one of the physical change. However, NRDC notes multiple meanings, the word ‘‘any’’ ordinary meanings of ‘physical that ‘‘aggregation of nominally separate makes clear that activities within each change.’ ’’ We agree with the contention changes that are not substantially of the common meanings of the phrase that, to the extent that our ‘‘substantially related’’ also may be within an ordinary are subject to NSR when the activity related’’ interpretation would exclude meaning of physical change, especially results in an emission increase.’’ 443 meanings that fit within a reasonable when substantially related is defined in F.3d at 890. The statute prohibits EPA understanding of the ordinary meaning terms of technical or economic from picking and choosing among of ‘‘any physical change,’’ the meanings of the phrase ‘‘any physical interpretation in the NSR Aggregation Worley, Chief, Air Permits Section, EPA Region 4, change * * * or change in the method Amendments would impermissibly to Heather Abrams, Georgia Environmental of operation’’ if it would result in Protection Division (July 5, 2005); Letter from David narrow the scope of CAA section Campbell, Chief, Permits & Technical Assessment omitting a common meaning that would 111(a)(4). We seek comment on our Branch, EPA Region 3, to Matthew Williams, subject an emission increase to review. analysis. Pennsylvania Department of Environmental Historically, EPA has analyzed the We specifically invite comment on Protection (Feb. 21, 2007). question of whether nominally-separate 10 ‘‘Response to Comments Document for the the following questions. Do we have the Final Action: PSD and Nonattainment New Source changes are one change by using a case- Review (NSR): Aggregation and Project Netting’’, by-case review of all relevant and 11 We do not believe the 3M-Maplewood letter EPA–HQ–OAR–2003–0064–0111, pg. 8. objective factors that looks for ‘‘indicia,’’ relies solely on this portion of its analysis.

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authority to aggregate nominally- 3. Questioning the Need for a Policy applicability and aggregation.’’ 14 separate changes that ‘‘fit within one of Change Finally, the National Association of the ordinary meanings’’ of a single An objection raised in NRDC’s Clean Air Agencies stated that the physical or operational change when petition is that the EPA’s 2006 proposal proposal left ‘‘* * * greater uncertainty they are viewed in the context of the on Aggregation failed to identify any than the previous, reasonably well- 15 source? Is New York II relevant to the actual problems or inconsistencies with developed policy.’’ We note that these question of whether we aggregate? Are longstanding aggregation policy as comments were made in the context of there ‘‘ordinary meanings’’ of physical or applied and explained in the 3M a proposed rule based on technical and operational change that do not fit within Maplewood letter. While the issue of economic dependence, not ‘‘substantially related,’’ but nevertheless ‘‘substantially related’’ as we describe it whether the historic policy on project illustrate a basic comfort level with the in the NSR Aggregation Amendments? aggregation had problems was raised by current practice. Do we have the authority to exclude our proposed rule, we did not request comment on the various factors we We request comment on whether these meanings in light of the New York there was a bona fide need for added II language? historically applied. Given that we now view the state of the record differently, clarity over and above what the old In one respect, the aggregation of we are taking this opportunity to request aggregation policy provided. If clarity nominally-separate changes that are comment on the need for a change in was lacking, we further solicit comment ‘‘substantially related’’ appears to be policy. on whether the NSR Aggregation distinguishable from the legal error The impetus for developing the NSR Amendments achieved added clarity. underlying the rule at issue in New York Aggregation Amendments emerged from We also note that it has been our II, the ‘‘Equipment Replacement a study conducted by EPA in 2001 on experience that the few applicability Provision’’ or ‘‘ERP’’. In the ERP, we the impact of NSR regulations on determinations we have issued where aggregation was the central issue have claimed that the excluded activities investment in new utility and refinery not been contested on appeal. The (e.g., replacements that were generation. This EPA study took input from a range of stakeholders and absence of contested applicability functionally equivalent and less than 20 determinations tends to support a belief percent of the replacement cost) were resulted in a report to the President in 2002 that included a suite of that there was not significant confusion not physical changes as meant by the or controversy with our historic policy. statute. In the NSR Aggregation recommendations for how to change the NSR rules to improve the effectiveness Through this reconsideration, we Amendments, we recognize that a specifically request comment from nominally-separate physical or of the program. One of the recommendations was for EPA to make reviewing authorities on the frequency operational change is a change by itself clarifying changes to the approach used of disputes with other parties over their and declare it not to be part of a ‘‘larger aggregation decisions, such as appeals 12 for aggregating projects. change’’ that also meets a common However, in reviewing the record for of applicability determinations where understanding of a single ‘‘change.’’ To the NSR Aggregation Amendments, we this has been an issue, adverse the extent that one event could be a part find that the only factual support for the comments in permitting proceedings, or of either a change that is smaller or a contention that our historic approach having to brief the issue in litigation. change that is larger, one may argue that caused confusion was anecdotal. The 4. State Plan Adoption it is ambiguous as to which meaning of parties supporting a change in policy As noted above, the NSR Aggregation change should apply. failed to provide us with any Amendments did not include characterization of the overall level of We are not persuaded that the same amendatory text for the Code of Federal uncertainty or other problems resulting event possibly being part of more than Registers (CFR). We agree with NRDC’s from the existing policy on aggregation. one change is an ambiguity that would assertion that the state and local Furthermore, through our Aggregation allow us to exclude the event from CAA implementation requirements of the proposal in 2006, we received section 111(a)(4). The New York II NSR Aggregation Amendments are countervailing testimony from decision requires that, when choosing unclear. The question of whether a SIP permitting agencies and other amendment is required when the CFR among meanings of ‘‘change’’ in various stakeholders that contended that there remains unchanged is likely to cause contexts, we must choose a meaning was little confusion in the application of confusion for reviewing authorities and that brings the emission-increasing our aggregation policy. For example, the other stakeholders. We view these change into the potential scope of the State of New Mexico wrote that ‘‘*** difficulties as clear support for the need modification definition. Therefore, we the current common sense approach of to have the rule not be effective until the do not consider the potential for a looking at the timing, scope, and completion of our reconsideration nominally-separate change to be either a interrelationship(s) of projects in proceeding. We also view it as added change by itself or a change that is part determining the occurrence of support for our preferred position in of a larger change to be an ambiguity aggregation is more straightforward than this notice, which is to revoke the NSR to narrowly evaluate the validity of that would allow us to select the less Aggregation Amendments, as discussed independent economic justification inclusive meaning. Nevertheless, were a in greater detail in the next section of reviewing court to find that there is *** or technical dependence of 13 this notice. some ambiguity in the statute as it various projects.’’ We also heard from In section III.3.a of this notice, we ask applies to the coverage of nominally- a local reviewing authority in Ohio, who for comment on whether the existing separate changes, we believe there may recommended that ‘‘* * * EPA propose NSR regulatory text can support the new be policy concerns that would warrant a test that more accurately represents interpretation provided by the NSR revocation of the NSR Aggregation current permitting authority practice Amendments. with regard to evaluating major NSR 14 John A. Paul, Regional Air Pollution Control Agency, EPA–HQ–OAR–2003–0064–0089.1. 13 Richard Goodyear, State of New Mexico 15 Bill O’Sullivan and John A. Paul, National 12 i.e., a subset of another physical change or Environment Department, EPA–HQ–OAR–2003– Association of Clean Air Agencies, EPA–HQ–OAR– change in the method of operation. 0064–0055.1. 2003–0064–0102.1.

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Aggregation Amendments if the rule apparent need for additional clarity Therefore, we propose to delay the remains in effect after this with the aggregation policy may have effective date of the NSR Aggregation reconsideration proceeding. Apart from been overstated. Furthermore, as Amendments, published in the Federal this important question, we are also discussed above, the rule introduces Register on January 15, 2009 (74 FR taking comment on when and how new ambiguities, particularly with 2376), until November 18, 2010. This reviewing authorities with EPA- respect to implementation, that may delay would be for an additional 6 approved plans in 40 CFR part 51.166 further reduce its effectiveness. months, which we believe would can implement the new policy Balancing this against the additional provide a reasonable period of time to interpretation given that there are no issues raised with respect to the legal complete action on the reconsideration. CFR changes to use as a basis for and implementation aspects of the final We solicit comment on a 6-month delay drafting amendments to their state rule, as well as our concern of possible of the effectiveness of the final rule, and plans. under-inclusiveness of the final rule we also solicit comment on a longer In a broader sense, when EPA issues (i.e., the chance that certain projects that delay (e.g., 9 or 12 months). an interpretive rule, have reviewing should be aggregated would avoid authorities with EPA-approved IV. Statutory and Executive Order aggregation under the approach from the Reviews implementation programs adopted the NSR Aggregation Amendments), we new interpretation in their believe that the prior agency policy A. Executive Order 12866: Regulatory implementation plans? Or have these may, on balance, provide a more Planning and Review agencies not required a plan amendment reasonable interpretation than the Under Executive Order (EO) 12866 and immediately applied the new policy interpretation contained in the (58 FR 51735, October 4, 1993), this interpretation? If a plan revision was final rule. We are therefore proposing as action is a ‘‘significant regulatory action’’ required, what was the proper our preferred option to revoke the final because it raises novel legal or policy mechanism for State adoption for an rule. If we ultimately decide through issues. Accordingly, EPA submitted this interpretive rule where there is no reconsideration to revoke the NSR action to the Office of Management and change to the CFR? We solicit comment Aggregation Amendments, we believe Budget (OMB) for review under EO on all of these questions. we should restore the past policy for 12866 and any changes made in 5. Proposal To Revoke Rule making case-by-case aggregation response to OMB recommendations determinations. As part of NRDC’s petition requesting have been documented in the docket for We specifically solicit comment on this action. reconsideration of the Aggregation the legal concerns and possible under- Amendments, NRDC further asked EPA inclusiveness with the final rule. As B. Paperwork Reduction Act ‘‘ to withdraw and abandon the final noted above, comments received on our rule.’’ While rare, the Administrator has This action does not impose any new proposal from various reviewing information collection burden. We are in the past withdrawn, or revoked, a authorities show some support for promulgated rule prior to its effective not proposing any new paperwork retaining the pre-existing aggregation requirements (e.g., monitoring, date. The reasons for such action by the factors. Thus, we also request comment Administrator are varied, but typically it reporting, recordkeeping) as part of this on whether the old policy framework for proposed action. This action simply is done when a final rule is determined aggregating nominally-separate changes to be either error prone, confusing, solicits comment on a number of legal is adequate if the NSR Aggregation and policy issues raised in a petition for overly burdensome, or unnecessary, Amendments is revoked. Has the such that leaving the rule in place reconsideration on the NSR Aggregation 16 decision in New York II helped to Amendments, and proposes an would not improve the program. improve the understanding of the past An overarching concern of EPA is that additional extension of the stay of the policy direction in 3M-Maplewood and our original policy goal for developing rule. other relevant memoranda? the Aggregation Amendments—i.e., to However, the OMB has previously provide improved clarity in making 6. Proposal To Extend Effective Date approved the information collection aggregation determinations—does not requirements contained in the existing As noted, the effective date of the appear to have been achieved. This regulations (40 CFR parts 51 and 52) NSR Aggregation Amendments is May concern is reflected in the petition for under the provisions of the Paperwork 18, 2010. This scheduled date was reconsideration, and we believe it has Reduction Act, 44 U.S.C. 3501 et seq., shifted from the original effective date sufficient merit that we must consider and has been assigned OMB control to allow time for the Agency to conduct whether retaining the NSR Aggregation number 2060–0003. The OMB control a full reconsideration of the final rule. Amendments is justified. While the rule numbers for EPA’s regulations in 40 We are concerned now, however, that may, in some respects, appear clearer CFR are listed in 40 CFR part 9. our reconsideration rulemaking than our past policy, we are not schedule will not meet the revised C. Regulatory Flexibility Act convinced that it achieved enough effective date. Furthermore, we still The Regulatory Flexibility Act (RFA) additional clarity to improve the process have concerns, as noted above, with the generally requires an agency to prepare of making aggregation assessments by final rule becoming effective prior to a regulatory flexibility analysis of any sources and reviewing authorities. As completion of our reconsideration rule subject to notice and comment noted above, our reexamination of the proceeding. Recognizing this, we are rulemaking requirements under the record also leads us to believe that the proposing additional time that would Administrative Procedure Act or any 16 See, e.g., ‘‘Withdrawal of Revisions to the Water enable us to fully evaluate comments on other statute unless the agency certifies Quality Planning and Management Regulation and issues that are in question and to that the rule will not have a significant Revisions to the National Pollutant Discharge complete any revisions of the rule that economic impact on a substantial Elimination System Program in Support of become necessary as a result of the number of small entities. Small entities Revisions to the Water Quality Planning and Management Regulation’’ proposed Dec. 27, 2002 reconsideration process, without the include small businesses, small (67 FR 79020) and finalized Mar. 19, 2003 (68 FR concern of the rule prematurely organizations, and small governmental 13608). becoming effective. jurisdictions.

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For purposes of assessing the impacts raised in NRDC’s petition for impractical. Voluntary consensus of this proposal on small entities, small reconsideration on the NSR Aggregation standards are technical standards (e.g., entity is defined as: (1) A small business Amendments, and proposes to revoke materials specifications, test methods, as defined by the Small Business the rule. Thus, Executive Order 13132 sampling procedures, and business Administration’s (SBA) regulations at 13 does not apply to this proposed rule. practices) that are developed or adopted CFR 121.201; (2) a small governmental In the spirit of Executive Order 13132, by voluntary consensus standards jurisdiction that is a government of a and consistent with EPA policy to bodies. NTTAA directs EPA to provide city, county, town, school district or promote communications between EPA Congress, through OMB, explanations special district with a population of less and state and local governments, EPA when the Agency decides not to use than 50,000; and (3) a small specifically solicits comment on this available and applicable voluntary organization that is any not-for-profit proposed rule from state and local consensus standards. enterprise which is independently officials. This proposed rulemaking does not owned and operated and is not involve technical standards. Therefore, dominant in its field. F. Executive Order 13175: Consultation and Coordination With Indian Tribal EPA is not considering the use of any After considering the economic voluntary consensus standards. impacts of this proposed rule on small Governments entities, I certify that this action will not This action does not have tribal J. Executive Order 12898: Federal have a significant economic impact on implications, as specified in Executive Actions To Address Environmental a substantial number of small entities. Order 13175 (65 FR 67249, November 9, Justice in Minority Populations and This proposed rule will not impose any 2000.) This action will not impose any Low-Income Populations new requirements on small entities. We new obligations or enforceable duties on Executive Order 12898 (59 FR 7629 have determined that small businesses tribal governments. (Feb. 16, 1994)) establishes Federal will not incur any adverse impacts EPA specifically solicits additional executive policy on environmental because no costs were associated with comment on this proposed action from justice. Its main provision directs the NSR Aggregation Amendments, and tribal officials. Federal agencies, to the greatest extent this proposed reconsideration of that G. Executive Order 13045: Protection of practicable and permitted by law, to rule simply requests comment on a Children From Environmental Health make environmental justice part of their variety of issues, none of which would and Safety Risks mission by identifying and addressing, create any new requirements or as appropriate, disproportionately high This action is not subject to EO 13045 burdens. Therefore, no costs are and adverse human health or (62 FR 19885), April 23, 1997) because associated with this proposed environmental effects of their programs, the Agency does not believe the amendment. policies, and activities on minority environmental health or safety risks We continue to be interested in the populations and low-income addressed by this action present a potential impacts of the proposed rule populations in the United States. on small entities and welcome disproportionate risk to children. We do EPA has determined that this comments on issues related to such not believe this action creates any proposed rule will not have impacts. environmental health or safety risks. The public is invited to submit disproportionately high and adverse D. Unfunded Mandates Reform Act comments or identify peer-reviewed human health or environmental effects This action does not contain a federal studies and data that assess effects of on minority or low-income populations mandate under the provisions of Title II early life exposure. because any impacts that it will have of the Unfunded Mandates Reform Act will be global in nature and will not H. Executive Order 13211: Actions of 1995 (‘‘URMA’’), 2 U.S.C. 1531–1538 affect local communities or populations Concerning Regulations That for state, local, and tribal governments in a manner that adversely affects the Significantly Affect Energy Supply, or the private sector. This action simply level of protection provided to human Distribution, or Use solicits comment on a number of issues health or the environment. raised in a petition for reconsideration This action is not a ‘‘significant energy K. Determination Under Section 307(d) on the NSR Aggregation Amendments, action’’ as defined under Executive and proposes to revoke the rule. Order 13211, ‘‘Actions Concerning Pursuant to sections 307(d)(1)(E) and Therefore, this action is not subject to Regulations That Significantly Affect 307(d)(1)(V) of the CAA, the the requirements of sections 202 or 205 Energy Supply, Distribution, or Use’’ (66 Administrator determines that this of UMRA. FR 28355, May 22, 2001) because it is action is subject to the provisions of This action is also not subject to the not likely to have a significant adverse section 307(d). Section 307(d)(1)(V) requirements of section 203 of UMRA effect on the supply, distribution, or use provides that the provisions of section because it contains no regulatory of energy. This action will not create 307(d) apply to ‘‘such other actions as requirements that might significantly or any new requirements for sources in the the Administrator may determine.’’ uniquely affect small governments. energy supply, distribution, or use V. Statutory Authority sectors. E. Executive Order 13132: Federalism The statutory authority for this action This action does not have federalism I. National Technology Transfer and is provided by section 301(a) of the CAA implications. It will not have substantial Advancement Act as amended (42 U.S.C. 7601(a)). This direct effects on the states, on the Section 12(d) of the National notice is also subject to section 307(d) relationship between the national Technology Transfer and Advancement of the CAA (42 U.S.C. 7407(d)). government and the states, or on the Act of 1995 (‘‘NTTAA’’), Public Law List of Subjects in 40 CFR Parts 51 distribution of power and 104–113, 12(d) (15 U.S.C. 272 note) and 52 responsibilities among the various directs EPA to use voluntary consensus levels of government, as specified in standards in its regulatory activities Administrative practices and Executive Order 13132. This action unless to do so would be inconsistent procedures, Air pollution control, simply solicits comment on issues with applicable law or otherwise Environmental protection,

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Intergovernmental relations, Wildlife Service; 4401 N. Fairfax Drive, habitat designation and why. Include Aggregation. Suite 222; Arlington, VA 22203. information on the distribution of these Dated: March 29, 2010. We will post all comments on http:// essential features and what special Lisa P. Jackson, www.regulations.gov. This generally management considerations or means that we will post any personal protections may be required to maintain Administrator. information you provide us (see the or enhance them. [FR Doc. 2010–7534 Filed 4–14–10; 8:45 am] Public Comments section below for • Areas proposed as critical habitat BILLING CODE 6560–50–P more information). that do not contain the physical and FOR FURTHER INFORMATION CONTACT: Jim biological features essential for the conservation of the species that should DEPARTMENT OF THE INTERIOR Bartel, Field Supervisor, U.S. Fish and Wildlife Service, Carlsbad Fish and not be designated as critical habitat. • Fish and Wildlife Service Wildlife Office, 6010 Hidden Valley Areas not occupied at the time of Road, Suite 101, Carlsbad, CA 92011; listing that are essential to the 50 CFR Part 17 telephone (760) 431–9440; facsimile conservation of the species and why. (760) 431–5901. Persons who use a (3) Land use designations and current [Docket No. FWS–R8–ES–2009–0038] telecommunications device for the deaf or planned activities in the areas [92210–1117–0000–B4] (TDD) may call the Federal Information occupied by the species, and their RIN 1018–AW22 Relay Service (FIRS) at (800) 877–8339. possible impacts on proposed critical SUPPLEMENTARY INFORMATION: habitat; Endangered and Threatened Wildlife (4) How the proposed revised critical and Plants; Revised Critical Habitat for Public Comments habitat boundaries could be refined to Navarretia fossalis (Spreading We intend that any final action more closely circumscribe landscapes Navarretia) resulting from the proposed rule is identified as containing the physical based on the best scientific data and biological features essential to the AGENCY: Fish and Wildlife Service, available and will be accurate and as conservation of the species. Interior. effective as possible. Therefore, we (5) Any foreseeable economic, ACTION: Proposed rule; reopening of request comments or information from national security, or other relevant comment period. other concerned government agencies, impacts that may result from the scientific community, industry, or designating particular areas as critical SUMMARY: We, the U.S. Fish and any other interested parties during this habitat, and, in particular, any impacts Wildlife Service (Service), announce the reopened comment period on our to small entities (e.g., small businesses reopening of the public comment period proposed rule to revise critical habitat or small governments), and the benefits on our June 10, 2009, proposed revised for Navarretia fossalis (spreading of including or excluding areas from the designation of critical habitat for navarretia), which we published in the proposed revised designation that Navarretia fossalis (spreading Federal Register on June 10, 2009 (74 exhibit these impacts. navarretia). We also announce the FR 27588), including the changes to (6) Special management availability of a draft economic analysis proposed critical habitat in Subunits considerations or protections that the (DEA); revisions to proposed critical 1A, 1B, 3B, 5C, 5I, 6A, 6B, and 6C, the essential physical and biological habitat, including proposed revisions to DEA of the proposed revised features identified in the proposed eight subunits based on the previous designation, and the amended required critical habitat may require. public comment period; and an determinations provided in this (7) Information on the extent to which amended required determinations document. We are particularly the description of potential economic section of the proposal. We are interested in comments concerning: impacts in the DEA is complete and reopening the comment period for an (1) The reasons why we should or accurate. additional 30 days to allow all should not revise the critical habitat (8) Whether any specific subunits interested parties an opportunity to under section 4 of the Endangered being proposed as critical habitat should comment on all of the above. If you Species Act of 1973, as amended (Act) be excluded under section 4(b)(2) of the submitted comments previously, you do (16 U.S.C. 1531 et seq.), including Act, and whether the benefits of not need to resubmit them because we whether there are threats to Navarretia potentially excluding any particular have already incorporated them into the fossalis from human activity, the type of area outweigh the benefits of including public record and will fully consider human activity causing these threats, that area as critical habitat. them in our final determination. and whether the benefit of designation (9) Our consideration to exclude the DATES: We will consider public would outweigh any threats to the portion of Subunit 4E that we are comments received on or before May 17, species caused by the designation, such proposing as critical habitat within the 2010. Any comments that are received that the designation of critical habitat is Ramona Grasslands Preserve under after the closing date may not be prudent. section 4(b)(2) of the Act, and whether considered in the final decision on this (2) Specific information on: such exclusion is appropriate and why; action. • The current amount and distribution (10) The likelihood of adverse social ADDRESSES: You may submit comments of Navarretia fossalis habitat. reactions to the designation of critical by one of the following methods: • Areas that provide habitat for N. habitat, and how the consequences of • Federal eRulemaking Portal: http:// fossalis that we did not discuss in our such reactions, if they occur, would www.regulations.gov. Follow the original proposed revised critical habitat relate to the conservation of the species instructions for submitting comments rule or in this reopening of the comment and regulatory benefits of the proposed on Docket No. FWS-R8-ES-2009-0038. period. revised critical habitat designation. • U.S. mail or hand-delivery: Public • Areas containing the physical and (11) Information on the extent to Comments Processing, Attn: FWS–R8– biological features essential to the which the description of potential ES–2009–0038; Division of Policy and conservation of N. fossalis that we economic impacts in the DEA is Directives Management; U.S. Fish and should include in the revised critical complete and accurate, and specifically:

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• Whether there are incremental costs scientific or commercial information Section 3 of the Act defines critical of critical habitat designation (e.g., costs you include. habitat as the specific areas within the attributable solely to the designation of Comments and materials we receive, geographical area occupied by a species, critical habitat for Navarretia fossalis) as well as supporting documentation at the time it is listed in accordance that have not been appropriately used to prepare this notice, will be with the Act, on which are found those identified or considered in our available for public inspection at http:// physical or biological features essential economic analysis, including costs www.regulations.gov, or by to the conservation of the species and associated with future administrative appointment, during normal business that may require special management costs or project modifications that may hours, at the U.S. Fish and Wildlife considerations or protection, and be required by Federal agencies related Service, Carlsbad Fish and Wildlife specific areas outside the geographical to section 7 consultation under the Act; Office (see FOR FURTHER INFORMATION area occupied by a species at the time • Whether there are incremental CONTACT). You may obtain copies of the it is listed, upon a determination that economic benefits of critical habitat proposed revision of critical habitat (74 such areas are essential for the designation that have not been FR 27588) and the DEA on the Internet conservation of the species. If the appropriately identified or considered at http://www.regulations.gov at Docket proposed rule is made final, section 7 of in our economic analysis. No. FWS-R8-ES-2009-0038, or by mail the Act will prohibit destruction or (12) The potential effects of climate from the Carlsbad Fish and Wildlife adverse modification of critical habitat change on this species and its habitat Office (see FOR FURTHER INFORMATION by any activity funded, authorized, or and whether the critical habitat may CONTACT). carried out by any Federal agency. adequately account for these potential Federal agencies proposing actions effects. Background affecting critical habitat must consult If you submitted comments or It is our intent to discuss only those with us on the effects of their proposed information on the proposed revised topics directly relevant to the proposed actions, under section 7(a)(2) of the Act. rule (74 FR 27588) during the initial comment period from June 10, 2009, to revised designation of critical habitat for Draft Economic Analysis Navarretia fossalis in this notice. For August 10, 2009, please do not resubmit Section 4(b)(2) of the Act requires that more information on previous Federal them. These comments are included in we designate or revise critical habitat actions concerning N. fossalis, see the the public record for this rulemaking, based upon the best scientific and and we will fully consider them in the 2005 final designation of critical habitat commercial data available, after taking preparation of our final determination. published in the Federal Register on into consideration the economic impact, Our final determination concerning the October 18, 2005 (70 FR 60658), or the impact on national security, or any revised critical habitat for Navarretia 2009 proposed revised designation of other relevant impact of specifying any fossalis will take into consideration all critical habitat published in the Federal particular area as critical habitat. written comments and any additional Register on June 10, 2009 (74 FR 27588), We prepared a DEA (Entrix, Inc. information we receive during both or contact the Carlsbad Fish and 2010), which identifies and analyzes the comment periods. On the basis of public Wildlife Office (see FOR FURTHER potential impacts associated with the comments, we may, during the INFORMATION CONTACT). proposed revised designation of critical development of our final determination, The Center for Biological Diversity habitat for Navarretia fossalis that we find that areas within the proposed filed a complaint in the U.S. District published in the Federal Register on revised critical habitat designation do Court for the Southern District of June 10, 2009 (74 FR 27588). The DEA not meet the definition of critical California on December 19, 2007, looks retrospectively at costs incurred habitat, that some modifications to the challenging our designation of critical since the October 13, 1998 (63 FR described boundaries are appropriate, or habitat for Navarretia fossalis and 54975), listing of N. fossalis as that areas may or may not be Brodiaea filifolia (Center for Biological threatened. The DEA quantifies the appropriate for exclusion under section Diversity v. United States Fish and economic impacts of all potential 4(b)(2) of the Act. Wildlife Service et al., Case No. 07–CV– conservation efforts for N. fossalis; some You may submit your comments and 2379–W–NLS). This lawsuit challenged of these costs will likely be incurred materials concerning our proposed rule, the validity of the information and regardless of whether or not we finalize the associated DEA, our changes to reasoning we used to exclude areas from the revised critical habitat rule. The subunits and considered exclusions as the 2005 critical habitat designation for economic impact of the proposed identified in this document, and our N. fossalis. We reached a settlement revised critical habitat designation is amended required determinations agreement on July 25, 2008, in which analyzed by comparing a ‘‘with critical section by one of the methods listed in we agreed to reconsider critical habitat habitat’’ scenario with a ‘‘without critical the ADDRESSES section. designation for N. fossalis. The habitat’’ scenario. The ‘‘without critical If you submit a comment via http:// settlement stipulated that we submit a habitat’’ scenario represents the baseline www.regulations.gov, your entire proposed revised critical habitat for the analysis, considering protections submission—including any personal designation for N. fossalis to the Federal already in place for the species (for identifying information—will be posted Register for publication by May 29, example, under the Federal listing and on the website. If your submission is 2009, and submit a final revised critical other Federal, State, and local made via a hard copy that includes habitat designation to the Federal regulations). The baseline, therefore, personal identifying information, you Register for publication by May 28, represents the costs incurred regardless may request at the top of your document 2010. On June 10, 2009, we published of whether critical habitat is designated. that we withhold this information from the revised proposed critical habitat The ‘‘with critical habitat’’ scenario public review. However, we cannot designation in the Federal Register (74 describes the incremental impacts guarantee that we will be able to do so. FR 27588). On January 20, 2010, we associated specifically with the We will post all hard copy comments on were granted an extension to submit a designation of critical habitat for the http://www.regulations.gov. Please final revised critical habitat designation species. The incremental conservation include sufficient information with your to the Federal Register for publication efforts and associated impacts are those comments to allow us to verify any by September 30, 2010. not expected to occur absent the critical

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habitat designation for N. fossalis. In Conservation costs associated with published in the Federal Register on other words, the incremental costs are section 7 consultations for development, June 10, 2009 (74 FR 27588), and adding those attributable solely to the transportation, and flood control a new Subunit 5C. We received designation of critical habitat above and projects comprise the quantified comments from the public and from one beyond the baseline costs; these are the incremental impacts for the proposed peer reviewer during the open comment costs we may consider in the final revised critical habitat rule. Impacts period indicating that we should designation of critical habitat relative to associated with transportation reevaluate the proposed boundaries of areas that may be excluded under constituted the largest portion of post- Subunits 1A, 1B, 3B, 5I, 6A, 6B, and 6C section 4(b)(2) of the Act. The analysis designation, upper-bound incremental and that we should include subunit 5C looks retrospectively at baseline impacts impacts, accounting for almost 47 in the proposed critical habitat. The incurred since the species was listed, percent of the forecast incremental purpose of the revisions described and forecasts both baseline and impacts applying a 7 percent discount below is to better delineate the areas incremental impacts likely to occur if rate. Conservation efforts related to that meet the definition of critical we finalize the proposed revised critical development and flood control activities habitat for Navarretia fossalis. All areas habitat. constitute the remainder of incremental added to the units proposed in the June The 2010 DEA (made available with impacts (37 percent and 16 percent, 10, 2009 (74 FR 27588), proposed rule the publication of this notice and respectively, of post-designation upper- are within the geographic range referred to as the DEA throughout this bound baseline impacts when a 7 occupied by the species at the time it document unless otherwise noted) percent discount rate is used) in areas was listed and contain the features estimates the foreseeable economic of proposed revised critical habitat. The impacts of the proposed revised critical DEA estimated total potential essential for the conservation of the habitat designation for Navarretia incremental economic impacts in areas species. These areas contain the primary fossalis. The economic analysis proposed as revised critical habitat over constituent elements (PCEs), which are identifies potential incremental costs as the next 20 years (2010–2029) to be the physical or biological features a result of the proposed revised critical $846,000 to $1.2 million ($80,000 to essential to the conservation of a habitat designation, which are those $100,000 annualized) in present value species, and which the species’ costs attributed to critical habitat over terms applying a 7 percent discount rate proposed or designated critical habitat and above those baseline costs (Entrix, Inc. 2010, pp. ES-3–ES-4). is based on, such as space for individual coextensive with listing. It also The DEA considers both economic and population growth, and for normal discusses the benefits of critical habitat efficiency and distributional effects. In behavior; food, water, air, light, designation. These benefits are the case of habitat conservation, minerals, or other nutritional or primarily presented in a qualitative efficiency effects generally reflect the physiological requirements; cover or manner. The DEA describes economic ‘‘opportunity costs’’ associated with the shelter; sites for breeding, reproduction, impacts of N. fossalis conservation commitment of resources to comply rearing of offspring, germination, or efforts associated with the following with habitat protection measures (such seed dispersal; and habitats that are categories of activity: (1) Development, as lost economic opportunities protected from disturbance or are (2) conservation lands management, (3) associated with restrictions on land representative of the species’ historic transportation, (4) pipeline projects, (5) use). The DEA also addresses how geographic and ecological distribution. flood control, (6) agriculture, and (7) fire potential economic impacts are likely to The revisions consist of both management. be distributed, including an assessment additions and removals of land that we Baseline economic impacts are those of any local or regional impacts of impacts that result from listing and habitat conservation and the potential proposed as critical habitat (74 FR other conservation efforts for Navarretia effects of conservation activities on 27588). The changes made in Subunits fossalis. Conservation efforts related to government agencies, private 1A, 1B, 3B, 5I, 6A, 6B, and 6C do not flood control and development activities businesses, and individuals. The DEA alter the description of these subunits in constitute the majority of total baseline measures lost economic efficiency the June 10, 2009, proposed rule (74 FR costs (approximately 84 percent of post- associated with residential and 27588); however, we include revised designation, upper-bound, baseline commercial development and public maps with this publication. We briefly impacts when a 7 percent discount rate projects and activities, such as describe the changes made for each of is used) in areas of proposed revised economic impacts on water these subunits below. We did not critical habitat. Impacts to conservation management and transportation include Subunit 5C in the proposed rule lands management, transportation, and projects, Federal lands, small entities, (74 FR 27588, June 10, 2009), so this pipeline projects compose the and the energy industry. Decision- notice includes the full description and remaining approximately 16 percent of makers can use this information to map for Subunit 5C below. As a result post-designation, upper-bound, baseline assess whether the effects of the revised of these revisions, the overall area impacts when a 7 percent discount rate designation might unduly burden a proposed for critical habitat is 7,609 is used. Total future baseline impacts particular group or economic sector. acres (ac) (3,079 hectares (ha)), an are estimated to be $30.1 to $123.5 increase of 737 ac (298 ha) from the million ($2.9 to $11.7 million Changes to Proposed Revised Critical 6,872 ac (2,781 ha) that we proposed as annualized) in present value terms Habitat critical habitat in the June 10, 2009, using a 7 percent discount rate, over the In this document we are proposing proposed rule (74 FR 27588). A next 20 years (2010–2029) in areas revisions to Subunits 1A, 1B, 3B, 5I, 6A, summary of the total acreage of each proposed as revised critical habitat 6B, and 6C, as identified and described proposed subunit is presented in Table (Entrix, Inc. 2010, pp. ES-3–ES-4). in the revised proposed rule that 1.

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TABLE 1. SUMMARY OF SUBUNITS PROPOSED AS CRITICAL HABITAT.

Location Total Subunit Area

Unit 1: Los Angeles Basin-Orange Management Area

1A. Cruzan Mesa 156 ac (63 ha)

1B. Plum Canyon 20 ac (8 ha)

Unit 2: San Diego: Northern Coastal Mesa Management Area

2. Poinsettia Lane Commuter Station 9 ac (4 ha)

Unit 3: San Diego: Central Coastal Mesa Management Area

3A. Santa Fe Valley (Crosby Estates) 5 ac (2 ha)

3B. Carroll Canyon 18 ac (7 ha)

3C. Nobel Drive 37 ac (15 ha)

3D. Montgomery Field 48 ac (20 ha)

Unit 4: San Diego: Inland Management Area

4C1. San Marcos (Upham) 34 ac (14 ha)

4C2. San Marcos (Universal Boot) 32 ac (13 ha)

4D. San Marcos (Bent Avenue) 5 ac (2 ha)

4E. Ramona 135 ac (55 ha)

Unit 5: San Diego: Southern Coastal Mesa Management Area

5A. Sweetwater Vernal Pools (S1-3) 95 ac (38 ha)

5B. Otay River Valley (M2) 24 ac (10 ha)

5C. Otay Mesa (J26) 42 ac (17 ha)

5F. Proctor Valley (R1-2) 88 ac (36 ha)

5G. Otay Lakes (K3-5) 140 ac (57 ha)

5H. Western Otay Mesa vernal pool complexes 143 ac (58 ha)

5I. Eastern Otay Mesa vernal pool complexes 221 ac (89 ha)

Unit 6: Riverside Management Area

6A. San Jacinto River 4,312 ac (1,745 ha)

6B. Salt Creek Seasonally Flooded Alkali Plain 943 ac (382 ha)

6C. Wickerd Road and Scott Road Pools 235 ac (95 ha)

6D. Skunk Hollow 158 ac (64 ha)

6E. Mesa de Burro 708 ac (287 ha)

Total 7,609 ac (3,079 ha)

Subunit 1A: Cruzan Mesa and include the watershed for the Subunit 1B: Plum Canyon ponding areas on Cruzan Mesa (PCE 2). We received comments indicating that The revised subunit consists of 156 ac We received information indicating we did not capture the entire watershed (63 ha) of private land, an increase of 27 that the placement of our proposed area necessary to fill the vernal pools critical habitat for Subunit 1B did not ac (11 ha) from what we proposed as supporting Navarretia fossalis in capture the vernal pool where critical habitat in the June 10, 2009, Subunit 1A. We reviewed aerial imagery Navarretia fossalis occurs in the Plum and topographic maps for this area and proposed rule (74 FR 27588). Canyon area. Due to a publication error, verified that the subunit needed the incorrect map was published in the revision to adequately capture areas that June 10, 2009, proposed rule (74 FR meet the definition of critical habitat 27588). In reviewing this subunit, we

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became aware of more accurate data of Otay Mesa north of Alta Road and Parkway. The revised subunit consists describing this area (Glenn Lukos south of Lower Otay Reservoir. Subunit of 4,312 ac (1,745 ha) of private land, an Associates 2009, Exhibit 3 (Appendix D- 5C consists of 42 ac (17 ha), including increase of 762 ac (308 ha) from what 3 of PCR 2009)). As a result of our 26 ac (11 ha) of State and local we proposed in the June 10, 2009, evaluation of this new information, we government-owned land and 16 ac (6 proposed rule (74 FR 27588). remapped the boundaries of Subunit 1B. ha) private land. This subunit meets our Our remapping corrects our publication criteria for satellite habitat; it supports Subunit 6B: Salt Creek Seasonally error and incorporates the new a stable occurrence of Navarretia Flooded Alkali Plain information. Subunit 1B contains fossalis and provides potential A peer reviewer recommended that physical and biological features that are connectivity between occurrences of N. we revise the boundaries of the essential to the conservation of N. fossalis in Subunits 5G and 5I. Subunit proposed critical habitat in three areas fossalis, including ephemeral wetland 5C contains the physical and biological of Subunit 6B, because we had included habitat (PCE 1), intermixed wetland and features that are essential to the areas that were disturbed by past upland habitats that act as the local conservation of N. fossalis, including activities and no longer meet the watershed (PCE 2), and the topography ephemeral wetland habitat (PCE 1), definition of critical habitat and had not and soils that support ponding during intermixed wetland and upland habitats included some areas that meet the winter and spring months (PCE 3). The that act as the local watershed (PCE 2), definition of critical habitat for revised subunit consists of 20 ac (8 ha) and the topography and soils that Navarretia fossalis. Following of private land, a decrease of 12 ac (5 support ponding during winter and evaluation of this area in greater detail, ha) from what we proposed in the June spring months (PCE 3). The physical we agreed with the peer reviewer and 10, 2009, proposed rule (74 FR 27588). and biological features essential to the made changes to this subunit in the conservation of the species in this Subunit 3B: Carroll Canyon central portion on the east side, on the subunit may require special north end, and near the Hemet Airport. We received information indicating management considerations or We are no longer proposing an area near that the western portion of Subunit 3B protection to address threats from the center on the east side that was had been graded and does not likely nonnative plant species, altered developed and disturbed many years contain the physical and biological hydrology, and human disturbance ago, has not supported N. fossalis since features essential to the conservation of activities (e.g., unauthorized grazing 1990, and therefore no longer meets the Navarretia fossalis. We reviewed aerial activity) that occur in the vernal pool definition of critical habitat. Also, we imagery and found this information to basins and associated watershed. Please be correct; therefore, we removed 2 ac are no longer proposing some land in see the ‘‘Special Management the northern portion of the proposed (1 ha) of land that no longer meets the Considerations or Protection’’ section of definition of critical habitat for this subunit because it is dry, disturbed, and the proposed rule for a discussion of the does not meet the definition of critical species. The revised subunit consists of threats to N. fossalis habitat and 18 ac (7 ha) (16 ac (6 ha) of land owned habitat for N. fossalis. Finally, we potential management considerations included vernal pool habitat on the by the City of San Diego and 2 ac (1 ha) (74 FR 27588, June 10, 2009). of private land), a decrease of 2 ac (1 ha) eastern edge of our proposed subunit from what we proposed in the June 10, Subunit 5I: Eastern Otay Mesa Vernal near the Hemet Airport that meets the 2009, proposed rule (74 FR 27588). Pool Complex definition of critical habitat for N. We are not proposing to revise the fossalis. The revised subunit consists of Subunit 5C: J26 Vernal Pool Complex boundaries of Subunit 5I; however, due 943 ac (382 ha) of private land, a We received information from the to a publication error, we are providing decrease of 111 ac (45 ha) from what we public that we should propose Subunit the correct map for Subunit 5I in this proposed in the June 10, 2009, proposed 5C, a subunit that was designated as document. For clarification, we reiterate rule (74 FR 27588). critical habitat in our October 18, 2005, that Subunit 5I consists of 221 ac (89 ha) Subunit 6C: Wickerd Road and Scott final rule (70 FR 60658), as revised of private land as described in the June Road Pools critical habitat in this rule. We did not 10, 2009, proposed rule (74 FR 27588). include Subunit 5C in the proposed rule We received information that we had (74 FR 27588, June 10, 2009) because we Subunit 6A: San Jacinto River not adequately captured the physical did not have data in our GIS database We received information from the and biological features essential to the indicating this area was occupied by public that we had not included some conservation of Navarretia fossalis in Navarretia fossalis. We subsequently additional areas that meet the definition Subunit 6C. We received new reviewed the data in our files on N. of critical habitat for Navarretia fossalis information describing the Wickerd fossalis in Subunit 5C (the J26 vernal in Subunit 6A. We reviewed the new Road vernal pool (Roberts 2009, p. 1). pool complex) and found records of N. information provided, including a 2005 We reviewed the new information, fossalis occupancy (The Environmental map that provided better survey data including the information about the Trust 2001, p. 1; 2000, p. 1). Based on along the San Jacinto River (Helix vernal pool and newer aerial imagery for this new information and because this Environmental, Inc. 2005, map). Based this area. As a result, we revised the vernal pool complex is also considered on the new information, we included subunit to include the upward sloping one of the best examples of vernal pool additional areas in this subunit that area between the Wickerd Road vernal habitat on Otay Mesa (The meet the definition of critical habitat for pool and Scott Road that meets the Environmental Trust 2002, p. 2), we are N. fossalis. We expanded the critical definition of critical habitat for N. proposing Subunit 5C as revised critical habitat designation boundary for fossalis and contributes to the habitat. We have mapped the boundary Subunit 6A in the following areas: (1) watershed of this vernal pool. The of this subunit to conform to our current Around 13th Street to the east of the San revised subunit consists of 235 ac (95 mapping methodology. Jacinto River, (2) east to Dawson Road ha) of private land, an increase of 30 ac Subunit 5C is located on eastern Otay and north to Ellis Road near Simpson (12 ha) from what we proposed in the Mesa in San Diego County, California. Road, (3) around the Case Road vernal June 10, 2009, proposed rule (74 FR This subunit is on the far eastern side pool, and (4) north of the Green Valley 27588).

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Additional Areas Currently Considered with several statutes and Executive concerns with fewer than 500 For Exclusion Under Section 4(b)(2) of Orders until the information concerning employees, wholesale trade entities the Act– The Ramona Grasslands potential economic impacts of the with fewer than 100 employees, retail Preserve designation and potential effects on and service businesses with less than $5 In the proposed revised critical landowners and stakeholders became million in annual sales, general and habitat designation published on June available in the DEA. We have now heavy construction businesses with less 10, 2009 (74 FR 27588), we identified made use of the DEA to make these than $27.5 million in annual business, lands in Subunit 4E as meeting the determinations. special trade contractors doing less than In this document, we affirm the definition of critical habitat for $11.5 million in annual business, and information in our June 10, 2009, agricultural businesses with annual Navarretia fossalis. Based on comments proposed rule (74 FR 27588) concerning sales less than $750,000. To determine submitted during the initial public Executive Order (E.O.) 12866 if potential economic impacts to these comment period from June 10, 2009, to (Regulatory Planning and Review), E.O. small entities are significant, we August 10, 2009, we are also 13132 (Federalism), E.O. 12988 (Civil considered the types of activities that considering for exclusion from critical Justice Reform), the Paperwork might trigger regulatory impacts under habitat under section 4(b)(2) of the Act Reduction Act, the National this designation as well as types of the portion of Subunit 4E within the Environmental Policy Act, and the project modifications that may result. In Ramona Grasslands Preserve. Of the 135 President’s memorandum of April 29, general, the term significant economic ac (55 ha) proposed in Subunit 4E, 51 1994, ‘‘Government-to-Government impact is meant to apply to a typical ac (21 ha) are part of the Ramona Relations with Native American Tribal small business firm’s business Grasslands Preserve, which is owned by Governments’’ (59 FR 22951). However, operations. the Nature Conservancy and San Diego based on the DEA data, we are To determine if the proposed revised County, and managed by San Diego amending our required determinations designation of critical habitat for County Department of Parks and concerning the Regulatory Flexibility Navarretia fossalis would affect a Recreation. The Ramona Grasslands Act (5 U.S.C. 601 et seq.), E.O. 13211 substantial number of small entities, we Preserve is covered by a conservation (Energy Supply, Distribution, or Use), consider the number of small entities easement and being managed and E.O. 12630 (Takings), and the Unfunded affected within particular types of monitored according to the ‘‘Area Mandates Reform Act (2 U.S.C. 1501 et economic activities, such as residential Specific Management Directives for the seq.). and commercial development. In order Ramona Grasslands Preserve’’ drafted by to determine whether it is appropriate Regulatory Flexibility Act (5 U.S.C. 601 San Diego County (2007). The for our agency to certify that this rule et seq.) management plan for the Ramona would not have a significant economic Grasslands Preserve provides for the Under the Regulatory Flexibility Act impact on a substantial number of small conservation of N. fossalis and its (5 U.S.C. 601 et seq., as amended by the entities, we considered each industry or habitat through vernal pool management Small Business Regulatory Enforcement category individually. In estimating the goals, including: managing nonnative Fairness Act (SBREFA) of 1996), numbers of small entities potentially invasive plant species, maintaining the whenever an agency is required to affected, we also considered whether vernal pool hydrology, and managing publish a notice of rulemaking for any their activities have any Federal grazing activities to benefit vernal pool proposed or final rule, it must prepare involvement. Critical habitat habitat (Conservation Biology Institute and make available for public comment designation will not affect activities that 2007, pp. 26–27, 31–34). This area will a regulatory flexibility analysis that do not have any Federal involvement; be incorporated into the North County describes the effect of the rule on small designation of critical habitat affects Multiple Species Conservation Plan entities (i.e., small businesses, small activities conducted, funded, permitted, (North County MSCP) upon completion organizations, and small government or authorized by Federal agencies. of that plan (San Diego County 2009). jurisdictions), as described below. If we finalize this proposed revised As we stated earlier, we request data However, no regulatory flexibility critical habitat designation, Federal and comments from the public on the analysis is required if the head of an agencies must consult with us under DEA, on all aspects of the proposed agency certifies the rule will not have a section 7 of the Act if their activities revised critical habitat rule (including significant economic impact on a may affect designated critical habitat. the changes to proposed critical habitat substantial number of small entities. Consultations to avoid the destruction in Subunits 1A, 1B, 3B, 5C, 5I, 6A, 6B, Based on our DEA of the proposed or adverse modification of critical and 6C), and our amended required revised designation, we provide our habitat would be incorporated into the determinations. The final revised rule analysis for determining whether the existing consultation process because may differ from the proposed revised proposed rule would result in a Navarretia fossalis is listed as a rule based on new information we significant economic impact on a threatened species under the Act. In the receive during the public comment substantial number of small entities. 2010 DEA, we evaluated the potential periods. In particular, we may exclude Based on comments we receive, we may economic effects on small business an area from critical habitat if we revise this determination as part of a entities resulting from implementation determine that the benefits of excluding final rulemaking. of conservation actions related to the the area outweigh the benefits of According to the Small Business proposed revision to critical habitat for including the area as critical habitat, Administration, small entities include Navarretia fossalis. The analysis was provided the exclusion will not result in small organizations, such as based on the estimated incremental the extinction of the species. independent nonprofit organizations; impacts associated with the proposed small governmental jurisdictions, rulemaking as described in sections 3 Required Determinations–—Amended including school boards and city and through 10 of the DEA. The SBREFA In our proposed rule published in the town governments that serve fewer than analysis evaluated the potential for Federal Register on June 10, 2009 (74 50,000 residents; and small businesses economic impacts related to several FR 27588), we indicated that we would (13 CFR 121.201). Small businesses categories, including: (1) Residential, defer our determination of compliance include manufacturing and mining commercial and industrial

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development; (2) conservation lands that may constitute ‘‘a significant must ensure that their actions do not management; (3) transportation; (4) adverse effect’’ when compared to no destroy or adversely modify critical pipeline projects; (5) flood control; (6) regulatory action. As discussed in habitat under section 7. Designation of agriculture; and (7) fire management Appendix A, the DEA finds that none of critical habitat may indirectly impact (Entrix, Inc. 2010, p. A-1). The DEA these criteria are relevant to this non-Federal entities that receive Federal found that the only category of activity analysis. The DEA concludes that no funding, assistance, or permits, or that where the designation may impact small incremental impacts on the production, otherwise require approval or businesses is residential, commercial, distribution, or use of energy are authorization from a Federal agency. and industrial development (Entrix, Inc. forecast associated specifically with this However, the legally binding duty to 2010, pp. A-1–A-4). For residential, rulemaking. All forecast impacts are avoid destruction or adverse commercial, and industrial expected to occur associated with the modification of critical habitat rests development, the DEA estimated that listing of Navarretia fossalis, regardless squarely on the Federal agency. there will be approximately 38 of the designation of critical habitat. Furthermore, to the extent that non- development projects in the areas Therefore, designation of critical habitat Federal entities are indirectly impacted proposed as critical habitat over the is not expected to lead to any adverse because they receive Federal assistance next 20 years. The total incremental outcomes (such as a reduction in or participate in a voluntary Federal aid impact to residential, commercial, and electricity production or an increase in program, the Unfunded Mandates industrial development was estimated the cost of energy production or Reform Act would not apply, nor would to be between $112,000 and $431,000 at distribution), and a Statement of Energy critical habitat shift the costs of the large a 7 percent discount rate over the next Effects is not required. entitlement programs listed above on to 20 years. On an annual basis this affects State governments. Unfunded Mandates Reform Act (2 approximately two development related (b) As discussed in the DEA of the U.S.C. 1501 et seq.) small businesses with a total annual proposed revised designation of critical impact ranging from $10,565 to $40,646 In accordance with the Unfunded habitat for Navarretia fossalis, we do not (Entrix, Inc. 2010, pp. A-3–A-4). In a Mandates Reform Act, the Service believe that this rule would significantly regional context, there are makes the following findings: or uniquely affect small governments approximately 500 small development (a) This rule will not produce a because it would not produce a Federal related businesses in San Diego County Federal mandate. In general, a Federal mandate of $100 million or greater in and 303 in Riverside County. The 38 mandate is a provision in legislation, any year; that is, it is not a ‘‘significant development related small businesses statute, or regulation that would impose regulatory action’’ under the Unfunded that may be impacted represent an enforceable duty upon State, local, or Mandates Reform Act. The DEA approximately 5 percent of the total Tribal governments, or the private concludes that incremental impacts may number of development related small sector, and includes both ‘‘Federal occur due to administrative costs of businesses in San Diego and Riverside intergovernmental mandates’’ and section 7 consultations for development, Counties. We do not believe that this ‘‘Federal private sector mandates.’’ transportation, and flood control represents a substantial number of These terms are defined in 2 U.S.C. projects activities; however, these are development-related small businesses or 658(5)-(7). ‘‘Federal intergovernmental not expected to affect small that an annual impact ranging from mandate’’ includes a regulation that governments. Incremental impacts $10,565 to $40,646 is a significant ‘‘would impose an enforceable duty associated with these activities [jsc8]are economic impact; therefore, we do not upon State, local, or Tribal expected to be borne by the Federal find that the designation of critical governments,’’ with two exceptions. Government, California Department of habitat for N. fossalis will have a First, it excludes ‘‘a condition of federal Transportation, California Department significant economic impact on a assistance.’’ Second, it also excludes ‘‘a of Fish and Game, Riverside County, substantial number of small entities. duty arising from participation in a Riverside County Flood Control and In summary, we considered whether voluntary Federal program,’’ unless the Water Conservation District, and City of the proposed revised designation would regulation ‘‘relates to a then-existing Perris, which are not considered small result in a significant economic impact Federal program under which governments. Consequently, we do not on a substantial number of small $500,000,000 or more is provided believe that the revised critical habitat entities. For the above reasons and annually to State, local, and Tribal designation would significantly or based on currently available governments under entitlement uniquely affect small government information, we certify that, if authority,’’ if the provision would entities. As such, a Small Government promulgated, the proposed revised ‘‘increase the stringency of conditions of Agency Plan is not required. critical habitat for Navarretia fossalis assistance’’ or ‘‘place caps upon, or Executive Order 12630 — Takings would not have a significant economic otherwise decrease, the Federal impact on a substantial number of small Government’s responsibility to provide In accordance with E.O. 12630 entities. Therefore, an initial regulatory funding’’ and the State, local, or Tribal (‘‘Government Actions and Interference flexibility analysis is not required. governments ‘‘lack authority’’ to adjust with Constitutionally Protected Private accordingly. ‘‘Federal private sector Property Rights’’), we analyzed the Executive Order 13211—Energy Supply, mandate’’ includes a regulation that potential takings implications of Distribution, and Use ‘‘would impose an enforceable duty proposing revised critical habitat for On May 18, 2001, the President issued upon the private sector, except (i) a Navarretia fossalis in a takings E.O. 13211 on regulations that condition of Federal assistance; or (ii) a implications assessment. Critical habitat significantly affect energy supply, duty arising from participation in a designation does not affect landowner distribution, and use. Executive Order voluntary Federal program.’’ actions that do not require Federal 13211 requires agencies to prepare Critical habitat designation does not funding or permits, nor does it preclude Statements of Energy Effects when impose a legally binding duty on non- development of habitat conservation undertaking certain actions. The OMB’s Federal Government entities or private programs or issuance of incidental take guidance for implementing this parties. Under the Act, the only permits to permit actions that do require Executive Order outlines nine outcomes regulatory effect is that Federal agencies Federal funding or permits. The

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proposed revised critical habitat for N. Regulations, as proposed to be amended e. Adding a new paragraph (19); fossalis does not pose significant takings at 74 FR 27588, June 10, 2009, as set f. Revising newly designated implications for the above reasons. forth below. paragraph (23)(ii), including the map of References Cited Subunit 5I (Eastern Otay Mesa Vernal PART 17—[AMENDED] Pool Complexes); A complete list of all references we 1. The authority citation for part 17 g. Revising newly designated cited in the proposed rule and in this continues to read as follows: paragraph (24)(ii), including the map of document is available on the Internet at Subunit 6A (San Jacinto River); http://www.regulations.gov or by Authority: 16 U.S.C. 1361–1407; 16 U.S.C. contacting the Carlsbad Fish and 1531–1544; 16 U.S.C. 4201–4245; Pub. L. 99– h. Revising newly designated 625, 100 Stat. 3500; unless otherwise noted. paragraph (25)(ii), including the map of Wildlife Office (see FOR FURTHER 2. Critical habitat for Navarretia Subunit 6B (Salt Creek Seasonally INFORMATION CONTACT). fossalis (spreading navarretia) in § Flooded Alkali Plain); and Authors 17.96(a), which was proposed for i. Revising newly designated revision on June 10, 2009, at 74 FR The primary authors of this notice are paragraph (26)(ii), including the map of 27620, is proposed to be further staff members of the Carlsbad Fish and Subunit 6C (Wickerd and Scott Road amended by: Pools), to read as follows: Wildlife Office (see FOR FURTHER a. Revising paragraph (5), including INFORMATION CONTACT). the index map of critical habitat units § 17.96 Critical habitat—plants. for Navarretia fossalis (spreading List of Subjects in 50 CFR Part 17 (a) Flowering plants. navarretia); Endangered and threatened species, b. Revising paragraph (7)(ii), * * * * * Exports, Imports, Reporting and including the map of Subunits 1A recordkeeping requirements, Family Polemoniaceae: Navarretia (Cruzan Mesa) and 1B (Plum Canyon); fossalis (spreading navarretia) Transportation. c. Revising paragraph (10)(ii), including the map of Subunit 3B * * * * * Proposed Regulation Promulgation (Carroll Canyon); (5) Note: Index Map of critical habitat Accordingly, we propose to further d. Redesignating paragraphs (19) units for Navarretia fossalis (spreading amend part 17, subchapter B of chapter through (27) as paragraphs (20) through navarretia) follows: I, title 50 of the Code of Federal (28); BILLING CODE 4310–55–S

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* * * * * (ii) Note: Map of Los Angeles Basin– (Cruzan Mesa) and 1B (Plum Canyon) (7) * * * Orange Management Area Subunits 1A follows:

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* * * * * (ii) Note: Map of Unit 3, Subunit 3B (10) * * * (Carroll Canyon) follows:

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* * * * * Diego County, CA. Subunit 5C: J26 Subunit 5C.] (19) Unit 5: San Diego: Southern Vernal Pool Complex. (ii) Note: Map of Unit 5, Subunit 5C Coastal Mesa Management Area, San (i) [Reserved for textual description of (J26 Vernal Pool Complex) follows:

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* * * * * (ii) Note: Map of Unit 5, Subunit 5I (23) * * * (Eastern Otay Mesa Vernal Pool Complexes) follows:

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(24) * * * (ii) Note: Map of Unit 6, Subunit 6A (San Jacinto River) follows:

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(25) * * * (ii) Note: Map of Unit 6, Subunit 6B (Salt Creek Seasonally Flooded Alkali Plain) follows:

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(26) * * * (ii) Note: Map of Unit 6, Subunit 6C (Wickerd and Scott Road Pools) follows:

* * * * * Dated: April 6, 2010 Thomas L. Strickland, Assistant Secretary for Fish and Wildlife and Parks. [FR Doc. 2010–8453 Filed 4–14–10; 8:45 am] BILLING CODE 4310–55–C

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DEPARTMENT OF THE INTERIOR facsimile (406) 499–5339. Persons who wolverines, their habitat, and their food use a telecommunications device for the sources in the contiguous United States. Fish and Wildlife Service deaf (TDD) may call the Federal (7) Information on the management of Information Relay Service (FIRS) at wolverines on both sides of the 50 CFR Part 17 800–877–8339. international boundary where [Docket No. FWS–R6–ES–2008–0029; MO SUPPLEMENTARY INFORMATION: populations occur and how this 92210–0–008] management may differ between Canada Request for Information and the United states in how it affects Endangered and Threatened Wildlife To ensure that the status review is the status of wolverines. and Plants; Initiation of Status Review complete and based on the best If you submit information, we request of the North American Wolverine in the available scientific and commercial you support it with documentation, Contiguous United States information, and to provide an such as data, maps, bibliographic opportunity to all interested parties to references, methods used to gather and AGENCY: Fish and Wildlife Service, provide information for consideration analyze the data, or copies of any Interior. during the status review, we are pertinent publications, reports, or letters ACTION: Notice; initiation of status requesting information concerning by knowledgeable sources. Submissions merely stating support review. North American wolverines rangewide for or opposition to the action under and in the contiguous United States. We SUMMARY: We, the U.S. Fish and consideration without providing are seeking: Wildlife Service (Service), under the supporting information, although noted, (1) General information concerning authority of the Endangered Species Act will not be considered in making a the taxonomy, biology, ecology, of 1973, as amended (Act), announce determination. Section 4(b)(1)(A) of the genetics, and status of North American the initiation of a status review of the Act directs that determinations as to wolverines rangewide and in the North American wolverine (Gulo gulo whether any species is an endangered or contiguous United States. luscus) in the contiguous United States. threatened species must be made ‘‘solely (2) Specific information relevant to We conduct status reviews to determine on the basis of the best scientific and the consideration of a potential distinct whether the entity should be listed as commercial data available.’’ endangered or threatened under the Act. population segment (DPS) of North You may submit your information Through this notice, we encourage all American wolverines in the contiguous concerning this status review by one of interested parties to provide us United States. This consideration will the methods listed in the ADDRESSES information regarding North American be guided by our Policy Regarding the section. If you submit information via wolverines throughout their range and Recognition of Distinct Vertebrate http://www.regulations.gov, your entire in the contiguous United States. Population Segments Under the submission—including any personal Endangered Species Act (16 U.S.C. 1531 DATES: To allow us adequate time to identifying information—will be posted et seq.) (61 FR 4722, February 7, 1996) conduct this review, we request that we on the website. We will also post all (known as the DPS Policy), which receive information on or before May hardcopy submissions on http:// specifically considers two elements: (i) 17, 2010. After this date, you must www.regulations.gov. If you include The discreteness of the population submit information directly to the Field personal identifying information in your segment in relation to the remainder of Office (See FOR FURTHER INFORMATION hardcopy submission, you may request the species to which it belongs; and (ii) CONTACT section below). Please note that at the top of your document that we the significance of the population we may not be able to address or withhold this personal identifying segment to the species to which it incorporate information that we receive information from public review. belongs. after the above requested date. However, we cannot guarantee that we (3) Specific information on the will be able to do so. ADDRESSES: You may submit conservation status of North American information by one of the following Information and supporting wolverines rangewide and in the documentation that we receive and use methods: contiguous United States, including • Federal eRulemaking Portal: http:// in preparing a finding will be available information on distribution, abundance, for you to review by appointment www.regulations.gov. Search for docket and population trends. FWS–R6–ES–2008–0029 and then during normal business hours at the (4) Specific information on threats to U.S. Fish and Wildlife Service, Montana follow the instructions for submitting North American wolverines rangewide comments. Ecological Services Field Office (see FOR • and in the contiguous United States, FURTHER INFORMATION CONTACT). U.S. mail or hand-delivery: Public including: (i) The present or threatened Comments Processing, Attn: FWS–R6– destruction, modification, or Background ES–2008–0029; Division of Policy and curtailment of its habitat or range; (ii) The North American wolverine (Gulo Directives Management; U.S. Fish and overutilization for commercial, gulo luscus) is the largest terrestrial Wildlife Service; 4401 N. Fairfax Drive, recreational, scientific, or educational member of the family Mustelidae. Adult Suite 222; Arlington, VA 22203. purposes; (iii) disease or predation; (iv) males weigh 12 to 18 kilograms (kg) (26 We will post all information on http: the inadequacy of existing regulatory to 40 pounds (lb)), and adult females //www.regulations.gov. This generally mechanisms; and (v) other natural or weigh 8 to 12 kg (17 to 26 lb) (Banci means that we will post any personal manmade factors affecting its continued 1994, p. 99). The wolverine resembles a information you provide us (see the existence. small bear with a bushy tail. It has a Request for Information section below (5) Specific information on broad, rounded head; short, rounded for more information). implemented or planned conservation ears; and small eyes. Each foot has five FOR FURTHER INFORMATION CONTACT: actions to improve wolverine habitats or toes with curved, semi-retractile claws Mark Wilson, Field Supervisor, decrease threats to wolverines in the used for digging and climbing (Banci Montana Ecological Services Field contiguous United States. 1994, p. 99). Office, 585 Shepard Way, Helena, MT (6) Specific information on the Wolverines exist in alpine and sub- 59601; telephone (406) 449–5225; potential effects of climate change on alpine habitats, which in the contiguous

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48 States occur at high elevations in the for the species concurrent with the Authority Rocky, North Cascade, and Sierra listing. The authority for this action is the On October 21, 2003, we published a Nevada mountains (Aubry et al. 2007, p. Endangered Species Act of 1973, as 90-day finding that the petition to list 2153). Wolverines have recently been amended (16 U.S.C. 1531 et seq.). positively documented in the Sierra the North American wolverine in the Nevada range in California and the contiguous United States did not Dated: March 30, 2010. southern Rocky Mountains of Colorado present substantial scientific and Daniel M. Ashe, for the first time since the early 20th commercial information indicating that Deputy Director, U.S. Fish and Wildlife . listing as threatened or endangered may Service. Wolverines are opportunistic feeders be warranted (68 FR 60112). We did not [FR Doc. 2010–8698 Filed 4–14–10; 8:45 am] and consume a variety of foods determine whether the contiguous U.S. BILLING CODE 4310–55–P depending on availability. They population of the North American primarily scavenge carrion, but also wolverine constituted a DPS (or other prey on small animals and birds, and eat listable entity), because sufficient DEPARTMENT OF THE INTERIOR fruits, berries, and insects (Hornocker information was not available at the and Hash 1981, p. 1290; Hash 1987, p. time. Fish and Wildlife Service 579; Banci 1994, pp. 111–113). On September 29, 2006, as a result of Wolverines have delayed onset of a complaint filed by Defenders of 50 CFR Part 17 reproduction in females and small litter Wildlife and others alleging we used the [Docket No. FWS-R6-ES-2008-0127] sizes, and often reproduce only every wrong standards to assess the July 2000 other year. wolverine petition, the U.S. District [MO 92210-0-0008-B2] Home ranges at the southern terminus Court, Montana District, ruled that our Endangered and Threatened Wildlife of the current range are large for 90-day petition finding was in error and and Plants; 12-Month Finding on a mammals of the size of wolverines, and ordered us to make a 12-month finding Petition to List the Wyoming Pocket may indicate that wolverines have high for the wolverine (Defenders of Wildlife Gopher as Endangered or Threatened energetic requirements and at the same et al. v. Norton and Hogan (9:05cv99 with Critical Habitat time occupy relatively unproductive DWM; D. MT)). On April 6, 2007, the niches (Inman et al. 2007a, p. 11). In Court approved an unopposed motion to AGENCY: Fish and Wildlife Service, addition, wolverines naturally occur in extend the deadline for this 12-month Interior. low densities that average about one finding to February 28, 2008, so that we ACTION: Notice of 12–month petition 2 2 wolverine per 150 km (58 mi ) would be able to use information finding. (Hornocker and Hash 1981, pp. 1292– published in the September 2007 1295; Hash 1987, p. 578; Copeland edition of the Journal of Wildlife SUMMARY: We, the U.S. Fish and 1996, pp. 31–32; Copeland and Yates Management containing a special Wildlife Service (Service), announce a 2006, p. 27; Inman et al. 2007a, p. 10; section on North American wolverine 12–month finding on a petition to list Squires et al. 2007, p. 2218). biology. On June 5, 2007, we published the Wyoming pocket gopher (Thomomys Previous Federal Actions a notice initiating a status review for the clusius) as endangered or threatened wolverine (72 FR 31048). and to designate critical habitat under We received a petition dated August On March 11, 2008, we published a the Endangered Species Act of 1973, as 3, 1994, from the Predator Project (now 12-month finding on the wolverine in amended. After review of all available named the Predator Conservation the contiguous United States (73 FR scientific and commercial information, Alliance) and Biodiversity Legal 12929). In that finding, we determined we find that listing the Wyoming pocket Foundation to list the North American that the wolverine in the contiguous gopher as either endangered or wolverine in the contiguous United United States did not constitute a DPS. threatened is not warranted at this time. States as an endangered or threatened Therefore, we determined that the We ask the public to continue to submit species under the Act and to designate wolverine in the contiguous United to us any new information that becomes critical habitat concurrent with listing. States was not a listable entity under the available concerning the status of, or On April 19, 1995, we published a Act. On September 30, 2008, Defenders threats to, the Wyoming pocket gopher finding (60 FR 19567) that the petition of Wildlife et al. filed a complaint or its habitat. did not present substantial information challenging our 12-month finding on the DATES: The finding announced in this indicating that listing the North basis of our application of the DPS document was made on April 15, 2010. American wolverine in the contiguous Policy and the Act. On March 23, 2009, United States may be warranted. We did ADDRESSES: This finding is available on we settled the lawsuit with the plaintiffs the Internet at http:// not make a determination as to whether and agreed to submit a new 12-month the contiguous U.S. population of the www.regulations.gov at Docket Number finding to the Federal Register by FWS-R6-ES-2008-0127. Supporting North American wolverine constituted a December 1, 2010. DPS or other listable entity. documentation we used in preparing On July 14, 2000, we received another References Cited this finding is available for public petition dated July 11, 2000, submitted A complete list of all references is inspection, by appointment, during by the Biodiversity Legal Foundation, available upon request from the Field normal business hours at the U.S. Fish Predator Conservation Alliance, Supervisor, Montana Ecological and Wildlife Service, Wyoming Defenders of Wildlife, Northwest Services Field Office (See FOR FURTHER Ecological Services Field Office, 5353 Ecosystem Alliance, Friends of the INFORMATION CONTACT). Yellowstone Road, Cheyenne, WY Clearwater, and Superior Wilderness 82009. Please submit any new Action Network, to list the North Author information, materials, comments, or American wolverine within the The primary authors of this document questions concerning this finding to the contiguous United States as an are the staff members of the U.S. Fish above street address. endangered or threatened species under and Wildlife Service, Montana FOR FURTHER INFORMATION CONTACT: the Act and to designate critical habitat Ecological Servies Field Office. Brian Kelly, Field Supervisor, Wyoming

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Ecological Services Field Office (see us to address the petition in fiscal year produce extreme variation in body size ADDRESSES); by telephone at 307-772- 2008. On November 4, 2008, the of individual pocket gophers and 2374; or by facsimile at 307-772-2358. If petitioners filed a complaint with the density of pocket gopher populations you use a telecommunications device U.S. District Court for the District of (Patton and Brylski 1987, p. 504). for the deaf (TDD), call the Federal Colorado against us for failing to Little is known about the Wyoming Information Relay Service (FIRS) at 800- complete the 90–day finding (Center for pocket gopher; assumptions about its 877-8339. Native Ecosystems and Biodiversity distribution, ecology, and status are SUPPLEMENTARY INFORMATION: Conservation Alliance v. U.S. Fish and based on a few museum records, reports Wildlife Service and Kempthorne (1:08- from more than 30 years ago, and Background cv-02394-JLK)). research conducted in 2008 and 2009. Section 4(b)(3)(B) of the Endangered On February 10, 2009, we published This lack of knowledge has led to the Species Act of 1973, as amended (Act) our finding that the petition to list the recent efforts to obtain information on (16 U.S.C. 1531 et seq.) requires that, for Wyoming pocket gopher presented its distribution, status, and habitat use any petition to revise the Federal Lists substantial scientific or commercial (Keinath and Griscom 2008, p. 1; of Endangered and Threatened Wildlife information indicating that listing the Griscom et al. 2010, p. 3). Where and Plants that presents substantial species may be warranted (74 FR 6558). specific life- information is scientific or commercial information On March 20, 2009, the petitioners lacking, and where appropriate, we have indicating that listing the species may provided a notice of intent to sue on provided information from other pocket be warranted, we make a finding within additional grounds for failure to gopher species, mainly in the 12 months of the date of the receipt of complete the 12–month finding within Thomomys genus. the petition. In this 12–month finding, 12 months of the petition. In a June 12, The Wyoming pocket gopher is we may determine that the petitioned 2009, stipulated settlement, the Service differentiated from other pocket gophers action is: (1) Not warranted, (2) agreed to complete the 12–month in its geographical range by being warranted, or (3) warranted, but the finding by April 10, 2010, which would smaller and paler, with a yellow cast to immediate proposal of a regulation allow us to include 2009 Wyoming the coat, especially in younger animals. implementing the petitioned action is pocket gopher survey data in our The dorsal coat is uniform in color, and precluded by other pending proposals to analysis. This notice constitutes our 12– the margins of the ears are fringed with determine whether species are month finding on the August 7, 2007, whitish hairs (Thaeler and Hinesley endangered or threatened, and petition to list the Wyoming pocket 1979, p. 483; Clark and Stromberg 1987, expeditious progress is being made to gopher as endangered or threatened. p. 123; Keinath and Beauvais 2006, p. 8; add or remove qualified species from Keinath and Griscom 2008, p. 2). This the Federal Lists of Endangered and Species Information species does not display sexual Threatened Wildlife and Plants. Section Life History dimorphism (differences in form 4(b)(3)(C) of the Act requires that we between the sexes) (Clark and Stromberg treat a petition for which the requested Pocket gophers are powerfully built 1987, p. 123; Keinath and Beauvais action is found to be warranted but mammals, characterized by a heavily 2006, p. 8). Adult Wyoming pocket precluded as though resubmitted on the muscled head without a noticeable gophers typically have a body length of date of such finding, that is, requiring a neck, strong front limbs with long nails 112-134 millimeters (mm) (4.41-5.28 subsequent finding to be made within used for digging, small ears, small eyes, inches (in)), hind foot length of 20-22 12 months. We must publish these 12– and fur-lined cheek pouches used to mm (0.79-0.87 in), and a weight of 44- month findings in the Federal Register. carry food (Verts and Carraway 1999, p. 72 grams (g) (1.54-2.54 ounces (oz)) 3). They are highly fossorial (adapted to (Thaeler and Hinesley 1979, pp. 483- Previous Federal Actions burrowing or digging), living, foraging, 484; Clark and Stromberg 1987, p. 123). On August 9, 2007, we received a and reproducing in burrow systems and The measurements of specimens petition, dated August 7, 2007, from the underground tunnels that provide captured in 2008 and 2009 included Biodiversity Conservation Alliance and protection from predators and from body lengths of 86-128 mm (3.38-5.04 Center for Native Ecosystems requesting extreme environmental conditions in), hind foot lengths of 15-23 mm (0.59- that we list the Wyoming pocket gopher (Clark and Stromberg 1987, p. 121). 0.91 in), and weights of 43-66 g (1.52- (Thomomys clusius) within its known Populations of pocket gophers 2.33 oz) (Griscom et al. 2010, p. 23). historic range, as threatened or generally tend to be small and patchily These somewhat smaller measurements endangered under the Act. Additionally, distributed across landscapes where for 2008-2009 data can be partly the petition requested that we designate they occur (Kennerly 1959, p. 251; explained by late summer captures that critical habitat concurrent with listing. Stinson 2005, p. 21). This distribution is included juveniles, whereas older We acknowledged receipt of the petition thought to be primarily determined by studies relied on captures prior to June in a letter dated September 6, 2007. In the availability of soils appropriate for 15 that would have included only adults that letter, we advised the petitioners digging and foraging (Kennerly 1959, p. (Griscom 2010a, pers. comm.). that we could not address their petition 249; Verts and Carraway 1999, p. 5). The Wyoming pocket gopher occurs at that time because responding to Specialization to local ecological entirely within the range of the northern existing court orders and settlement conditions has resulted in a high degree pocket gopher (Thomomys talpoides), agreements for other listing actions of morphological variation across the but the two species likely occupy required nearly all of our listing range of each species (Patton and different habitats locally (Thaeler and funding. We also concluded in that Brylski 1987, p. 493). For example, Hinesley 1979, p. 486; Keinath and September 6, 2007, letter that pocket gopher coat color is highly Beauvais 2006, p. 8; Griscom et al. 2010, emergency listing of the Wyoming variable, strongly correlated with soil p. 15). Approximately 50 percent of the pocket gopher was not warranted. color, and thought to be an adaptive known range of the species occurs on On July 11, 2008, we informed the response to predation (Ingles 1950, p. Bureau of Land Management (BLM) petitioners that, due to progress on 357; Wlasiuk and Nachman 2007, p. lands (Service 2009a, p. 1). A Wyoming addressing other priority listing actions, 567). Differences in abundance and Natural Diversity Database (WYNDD) funding had become available to allow nutritional content of forage can predictive distribution model for the

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Wyoming pocket gopher developed in Previously, the Wyoming pocket gophers can have strong effects on soil January 2010 shows the species could gopher was believed to exclusively formation, hydrology, nutrient flows, occur in Sweetwater, Carbon, and occupy well-drained, gravelly ridges plant diversity, and competitive Fremont Counties in Wyoming (Griscom instead of the valley bottoms and interactions of plants (Tilman 1983, pp. et al. 2010, p. 32). The predicted range riparian areas with deeper soils 290-292; Huntly and Inouye 1988, abuts Colorado’s northern border, but preferred by the northern pocket gopher entire; Reichman and Seabloom 2002, Colorado was not included in the (Thaeler and Hinesley 1979, p. 486). entire; Sherrod et al. 2005, pp. 586-587; distribution analysis (Griscom et al. However, recent research showed Kyle et al. 2008, p. 377). The effects of 2010, p. 32). Additional specimens are Wyoming pocket gophers occupy sites pocket gopher burrowing on physical considered unlikely to be found south of with more varied topography (Keinath and chemical soil properties vary based current distribution points (Griscom et and Griscom 2008, p. 2). Compared to on the nature of the soil (Kerley et al. al. 2010, p. 12). To date, Wyoming northern pocket gophers, Wyoming 2004, pp. 164-165). pocket gophers have been located only pocket gophers appear to prefer areas of The diet of pocket gophers consists of in Sweetwater and Carbon Counties, lesser slopes (Griscom et al. 2010, p. 15). roots, stems, and leaves of forbs, with which is consistent with historical Wyoming pocket gophers appear to use some consumption of grasses and records that show this area to be the a variety of soil types that can be more shrubs (Aldous 1951, pp. 85-86; Ward extent of the species’ range. Although compacted than those used by northern and Keith 1962, p. 747). The average the full historic range of the species has pocket gophers (Griscom et al. 2010, p. consumption of forbs by pocket gophers not been defined, we consider the 15). These soils often have a substantial in west-central Colorado, as measured capture points in Sweetwater and gravel component, usually contain little by stomach content, was highest in July Carbon Counties presented by Thaeler clay (Keinath and Griscom 2008, p. 2), and August at 96 percent, decreasing to and Hinesley (1979, pp. 482, 486-487) to and tend to be more alkaline than the 73 percent in October (Ward and Keith present an approximation of historic soils that northern pocket gophers prefer 1962, p. 747). Consumption of shrubs range. This historic range includes the (Griscom 2009a, pers. comm.). In and roots of all types increased in late type specimen collected in 1857, two general, pocket gophers in the September and October, and specimens collected in 1949 and 1951, Thomomys genus are more specialized consumption of grasses increased in and several specimens collected in the for tooth digging rather than claw June, September, and October (Ward 1960s and 1970s (Thaeler and Hinesley digging, which allows for exploitation of and Keith 1962, p. 747). Pocket gophers 1979, p. 487). Very little information a broader range of soil types (Lessa and in the Thomomys genus throughout the exists regarding the actual population Thaeler 1989, p. 696). Based on the western United States generally prefer size of the Wyoming pocket gopher characterization of the Wyoming pocket forb shoots during the growing season, (Keinath and Beauvais 2006, p. 21). The gopher’s size and habitat, it appears to and grass shoots, corms, and roots only population estimate we found was fit the island model of isolation during periods of plant dormancy (Hunt 10,000 (NatureServe 2009, displayed by other species of pocket 1992, pp. 47-48). Other species of the unpaginated). However, we are unable gophers specifically adapted to the soils Thomomys genus (e.g., northern pocket to determine the basis for this estimate of an area (Miller 1964, pp. 259-260). gopher, Botta’s (valley) pocket gopher and thus have no way to determine its The limited distribution of the (T. bottae), Townsend’s pocket gopher scientific validity. Wyoming pocket gopher relative to (T. townsendii), Mazama (western) pocket gopher (T. mazama), and Camas other species of pocket gopher may be Vegetation composition of a site may pocket gopher (T. bulbivorus)) are not due to its specialized habitat be more important in determining strict herbivores, in that they also requirements (Keinath and Beauvais habitat for the Wyoming pocket gopher seasonally consume the fungi associated 2006, pp. 12-15). than soils or topography (Keinath and with plant roots (i.e., are mycophagous) Griscom 2008, p. 2). The Wyoming Pocket gophers construct extensive (Maser et al. 1978, p. 805; Taylor et al. pocket gopher occurs primarily in small burrow systems. These systems consist 2009, p. 367). Pocket gophers may cut ‘‘islands’’ of low vegetation within a of a main tunnel with side branches of their food into small pieces and carry it sagebrush matrix. This matrix typically shallow feeding tunnels (tunnels dug to in their cheek pouches back to the main includes Artemesia tridentada forage on plant material). Additional burrow where it is consumed, stored for wyomingensis (Wyoming big sagebrush), feeding tunnels can be constructed winter, used for nest building, or taken Chrysothamnus spp. (rabbitbrush), and when plant production is poor (Davis into tunnels and later pushed to the other low shrubs, cushion plants, 1938, p. 338; Reichman et al. 1982, p. surface (Aldous 1951, p. 84; Verts and grasses, and forbs (Keinath and Griscom 691). The main tunnel also connects to Carraway 1999, p. 6). Pocket gophers 2009, p. 1). In comparison to a smaller system of chambers that serve remain active all winter (Clark and unoccupied control sites and northern as nest sites, food caches, and latrines Stromberg 1987, p. 121). pocket gopher capture sites, the (Miller 1964, p. 257; Keinath and Based on the life of other Wyoming pocket gopher appears to Beauvais 2006, p. 16). Depths of the pocket gophers, Wyoming pocket prefer areas within this matrix with less burrows vary from 6 to 12 inches below gophers presumably reproduce the perennial grass cover, less Artemesia the ground surface. All aboveground year following birth, have one tridentata (Big sagebrush), more entrances are plugged with soil (Clark litter with 4 to 6 young per year, and Krascheninnikovia lanata (winterfat), and Stromberg 1987, p. 121). Burrow usually do not live more than two more Atriplex gardneri (Gardner widths of the Wyoming pocket gopher breeding seasons (Keinath and Beauvais saltbush), more bare soil, less litter, and are significantly smaller than those of 2006, p. 18). However, one northern fewer surface rocks (Griscom et al. 2010, the northern pocket gopher, likely pocket gopher is known to have p. 15). Difference in habitat use would reflecting their smaller body size survived for about 4 years (Hansen be expected, given that phenotype (Griscom et al. 2010, p. 15). The extent 1962, p. 153). Some species of pocket (observable physical characteristics) has of burrow systems can vary with the gophers have more than one litter per been shown to correlate with habitat for size of the individual, soil type, and year in southern climates with longer pocket gophers (Ingles 1950, p. 357; plant production. The extensive breeding seasons (Miller 1946, pp. 335- Wlasiuk and Nachman 2007, p. 567). tunneling and feeding activity of pocket 336). Hansen (1960, p. 332) found no

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evidence of more than one annual litter birth, while males typically delay necessary for positive identification. per female in the Rocky Mountain dispersal for up to one year after birth Northern pocket gophers differ from region. (Daly and Patton 1990, p. 1287). Spring Wyoming pocket gophers in that they Pocket gophers are solitary animals dispersal is common in reproductive have a karyotype of 2n = 48 or 56, and are typically found together only adults of both sexes. Fifty percent of depending on the subspecies (Thaeler during the breeding season, or when plains pocket gopher (Geomys and Hinesley 1979, p. 483). However, females have young. Variation in levels bursarius) female adults relocate after based on the amplified fragment length of tolerance between males and females raising a litter, leaving the site in polymorphism (AFLP) analysis ranges from being together only during possession of female young (Zinnel and completed on tail clippings during the mating to raising young of the year Tester 1994, p. 99). Once pocket gophers 2008 field season, field assessment of together (Hansen and Miller 1959, pp. establish territories and burrows, they phenotype was shown to be a 581-582). Pocket gophers are usually may shift to other areas based on polygynous (Reichman et al. 1982, p. environmental conditions or reasonably reliable method for 693). However, some evidence of serial interactions with other pocket gophers, discerning the two species from each monogamy has been found in Botta’s but they generally do not move far from other (Hayden-Wing Associates 2008, p. pocket gopher in Arizona (Reichman et original territories (Miller 1964, p. 262; 3; Beauvais 2009, p. 1; McDonald 2009a, al. 1982, p. 693). The sex ratio for Reichman et al. 1982, pp. 687-688; Daly pers. comm.). AFLP testing showed Botta’s pocket gopher was one male per and Patton 1990, p. 1286). strong genetic signals that clearly one female; however, the effective sex differentiate the Wyoming pocket ratio was one male per two females as Taxonomy gopher from other species of pocket some small males did not reproduce The Wyoming pocket gopher gophers (Beauvais 2009, p. 1; McDonald (Reichman et al. 1982, p. 693). (Thomomys clusius) is a member of the 2009a, pers. comm.). This recent genetic Populations of Botta’s pocket gopher in Geomyidae (pocket gopher) family. analysis has confirmed definitively California showed a much more skewed Including the Wyoming pocket gopher, what taxonomists had determined sex ratio, ranging from 1.4 to 4.67 nine species are currently assigned to historically: the Wyoming pocket females per male (Patton and Feder the genus Thomomys. The type gopher is a unique species representing 1981, p. 917). We do not have specific specimen for Wyoming pocket gopher a monophyletic clade (i.e., descended was collected in 1857 by Dr. W.A. information regarding the Wyoming from one common ancestor) (McDonald Hammond near Rawlins, Wyoming, but pocket gopher mating system or sex 2009a, pers. comm.). ratio. was not described and given the name Outside of the breeding season, Thomomys clusius until 18 years later Summary of Information Pertaining to pocket gophers are highly territorial, (Coues 1875, p. 138). The designation of the Five Factors and males and females have exclusive the Wyoming pocket gopher within territories. Generally, pocket gophers Thomomys has changed over time, with Section 4 of the Act, and its avoid each other (Reichman et al. 1982, the name clusius being applied at both implementing regulations at 50 CFR p. 693). The infrequent interactions that the species and subspecies level to 424, set forth the procedures for adding occur are mostly agonistic, occasionally various pocket gopher specimens species to, removing species from, or escalating to open combat and even collected in southern Wyoming (Keinath reclassifying species on the Federal death (Zinnel and Tester 1994, p. 96). and Beauvais 2006, p. 11). Lists of Endangered and Threatened This aggression appears to have evolved Thaeler and Hinesley (1979, entire) Wildlife and Plants. Under section as a means to ensure adequate clarified the Wyoming pocket gopher 4(a)(1) of the Act, a species may be individual food supplies, but could also taxonomy with karyotype (i.e., a count determined to be endangered or be related to reproductive behaviors like of the number of diploid chromosomes) threatened based on any of the and morphological analyses of pocket mate guarding (Zinnel and Tester 1994, following five factors: (A) The present or gopher specimens collected in pp. 99-100). Pocket gopher population threatened destruction, modification, or density is likely to be primarily Wyoming. Members of the pocket curtailment of its habitat or range; (B) regulated through intraspecific gopher genus Thomomys are the most aggression; the number of animals an karyotypically and morphologically overutilization for commercial, area can hold appears to be determined diverse group of mammals known recreational, scientific, or educational by combative interactions (Zinnel and (Patton 1972, p. 574; Patton and Brylski purposes; (C) disease or predation; (D) Tester 1994, p. 100). 1987, p. 493). The Wyoming pocket the inadequacy of existing regulatory Dispersal strategies of the Wyoming gopher has a unique karyotype of 2n = mechanisms; or (E) other natural or pocket gopher are unknown, but may be 46, a yellowish coat, and a generally manmade factors affecting its continued similar to other pocket gopher species. small size, which support the validity of existence. Under section 4(b)(1)(A), this Although dispersal was common, 63 Wyoming pocket gopher as a distinct determination should be made on the percent of individual Botta’s pocket species within Thomomys (Thaeler and basis of the best scientific and gophers set up their territory within 40 Hinseley 1979, p. 483). These traits commercial data available and after meters (m) (131.23 feet (ft)) of their natal differed significantly from the northern conducting a status review and taking home (Daly and Patton 1990, p. 1291). pocket gopher, which occurs across the into consideration State conservation Average dispersal lengths for Botta’s range of the Wyoming pocket gopher. efforts. In making our 12–month finding pocket gopher are estimated at 100-500 Although northern pocket gophers are on a petition to list the Wyoming pocket m (328.08-1,640.42 ft) per year (Hafner generally darker and larger, they share gopher, we considered and evaluated et al. 1998, p. 281). Individual Botta’s morphological similarities with the best available scientific and pocket gophers that disperse are Wyoming pocket gophers that had led to commercial information. Information typically young, pre-reproductive, and some misidentification of specimens in pertaining to the status and threats to more likely to be female (Daly and earlier publications (e.g., Bailey 1915 the Wyoming pocket gopher in relation Patton 1990, p. 1287). Pre-reproductive and Long 1965, cited in Keinath and to the five factors provided in section juvenile females begin dispersing as Beauvais 2006, p. 11). Thus, karyotype 4(a)(1) of the Act is discussed below. early as the summer following their analysis was previously thought

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Factor A. The Present or Threatened Similarly, pocket gopher (Thomomys understand the species’ range and Destruction, Modification, or spp.) burrows were frequently observed distribution, habitat requirements and Curtailment of Its Habitat or Range along roadways in Nevada, but not the preferences, and the genetic and Wyoming pocket gopher habitat is adjacent creosote habitats, suggesting morphological differences between exposed to a number of influences that they were using areas where the habitat species (WYNDD 2009, p. 2; Hayden- may affect the species, including energy would have been unsuitable without the Wing Associates 2008, p. 1; Keinath and exploration and development, road disturbance (Garland and Bradley 1984, Griscom 2008, p. 1; Griscom et al. 2010, construction and use, climate change p. 54). In contrast, plains pocket gophers pp. 5-7). This effort resulted in the and drought, introduction of nonnative and yellow-faced pocket gophers in successful trapping of 31 confirmed species, grazing, and urbanization. southwestern Kansas are not present Wyoming pocket gophers distributed However, no studies have been within areas of intensive agricultural across the species’ currently known conducted to determine the species’ operations involving annual plowing or range (Griscom et al. 2010, p. 5; Griscom disking (Hoffman et al. 2007, p. 300). response to these influences, or to the 2010b, pers. comm.). Prior to 2008, a Intensive residential and commercial potential changes in habitat that may total of 16 confirmed Wyoming pocket development has reduced patch sizes of result. Where information specific to the gophers had been captured, and all of Mazama pocket gopher habitat in Wyoming pocket gopher is lacking, we these confirmed specimens were have utilized information from other western Washington such that the species no longer occurs in many areas collected by Charles Thaeler pocket gopher species, mainly in the approximately 40 years ago (Griscom Thomomys genus. (Service 2009b, pp. 7-8; Flotlin 2010, Literature describes both positive and pers. comm.). The response to 2009b, pers. comm). This information negative effects to other species of disturbance may be dependent on the provided both historic and recent pocket gophers resulting from various species, as the plains pocket gopher is locations for our use in creating a types of disturbance. Many pocket more common in disturbed areas, such general assessment of Wyoming pocket gopher species exhibit a positive as roadsides and cultivated fields, while gopher presence to ascertain if the response of increased rates of mound- the yellow-faced pocket gopher is more known locations of the species have building activities when vegetation has common in native shortgrass prairie in changed over time. Based on the limited been disturbed (Mielke 1977, p. 175). southeastern Colorado (Moulton et al. number of collection sites, the species Three species (Botta’s pocket gopher, 1983, p. 58). appears to be currently distributed plains pocket gopher, and yellow-faced In 2008 and 2009, WYNDD, with the throughout its known range in a pattern pocket gopher (Cratogeomys castanops)) assistance of several other groups, that approximates historic distribution are more common in disturbed areas, trapped Wyoming pocket gophers, (Figure 1). Therefore, we find no such as roadways and floodplains, in northern pocket gophers, and Idaho evidence that curtailment of the species’ New Mexico (Best 1973, p. 1314). pocket gophers (T. idahoensis) to better range is occurring.

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Figure 1: Historic and current capture of the Wyoming pocket gopher is These variables that may affect the locations of the Wyoming pocket gopher exposed to various influences that may species’ habitat are discussed below. (Data compiled from Service, Bureau of affect the species, including energy Energy Exploration and Development Land Management, WYNDD, U.S. exploration and development, road Geological Survey, U.S. Census Bureau, construction and use, introduction of The primary forms of existing and ESRI). nonnative species, climate change, planned energy development in the Although there is no evidence of drought, grazing, and urbanization. range of the Wyoming pocket gopher are curtailment of the species’ range, habitat oil, gas, and wind. Based on existing

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National Environmental Policy Act and detonating explosives or using a shifts. Therefore, we are unable to assess (NEPA) (42 U.S.C. 4321 et seq.) vibrating pad that is driven across an how changes in the vegetation due to documents for major oil and gas area using heavy vehicles. The extent of herbicide use may affect the Wyoming developments, estimates of project life impacts from either exploration method pocket gopher. The BLM does not use for major oil and gas developments on pocket gophers is unknown. The pesticides or rodenticides in Wyoming within the Wyoming pocket gopher’s vibrations and potential soil impacts to protect reclamation areas (Abbott range are between 10-50 years (Service would, at a minimum, temporarily alter 2009a, pers. comm.), so we do not 2010a, p. 3). Some non-renewable habitat and may result in collapse of anticipate direct mortality from these energy development is already burrows. Pocket gophers in the substances in reclamation areas. occurring within the species’ known immediate vicinity of operations would Introduction and spread of nonnative occupied range. Renewable energy likely notice the activity, but the type of plants may result from energy development is estimated to reach response is unknown. Pocket gopher development activities, and the maximum development by 2030 (U.S. communication likely occurs through potential threat of nonnative vegetation Department of Energy 2008, p. 10), and seismic signals (Mason and Narins 2001, to the Wyoming pocket gopher is several developments are being p. 1177), and frequent vibrations could discussed separately below. considered within the species’ range. disrupt signals used to attract mates, We used information from Wyoming Based on this information, we estimate warn of intruders, or avoid predators. pocket gopher trapping and from known the foreseeable future of energy However, we have no information to oil and gas development to assess the development at a minimum of 10 years, support that energy exploration extent to which energy development but anticipate that energy development negatively impacts the species. may be affecting the species. By will be present for up to 50 years. Oil and gas development involves overlaying producing wells on a map WYNDD is analyzing potential threats staging a drilling rig and setting up with species capture sites, we found to Wyoming’s 152 species of greatest additional equipment that is used that the locations of capture sites in conservation need related to energy during production. Generally, relation to new and existing development in its Assessment of developers build roads to access each development does not appear to reflect Wildlife Vulnerability to Energy site and clear and level well pads. These a pattern of either species avoidance of, Development (AWVED). Preliminary soil-disturbing activities would affect or preference for, producing oil and gas conclusions from the AWVED analysis the habitat that lies within and adjacent wells. Some capture sites are as near as indicate that the Wyoming pocket to the footprint of well pads and roads. 95 m (312 ft) to a producing well site gopher is Wyoming’s species with the Any soil that is moved could have a (Service 2010b, p. 2), while others are in highest potential risk for energy-related direct impact on pocket gophers that are areas that have no oil or gas wells. We effects based on its proximity to existing present. Once a rig is in place, the recognize that this simple geospatial wells, the proportion of lands leased for drilling process creates vibrations that assessment has limitations in oil and gas within its range, and the could affect habitat and any pocket determining what effects oil and gas density of wells within that range gophers in the area. Once a well has development has on the species. We (Keinath 2009, pp. 12-13). This potential been drilled and is producing, energy also recognize dispersal is likely already risk is based on exposure to energy companies make regular trips to well difficult across portions of the range that development across the species’ range pads to monitor production, conduct do not currently have pocket gophers, and is not based on any known effects maintenance, or collect extracted and recolonization following local to the species from energy development resources. These regular trips may extirpation would be unlikely (Keinath activities. Our February 10, 2009, 90– disturb, either directly or through the et al. 2008, p. 7). day finding (74 FR 6558) acknowledged resulting noise, pocket gophers that are The amount of surface disturbance that the likelihood of oil and gas present at or near well pads and roads. provides another approach to consider development throughout the species’ In the past, the Wyoming pocket gopher the impacts of natural gas development. range is high based on the energy has been considered potentially The two largest natural gas development potential and existing vulnerable to disturbance because the developments not yet fully built in the leases that cover much of the range. reasons for the species’ limited Wyoming pocket gopher range are Approximately 4,000 actively producing distribution had not yet been explained Atlantic Rim and Continental Divide- oil and gas wells are within the range of (Keinath and Beauvais 2006, p. 21). Creston (Service 2010a, p. 1). The the species (Service 2010b, p. 3), and an However, as described above, certain scoping notice for the Continental- additional 10,000 oil and gas wells have types of disturbance can elicit a positive Divide Creston development states been proposed in that area (Service population response in some pocket disturbances during initial development 2010a, p. 1). In this finding, rather than gopher species. will be approximately 47,060 acres (ac) what was done in our previous 90–day Energy producers often try to (19,045 hectares (ha)) of 1.1 million ac finding on the petition, we are maintain a clear work area by using (445,154 ha), or 4.28 percent of the determining whether the best available herbicides on well pads and along project area (BLM 2006a, p. 4). The information indicates that the species roads. Herbicide use and the direct impacted area will be reduced to 1.67 meets the definition of a threatened or impacts of development would reduce percent through interim reclamation endangered species and therefore the availability and quality of (BLM 2006a, p. 4). As this proposal warrants listing under the Act, which is vegetation, creating negative effects to includes areas of infill, the amount of a more in-depth analysis than the one Wyoming pocket gopher habitat (Keith disturbance described in the scoping conducted for the 90–day finding. et al. 1959, pp. 142-144). In general, notice does not include existing Several different types of oil and gas broadcast herbicide application is development (BLM 2006a, p. 1). The exploration and development activities assumed to be minimal in southern proposed well density includes 8 wells occur within the range of the Wyoming Wyoming (Keinath and Beauvais 2006, per square mile, with a possibility of up pocket gopher. Oil and gas geophysical p. 22). We do not have information on to 16 wells per square mile in certain exploration is conducted to generate a use of herbicides for oil and gas areas (BLM 2006a, p. 1). The Record of subsurface image of fluid minerals and development, and we are unaware of Decision for the Atlantic Rim usually involves either drilling holes monitoring for resulting vegetative development allows a total surface

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disturbance of 2.8 percent of the project the area around wind towers (Thelander precipitation run-off. As described area at a given time, with well spacing et al. 2003, p. 24). We anticipate that the above, roads can have a positive effect of 8 wells per square mile (BLM 2007, response of the Wyoming pocket gopher on other pocket gopher species (Best p. 10). For comparison, the existing may be similar, but we lack species- 1973, p. 1314; Moulton et al. 1983, p. Continental Divide/Wamsutter II gas specific information. Therefore, the best 58; Garland and Bradley 1984, p. 54). development has been mostly available information does not indicate The effects of roads on Wyoming pocket developed, with 22,400 ac (9,065 ha) of whether current or future wind gopher populations are not known; surface disturbance across 1,061,200 ac development will have positive or however, we have limited anecdotal (429,452 ha) (2.11 percent of the project negative effects on the Wyoming pocket observations of individual gopher area) and well densities of 1 to 8 wells gopher. occupancy near roads. In 2009, one per square mile (BLM 2000, section 2.0). Summary of Energy Exploration and Wyoming pocket gopher specimen was All of these surface disturbance Development captured 7 m (23 ft) from a graded dirt percentages are small. Although we do road, and northern pocket gophers were not know how the Wyoming pocket Little information exists to indicate captured as close as 2 m (6.5 ft) to a gopher is likely to respond to any whether the Wyoming pocket gopher graded dirt road (Griscom 2009b, pers. proposed increases in well numbers, the will be affected by an increased density comm.). Small mammals may avoid level of development indicates that large of wells or by an expansion of oil, gas, roads due to noise and other factors, but interstitial will continue to be and wind development into currently roads may also provide additional available for Wyoming pocket gopher undeveloped areas. The response to habitat or movement corridors (Garland use. We know from our analysis that the disturbance in pocket gophers appears and Bradley 1984, entire; U.S. Wyoming pocket gopher does occur to be species-specific. For example, in Department of Transportation 2009, near developed areas (Service 2010b, p. southeastern Colorado, the plains unpaginated). Northern pocket gophers 2). pocket gopher is more common in have been observed digging tunnels The BLM administers approximately disturbed areas, but the yellow-faced underneath a right-of-way road (Richens half of the lands within the Wyoming pocket gopher is more common in 1966, p. 532). native versus disturbed habitats pocket gopher range (Service 2009a, p. Depending upon the size of the road (Moulton et al. 1983, p. 58). Based on 1). Throughout the range, the BLM has and the associated degree of soil our current understanding of the leased 41.23 percent of the Wyoming compaction, a road may impact the Wyoming pocket gopher, energy pocket gopher range for oil and gas dispersal of Wyoming pocket gophers. development, and 11.23 percent of the development, at levels that we can For example, distribution of the Shelton range on BLM lands has producing oil detect or anticipate, is as likely to pocket gopher (T. mazama couchi) was and gas leases (Service 2010c, p. 2). We benefit Wyoming pocket gophers as it is impacted by soil compaction around an are unable to determine whether to harm them. airport runway, and no pocket gopher development will occur on all leases. We have no information that Given limited knowledge of pocket additional energy development activity activity was observed in graded areas gopher response to oil and gas will fragment habitat in a way that will that appeared to be highly compacted development, and both the positive and significantly limit dispersal, movement, (GeoEngineers 2003, p. 15). The negative observed impacts of or genetic interchange. Using the best Wyoming pocket gopher apparently can disturbance to other species of pocket available information, we conclude that use more compacted soils than the gophers, we do not consider producing these habitat alterations do not northern pocket gopher (Griscom et al. wells at current or projected levels to be constitute a threat to the Wyoming 2010, p. 15), but we are unsure what a threat to the Wyoming pocket gopher. pocket gopher now, or in the foreseeable amount of soil compaction would begin Although little wind development has future. to limit habitat use by the Wyoming occurred within the range of the species, pocket gopher. Road Construction and Use projections for future wind energy are Many roads in the range of the significant. One major proposal, the Roads are built to create access for oil, Wyoming pocket gopher have been on Chokecherry and Sierra Madre Wind gas, and wind developments, as well as the landscape for or for more Energy Project, includes 1,000 wind for other activities that occur on the than a century, while others have been turbines across 98,500 ac (39.66 ha) landscape, including recreation, grazing, developed within the past few years. within the range of the Wyoming pocket and land management. Much of the Evidence suggests some historic wagon gopher (AECOM 2009, p. 1). Wind recent expansion of road networks in trails (a type of road) have lasted for development may cause effects to Wyoming pocket gopher habitat is well over 100 years (BLM 2009, habitat that are similar to oil and gas related to energy development, but some unpaginated), even when use of the road development. Wind development also areas have also likely experienced an is discontinued. Other roads are results in a network of pads connected increase in access by recreational reclaimed and do not have such a by roads. Soils are disturbed during vehicles. Expansion of road networks lasting effect. We anticipate that the development, and frequent maintenance may fragment the species’ habitat, create existing roads within the range of the trips are necessary. The Wyoming barriers to movement of the species, Wyoming pocket gopher will persist for pocket gopher’s response to wind isolate individual populations, and at least 10 to 50 years in support of development within its habitat is not increase opportunities for invasive energy development activities. known. For the Botta’s pocket gopher, species (Keinath and Beauvais 2006, pp. Additional roads may also be researchers mapping prey base to better 22-23). Roads may increase direct constructed to support that understand raptor mortalities at a wind mortality from vehicles, but this source development, while others are farm in California observed that pocket of mortality is not always significant to reclaimed when no longer necessary. gophers were clustered near the wind populations (Garland and Bradley 1984, We anticipate that county roads turbines (Thelander et al. 2003, p. 23). p. 52). Roads also may improve habitat providing access to livestock They attributed this to the pocket for pocket gophers in some ways by management facilities, homes, and gophers’ attraction to the vertical and providing looser soil and increasing recreational opportunities will persist lateral edges formed by access roads and vegetation in rights-of-way from indefinitely.

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We conclude the effects of roads on al. 1967, pp. 642-643). Grasses, when Climate Change the Wyoming pocket gopher may be not consumed with other vegetation, do The Intergovernmental Panel on positive and negative. Although we not seem to provide an adequate diet for Climate Change (IPCC) has concluded remain concerned about the potential Thomomys species (Cox 1989, p. 80). that warming of the climate is impacts of roads, the best available While Bromus tectorum may impact the unequivocal and that continued information does not indicate that road abundance of forbs in the species’ greenhouse gas emissions at or above construction and use poses a threat to habitat, B. tectorum may also be used by current rates will cause further warming the Wyoming pocket gopher now, or in Wyoming pocket gophers. Small (IPCC 2007, p. 30). Eleven of the 12 the foreseeable future. quantities of the seeds of B. tectorum years from 1995 through 2006 rank Nonnative Species have been occasionally found in tunnels among the 12 warmest years in the of northern pocket gophers, although instrumental record of global surface The introduction of nonnative species seed heads of B. tectorum were not may affect the Wyoming pocket gopher, temperature since 1850 (Independent preferred as forage (Cox 1989, pp. 78- Scientific Advisory Board 2007, p. 6). but the degree of impact from these 80). Northern pocket gophers also occur species is not clear. A review of Climate-change scenarios estimate that at locations where B. tectorum was the mean air temperature could increase Wyoming pocket gopher information considered to be a prevalent plant resulted in no information indicating a by more than 3 degrees Celsius (5.4 species (Ostrow et al. 2002, p. 992). degrees Fahrenheit) by 2100 (IPCC 2007, likelihood that nonnative vegetation During their breeding season, Botta’s alters or restricts pocket gopher p. 46). The IPCC also projects that there pocket gophers have been found to will very likely be regional increases in populations; nonnative species were consume substantial quantities of viewed as a potential threat, but not a the frequency of hot extremes, heat species related to B. tectorum, B. mollis waves, and heavy precipitation (IPCC current threat (Keinath and Beauvais (soft brome) and B. rubens (red brome), 2006, p. 23). We do not fully understand 2007, p. 46), as well as increases in when the nutrient content of the plants atmospheric carbon dioxide (IPCC 2007, the extent to which nonnative species was highest (Hunt 1992, p. 49). will spread throughout the species’ p. 36). While Bromus tectorum appears to range into the future. Nonnative Plant species provide habitat and have the potential to impact Wyoming vegetation is considered a threat to the forage that affect the ability of mammal pocket gopher habitat, the spread of B. Mazama pocket gopher in western species, such as the Wyoming pocket tectorum throughout the habitat of the Washington (Service 2009b, pp. 7-8). gopher, to persist over time. A variety of The Mazama pocket gopher is adapting Wyoming pocket gopher is not a plant-related factors are not included in to the presence of many types of foregone conclusion. In Wyoming, B. climate space models, including the nonnative vegetation; however, the tectorum can be locally abundant, but effect of elevated carbon dioxide on presence of Cytisus scoparius (Scotch precipitation and elevation differences plant water-use efficiency, the broom), which has large root masses, influence where B. tectorum occurs physiological effect to the species of restricts pocket gopher dispersal. The (Smith and Enloe 2006, p. 1). In exceeding the assumed (modeled) loss of prairie habitat to conifer southern Wyoming counties, the fall bioclimatic limit, the life stage at which encroachment is also a threat to the precipitation prior to cold weather the limit affects the species (seedling Mazama pocket gopher (Flotlin 2010, needed for B. tectorum germination is versus adult), the life span of the pers. comm.). Cytisus scoparius does generally rare in zones where 14 inches species, and the movement of other not occur within the range of the or less of precipitation is received organisms into the species’ range Wyoming pocket gopher, and conifer annually (Smith and Enloe 2006, p. 1). (Shafer et al. 2001, p. 207). These factors encroachment is limited. The annual precipitation within the would likely help determine how To inform our evaluation of the range of the Wyoming pocket gopher is climate change would affect plant potential threat from nonnative species, generally less than 14 inches of species distributions. While more we looked at the potential for Bromus precipitation annually (National Atlas empirical studies are needed on what tectorum (cheatgrass) to impact 2005, unpaginated). determines species and multi-species Wyoming pocket gopher populations. In approximately the last 100 years, distributions, those data are often The conversion from A. tridentata spp. no broad-scale B. tectorum eradication lacking; in their absence, climatic space to B. tectorum has been shown to method has been developed. Given the models can play an important role in negatively impact other small mammals history of invasive plants on the characterizing the types of changes that (Yensen et al. 1992, p. 309). The spread landscape, the continued challenges in may occur so that the potential impacts of B. tectorum has the potential to controlling such species, and the on natural systems can be assessed change vegetative communities in a way current infestation of invasive plants (Shafer et al. 2001, p. 213). that could affect the Wyoming pocket across the Wyoming pocket gopher’s One study modeled potential climate gopher. As discussed previously, forbs range, we anticipate that invasive plants change impacts to A. tridentata spp., are an important component of pocket will be on the landscape for the next which are representative of the gopher diets, and high densities of B. 100 years or longer. However, studies ecosystem currently known to be tectorum reduce the biomass and indicate B. tectorum germination may occupied Wyoming pocket gopher growth rates of forbs, as well as seedling be generally rare in Wyoming pocket habitat (Shafer et al. 2001, pp. 200-215). survival for some forb species gopher habitat, possibly inhibiting the Each scenario in the study predicted a (Parkinson 2008, pp. 37-46). Further, future spread and impact of this reduction in the size of the overall range when chemical treatments were used to invasive species in Wyoming pocket of sagebrush and shift where sagebrush experimentally reduce the abundance of gopher habitat. In summary, we could may occur. These simulated changes weedy forbs in favor of grasses, a find no information suggesting that were the result of increases in the mean northern pocket gopher population nonnative species or B. tectorum, where temperature of the coldest month, declined roughly in proportion to the it occurs within the occupied range of which the authors speculated may loss of forbs (Keith et al. 1959, p. 231). the Wyoming pocket gopher, represent a interact with soil moisture levels to Pocket gophers that eat grass species threat to the species now, or in the produce the simulated impact. Each have reduced body weights (Tietjen et foreseeable future. model predicted that climate suitability

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for big sagebrush would shift north into forage important to pocket gophers Summary of Climate Change and Canada. Other areas within big through shifts in timing and amount of Drought sagebrush distributions would become precipitation, or through changes in The direct, long-term impact from less suitable climatically and would seasonal high, low, or average climate change to the Wyoming pocket potentially cause a significant temperatures (Bachelet et al. 2001, p. gopher is not known. Shifts in the contraction in sagebrush range. Since 174). For example, warmer temperatures vegetative community may affect the the Wyoming pocket gopher is and greater concentrations of species’ ability to forage. However, associated with sagebrush in the matrix atmospheric carbon dioxide create given our lack of knowledge of that forms Wyoming pocket gopher conditions favorable to Bromus important food resources for the habitat, contractions of sagebrush could tectorum, which outcompetes native Wyoming pocket gopher, our resulting result in negative effects to the species. vegetation and greatly accelerates the lack of understanding about how However, although the Wyoming pocket natural fire cycle in areas where it changes in the forage base may affect the gopher occurs within sagebrush becomes established (Chambers and species, and our uncertainty regarding habitats, the species prefers vegetation Pellant 2008, p. 31; Global Climate the effects of climate change on those other than sagebrush at a finer scale Change Impacts in the United States food resources, we cannot consider within that matrix (Griscom et al. 2010, 2009, p. 83). Future carbon dioxide climate change to be a threat to the p. 15). emissions from energy use are projected species now, or in the foreseeable In some cases, effects of climate to increase by 40 to 110 percent between future. A reduction in forage availability change can be demonstrated (e.g., 2000 and 2030 (IPCC 2007, p. 44). If a may also occur during periods of McLaughlin et al. 2002, p. 6073). Where resulting shift in the vegetative it can be, we rely on that empirical communities occurs within the range of drought. However, we have no data to evidence, such as increased stream the Wyoming pocket gopher, the facilitate our understanding of what temperatures (see Rio Grande cutthroat displacement of native forbs and grasses impacts this may have on the species. trout, 73 FR 27900, May 14, 2008) or could significantly alter the availability Additionally, the Wyoming pocket loss of sea ice (see polar bear, 73 FR of sufficient forage resources. This could gopher has persisted within its known 28212, May 15, 2008), and treat it as a then be exacerbated by the continued range since at least 1857 (Thaeler and threat that can be analyzed. The degree loss of those resources as a result of the Hinesley 1979, p. 480) despite periods to which climate change will interact shortened fire cycle. of natural drought. Therefore, while with ecological processes important to Application of continental-scale there may be population variation as a Wyoming pocket gophers is not climate change models to regional result of drought, we do not have any currently known. landscapes and even more local or data indicating that drought creates a Based on the evolutionary and ‘‘step-down’’ models projecting habitat threat to the Wyoming pocket gopher ecological response of pocket gopher potential based on climatic factors is now, or in the foreseeable future. species to past global warming and informative, but contains a high level of Grazing cooling events, changes in temperature uncertainty when predicting future and precipitation may result in effects to the Wyoming pocket gopher Currently, livestock grazing is the phenotypic and density changes in and its habitat due to a variety of most widespread type of land use across Wyoming pocket gopher populations factors, including regional weather the sagebrush biome, which includes (Hadly 1997, p. 292; Hadly et al. 1998, patterns, local physiographic the known range of the Wyoming pocket p. 6896; Barnosky et al. 2003, pp. 360- conditions, life stages of individual gopher (Knick et al. 2003, p. 616; 361), but we have no information species, of species, and Connelly et al. 2004, pp. 7-29; Knick et specific to the Wyoming pocket gopher. species’ reactions to changing carbon al., in press, p. 27). Several studies have If the Wyoming pocket gopher’s range dioxide levels. The models summarized shown that livestock grazing can result experiences increased temperatures and above are limited by these types of in reduced pocket gopher abundance reduced precipitation in the future, factors; therefore, their usefulness in and in some cases complete exclusion these changes could include reduced assessing the threat of climate change on (Phillips 1936, p. 676; Hunter 1991, p. body size and population abundance the Wyoming pocket gopher into the 117; Stromberg and Griffin 1996, p. (Hadly 1997, p. 292). Past climate- future is also limited. 1205; Eviner and Chapin 2003, p. 125). induced, population-level, phenotypic Livestock grazing has the potential to change in pocket gophers was likely the Drought negatively affect pocket gophers through result primarily of developmental Drought conditions occur within the a variety of mechanisms, such as soil plasticity within populations and not range of the Wyoming pocket gopher compaction (Phillips 1936, pp. 677- large-scale migration (Hadly et al. 1998, and are a natural process that has 678). However, direct competition for p. 6896; Barnosky et al. 2003, p. 362). historically occurred separately from forage likely has the largest negative Measured changes in phenotype and climate change. We anticipate natural effect on pocket gopher populations population size appeared to be an initial drought cycles to occur periodically (Phillips 1936, p. 677). Wild ungulate response to global warming episodes, within the range of the Wyoming pocket grazing has been found to have similar with the extent of change being gopher into the future. We could find no competitive effects to other small dependent upon the magnitude and specific information regarding the mammals (Coa¨te et al. 2004, p. 129), and duration of climatic change (Barnosky et effects of drought on the Wyoming this interaction may impact pocket al. 2003, pp. 364-365). pocket gopher. Presumably drought gophers. However, we have no Smaller body size and reduced would likely affect forage growth and information to suggest that this abundance experienced by historical potentially limit food availability. While competition is occurring with the pocket gopher populations during global this may have temporary effects on Wyoming pocket gopher. hot, dry periods is likely a response to population numbers and the Historically, pocket gophers have reduced food availability during those reproductive ability of the Wyoming been recognized by livestock producers periods (Hadly 1997, p. 290). Projected pocket gopher, the species continues to as competitors with livestock for limited climate change has the potential to occupy its known range despite historic rangeland forage (Richens 1965, p. 424; significantly alter the distribution of periods of natural drought. Julander et al. 1969, p. 325; Turner

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1969, p. 377; Laycock and Richardson pocket gopher now, or in the foreseeable gophers can occur where B. tectorum is 1975, p. 458). Pocket gophers primarily future. a prevalent plant species (Ostrow et al. feed on forbs; however, diet 2002, p. 992), and the seeds of B. Urbanization composition can shift seasonally to tectorum were occasionally found in include varying percentages of grasses Urbanization is considered a their burrows (Cox 1989, pp. 78-80). and shrubs (see discussion above under significant threat to other species of Many species of pocket gophers increase Life History; Aldous 1951, pp. 85-86; pocket gopher, such as the Mazama rates of mound building in areas of Ward and Keith 1962, p. 747). Cattle are pocket gopher (Service 2009b, p. 8); disturbed vegetation, while others are grazers, feeding mostly on grasses, but however, urbanization is limited within not found in areas of disturbance they will make seasonal use of forbs and the range of the Wyoming pocket (Moulton et al. 1983, p. 58). Therefore, shrub species (Vallentine 1990, p. 226). gopher. This area is largely rural, with predicting the potential effects of habitat Domestic sheep are intermediate approximately 55,000 people residing in disturbances or alteration on the feeders, making high use of forbs but Carbon and Sweetwater Counties in Wyoming pocket gopher based on the also using a large volume of grass and 2008 (U.S. Census Bureau 2009, p. 94), responses of other pocket gophers is not shrub species (Vallentine 1990, pp. 240- which is an average of 3 people per possible. The species continues to 241). Horses are generalists, but square mile (2.6 square kilometers). occupy its known historic range despite seasonally their diets can be almost However, most of this population is habitat alterations that have occurred wholly comprised of grasses (Wagner concentrated in the population centers within that range, and we have no 1983, pp. 119-120). The degree of of Rock Springs, Green River, and evidence of population declines. competition between pocket gophers Rawlins, which are at the edges of the We conclude that the best scientific and livestock due to diet varies with potential Wyoming pocket gopher range. and commercial information available local conditions that affect type and The BLM administers approximately indicates that the Wyoming pocket abundance of vegetation, stocking rates, half of the land in the range of the gopher is not now, or in the foreseeable and types of livestock (Phillips 1936, p. species, so urban development is future, threatened by the present or 676; Eviner and Chapin 2003, p. 125). precluded from those areas. Limited threatened destruction, modification, or We are unable to assess the levels of housing development is occurring near curtailment of its habitat or range to the competition that are occurring, but Wyoming pocket gopher collection sites, extent that listing under the Act as an competition has likely remained primarily to support gas field workers. endangered or threatened species is constant since grazing levels on BLM These areas provide concentrated areas warranted at this time. of disturbance, which create fewer lands have generally been stable since Factor B. Overutilization for 1978 (Laycock et al. 1996, p. 50). We impacts to the overall range of the species. The limited amount of housing Commercial, Recreational, Scientific, or anticipate future levels of competition Educational Purposes from grazing to remain constant, as the across the range of the species also recently renewed BLM Resource restricts the opportunities for domestic Overutilization is the consumptive Management Plan for much of the range pet predation on Wyoming pocket use of an organism, where individuals of the Wyoming pocket gopher does not gophers. We are unable to quantify a are intentionally captured or taken for a include a change in past livestock foreseeable future, but anticipate that variety of purposes. Examples include stocking rates (BLM 2008, pp. 2-19). additional urbanization will be limited take for human consumption, use of Domestic livestock grazing will based on the isolated nature of the area feathers or fur to create garments, and continue at present levels within the and the harsh environment that has not capture and removal of individuals for range of the Wyoming pocket gopher historically attracted many people. scientific or educational examinations (BLM 2008, pp. 2-19). The current Based on the limited amount of or study. We have no data indicating amounts, kinds, and seasons of livestock urbanization, we do not consider it to be that the Wyoming pocket gopher has grazing use will be authorized until a significant threat to the Wyoming been, is currently being, or will be in the monitoring, field observations, pocket gopher now, or in the foreseeable future, used for commercial, ecological site inventory, or other data future. recreational, or educational purposes. In the late 1970s, in Wyoming and acceptable to the BLM indicates an Summary of Factor A adjustment to grazing use is necessary Colorado, 228 pocket gophers of three (BLM 2008, pp. 2-19). While we cannot We conclude that the range of the different species were collected and provide an exact estimate of the Wyoming pocket gopher has euthanized to collect tissue for foreseeable future for grazing, we expect experienced and will continue to taxonomic delineation (Thaeler and this use to be persistent across the experience significant changes, Hinesley 1979, p. 480). Forty of the Wyoming pocket gopher’s range for primarily related to oil, gas, and wind animals collected were identified as several decades. development. The range is also likely to Wyoming pocket gophers, although the We recognize the potential for experience some changes related to authors note that tissue preparation on negative impacts to Wyoming pocket climate change. Changes from other 83 individuals was insufficient to do gopher populations due to direct sources, including nonnative vegetation, genetic analyses. Therefore, more competition with livestock, but have no grazing, and urbanization, may occur to Wyoming pocket gophers may have information about the impacts of grazing a lesser degree. However, we are unable been collected but not identified. No practices or grazing intensity to the to demonstrate that these alterations to further documented captures of the species. Livestock grazing has remained habitat will result in negative effects to Wyoming pocket gopher occurred until consistent over time, and the Wyoming the species. Examining data from 2008, when 12 individuals were trapped pocket gopher has continued to occupy studies on other species of pocket to collect genetic and morphological its known range. Additionally, we are gophers’ responses to similar information for species determination unaware of any studies linking grazing disturbances did not provide clarity as (Griscom et al. 2010, p. 5). Two of those practices to population levels of the the response appeared to vary by pocket gophers were euthanized to Wyoming pocket gopher. Therefore, we species. For example, the invasive obtain the tissue necessary for have no information to indicate that Bromus tectorum may negatively affect karyotyping procedures (McDonald grazing poses a threat to the Wyoming pocket gophers, but northern pocket 2009b, pers. comm.). Trapping

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continued in 2009 to collect distribution future, threatened by overutilization for range of the Wyoming pocket gopher as and habitat information. A total of 19 commercial, recreational, scientific, or a result of energy development individuals were captured in 2009 educational purposes to the extent that activities, there is likely no effect on (Griscom 2010b, pers. comm.), with 2 listing under the Act as an endangered Wyoming pocket gophers. We were individuals found dead in the traps or threatened species is warranted at unable to find any other information to (Griscom et al. 2010, p. 9). No other this time. suggest that the predator-prey balance Wyoming pocket gopher mortalities for the Wyoming pocket gopher has Factor C. Disease or Predation from these trapping efforts were been affected by any anthropogenic reported. Tissue samples (removing the Disease and parasites have not been activity, or may be affected within the tip of the tail) were collected from 5 demonstrated to limit populations of forseeable future. individuals in 2008 and 15 individuals pocket gophers (Keinath and Beauvais Based on our understanding of past in 2009 prior to their subsequent release 2006, p. 20). In general, pocket gophers and current effects, we do not anticipate at the capture location (Griscom 2009c, host some endo- and exo-parasites, most the effects of disease, parasites, or pers. comm.; Griscom et al. 2010, p. 22). of which have been identified predation to change for the foreseeable Some individuals may have died after incidentally to other research (Keinath future. and Beauvais 2006, p. 21). In some release at the capture location; however, Summary of Factor C one Wyoming pocket gopher (Griscom cases, northern pocket gophers have 2009c, pers. comm.) and a pocket been found with sufficient levels of We conclude that the best scientific gopher of another species were botfly larvae to result in mortality, with and commercial information available recaptured a day or two after the tip of up to 25 to 37 percent of local gopher indicates that the Wyoming pocket the tail was removed (Griscom et al. populations affected (Keinath and gopher is not now, or in the foreseeable 2010, p. 11). The wounds were healing, Beauvais 2006, p. 21 and references future, threatened by disease or and the pocket gophers did not appear therein). However, the effects of these predation to the extent that listing under to show any ill effects (Griscom et al. infestations on population persistence the Act as an endangered or threatened 2010, p. 11). Northern pocket gophers were not provided. No research has species is warranted at this time. survived in a lab environment for been conducted on diseases and Factor D: The Inadequacy of Existing several after having their tails parasites of the Wyoming pocket Regulatory Mechanisms clipped (McDonald 2009a, pers. comm.). gopher. Therefore, combined with the This limited evidence suggests that this lack of population data, we have no way Under this factor, we examine tissue collection does not result in of assessing the current or future impact whether identified threats to the mortality. of this factor on this species. We Wyoming pocket gopher are adequately The Wyoming Game and Fish recognize that lower levels of genetic addressed by existing regulatory Department (WGFD) issued collection diversity may allow a population to mechanisms. These mechanisms could permits for Wyoming pocket gophers for have greater susceptibility to diseases include: (1) Local land use laws, the scientific work that occurred in 2008 (Sanjayan et al. 1996, p. 1525), but we processes, and ordinances; (2) State and 2009 (Emmerich 2009, p. 2). The do not have information indicating that laws and regulations; and (3) federal review associated with the permitting disease poses a threat to the Wyoming laws and regulations. Regulatory process provided a protective measure pocket gopher, and we do not have mechanisms, if they exist, may preclude to the species by limiting take to those sufficient information to describe listing if such mechanisms are judged to individuals authorized to perform the genetic diversity of the species. adequately address the threat to the work (Wyoming Game and Fish Additionally, we do not have species such that listing is not Commission (WGFC) 1998, pp. 52-8–52- information indicating that human warranted. 9). Based on recent interest in the activities in the area increase the We could find no local land use laws, Wyoming pocket gopher, we anticipate susceptibility of the Wyoming pocket processes, or ordinances that provide a that some utilization of the species gopher to disease or parasites due to regulatory mechanism for the Wyoming related to scientific research will occur increased physiological stress. pocket gopher. The State of Wyoming in 2010 and possibly in future years. Pocket gophers are subject to has identified the Wyoming pocket We could find no other information predation from gopher snakes (Pituophis gopher as a Native Species Status 4, on research or scientific use of the catenifer), rattlesnakes (Crotalus viridis), meaning that while populations are Wyoming pocket gopher. The lack of long-tailed weasels (Mustela frenata), restricted in distribution, the species’ population data for this species results coyotes (Canis latrans), bobcats (Lynx habitat does not appear to be declining, in difficulties in determining whether rufus), badgers (Taxidea taxus), foxes and there are no known sensitivities to the Wyoming pocket gopher is adversely (Vulpes spp.), skunks (Mephitis spp.), human disturbance (Oakleaf et al. 2002, impacted by scientific purposes. numerous owls (Keinath and Beauvais p. 263). Important conservation efforts However, we do not believe 2006, p. 20), and domestic pets (Stinson for this species identified by the WGFD overutilization to be a current or future 2005, p. 51). However, we have no data are to collect more information on the threat because relatively few individuals indicating that predation limits species’ status, trends, and habitat use. have been affected by scientific Wyoming pocket gopher populations. The Wyoming pocket gopher is research, research methodologies Ravens (Corvus corax) use road identified in the WGFD Comprehensive generally involve live captures, and networks associated with oil fields in Wildlife Conservation Strategy (WGFD available information indicates captured southwestern Wyoming for foraging 2005, pp. 250-251) as a species of individuals can survive without activities (Bui 2009, p. 31), and common concern, which signifies a decline or noticeable effects. raven abundance increases in restriction to the population or its association with oil and gas habitat or both, but confers no State Summary of Factor B development in southwestern Wyoming protection to the species. The Wyoming We conclude that the best scientific (Holmes 2009, p. 1). However, we could pocket gopher received this designation and commercial information available find no information that ravens prey based on restricted habitat and limited indicates that the Wyoming pocket upon pocket gophers. Therefore, if raven available information on the species gopher is not now, or in the foreseeable abundance is increasing within the (Emmerich 2009, p. 1). The WGFD does

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restrict the take of the Wyoming pocket Factor E. Other Natural or Manmade the scientific literature for all species, gopher under Chapter 52 of the WGFC Factors Affecting Its Continued Wyoming pocket gophers are not regulations (WGFC 1998, p. 52-9; Existence thought capable of dispersing long Emmerich 2009, p. 1). This designation Other natural or manmade factors distances and may be restricted by the protects individuals of the species from affecting the continued existence of the energetic demands of tunneling (Hansen take unless take is authorized by Wyoming pocket gopher that we 1962, p. 152; Vaughan 1963, p. 371; regulations or is necessary to address analyzed include vulnerability of small Keinath and Beauvais 2006, p. 16). human health or safety (WGFC 1998, populations, use of poisons to target the There may be some above-ground dispersal at night (Griscom 2009a, pers. pp. 52-58). No state regulatory species, and recreational activities. We comm.) or when there is snow cover mechanisms provide for protection of are unaware of other factors that may (Vaughan 1963, p. 369). The patchy the species’ habitat. affect the continued existence of the distribution and low dispersal The Wyoming pocket gopher has been species. identified as a sensitive species by capability result in a low probability for Region 2 of the U.S. Forest Service Vulnerability of Small Populations recolonization following local (USFS) based on the species’ rarity and The Wyoming pocket gopher is a population extinctions (Keinath et al. potential sensitivity to disturbance narrow endemic species (i.e., a species 2008, p. 7). When the area over which (Keinath and Beauvais 2006, p. 6; USFS whose natural occurrence is confined to a colonization-extinction process 2006, p. 10), although we are unaware a certain region and whose distribution operates is geographically small, as is of any occurrence of this species on is relatively limited). The best available the case with Wyoming pocket gopher, USFS lands (Keinath and Beauvais scientific data suggest that this species a single local extinction that is not 2006, p. 7). The USFS does not confer occurs in just two counties in southwest followed by recolonization can have a large impact on the occupancy of the any protective regulations to identified Wyoming. Small geographic range has total area (Oborny et al. 2005, p. 291). sensitive species. The BLM in Wyoming been identified as the most important also identifies the Wyoming pocket The Wyoming pocket gopher has single indicator of elevated extinction persisted since at least 1857 (Coues gopher as a sensitive species (Abbott risk in mammals (Purvis et al. 2000, p. 2009b, pers. comm.), which requires the 1875, p. 138) and may never have had 1949; Oborny et al. 2005, p. 291; a large population size. The species agency to consider the welfare of these Cardillo et al. 2006, pp. 4157-4158; species when evaluating any action on appears to be currently distributed Cardillo et al. 2008, p. 1445; Davies et throughout its known range in a pattern public lands (BLM 2001, pp. 21J- al. 2008, p. 11559). The inherent that approximates historic distribution 22D3c(2)). The BLM has identified the vulnerability associated with small (see Figure 1 above). However, it Wyoming pocket gopher in NEPA geographic range is due to the fact that appears to have several characteristics, documents in the areas of the Wyoming a single localized threat, whether it is such as small geographic range, isolated pocket gopher’s distribution, such as the manmade (e.g., development) or populations, and low dispersal ability, 2006 Atlantic Rim Final Environmental environmental (e.g., disease), can which increase the species’ Impact Statement (BLM 2006b, p. 4-89). potentially impact the entire vulnerability to extinction from Project proponents for future projects on distribution of the species, resulting in stochastic events and other threats on BLM lands were instrumental in an increased probability of extinction the landscape. Currently, we do not collecting distributional data in 2008 (Davies et al. 2008, p. 11559). have information on these threats to an and 2009 (Beauvais 2009, p. 4; Griscom Small population size has also been extent that allows us to know whether et al. 2010, p. 6). However, species- identified as an important predictor of small population size allows for other specific management actions have not extinction vulnerability (O’Grady et al. manmade or environmental factors to been developed by the BLM (Keinath 2004, p. 517). Although we have no create a threat to the Wyoming pocket and Beauvais 2006, pp. 6-8; Abbott information on Wyoming pocket gopher gopher. Further, the historic range and 2010, pers. comm.). Despite the lack of abundance, restricted geographic range persistence of the species’ population regulatory mechanisms, this species frequently correlates with small size indicate the species occurs in continues to occupy its known range. population size (Purvis et al. 2000, p. normally low population densities. We We anticipate no changes in the 1947). Thus, it is reasonable to assume are unable to quantify a foreseeable current regulatory mechanisms for the that abundance is low relative to other future for stochastic events that may foreseeable future, unless research on pocket gopher species with larger have disproportionate negative effects the Wyoming pocket gopher indicates geographic ranges (e.g., northern pocket on small population sizes. We do not that regulatory mechanisms are gopher). Given their restricted anticipate the effects of these events on necessary and can help prescribe distribution and presumably relatively small population size to change, but our specific effective protections. small population size, Wyoming pocket understanding of these effects may gophers are more vulnerable to Summary of Factor D improve over time. demographic, environmental, and We conclude that the best scientific genetic stochasticity than larger, more Lethal Control of Pocket Gophers and commercial information available widely distributed species, which could Campaigns to eliminate other species indicates that the Wyoming pocket affect the Wyoming pocket gopher’s of pocket gophers are often pursued in gopher is not now, or in the foreseeable likelihood for long-term persistence. association with development, future, threatened by the inadequacy of Wyoming pocket gopher distribution farmlands, and ranchlands. We have no existing regulatory mechanisms to the appears to be discontinuous, and it information that indicates that pocket extent that listing under the Act as an remains undetermined if a gophers are the target of lethal control endangered or threatened species is metapopulation structure (a group of campaigns within the range of the warranted at this time. It is unclear that spatially separated populations which Wyoming pocket gopher. Strychnine regulatory mechanisms in addition to interact at some level) exists for this and Rozol are both rodenticides those described are needed for the species (Keinath and Beauvais 2006, p. approved by the U.S. Environmental species based on the current 19). Based on the abilities of other Protection Agency for control of pocket understanding of threats. pocket gophers, which is consistent in gophers, and these substances may

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create a threat to the Wyoming pocket more susceptible to threat factors, if warrants listing as threatened or gopher through targeted application or they are present. Many naturally rare endangered as those terms are defined non-target poisonings of another species species have persisted for long periods by the Act. This does not necessarily (Dickerson 2009a, pers. comm.). We are within small geographic areas, and require empirical proof of a threat. The unable to show the extent to which many naturally rare species exhibit combination of exposure and some these and similar substances are used on traits that allow them to persist despite corroborating evidence of how the private lands in the area; however, their small population sizes (Nevo et al. species is likely impacted could suffice. rangelands, which form the majority of 1997, p. 388; Rubinoff and Powell 2004, The mere identification of factors that Wyoming pocket gopher habitat, are not p. 2547; Lawson et al. 2008, p. 927; could impact a species negatively is not typically the target of pocket gopher Abeli et al. 2009, p. 3887). The sufficient to compel a finding that control measures (Dickerson 2009b, Wyoming pocket gopher is one of these listing is appropriate; we require pers. comm.). Additionally, the BLM species, existing in a limited range since evidence that these factors are operative does not use pesticides or rodenticides its discovery in 1857. We have no threats that act on the species to the in Wyoming to protect reclamation areas information that this rarity is working in point that the species meets the (Abbott 2009a, pers. comm.). We are combination with any threat factors that definition of threatened or endangered unable to determine if the Wyoming would cause the species to be likely to under the Act. We were able to quantify pocket gopher may be targeted by, or become in danger of extinction in all or the foreseeable future only for energy exposed to, substances used for lethal a significant portion of its range in the development and scientific utilization control in the future. We are unaware of foreseeable future. We have identified of the species, but discussed how we other methods that are commonly used lethal control of pocket gophers and anticipate each factor to change over for lethal control of pocket gopher recreational activities as other manmade time. We were unable to project changes populations. We currently do not have factors that may impact the species, but to the species into the future because we any information that would lead us to we have no information that these do not have sufficient data to know if anticipate an increase in lethal control factors are negatively impacting the these factors will result in positive or of the Wyoming pocket gopher for the species at this time. negative effects to the species. foreseeable future. We conclude that the best scientific Our review of the best available and commercial information available scientific and commercial information Recreational Activities indicates that the Wyoming pocket pertaining to the five factors does not Recreational activities within the gopher is not now, or in the foreseeable support the assertion that there are range of the Wyoming pocket gopher future, threatened by other natural or threats of sufficient imminence, include hunting, camping, hiking, horse manmade factors affecting its continued intensity, or magnitude to indicate the riding, use of all-terrain vehicles, and existence to the extent that listing under Wyoming pocket gopher is in danger of visiting historic sites. These activities the Act as an endangered or threatened extinction (endangered), or is likely to may cause elevated levels of human species is warranted at this time. become endangered within the presence on the landscape and resultant foreseeable future (threatened), Finding disturbances to habitat, which were throughout all or a significant portion of discussed in Factor A. We have no As required by the Act, we considered its range. Therefore, we find that listing information to indicate that increased the five factors in assessing whether the the Wyoming pocket gopher throughout human presence related to recreation Wyoming pocket gopher is endangered all or a significant portion of its range poses a threat to the Wyoming pocket or threatened throughout all or a is not warranted at this time. gopher. We anticipate that recreational significant portion of its range. We have In making this finding, we recognize activities will continue at current or carefully examined the best scientific that the Wyoming pocket gopher, slightly increased levels within the and commercial information available despite not being warranted for listing range of the Wyoming pocket gopher for regarding the status and the past, as endangered or threatened, may the foreseeable future. present, and future threats faced by the benefit from increased management Wyoming pocket gopher. We reviewed emphasis due to its limited distribution Summary of Factor E the petition, information available in and range. In particular, future oil, gas, Based on the best available our files, and other published and and wind development may have information, we have no indication that unpublished information submitted to positive or negative impacts to the other natural or manmade factors are us by the public following our 90–day species and should be carefully likely to significantly threaten the petition finding. We also consulted with considered and monitored. We existence of the species. We recognize Wyoming pocket gopher experts and recommend precautionary measures be the inherent vulnerabilities of small other Federal and State resource taken to protect the species, and that populations and restricted geographic agencies. In considering what factors additional research be pursued to range, which appear to be exhibited by might constitute threats, we must look improve the understanding of the the Wyoming pocket gopher. The beyond the mere exposure of the species species so that the responses to future impacts of various potential threats can to the factor to determine whether the potential threats can be better be more pronounced on small or species responds to the factor in a way understood. isolated populations, and we have that causes actual impacts to the identified numerous activities occurring species. If there is exposure to a factor, Distinct Vertebrate Population on the landscape within the range of the but no response, or only a positive Segments Wyoming pocket gopher (see Factor A response, that factor is not a threat. If After assessing whether the species is discussion). However, at this time, we there is exposure and the species endangered or threatened throughout its do not have information to indicate that responds negatively, the factor may be range, we next consider whether a these activities pose a threat to the a threat and we then attempt to distinct vertebrate population segment Wyoming pocket gopher. Additionally, determine how significant a threat it is. (DPS) of the Wyoming pocket gopher we do not consider a small population If the threat is significant, it may drive meets the definition of endangered or is alone to be a threat to species; rather, it or contribute to the risk of extinction of likely to become endangered in the can be a vulnerability that can make it the species such that the species foreseeable future (threatened).

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Under the Service’s Policy Regarding gopher is in danger of extinction or is However, if the Service determines both the Recognition of Distinct Vertebrate likely to become endangered in the that a portion of the range of a species Population Segments Under the foreseeable future. is significant and that the species is Endangered Species Act (61 FR 4722, On March 16, 2007, a formal opinion endangered or threatened there, the February 7, 1996), three elements are was issued by the Solicitor of the Service will specify that portion of the considered in the decision concerning Department of the Interior (USDI), ‘‘The range as endangered or threatened the establishment and classification of a Meaning of ‘In Danger of Extinction under section 4(c)(1) of the Act. possible DPS. These are applied Throughout All or a Significant Portion The terms ‘‘resiliency,’’ ‘‘redundancy,’’ similarly for additions to or removals of Its Range’’’ (USDI 2007, entire). We and ‘‘representation’’ are intended to be from the Federal List of Endangered and have summarized our interpretation of indicators of the conservation value of Threatened Wildlife. These elements that opinion and the underlying portions of the range. Resiliency of a include: (1) The discreteness of a statutory language below. A portion of species allows the species to recover population in relation to the remainder a species’ range is significant if it is part from periodic disturbance. A species of the taxon to which it belongs; (2) the of the current range of the species and will likely be more resilient if large significance of the population segment it contributes substantially to the populations exist in high-quality habitat to the taxon to which it belongs; and (3) representation, resiliency, or that is distributed throughout the range the population segment’s conservation redundancy of the species. The of the species in such a way as to status in relation to the Act’s standards contribution must be at a level such that capture the environmental variability for listing, delisting (removal from the its loss would result in a decrease in the found within the range of the species. A list), or reclassification (i.e., is the ability to conserve the species. portion of the range of a species may population segment endangered or In determining whether a species is make a meaningful contribution to the threatened). endangered or threatened in a resiliency of the species if the area is As stated above, the Wyoming pocket significant portion of its range, we first relatively large and contains particularly gopher is a narrow endemic species, identify any portions of the range of the high-quality habitat, or if its location or historically and currently found in only species that warrant further characteristics make it less susceptible consideration. The range of a species two counties in south-central Wyoming. to certain threats than other portions of can theoretically be divided into Only 47 confirmed Wyoming pocket the range. When evaluating whether or portions in an infinite number of ways. gophers have been trapped over how a portion of the range contributes However, there is no purpose to approximately the past 40 years, and the to resiliency of the species, we evaluate analyzing portions of the range that are species appears to be currently the historical value of the portion and not reasonably likely to be significant distributed throughout its known range how frequently the portion is used by and endangered or threatened. To in a pattern that approximates historic the species, if possible. In addition, the distribution (see Figure 1 above). identify only those portions that warrant portion may contribute to resiliency for Dispersal strategies of the Wyoming further consideration, we determine other reasons—for instance, it may pocket gopher are unknown (see whether there is substantial information contain an important concentration of discussion under Life History above). indicating that: (1) The portions may be certain types of habitat that are However, in other species of pocket significant, and (2) the species may be necessary for the species to carry out its gophers, dispersal has been well in danger of extinction there or likely to life-history functions, such as breeding, documented (e.g., Daly and Patton 1990, become so within the foreseeable future. feeding, migration, dispersal, or p. 1291; Hafner et al. 1998, p. 281), and In practice, a key part of this analysis is wintering. we have no evidence to suggest that the whether the threats are geographically Wyoming pocket gopher does not concentrated in some way. If the threats Redundancy of populations may be disperse within its known range. to the species are essentially uniform needed to provide a margin of safety for Therefore, we have no evidence throughout its range, no portion is likely the species to withstand catastrophic suggesting that the Wyoming pocket to warrant further consideration. events. This does not mean that any gopher is isolated in any part of its Moreover, if any concentration of portion that provides redundancy is range. We determine, based on a review threats applies only to portions of the necessarily a significant portion of the of the best available information, that no species’ range that are not significant, range of a species. The idea is to portion of the Wyoming pocket gopher such portions will not warrant further conserve enough areas of the range such range meets the discreteness conditions consideration. that random perturbations in the system of the 1996 DPS policy. The DPS policy If we identify portions that warrant act on only a few populations. is clear that significance is analyzed further consideration, we then Therefore, each area must be examined only when a population segment has determine whether the species is based on whether that area provides an been identified as discrete. Since we endangered or threatened in these increment of redundancy that is found that no population segment meets portions of its range. Depending on the important to the conservation of the the discreteness element, and therefore biology of the species, its range, and the species. no population segment qualifies as a threats it faces, the Service may address Adequate representation ensures that DPS under the Service’s DPS policy, we either the significance question or the the species’ adaptive capabilities are will not conduct an evaluation of status question first. Thus, if the Service conserved. Specifically, the portion significance. considers significance first and should be evaluated to see how it determines that a portion of the range is contributes to the genetic diversity of Significant Portion of the Range not significant, the Service need not the species. The loss of genetically Having determined that the Wyoming determine whether the species is based diversity may substantially pocket gopher does not meet the endangered or threatened there. reduce the ability of the species to definition of an endangered or Likewise, if the Service considers status respond and adapt to future threatened species throughout its entire first and determines that the species is environmental changes. A peripheral region, we must next consider whether not endangered or threatened in a population may contribute meaningfully there are any significant portions of the portion of its range, the Service need not to representation if there is evidence range where the Wyoming pocket determine if that portion is significant. that it provides genetic diversity due to

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its location on the margin of the species’ potential threats imperil a significant the Wyoming pocket gopher or any habitat requirements. portion of the species’ range. Further, other species, we will act to provide Section 4(c)(1) of the Act requires the for those potential threats with more immediate protection. well-understood impacts to the species Service to determine whether a portion References Cited of a species’ range, if not all, meets the (e.g., poisoning), we could find no definition of endangered or threatened. portion of the range in which threats are A complete list of all references cited As stated above, based on the best concentrated or otherwise likely to in this document is available on the scientific information, we find listing impact a significant portion of the Internet at http://www.regulations.gov the Wyoming pocket gopher across its species’ range. and upon request from the Wyoming Ecological Services Field Office (see entire range is not warranted. We were Conclusion unable to identify any significant ADDRESSES section). portion of the range that merits We do not find that the Wyoming Author additional analysis. The 31 Wyoming pocket gopher is in danger of extinction The primary authors of this document pocket gopher captures that occurred in now, nor is it likely to become are staff members of the Wyoming 2008 and 2009 indicate that the species endangered within the foreseeable Ecological Services Field Office (see is currently distributed throughout its future, throughout all or a significant ADDRESSES section). known historic range (see Figure 1 portion of its range. Therefore, listing above). The limited information the species as endangered or threatened Authority available on the Wyoming pocket under the Act is not warranted at this time. The authority for this action is section gopher, such as the lack of population 4 of the Endangered Species Act of numbers and dynamics, does not allow We request that you submit any new 1973, as amended (16 U.S.C. 1531 et us to determine what portion of the information concerning the status of, or seq.). range, if any, contributes substantially threats to, the Wyoming pocket gopher and differentially to the long-term to our Wyoming Ecological Services Dated: March 30, 2010. persistence of the species. As discussed Field Office (see ADDRESSES section) Daniel M. Ashe, previously, we do not know how the whenever it becomes available. New Acting Director, U.S. Fish and Wildlife species is likely to respond to many information will help us monitor this Service. potential threats (e.g., wind energy), and species and encourage its conservation. [FR Doc. 2010–8578 Filed 4–14–10; 8:45 am] therefore we cannot determine if the If an emergency situation develops for BILLING CODE 4310–55–S

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Notices Federal Register Vol. 75, No. 72

Thursday, April 15, 2010

This section of the FEDERAL REGISTER Regional Contacts for Recreation RACs 3. Show their past experience in contains documents other than rules or 1. Pacific Northwest Regional Office: working successfully as part of a proposed rules that are applicable to the collaborative group; and public. Notices of hearings and investigations, Shandra Terry, Regional Public committee meetings, agency decisions and Involvement Coordinator, Public 4. Complete Form AD–755, Advisory rulings, delegations of authority, filing of Affairs, 333 SW 1st Ave., Portland, OR Committee or Research and Promotion petitions and applications and agency 97208, (503) 808–2242. Background Information. statements of organization and functions are FOR FURTHER INFORMATION CONTACT: Julie Letters of recommendation are examples of documents appearing in this Cox, National Recreation RAC section. welcome. Individuals may also Coordinator, 333 SW 1st Avenue, nominate themselves. Nominees do not Portland, OR 97208, (503) 808–2984. need to live in a State within a DEPARTMENT OF AGRICULTURE SUPPLEMENTARY INFORMATION: particular Recreation RAC area of Nomination and Application jurisdiction nor live in a State in which Forest Service Information for Recreation RACs Forest Service-managed lands are located. Recreation Resource Advisory Each Forest Service Recreation RAC Committees shall consist of 11 members appointed Application packets, including by the Secretary of Agriculture. These evaluation criteria and the AD–755 AGENCY: Forest Service, USDA. members shall provide a broad and form, are available at http:// ACTION: Call for nominations for the balanced representation from the www.fs.fed.us/passespermits/rrac or by Pacific Northwest Recreation Resource recreation community as follows: contacting the respective regions Advisory Committees. 1. Five persons who represent identified in this notice. Nominees must recreation users and that include, as submit all documents to the appropriate SUMMARY: The Secretary of Agriculture appropriate, the following: regional contact. Additional information has established the Pacific Northwest a. Winter motorized recreation, such about recreation fees and REA is Recreation Resource Advisory as snowmobiling; available at http://www.fs.fed.us/ b. Winter nonmotorized recreation, Committees (Recreation RACs) pursuant passespermits/about-rec-fees.shtml. such as snowshoeing, cross country and to section 4 of the Federal Lands downhill skiing, and snowboarding; The Agency will also work with Recreation Enhancement Act (REA) that c. Summer motorized recreation, such Governors and county officials to was passed into law as part of the 2005 as motorcycles, boaters, and off-highway identify potential nominees. Consolidated Appropriations Act (Pub. vehicles; L. 108–447) on December 8, 2004. The The Agency will review the d. Summer nonmotorized recreation, purpose of this Recreation RAC is to applications and prepare a list of such as backpacking, horseback riding, provide recommendations regarding qualified applicants from which the mountain biking, canoeing, and rafting; recreation fees to both the Forest Service Secretary of Agriculture shall appoint and and the Bureau of Land Management both committee members and alternates. e. Hunting and fishing. An alternate will become a participating (BLM) as appropriate. There are 2. Three persons who represent member of the Recreation RACs only if currently three vacancies on the interest groups that include, as the member for whom the alternate is Recreation RAC: Summer Motorized appropriate, the following: Recreation, Summer Motorized Outfitter a. Motorized outfitters and guides; appointed to replace leaves the and Guide Recreation, and Tribal. The b. Nonmotorized outfitters and committee permanently. public is invited to submit nominations guides; and Recreation RAC members serve for membership on the Recreation c. Local environmental groups. without pay but are reimbursed for RACs. 3. Three persons, as follows: travel and per diem expenses for DATES: All nominations should be a. A State tourism official to represent regularly scheduled committee received by the appropriate Regional the State; meetings. All Recreation RAC meetings Office by May 5, 2010. If necessary, b. A person who represents affected are open to the public and an open manager may continue accepting Indian tribes; and public forum is part of each meeting. c. A person who represents affected applications beyond this date to ensure Meeting dates and times will be local government interests. broad and balanced representation on determined by Agency officials in Any individual or organization may the Recreation RAC. Nominations must consultation with the Recreation RAC nominate one or more qualified persons contain a completed application packet members, when the committee is to represent the interests listed above to that includes background information serve on the Recreation RAC. To be formed. and other information that addresses a considered for membership, nominees Dated: April 8, 2010. nominee’s qualifications. Application must— packets for Recreation RACs can be J. Lenise Lago, 1. Identify what interest group they obtained from the Forest Service Deputy Regional Forester. would represent and how they are Regional Office listed below or on the [FR Doc. 2010–8487 Filed 4–14–10; 8:45 am] qualified to represent that group; Web at http://www.fs.fed.us/ 2. State why they want to serve on the BILLING CODE 3410–11–M passespermits/rrac-application.shtml. committee and what they can ADDRESSES: contribute;

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DEPARTMENT OF AGRICULTURE Southwestern Regional Office Coronado National Forest Notices for Availability for Forest Service Regional Forester Comments, Decisions and Objections by Notices of Availability for Comment Forest Supervisor and Santa Catalina Newspapers Used for Publication of and Decisions and Objections affecting Ranger District are published in:—‘‘The Legal Notices in the Southwestern New Mexico Forests:— ‘‘Albuquerque ’’ Region, Which Includes Arizona, New ’’ Arizona Daily Star , Tucson, Arizona. Journal , Albuquerque, New Mexico, for Douglas Ranger District Notices are Mexico, and Parts of Oklahoma and National Forest System Lands in the published in:—‘‘Daily Dispatch’’, Texas State of New Mexico and for any Douglas, Arizona. projects of Region-wide impact. Nogales Ranger District Notices are AGENCY: Forest Service, USDA. Regional Forester Notices of Availability published in:—‘‘Nogales International’’, ACTION: Notice. for Comment and Decisions and Nogales, Arizona. Objections affecting Arizona Forests:— Sierra Vista Ranger District Notices ‘‘The Arizona Republic’’, Phoenix, SUMMARY: This notice lists the are published in:—‘‘Sierra Vista Herald’’, Arizona, for National Forest System newspapers that will be used by all Sierra Vista, Arizona. lands in the State of Arizona and for any Ranger Districts, Grasslands, Forests, Safford Ranger District Notices are projects of Region-wide impact. and the Regional Office of the published in:—‘‘Eastern Arizona Regional Forester Notices of Availability Southwestern Region to give legal notice Courier’’, Safford, Arizona. for Comment and Decisions and for the availability for comments on Objections affecting National Grasslands Kaibab National Forest projects under 36 CFR 215, notice of in New Mexico, Oklahoma, and Texas Notices for Availability for decisions that may be subject to are listed by Grassland and location as Comments, Decisions and Objections by administrative appeal under 36 CFR follows: Kiowa National Grassland Forest Supervisor, North Kaibab Ranger part 215 or Optional Appeal Procedures Notices published in:—‘‘Union County District, Tusayan Ranger District, and Available During the Planning Rule Leader’’, Clayton, New Mexico. Rita Williams Ranger District Notices are Transition Period (formerly 36 CFR part Blanca National Grassland in Cimarron published in:—‘‘Arizona Daily Sun’’, 217), and for opportunities to object to County, Oklahoma Notices published Flagstaff, Arizona. proposed authorized hazardous fuel in:— ‘‘Boise City News’’, Boise City, reduction projects under 36 CFR 218.4. Oklahoma. Rita Blanca National Prescott National Forest This notice also lists newspapers of Grassland in Dallam County, Texas Notices for Availability for record for notices pertaining to plan Notices published in:— ‘‘The Daihart Comments, Decisions and Objections by amendments and revisions under 36 Texan’’, Daihart, Texas. Black Kettle Forest Supervisor, Bradshaw Ranger CFR 219. Newspaper publication is in National Grassland in Roger Mills District, Chino Valley Ranger District addition to mailings and direct notice County, Oklahoma Notices published and Verde Ranger District are published made to those who have participated in in:— ‘‘Cheyenne Star’’, Cheyenne, in:—‘‘Daily Courier’’, Prescott, Arizona. the planning of projects or plan Oklahoma. Black Kettle National Tonto National Forest revisions and amendments by Grassland in Hemphill County, Texas submitting comments and/or requesting notices published in:—‘‘The Canadian Notices for Availability for notice. Record’’, Canadian, Texas. McClellan Comments, Decisions, and Objections by Forest Supervisor are published in:— DATES: Use of these newspapers for the Creek National Grassland in Gray ‘‘ ’’ purpose of publishing legal notice for a County, Texas Notices published in:— Arizona Capitol Times , in Phoenix, plan amendment decision that is subject ‘‘The Pampa News’’, Pampa, Texas. Arizona. Cave Creek Ranger District Notices are to appeal under ‘‘Optional Appeal Arizona National Forests published in:—‘‘Arizona Capitol Times’’, Procedures Available During the in Phoenix, Arizona. ’’ Apache-Sitgreaves National Forests Planning Rule Transition Period Globe Ranger District Notices are (formerly 36 CFR Part 217), for a Notices for Availability for published in:—‘‘Arizona Silver Belt’’, comment and project decision that may Comments, Decisions and Objections by Globe, Arizona. Mesa Ranger District be subject to appeal under 36 CFR part Forest Supervisor, Alpine Ranger Notices are published in:—‘‘Arizona 215, for opportunity to object under 36 District, Black Mesa Ranger District, Capitol Times’’, in Phoenix, Arizona. CFR 218, and for planning notices on a Lakeside Ranger District, and Payson Ranger District, Pleasant plan revision or plan amendment under Springerville Ranger District are Valley Ranger District and Tonto Basin 36 CFR part 219 shall begin on the date published in:—‘‘The White Mountain Ranger District Notices are published of this publication and continue until Independent’’, Show Low and Navajo in:—‘‘Payson Roundup’’, Payson, further notice. County, Arizona. Arizona. Clifton Ranger District Notices are ADDRESSES: Southwestern Region, published in:—‘‘Copper ’’, Clifton, New Mexico National Forests ATTN: Regional Appeals Assistant, 333 Arizona. Broadway SE., Albuquerque, NM Carson National Forest 87102–3498. Coconino National Forest Notices for Availability for FOR FURTHER INFORMATION CONTACT: Notices for Availability for Comments, Decisions and Objections by Connie Smith, 505–842–3223. Comments, Decisions and Objections by Forest Supervisor, Camino Real Ranger Forest Supervisor, Mogollon Rim Ranger District, Tres Piedras Ranger District SUPPLEMENTARY INFORMATION: Where District, Mormon Lake Ranger District, and Questa Ranger District are more than one newspaper is listed for and Peaks Ranger District are published published in:—‘‘The Taos News’’, Taos, any unit, the first newspaper listed is in:—‘‘Arizona Daily Sun’’, Flagstaff, New Mexico. the primary newspaper of record of Arizona. Canjilon Ranger District and El Rito which publication date shall be used for Red Rock Ranger District Notices are Ranger District Notices are published calculating the time period to file published in:—‘‘Red Rock News’’, in:—‘‘Rio Grande Sun’’, Espanola, New comment, appeal or an objection. Sedona, Arizona. Mexico.

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Jicarilla Ranger District Notices are Gila National Forest Whereas, the Board’s regulations (15 published in:—‘‘Farmington Daily Notices for Availability for CFR Part 400) provide for the Times’’, Farmington, New Mexico. Comments, Decisions and Objections by establishment of special-purpose subzones when existing zone facilities Cibola National Forest and National Forest Supervisor, Quemado Ranger cannot serve the specific use involved, Grasslands District, Reserve Ranger District, Glenwood Ranger District, Silver City and when the activity results in a Notices for Availability for Ranger District and Wilderness Ranger significant public benefit and is in the Comments, Decisions and Objections by District are published in:—‘‘Silver City public interest; Forest Supervisor affecting lands in Daily Press’’, Silver City, New Mexico. Whereas, the Foreign Trade Zone of New Mexico, except the National Black Range Ranger District Notices Wisconsin, Ltd., grantee of FTZ 41, has Grasslands are published in:- are published in:—‘‘The Herald’’, Truth made application to the Board for ‘‘Albuquerque Journal’’, Albuquerque, or Consequences, New Mexico. authority to establish special-purpose New Mexico. Forest Supervisor Notices affecting Lincoln National Forest subzone status with manufacturing National Grasslands in New Mexico, authority at the CNH America, LLC Notices for Availability for (CNH) facilities, located in Racine, Oklahoma and Texas are published by Comments, Decisions and Objections by grassland and location as follows: Wisconsin (FTZ Docket 42–2009, filed Forest Supervisor and the Sacramento 10/6/2009); Kiowa National Grassland in Colfax, Ranger District are published in:— Harding, Mora and Union Counties, ‘‘Alamogordo Daily News’’, Alamogordo, Whereas, notice inviting public New Mexico published in:—‘‘Union New Mexico. comment has been given in the Federal County Leader’’, Clayton, New Mexico. Guadalupe Ranger District Notices are Register (74 FR 52455, 10/13/2009) and Rita Blanca National Grassland in published in:—‘‘Carlsbad Current the application has been processed Cimarron County, Oklahoma published Argus’’, Carlsbad, New Mexico. pursuant to the FTZ Act and the Board’s in:—‘‘Boise City News’’, Boise City, Smokey Bear Ranger District Notices regulations; and, Oklahoma. Rita Blanca National are published in:—‘‘Ruidoso News’’, Whereas, the Board adopts the Grassland in Dallam County, Texas Ruidoso, New Mexico. findings and recommendations of the published in:— ‘‘The Dalhart Texan’’, Santa Fe National Forest examiner’s report, and finds that the Dalhart, Texas. Black Kettle National requirements of the FTZ Act and Grassland, in Roger Mills County, Notices for Availability for Board’s regulations are satisfied, and Oklahoma published in:—‘‘Cheyenne Comments, Decisions and Objections by that the proposal is in the public Star’’, Cheyenne, Oklahoma. Black Forest Supervisor, Coyote Ranger interest; District, Cuba Ranger District, Espanola Kettle National Grassland, in Hemphill Now, Therefore, the Board hereby County, Texas published in:—‘‘The Ranger District, Jemez Ranger District and Pecos-Las Vegas Ranger District are grants authority for subzone status for Canadian Record’’, Canadian, Texas. activity related to the manufacturing McClellan Creek National Grassland published in:—‘‘Albuquerque Journal’’, Albuquerque, New Mexico. and distribution of agricultural published in:—‘‘The Pampa News’’, equipment at the facilities of CNH Pampa, Texas. Dated: April 5, 2010. America, LLC, located in Racine, Mt. Taylor Ranger District Notices are Gilbert Zepeda, Wisconsin (Subzone 41I), as described published in:—‘‘Cibola County Beacon’’, Deputy Regional Forester, Southwestern in the application and Federal Register Grants, New Mexico. Region. notice, subject to the FTZ Act and the Magdalena Ranger District Notices are [FR Doc. 2010–8440 Filed 4–14–10; 8:45 am] Board’s regulations, including Section published in:—‘‘Defensor-Chieftain’’, BILLING CODE 3410–11–M 400.28. Socorro, New Mexico. Mountainair Ranger District Notices Signed at Washington, DC, this 1st day of April 2010. are published in:—‘‘Mountain View DEPARTMENT OF COMMERCE Telegraph’’, Moriarty, New Mexico. Ronald K. Lorentzen, Sandia Ranger District Notices are Foreign-Trade Zones Board Deputy Assistant Secretary for Import published in:—‘‘Albuquerque Journal’’, Administration, Alternate Chairman, Foreign- Albuquerque, New Mexico. [Order No. 1673] Trade Zones Board. Kiowa National Grassland Notices are Grant of Authority for Subzone Status, [FR Doc. 2010–8555 Filed 4–14–10; 8:45 am] ‘‘ ’’ published in:— Union County Leader , CNH America, LLC, (Agricultural BILLING CODE 3510–DS–P Clayton, New Mexico. Equipment and Component Parts) Rita Blanca National Grassland Racine, WI Notices in Cimarron County, Oklahoma DEPARTMENT OF COMMERCE are published in:—‘‘Boise City News’’, Pursuant to its authority under the Boise City, Oklahoma while Rita Blanca Foreign-Trade Zones Act of June 18, International Trade Administration National Grassland Notices in Dallam 1934, as amended (19 U.S.C. 81a-81u), County, Texas are published in:—‘‘The the Foreign-Trade Zones Board (the [A–821–801] Dalhart Texan’’, Dalhart, Texas. Board) adopts the following Order: Black Kettle National Grassland Whereas, the Foreign-Trade Zones Act Solid Urea From the Russian Notices in Roger Mills County, provides for ‘‘ * * * the establishment Federation: Preliminary Results of Oklahoma are published in:— * * * of foreign-trade zones in ports of Antidumping Duty Administrative ‘‘Cheyenne Star’’, Cheyenne, Oklahoma, entry of the United States, to expedite Review while Black Kettle National Grassland and encourage foreign commerce, and Notices in Hemphill County, Texas are for other purposes,’’ and authorizes the AGENCY: Import Administration, published in:—‘‘The Canadian Record’’, Foreign-Trade Zones Board to grant to International Trade Administration, Canadian, Texas. McClellan Creek qualified corporations the privilege of Department of Commerce. National Grassland Notices are establishing foreign-trade zones in or SUMMARY: The Department of Commerce published in:—‘‘The Pampa News’’, adjacent to U.S. Customs and Border (the Department) is conducting an Pampa, Texas. Protection ports of entry; administrative review of the

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antidumping duty order on solid urea of initiation of administrative review of determining appropriate product from the Russian Federation. The the order. See Initiation of Antidumping comparisons to the U.S. sales of subject review covers one producer/exporter of and Countervailing Duty Administrative merchandise. We compared the U.S. the subject merchandise, MCC Reviews and Request for Revocation in sales to home–market sales of identical EuroChem (EuroChem). The period of Part, 74 FR 42873 (August 25, 2009). We merchandise that were most review (POR) is July 1, 2008, through are conducting the administrative contemporaneous with the U.S. sales in June 30, 2009. We preliminarily review of the order in accordance with accordance with 19 CFR 351.414(e). determine that, during the POR, section 751(a) of the Act. Pursuant to section 777A(d)(2) of the Act, we compared the CEP of each U.S. EuroChem sold the subject merchandise Scope of the Order at less than normal value. transaction to the weighted–average We invite interested parties to The merchandise subject to the order price of sales of the foreign like product comment on these preliminary results. is solid urea, a high–nitrogen content for the calendar month that corresponds Parties who submit argument in this fertilizer which is produced by reacting most closely to the calendar month of proceeding are requested to submit with ammonia with carbon dioxide. The the individual export sale. product is currently classified under the the argument (1) a statement of the issue Product Comparisons and (2) a brief summary of the Harmonized Tariff Schedules of the argument. United States (HTSUS) item number We compared U.S. sales to weighted– 3102.10.00.00. Previously such average prices of home–market EFFECTIVE DATE: April 15, 2010. merchandise was classified under item contemporaneous sales of the foreign FOR FURTHER INFORMATION CONTACT: number 480.3000 of the Tariff like product. Wherever possible, we Dustin Ross or Minoo Hatten, AD/CVD Schedules of the United States. compared U.S. sales with sales of the Operations, Office 5, Import Although the HTSUS subheading is foreign like product in the home market. Administration, International Trade provided for convenience and customs Specifically, in making our Administration, U.S. Department of purposes, the written description of the comparisons, if an identical home– Commerce, 14th Street and Constitution merchandise subject to the order is market model was reported as described Avenue, NW, Washington, DC 20230; dispositive. by the characteristics listed below, we telephone: (202) 482–0747 or (202) 482– made comparisons to weighted–average 1690, respectively. Sales Analyzed home–market prices of that model. We SUPPLEMENTARY INFORMATION: During the review we learned from calculated the weighted–average home– the respondent that liquidation of Background market prices on a level of trade– entries of EuroChem’s subject specific basis. If there were no On July 14, 1987, the Department merchandise was not suspended due to contemporaneous sales of an identical published the antidumping duty order the importer’s misclassification of model, we identified the most similar on solid urea from the Union of Soviet entries during the POR. EuroChem home–market model. We found Socialist Republics (Soviet Union). See stated that it requested U.S. Customs contemporaneous sales of identical Antidumping Duty Order; Urea From and Border Protection (CBP) to do a merchandise in the home market for all the Union of Soviet Socialist Republics, post–entry adjustment to suspend U.S. sales in accordance with section 52 FR 26367 (July 14, 1987). Following liquidation. After querying CBP’s 771(16) of the Act. the break–up of the Soviet Union, the system, we are satisfied that there is one In accordance with section 771(16) of antidumping duty order on solid urea suspended entry on which to assess the Act, we compared products from the Soviet Union was transferred collectable duties. See memo to file produced by EuroChem and sold in the to the individual members of the dated March 29, 2010, which is on file U.S. and home markets on the basis of Commonwealth of Independent States. in the Central Records Unit (CRU) of the the comparison product which met the See Solid Urea From the Union of Soviet main Commerce building, room 1117. physical characteristics of the product Socialist Republics; Transfer of the Therefore, pursuant to section sold in the United States. In order of Antidumping Order on Solid Urea From 751(a)(2)(C) of the Act, we have importance, these characteristics are the Union of Soviet Socialist Republics calculated the weighted–average margin form, grade, nitrogen content, size, to the Commonwealth of Independent using all of EuroChem’s sales of solid urea–formaldehyde content, other States and the Baltic States and urea during the POR. For details on our additive/conditioning agent, coating Opportunity to Comment, 57 FR 28828 methodology for assessing duties for agent, and biuret content. (June 29, 1992). The rate established in entries in this POR, see ‘‘Assessment Date of Sale the less–than-fair–value investigation Rates’’ section below. for the Soviet Union was applied to Section 351.401(i) of the Department’s each new independent state, including Fair–Value Comparisons regulations states that, normally, the the Russian Federation (Russia). To determine whether EuroChem’s Department will use the date of invoice, Pursuant to section 751(a)(1) of the sales of solid urea from Russia were as recorded in the producer’s or Tariff Act of 1930, as amended (the Act), made in the United States at less than exporter’s records kept in the ordinary and 19 CFR 351.213(b), the Ad Hoc normal value, we compared the course of business, as the date of sale. Committee of Domestic Nitrogen constructed export price (CEP) to the The regulation provides further that the Producers and its individual urea– normal value as described in the Department may use a date other than producing members, CF Industries, Inc., ‘‘Constructed Export Price’’ and ‘‘Normal the date of the invoice if the Secretary and PCS Nitrogen (collectively, the Ad Value’’ sections of this notice. is satisfied that a different date better Hoc Committee), requested an When making this comparison in reflects the date on which the material administrative review of the accordance with section 771(16) of the terms of sale are established. The antidumping duty order on solid urea Act, we considered all products sold in Department has a long–standing from Russia with respect to EuroChem the home market as described in the practice of finding that, where shipment on July 31, 2009. On August 25, 2009, ‘‘Scope of the Order’’ section of this date precedes invoice date, shipment in accordance with 19 CFR notice, above, that were in the ordinary date better reflects the date on which 351.221(c)(1)(i), we published a notice course of trade for purposes of the material terms of sale are

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established. See Notice of Final market to serve as a viable basis for same level of trade as the U.S. sales. Determination of Sales at Less Than calculating normal value (i.e., the When there were no sales at the same Fair Value and Negative Final aggregate volume of home–market sales level of trade, we compared U.S. sales Determination of Critical of the foreign like product is five to home–market sales at a different level Circumstances: Certain Frozen and percent or more of the aggregate volume of trade. The normal–value level of Canned Warmwater Shrimp From of U.S. sales), we compared the volume trade is that of the starting–price sales Thailand, 69 FR 76918 (December 23, of EuroChem’s home–market sales of the in the home market. To determine 2004), and accompanying Issues and foreign like product to the volume of its whether home–market sales are at a Decision Memorandum at Comment 10; U.S. sale of subject merchandise in different level of trade than U.S. sales, see also Notice of Final Determination accordance with section 773(a)(1)(C) of we examined stages in the marketing of Sales at Less Than Fair Value: the Act. Based on this comparison, we process and selling functions along the Structural Steel Beams From Germany, determined that EuroChem had a viable chain of distribution between the 67 FR 35497 (May 20, 2002), and home market during the POR. producer and the unaffiliated customer. accompanying Issues and Decision Consequently, we based normal value In the home market, EuroChem Memorandum at Comment 2. on home–market sales to unaffiliated reported a single channel of For all U.S. sales, EuroChem reported purchasers made in the usual quantities distribution. Within this single channel shipment dates which preceded the date in the ordinary course of trade and sales of distribution, EuroChem reported a of invoice. For each of these sales, made to affiliated purchasers where we single level of trade for all three EuroChem reported the date of invoice find prices were made at arm’s length, customer types (i.e., distributors, as the date of sale. The date of invoice described in detail below. traders, and end–users). EuroChem is the date on which the final invoice is We based normal value on the starting states that, within this single level of printed for the U.S. customer following prices to home–market customers. trade, greater selling functions are the transfer of subject urea from the Pursuant to section 773(a)(6)(B)(ii) of performed for end–users relative to ocean vessel to the barge at the U.S. the Act, we deducted inland–freight distributors or traders. After analyzing port. Based on record evidence, all expenses EuroChem incurred on its the data on the record with respect to material terms of sale are established at home–market sales. Pursuant to section these functions, we find that EuroChem the time of shipment, with provisions 773(a)(6)(B)(i) of the Act, we deducted made all home–market sales at a single between customer and producer for home–market packing costs. We made marketing stage (i.e., one level of trade) variance between agreed–upon price deductions for direct selling expenses, in the home market. and quantity and final measured price as appropriate. The Department may calculate normal In the U.S. market, EuroChem had and quantity at the U.S. port of only CEP sales through its affiliated unloading. Consistent with our normal value based on a sale to an affiliated party only if it is satisfied that the price reseller to unaffiliated customers practice, for all U.S. sales EuroChem through a single channel of distribution reported we used the date of shipment to the affiliated party is comparable to the price at which sales are made to and, thus, a single level of trade. See as the date of sale. section 772(b) of the Act. We found that With respect to EuroChem’s home– parties not affiliated with the exporter there were significant differences market sales, shipment date and invoice or producer, i.e., sales were made at between the selling activities associated date are the same for every transaction. arm’s–length prices. See 19 CFR with the CEP level of trade and those Therefore, we use invoice date as the 351.403(c). We excluded from our associated with the home–market level date of sale for all home–market sales. analysis sales to affiliated customers for consumption in the home market that of trade. For example, the CEP level of Constructed Export Price we determined not to be arm’s–length trade involved little or no sales–strategic In accordance with section 772(b) of prices. To test whether these sales were and economic planning, distributor/ the Act, we used CEP for EuroChem made at arm’s–length prices, we dealer training, procurement/sourcing because the subject merchandise was compared the prices of sales of service, order input/processing, and sold in the United States by a U.S. seller comparable merchandise to affiliated freight/delivery service. Therefore, we affiliated with the producer and export and unaffiliated customers, net of all considered the CEP level of trade to be price was not otherwise indicated. rebates, movement charges, direct different from the home–market level of We calculated CEP based on the free– selling expenses, and packing. Pursuant trade and at a less advanced stage of on-board or delivered price to to 19 CFR 351.403(c) and in accordance distribution than the home–market level unaffiliated purchasers in, or for with our practice, when the prices of trade. Consequently, we could not exportation to, the United States. We charged to an affiliated party were, on match U.S. sales to sales at the same also made deductions for any movement average, between 98 and 102 percent of level of trade in the home market nor expenses in accordance with section the prices charged to unaffiliated parties could we determine a level–of-trade 772(c)(2)(A) of the Act. In accordance for merchandise comparable to that sold adjustment based on EuroChem’s home– with section 772(d)(1) of the Act, we to the affiliated party, we determined market sales of the foreign like product. calculated the CEP by deducting selling that the sales to the affiliated party were Because the data available do not expenses associated with economic at arm’s–length prices. See provide an appropriate basis to activities occurring in the United States, Antidumping Proceedings: Affiliated determine a level–of-trade adjustment which includes direct selling expenses Party Sales in the Ordinary Course of and the home–market level of trade is at and indirect selling expenses. Finally, Trade, 67 FR 69186 (November 15, a more advanced stage of distribution we made an adjustment for profit 2002). We included in our calculation of than the CEP, we have made a CEP– allocated to these expenses in normal value those sales to affiliated offset adjustment to normal value in accordance with section 772(d)(3) of the parties that were made at arm’s–length accordance with section 773(a)(7)(B) of Act. prices. the Act. The CEP offset is the sum of indirect selling expenses incurred on Normal Value Level of Trade the home–market sales up to the amount In order to determine whether there is To the extent practicable, we of indirect selling expenses incurred on a sufficient volume of sales in the home determined normal value for sales at the the U.S. sales.

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Preliminary Results of the Review May 6, 2003. This clarification applies occurred and the subsequent assessment As a result of this review, we to entries of subject merchandise during of double antidumping duties. We are issuing and publishing this preliminarily determine that a dumping the POR produced by EuroChem where notice in accordance with sections margin of 20.92 percent exists for EuroChem did not know that its 751(a)(1) and 777(i)(1) of the Act. EuroChem for the period July 1, 2008, merchandise was destined for the United States. In such instances, we will through June 30, 2009. Dated: April 9, 2010. instruct CBP to liquidate unreviewed Ronald K. Lorentzen, Disclosure and Public Hearing entries EuroChem–produced Deputy Assistant Secretary for Import We will disclose the calculations used merchandise at the all–others rate if Administration. in our analysis to parties to this review there is no rate for the intermediate company(ies) involved in the [FR Doc. 2010–8644 Filed 4–14–10; 8:45 am] within five days of the date of BILLING CODE 3510–DS–S publication of this notice. See 19 CFR transaction. For a full discussion of this 351.224(b). Any interested party may clarification, see Antidumping and Countervailing Duty Proceedings: request a hearing within 30 days of the DEPARTMENT OF COMMERCE publication of this notice in the Federal Assessment of Antidumping Duties, 68 FR 23954 (May 6, 2003). Register. See 19 CFR 351.310(c). If a International Trade Administration The Department intends to issue hearing is requested, the Department assessment instructions directly to CBP [A–570–908] will notify interested parties of the 15 days after the date of publication of hearing schedule. the final results of this administrative First Administrative Review of Sodium Interested parties are invited to review. Hexametaphosphate from the People’s comment on the preliminary results of Republic of China: Notice of this review. Interested parties may Cash–Deposit Requirements Preliminary Results of the submit case briefs within 30 days of the The following deposit requirements Antidumping Duty Administrative date of publication of this notice. See 19 will be effective upon publication of the Review CFR 351.309(c). Rebuttal briefs, which notice of final results of administrative AGENCY: Import Administration, must be limited to issues raised in the review for all shipments of subject International Trade Administration, case briefs, may be filed not later than merchandise entered, or withdrawn Department of Commerce. 35 days after the date of publication of from warehouse, for consumption on or SUMMARY: The Department of Commerce this notice. See 19 CFR 351.309(d). after the date of publication, as provided Parties who submit case briefs or (‘‘Department’’) is conducting the first by section 751(a)(1) of the Act: (1) the administrative review of the rebuttal briefs in this review are cash–deposit rate for EuroChem will be antidumping duty order on sodium requested to submit with each argument the rate established in the final results hexametaphosphate (‘‘sodium hex’’) (1) a statement of the issue and (2) a of this review; (2) for previously from the People’s Republic of China brief summary of the argument with an reviewed or investigated companies not (‘‘PRC’’) for the period of review (‘‘POR’’) electronic version included. listed above, the cash–deposit rate will September 14, 2007, through February We intend to issue the final results of continue to be the company–specific 28, 2009. The Department has this administrative review, including rate published for the most recent preliminarily determined that sales have the results of our analysis of issues period; (3) if the exporter is not a firm been made below normal value (‘‘NV’’) raised in the case briefs, within 120 covered in this review, a prior review, by the respondent. If these preliminary days after the date on which the or the less–than-fair–value investigation results are adopted in our final results preliminary results are published. See but the manufacturer is, the cash– of this review, the Department will 19 CFR 351.213(h)(1). deposit rate will be the rate established instruct U.S. Customs and Border for the most recent period for the Assessment Rates Protection (‘‘CBP’’) to assess manufacturer of the merchandise; (4) if antidumping duties on all appropriate The Department shall determine, and neither the exporter nor the entries of subject merchandise during CBP shall assess, antidumping duties on manufacturer is a firm covered in this the POR. Interested parties are invited to all appropriate entries. In accordance review, the cash–deposit rate will be comment on these preliminary results. with 19 CFR 351.212, we have 64.93 percent, the all–others rate calculated an importer/customer– established in Urea From the Union of EFFECTIVE DATE: April 15, 2010. specific assessment rate for these Soviet Socialist Republics; Final FOR FURTHER INFORMATION CONTACT: Paul preliminary results of review. We Determination of Sales at Less Than Walker, AD/CVD Operations, Office 9, divided total dumping margins for the Fair Value, 52 FR 19557 (May 26, 1987). Import Administration, International reviewed sales by the entered value of These deposit requirements, when Trade Administration, Department of the single suspended entry for this POR. imposed, shall remain in effect until Commerce, 14th Street and Constitution For detailed explanation of our method further notice. Avenue, NW, Washington, DC 20230; for assessing duties, see ‘‘2008–2009 telephone: (202) 482–0413. Notification to Importer Administrative Review of the SUPPLEMENTARY INFORMATION: Antidumping Duty Order on Solid Urea This notice also serves as a from Russia – Preliminary Results preliminary reminder to importers of Case Analysis Memorandum for EuroChem’’ their responsibility under 19 CFR On April 27, 2009, the Department on file in the CRU of the main 351.402(f)(2) to file a certificate published in the Federal Register a Commerce building, room 1117. We will regarding the reimbursement of notice of initiation of an administrative instruct CBP to assess the importer/ antidumping duties prior to liquidation review of sodium hex from the PRC, customer–specific rate on the of the relevant entries during this covering the POR, for one company, suspended entry of subject merchandise review period. Failure to comply with Hubei Xingfa Chemical Group Co., Ltd. made by the importer during the POR. this requirement could result in the (‘‘Xingfa’’). See Initiation of The Department clarified its Secretary’s presumption that Antidumping and Countervailing Duty ‘‘automatic assessment’’ regulation on reimbursement of antidumping duties Administrative Reviews and Request for

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Revocation in Part, 74 FR 19042 (April surrogate country and information to crushed, granule, powder, fines, or other 27, 2009) (‘‘Initiation’’). value factors of production (‘‘FOP’’). form, and whether or not in solution. On November 25, 2009, the Verification However, the product covered by this Department published a notice review does not include sodium extending the time period for issuing Pursuant to 19 CFR 351.307(b)(iv), hexametaphosphate when imported in a the preliminary results by 60 days to from November 19–23, 2009, the blend with other materials in which the January 30, 2010. See First Antidumping Department conducted verification of sodium hexametaphosphate accounts Duty Administrative Review of Sodium Hubei Xingfa’s questionnaire responses. for less than 50 percent by volume of Hexametaphosphate from the People’s See Memorandum to the File through the finished product. Republic of China: Extension of Time Scot T. Fullerton, Program Manager, Limit for the Preliminary Results, 74 FR Office 9, from Paul Walker, Senior Case Non–Market Economy (‘‘NME’’) Country 61656 (November 25, 2009). On Analyst, ‘‘First Administrative Review of Status Sodium Hexametaphospahte from the February 5, 2010, the Department In every case conducted by the People’s Republic of China: Verification published a notice extending the time Department involving the PRC, the PRC of Hubei Xingfa Chemical Group Co., period for issuing the preliminary has been treated as an NME country. In Ltd.,’’ dated concurrently with this results by 41 days to March 12, 2010. accordance with section 771(18)(C)(i) of notice (‘‘Hubei Xingfa Verification See First Antidumping Duty the Act, any determination made that a Report’’). Administrative Review of Sodium foreign country is an NME country shall Hexametaphosphate from the People’s Scope of the Order remain in effect until revoked by the Republic of China: Extension of Time administering authority. See, e.g., Brake Limit for the Preliminary Results, 75 FR The merchandise subject to this review is sodium hexametaphosphate. Rotors from the People’s Republic of 5946 (February 5, 2010). China: Final Results and Partial As explained in the memorandum Sodium hexametaphosphate is a water– soluble polyphosphate glass that Rescission of the 2004/2005 from the Deputy Assistant Secretary for Administrative Review and Notice of Import Administration, the Department consists of a distribution of polyphosphate chain lengths. It is a Rescission of 2004/2005 New Shipper has exercised its discretion to toll Review, 71 FR 66304 (November 14, deadlines for the duration of the closure collection of sodium polyphosphate polymers built on repeating NaPO3 2006). None of the parties to this of the Federal Government from proceeding have contested such February 5, through February 12, 2010. units. SHMP has a P2O5 content from 60 to 71 percent. Alternate names for treatment. Accordingly, the Department See Memorandum to the Record calculated NV in accordance with regarding ‘‘Tolling of Administrative sodium hexametaphosphate include the following: Calgon; Calgon S; Glassy section 773(c) of the Act, which applies Deadlines As a Result of the Sodium Phosphate; Sodium to NME countries. Government Closure During the Recent Polyphosphate, Glassy; Metaphosphoric Snowstorm,’’ dated February 12, 2010. Surrogate Country Acid; Sodium Salt; Sodium Acid Thus, all deadlines in this segment of Metaphosphate; Graham’s Salt; Sodium When the Department reviews the proceeding have been extended by Hex; Polyphosphoric Acid, Sodium Salt; imports from an NME country and the seven days, and the revised deadline for Glass H; Hexaphos; Sodaphos; Vitrafos; available information does not permit the preliminary results of this review and BAC–N-FOS. Sodium the Department to determine NV, became March 19, 2010. pursuant to section 773(a) of the Act, On March 26, 2010, the Department hexametaphosphate is typically sold as then, pursuant to section 773(c)(4) of the published a notice extending the time a white powder or granule (crushed) Act, the Department bases NV on an period for issuing the preliminary and may also be sold in the form of NME producer’s FOPs, to the extent results by 17 days to April 5, 2010. See sheets (glass) or as a liquid solution. It possible, in one or more market– First Antidumping Duty Administrative is imported under heading economy countries that (1) are at a level Review of Sodium Hexametaphosphate 2835.39.5000, HTSUS. It may also be of economic development comparable to from the People’s Republic of China: imported as a blend or mixture under that of the NME country, and (2) are Extension of Time Limit for the heading 3824.90.3900, HTSUS. The significant producers of comparable Preliminary Results, 75 FR 14568 American Chemical Society, Chemical ‘‘ ’’ merchandise. The Department (March 26, 2010). Abstract Service ( CAS ) has assigned the name ‘‘Polyphosphoric Acid, determined India, Philippines, Submissions by Interest Parties Sodium Salt’’ to SHMP. The CAS Indonesia, Columbia, Thailand, and As noted above, on April 27, 2009, registry number is 68915–31–1. Peru are countries comparable to the this administrative review was initiated However, sodium hexametaphosphate is PRC in terms of economic development. on one company, Hubei Xingfa. On May commonly identified by CAS No. See July 6, 2009, Letter to All Interested 4, 2009, the Department issued Hubei 10124–56–8 in the market. For purposes Parties, regarding ‘‘Antidumping Duty Xingfa the antidumping duty of the review, the narrative description Administrative Review of Sodium questionnaire. From May 26, 2009 to is dispositive, not the tariff heading, Hexametaphosphate from the People’s October 28, 2009, Hubei Xingfa CAS registry number or CAS name. Republic of China,’’ attaching July 2, submitted responses to the Department’s The product covered by this review 2009, Memorandum to Scot T. antidumping duty questionnaires. includes sodium hexametaphosphate in Fullerton, Program Manager, Office 9, On July 6, 2009, the Department sent all grades, whether food grade or AD/CVD Operations, from Kelly interested parties a letter inviting technical grade. The product covered by Parkhill, Acting Director, Office for comments on surrogate country this review includes sodium Policy, regarding ‘‘Request for List of selection and surrogate value data. On hexametaphosphate without regard to Surrogate Countries for an November 6, 2009, Hubei Xingfa and the chain length i.e., whether regular or Administrative Review of the Petitioners1 submitted comments on long chain. The product covered by this Antidumping Duty Order on Sodium review includes sodium Hexametaphosphate from the People’s 1 ICL Performance Products and Innophos, Inc. hexametaphosphate without regard to Republic of China’’ (‘‘Surrogate Country (collectively, the ‘‘Petitioners’’). physical form, whether glass, sheet, List’’).

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Based on publicly available independent so as to be entitled to a and sign contracts and other information placed on the record, the separate rate. See, e.g., Diamond agreements; (3) whether the respondent Department determines India to be a Sawblades, 71 FR at 29307. Exporters has autonomy from the government in reliable source for surrogate values can demonstrate this independence making decisions regarding the because India is at a comparable level of through the absence of both de jure and selection of management; and (4) economic development, pursuant to de facto government control over export whether the respondent retains the section 773(c)(4) of the Act, is a activities. Id. The Department analyzes proceeds of its export sales and makes significant producer of subject each entity exporting the subject independent decisions regarding merchandise, and has publicly available merchandise under a test arising from disposition of profits or financing of and reliable data. Furthermore, all the the Notice of Final Determination of losses. See Silicon Carbide, 59 FR at surrogate values placed on the record by Sales at Less Than Fair Value: Sparklers 22587; see also Notice of Final the parties were obtained from sources from the People’s Republic of China, 56 Determination of Sales at Less Than in India. Accordingly, the Department FR 20588, 20589 (May 6, 1991) Fair Value: Furfuryl Alcohol from the selected India as the surrogate country (‘‘Sparklers’’), as further developed in People’s Republic of China, 60 FR for purposes of valuing the FOPs Notice of Final Determination of Sales 22544, 22545 (May 8, 1995). The because it meets the Department’s at Less Than Fair Value: Silicon Carbide Department has determined that an criteria for surrogate country selection. from the People’s Republic of China, 59 analysis of de facto control is critical in FR 22585, 22586–87 (May 2, 1994) determining whether respondents are, Separate Rates (‘‘Silicon Carbide’’). However, if the in fact, subject to a degree of In 2005, the Department notified Department determines that a company government control which would parties of a new application and is wholly foreign–owned or located in a preclude the Department from assigning certification process by which exporters market economy, then a separate rate separate rates. The evidence provided and producers may obtain separate rate analysis is not necessary to determine by Hubei Xingfa supports a preliminary status in an NME review. The process whether it is independent from finding of de facto absence of requires exporters and producers to government control. See, e.g., Final government control based on the submit a separate rate status Results of Antidumping Duty following: (1) the companies set their certification and/or application. See Administrative Review: Petroleum Wax own export prices independent of the Policy Bulletin 05.1: Separate–Rates Candles from the People’s Republic of government and without the approval of Practice and Application of China, 72 FR 52355, 52356 (September a government authority; (2) the Combination Rates in Antidumping 13, 2007). companies have authority to negotiate Investigations involving Non–Market and sign contracts and other a. Absence of De Jure Control Economy Countries, (April 5, 2005) agreements; (3) the companies have (‘‘Policy Bulletin’’), available at: http:// The Department considers the autonomy from the government in ia.ita.doc.gov. However, the standard following de jure criteria in determining making decisions regarding the eligibility criteria for determining whether an individual company may be selection of management; and (4) there whether a firm is eligible for a separate granted a separate rate: (1) an absence of is no restriction on any of the rate (i.e., a demonstration of an absence restrictive stipulations associated with company’s use of export revenue. See of both de jure and de facto government an individual exporter’s business and Hubei Xingfa’s May 26, 2009 control over export activities), has not export licenses; (2) any legislative submission at 2–11; see also Hubei changed. enactments decentralizing control of Xingfa’s August 21, 2009 submission at A designation of a country as an NME companies; and (3) any other formal 6–16. Therefore, the Department remains in effect until it is revoked by measures by the government preliminarily finds that Hubei Xingfa the Department. See section decentralizing control of companies. See has established that it qualifies for a 771(18)(c)(i) of the Act. In proceedings Sparklers, 56 FR at 20589. The evidence separate rate under the criteria involving NME countries, it is the provided by Hubei Xingfa supports a established by Silicon Carbide and Department’s practice to begin with a preliminary finding of de jure absence Sparklers. rebuttable presumption that all of government control based on the companies within the country are following: (1) an absence of restrictive Date of Sale subject to government control and thus stipulations associated with the The date of sale is generally the date should be assessed a single antidumping individual exporter’s business and on which the parties agree upon all duty rate. See Policy Bulletin; see also export licenses; (2) there are applicable substantive terms of the sale. This Notice of Final Determination of Sales legislative enactments decentralizing normally includes the price, quantity, at Less Than Fair Value, and control of the companies; and (3) there delivery terms and payment terms. See Affirmative Critical Circumstances, In are formal measures by the government Carbon and Alloy Steel Wire Rod from Part: Certain Lined Paper Products from decentralizing control of companies. See Trinidad and Tobago: Final Results of the People’s Republic of China, 71 FR Hubei Xingfa’s May 26, 2009 Antidumping Duty Administrative 53079, 53082 (September 8, 2006); Final submission at 2–11; see also Hubei Review, 72 FR 62824 (November 7, Determination of Sales at Less Than Xingfa’s August 21, 2009 submission at 2007) and accompanying Issues and Fair Value and Final Partial Affirmative 6–16. Decision Memorandum at Comment 1; Determination of Critical see also Notice of Final Determination Circumstances: Diamond Sawblades b. Absence of De Facto Control of Sales at Less Than Fair Value: and Parts Thereof from the People’s Typically the Department considers Certain Cold–Rolled Flat–Rolled Carbon Republic of China, 71 FR 29303, 29307 four factors in evaluating whether each Quality Steel Products from Turkey, 65 (May 22, 2006) (‘‘Diamond Sawblades’’). respondent is subject to de facto FR 15123 (March 21, 2000) and It is the Department’s policy to assign government control of its export accompanying Issues and Decision all exporters of merchandise subject to functions: (1) whether the export prices Memorandum at Comment 2. review in an NME country this single are set by or are subject to the approval Section 351.401(i) of the Department’s rate unless an exporter can affirmatively of a government agency; (2) whether the regulations state that, ‘‘{i}n identifying demonstrate that it is sufficiently respondent has authority to negotiate the date of sale of the merchandise

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under consideration or foreign like Normal Value Fish Fillets From the Socialist Republic product, the Secretary normally will use Section 773(c)(1) of the Act provides of Vietnam: Final Resultsof the date of invoice, as recorded in the that the Department shall determine the Antidumping Duty Administrative exporter or producer’s records kept in NV using a FOP methodology if the Review and Partial Rescission, 73 FR the normal course of business.’’ The merchandise is exported from an NME 15479 (March 24, 2008) (‘‘Fish Fillets’’) Secretary may use a date other than the and the information does not permit the and accompanying Issues and Decision date of invoice if the Secretary is calculation of NV using home–market Memorandum at Comment 5C. As a satisfied that a different date better prices, third–country prices, or consequence, when valuing the reflects the date on which the exporter constructed value under section 773(a) intermediate input to the subject or producer establishes the material of the Act. The Department bases NV on merchandise in its calculation of the NV terms of sale. See 19 CFR 351.401(i); see the FOPs because the presence of in Fish Fillets, the Department also Allied Tube, 132 F. Supp. 2d at government controls on various aspects employed a surrogate value, rather than the FOPs used to produce the 1090–1092. However, as noted by the of non–market economies renders price intermediate input. Id. Similarly, Court of International Trade (‘‘CIT’’) in comparisons and the calculation of because Hubei Xingfa’s electricity production costs invalid under the Allied Tube, a party seeking to establish suppliers represent distinct legal a date of sale other than invoice date Department’s normal methodologies. In its questionnaire responses, Hubei entities that are not involved in the bears the burden of establishing that ‘‘ ‘a production of the subject merchandise different date better reflects the date on Xingfa claimed to self–produce a portion of the electricity used to at issue, for these preliminary results, which the exporter or producer we are applying a surrogate value to the produce sodium hex, stating that it establishes the material terms of sale.‘ ‘‘ amount of electricity self–produced by owned several hydroelectric power See Allied Tube & Conduit Corp. v. Hubei Xingfa. See the Hubei Xingfa stations which provided a portion of the United States, 132 F. Supp. 2d at 1087, Verification Report at Exhibits 14 and electricity used to produce sodium hex. 1090 (CIT 2001) (quoting 19 CFR 16. In addition, because Hubei Xingfa In addition, in response to the 351.401(i)) (‘‘Allied Tube’’). reported labor as the FOP input into Department’s request for all valid self–produced electricity, we have Hubei Xingfa reported that the date of business licenses held by Hubei Xingfa deducted the labor usage rate for self– sale was determined by the invoice during the POR, Hubei Xingfa did not produced electricity from Hubei issued by the affiliated importer to the provide separate licenses for the unaffiliated United States customer. In Xingfa’s overall reported labor. Because hydroelectric power stations. See Hubei these calculations are proprietary, see this case, as the Department found no Xingfa’s August 21, 2009 submission at evidence contrary to Hubei Xingfa’s Memorandum to the File, through Scot 14–15 and Exhibit 13. In addition, T. Fullerton, Program Manager, Office 9, claims that invoice date was the because, Hubei Xingfa claimed to self– appropriate date of sale, the Department from Paul Walker, Senior Analyst, ‘‘First produce its own electricity, it reported Administrative Review of Sodium used invoice date as the date of sale for the labor consumed at its hydroelectric these preliminary results. See, e.g., Hexametaphosphate from the People’s power stations in lieu of reporting the Republic of China: Hubei Xingfa Hubei Xingfa’s August 21, 2009 electricity, or intermediate input, these Chemical Group Co., Ltd.,’’ dated submission at 4. stations generated. However, at concurrently with this notice (‘‘Hubei Fair Value Comparisons verification the Department discovered Xingfa Analysis Memo’’), for further that that each of Hubei Xingfa’s details. To determine whether sales of sodium hydroelectric power stations has its own hex to the United States by Hubei business license, and thus are separate Factor Valuations Xingfa were made at less than fair value, legal entities that operate apart from In accordance with section 773(c) of the Department compared the export Hubei Xingfa. See Hubei Xingfa the Act, we calculated NV based on FOP price (‘‘EP’’) to NV, as described in the Verification Report at 2. data reported by Hubei Xingfa. To ‘‘U.S. Price,’’ and ‘‘Normal Value’’ We do not find that the record calculate NV, we multiplied the sections below. evidence sufficiently supports the claim reported per–unit factor–consumption that Hubei Xingfa produced its own rates by publicly available surrogate U.S. Price electricity because its electricity values. In selecting the surrogate values, suppliers operate as distinct legal we considered the quality, specificity, In accordance with section 772(a) of entities. Pursuant to 19 CFR 351.401(f), and contemporaneity of the data. See, the Act, we calculated the EP for sales the Department will collapse producers e.g., Fresh Garlic from the People’s to the United States for Hubei Xingfa. and treat them as a single entity where Republic of China: Final Results of We calculated EP based on the price to (1) those producers are affiliated, (2) the Antidumping Duty New Shipper Review, unaffiliated purchasers in the United producers have production facilities for 67 FR 72139 (December 4, 2002) and States. In accordance with section producing similar or identical products accompanying Issues and Decision 772(c) of the Act, as appropriate, we that would not require substantial Memorandum at Comment 6; see also deducted from the starting price to retooling of either facility in order to Final Results of First New Shipper unaffiliated purchasers foreign inland restructure manufacturing priorities, Review and First Antidumping Duty freight, foreign brokerage and handling, and (3) there is a significant potential Administrative Review: Certain customs duties, domestic brokerage and for manipulation of price or production. Preserved Mushrooms from the People’s handling and other movement expenses In Fish Fillets, for example, the Republic of China, 66 FR 31204 (June incurred. For the services provided by Department did not collapse a 11, 2001) and accompanying Issues and an NME vendor or paid for using an respondent with an affiliated input Decision Memorandum at Comment 5. NME currency we based the deduction producer when the affiliate did not have As appropriate, we adjusted input of these movement charges on surrogate the ability to produce or export similar prices by including freight costs to make values. See Surrogate Values Memo for or identical products, and could not them delivered prices. Specifically, we details regarding the surrogate values for produce such products without added to Indian import surrogate values movement expenses. substantial retooling. See Certain Frozen a surrogate freight cost using the shorter

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of the reported distance from the Circumstances: Certain Polyester Staple from the average value, because the domestic supplier to the factory or the Fiber from the People’s Republic of Department could not be certain that distance from the nearest seaport to the China, 71 FR 77373, 77380 (December they were not from either an NME factory where appropriate. This 26, 2006)(‘‘PSF’’). country or a country with general export adjustment is in accordance with the Furthermore, with regard to the subsidies. See, e.g., PET Film. Court of Appeals for the Federal Indian import–based surrogate values, For direct, indirect, and packing Circuit’s decision in Sigma Corp. v. we have disregarded import prices that labor, consistent with 19 CFR United States, 117 F.3d 1401, 1407–08 we have reason to believe or suspect 351.408(c)(3), we used the PRC (Fed. Cir. 1997). For a detailed may be subsidized. See Certain Frozen regression–based wage rate as reported description of all surrogate values used Fish Fillets from the Socialist Republic on Import Administration’s home page, for Hubei Xingfa, see Memorandum to of Vietnam: Preliminary Results and Import Library, Expected Wages of the File through Scot Fullerton, Program Preliminary Partial Rescission of Selected NME Countries, revised in Manager, Office 9, from Paul Walker, Antidumping Duty Administrative October 2009. See 2009 Calculation of Senior Case Analyst, ‘‘First Review, 70 FR 54007, 54011 (September Expected Non–Market Economy Wages, Administrative Review of Sodium 13, 2005), results unchanged in Certain 74 FR 65092 (December 9, 2009), and Hexametaphosphate from the People’s Frozen Fish Fillets From the Socialist http://ia.ita.doc.gov/wages/index.html. Republic of China: Surrogate Factor Republic of Vietnam: Final Results of The source of these wage–rate data on Valuations for the Preliminary Results,’’ the First Administrative Review, 71 FR the Import Administration’s web site is dated concurrently with this notice 14170 (March 21, 2006); and China Nat’l the Yearbook of Labour Statistics 2005, (‘‘Surrogate Values Memo’’). Machinery Import & Export Corp. v. ILO (Geneva: 2007), Chapter 5B: Wages United States, 293 F. Supp. 2d 1334, in Manufacturing. Because this For these preliminary results, in 1336 (Ct. Int’l. Trade 2003), aff’d 104 regression–based wage rate does not accordance with the Department’s Fed. Appx. 183 (Fed. Cir. 2004). In separate the labor rates into different practice, we used data from Indian determining whether to disregard inputs skill levels or types of labor, we have Import Statistics and other publicly the Department believes may be applied the same wage rate to all skill available Indian sources in order to subsidized, the Department, guided by levels and types of labor reported by calculate surrogate values for Hubei the legislative history, does not conduct Hubei Xingfa. Xingfa’s raw materials, packing, by– a formal investigation to ensure that We valued electricity using price data products, and energy. In selecting the such prices are not subsidized. See for small, medium, and large industries, best available information for valuing Omnibus Trade and Competitiveness as published by the Central Electricity FOPs, in accordance with section Act of 1988, Conference Report to Authority of the Government of India in 773(c)(1) of the Act, the Department’s accompany H.R. Rep. 100–576 at 590 its publication titled Electricity Tariff & practice is to select, to the extent (1988), reprinted in 1988 U.S.C.C.A.N. Duty and Average Rates of Electricity practicable, surrogate values which are 1547, 1623–24. Rather, the Department Supply in India, dated March 2008. non–export average values, most bases its decision on information that is These electricity rates represent actual contemporaneous with the POR, available to it at the time it makes its country–wide, publicly available product–specific, and tax–exclusive. determination. See Polyethylene information on tax–exclusive electricity See, e.g., Notice of Preliminary Terephthalate Film, Sheet, and Strip rates charged to industries in India. As Determination of Sales at Less Than from the People’s Republic of China: the rates listed in this source became Fair Value, Negative Preliminary Preliminary Determination of Sales at effective on a variety of different dates, Determination of Critical Circumstances Less Than Fair Value, 73 FR 24552, we are not adjusting the average value and Postponement of Final 24559 (May 5, 2008), unchanged in for inflation. Determination: Certain Frozen and Polyethylene Terephthalate Film, Sheet, We valued truck freight expenses Canned Warmwater Shrimp From the and Strip from the People’s Republic of using a per–unit average rate calculated Socialist Republic of Vietnam, 69 FR China: Final Determination of Sales at from data on the Infobanc Web site: 42672, 42682 (July 16, 2004), unchanged Less Than Fair Value, 73 FR 55039 http://www.infobanc.com/logistics/ in Final Determination of Sales at Less (September 24, 2008) (‘‘PET Film’’). logtruck.htm. The logistics section of Than Fair Value: Certain Frozen and In this instance, we have reason to this Web site contains inland freight Canned Warmwater Shrimp from the believe or suspect that prices of inputs truck rates between many large Indian Socialist Republic of Vietnam, 69 FR from Indonesia, South Korea, and cities. Since this value is 71005 (December 8, 2004). The record Thailand may have been subsidized contemporaneous with the POR, we did shows that data in the Indian Import because we found in other proceedings not adjust it for inflation. Statistics, as well as those from the that these countries maintain broadly We continued our recent practice to other Indian sources, are available, non–industry-specific export value brokerage and handling using a contemporaneous with the POR, subsidies. See, e.g., Dynamic Random simple average of the brokerage and product–specific, and tax–exclusive. Access Memory Semiconductors from handling costs that were reported in See Surrogate Values Memo. In those the Republic of Korea: Final Results of public submissions that were filed in instances where we could not obtain Countervailing Duty Administrative three antidumping duty cases. publicly available information Review, 74 FR 60238 (November 20, Specifically, we averaged the public contemporaneous to the POR with 2009). It is thus reasonable to infer that brokerage and handling expenses which to value factors, we adjusted the all exports to all markets from these reported by Navneet Publications (India) surrogate values using, where countries may be subsidized. Therefore, Ltd. in the 2007–2008 administrative appropriate, the Indian Wholesale Price we have not used prices from these review of certain lined paper products Index (‘‘WPI’’) as published in the countries in calculating the Indian from India, Essar Steel Limited in the International Financial Statistics of the import–based surrogate values. 2006–2007 antidumping duty International Monetary Fund. See, e.g., Additionally, we disregarded prices administrative review of hot–rolled Preliminary Determination of Sales at from NME countries. Finally, imports carbon steel flat products from India, Less Than Fair Value and Partial that were labeled as originating from an and Himalaya International Ltd. in the Affirmative Determination of Critical ‘‘unspecified’’ country were excluded 2005–2006 administrative review of

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certain preserved mushrooms from rebuts, clarifies, or corrects information minimis, we will instruct CBP to India. See Surrogate Values Memo. recently placed on the record. The liquidate appropriate entries without Since the Essar and Navneet brokerage Department generally cannot accept the regard to antidumping duties. See 19 and handling expense are submission of additional, previously CFR 351.106(c)(2). contemporaneous with the POR, we did absent–from-the–record alternative not adjust them for inflation. However, surrogate value information pursuant to Cash Deposit Requirements because the Himalaya brokerage and 19 CFR 351.301(c)(1). See Glycine from The following cash deposit handling expense is not the People’s Republic of China: Final requirements will be effective upon contemporaneous with the POR, we Results of Antidumping Duty inflated it using the WPI. Administrative Review and Final publication of the final results of this To value factory overhead, selling, Rescission, in Part, 72 FR 58809 administrative review for all shipments general, and administrative (‘‘SG&A’’) (October 17, 2007) and accompanying of the subject merchandise entered, or expenses, and profit, the Department Issues and Decision Memorandum at withdrawn from warehouse, for used the audited financial statement of Comment 2. consumption on or after the publication Tata Chemicals, as it is the only Interested parties may submit case date, as provided for by section financial statement on the record of this briefs and/or written comments no later 751(a)(2)(C) of the Act: (1) for the review. than 30 days after the date of exporter listed above, the cash deposit We made currency conversions into publication of these preliminary results rate will be established in the final U.S. dollars, in accordance with section of review. See 19 CFR 351.309(c)(ii). results of this review (except, if the rate 773A(a) of the Act, based on the Rebuttal briefs and rebuttals to written is zero or de minimis, i.e., less than 0.5 exchange rates in effect on the dates of comments, limited to issues raised in percent, no cash deposit will be the U.S. sales as certified by the Federal such briefs or comments, may be filed required for that company); (2) for all Reserve Bank. no later than five days after the deadline PRC exporters of subject merchandise We are preliminarily granting a by– for filing case briefs. See 19 CFR which have not been found to be product offset to Hubei Xingfa for ferro– 351.309(d). The Department urges entitled to a separate rate, the cash interested parties to provide an phosphorous and slag because Hubei deposit rate will be the PRC–wide rate Xingfa provided evidence that these by executive summary of each argument of 188.05 percent; and (3) for all non– by–products were produced and sold contained within the case briefs and PRC exporters of subject merchandise during the POR. rebuttal briefs. The Department will issue the final which have not received their own rate, Preliminary Results of Review results of this administrative review, the cash deposit rate will be the rate The Department preliminarily which will include the results of its applicable to the PRC exporters that determines that the following weighted– analysis of issues raised in any such supplied that non–PRC exporter. These average dumping margins exist: comments, within 120 days of deposit requirements, when imposed, publication of these preliminary results, shall remain in effect until further Manufacturer/Exporter Weighted Average pursuant to section 751(a)(3)(A) of the notice. Margin (Percent) Act. Notification to Importers Hubei Xingfa ...... 118.79 Assessment Rates This notice also serves as a Upon issuance of the final results, the Disclosure and Public Hearing Department will determine, and CBP preliminary reminder to importers of The Department will disclose to shall assess, antidumping duties on all their responsibility under 19 CFR parties the calculations performed in appropriate entries covered by this 351.402(f)(2) to file a certificate connection with these preliminary review. The Department intends to issue regarding the reimbursement of results within five days of the date of assessment instructions to CBP 15 days antidumping duties prior to liquidation publication of this notice. See 19 CFR after the publication date of the final of the relevant entries during this 351.224(b). results of this review excluding any review period. Failure to comply with In accordance with 19 CFR reported sales that entered during the this requirement could result in the 351.301(c)(3)(ii), for the final results of gap period. In accordance with 19 CFR Secretary’s presumption that this administrative review, interested 351.212(b)(1), we calculated exporter/ reimbursement of antidumping duties parties may submit publicly available importer (or customer)-specific occurred and the subsequent assessment information to value FOPs within 20 assessment rates for the merchandise of double antidumping duties. days after the date of publication of subject to this review. Because we do These results are issued and these preliminary results. Interested not have entered values for all U.S. published in accordance with sections parties must provide the Department sales, we calculated an ad valorem 751(a)(1) and 777(i)(1) of the Act and 19 with supporting documentation for the assessment rate by aggregating the CFR 351.221(b)(4). publicly available information to value antidumping duties due for all U.S. each FOP. Additionally, in accordance sales to each importer (or customer) and April 5, 2010. with 19 CFR 351.301(c)(1), for the final dividing this amount by the total Ronald K. Lorentzen, results of this administrative review, quantity sold to that importer (or Deputy Assistant Secretary for Import interested parties may submit factual customer). See 19 CFR 351.212(b)(1). To Administration. information to rebut, clarify, or correct determine whether the duty assessment [FR Doc. 2010–8643 Filed 4–14–10; 8:45 am] factual information submitted by an rates are de minimis, in accordance with BILLING CODE 3510–DS–S interested party less than ten days the requirement set forth in 19 CFR before, on, or after, the applicable 351.106(c)(2), we calculated importer deadline for submission of such factual (or customer)-specific ad valorem ratios information. However, the Department based on the estimated entered value. notes that 19 CFR 351.301(c)(1) permits Where an importer (or customer)- new information only insofar as it specific ad valorem rate is zero or de

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COMMODITY FUTURES TRADING DATES: Comments must be received on futures subject to the CEA and CFTC COMMISSION or before May 17, 2010. regulations thereunder governing ADDRESSES: Comments may be security futures, in OCC’s capacity as a Request for Comment on a Proposal submitted by any of the following registered securities clearing agency To Exempt, Pursuant to the Authority methods: (and not in its capacity as a DCO).9 in Section 4(c) of the Commodity • Federal eRulemaking Portal: http:// Section 5c(c)(3) provides that the CFTC Exchange Act, the Trading and www.regulations.gov. Follow the must approve such rules and rule Clearing of Certain Products Related to instructions for submitting comments. amendments submitted for approval ETFS Physical Swiss Gold Shares and • E-mail: [email protected]. unless it finds that the rules or rule ETFS Physical Silver Shares Include ‘‘Options and Security Futures amendments would violate the CEA. ’’ AGENCY: Commodity Futures Trading on ETFS Gold and Silver Products in In each case, the shares of the ETFS Commission. the subject line of the message. Gold Trust and the ETFS Silver Trust • Fax: 202–418–5521. are designed to reflect the performance ACTION: Notice of Proposed Order and • Mail: Send to David A. Stawick, Request for comment. of the price of gold and silver bullion, Secretary, Commodity Futures Trading respectively, less the expenses of Trust SUMMARY: The Commodity Futures Commission, Three Lafayette Centre, operations. The shares of each Trust Trading Commission (‘‘CFTC’’ or the 1155 21st Street, NW., Washington, DC represent beneficial interest in the Trust ‘‘Commission’’) is proposing to exempt 20581. which in turn holds physical allocated • the trading and clearing of certain Courier: Same as mail above. gold bullion (ETFS Gold Trust) and contracts called ‘‘options’’ and other All comments received will be posted silver bullion (ETFS Silver Trust). The contracts called ‘‘security futures’’ on without change to http:// gold and silver bullion is held in vault each of ETFS Physical Swiss Gold www.CFTC.gov/. All comments must be by or on behalf of the Trust’s custodian. Shares (‘‘Gold Products’’) and ETFS in English or, if not, accompanied by an Each physical bar is properly segregated Physical Silver Shares (‘‘Silver English translation. and allocated to the property of the Products’’) (collectively, ‘‘Gold and FOR FURTHER INFORMATION CONTACT: Trust. All physical gold and silver Silver Products’’), which would be Robert B. Wasserman, Associate conforms to the London Bullion Market traded on national securities exchanges Director, 202–418–5092, Association’s rules for good delivery. (as to options) and designated contract [email protected], or Lois J. Gregory, ETFS Gold Trust Shares and ETFS markets registered with the Securities Special Counsel, 202–418–5569, Silver Trust Shares are listed and traded and Exchange Commission (‘‘SEC’’) as [email protected], Division of Clearing on NYSEArca. limited purpose national securities and Intermediary Oversight, Commodity exchanges (as to security futures), and Futures Trading Commission, Three II. Section 4(c) of the Commodity in either case cleared through the Lafayette Centre, 1151 21st Street, NW., Exchange Act Options Clearing Corporation (‘‘OCC’’) in Washington, DC 20581. Section 4(c)(1) of the CEA empowers its capacity as a registered securities SUPPLEMENTARY INFORMATION: the CFTC to ‘‘promote responsible clearing agency, from the provisions of economic or financial innovation and I. Introduction the Commodity Exchange Act (‘‘CEA’’) 1 fair competition’’ by exempting any and the regulations thereunder, to the The OCC is both a Derivatives transaction or class of transactions from extent necessary to permit them to be so Clearing Organization (‘‘DCO’’) any of the provisions of the CEA traded and cleared. Authority for this registered pursuant to Section 5b of the (subject to exceptions not relevant here) exemption is found in Section 4(c) of CEA,4 and a securities clearing agency where the Commission determines that the CEA.2 The Commission also is registered pursuant to Section 17A of the exemption would be consistent with requesting comment on whether it the Securities Exchange Act of 1934 the public interest.10 The Commission should amend all orders issued (‘‘the ’34 Act’’).5 exempting the trading and clearing of OCC has filed with the CFTC, 9 See Securities Exchange Act Release No. 61591 options and futures on gold and silver pursuant to Section 5c(c) of the CEA (February 25, 2010), 75 FR 9981 (March 4, products from CEA provisions and and Commission Regulations 39.4(a) 2010)(File No. SR–OCC–2009–20 filed with both 6 the Commission and the Securities and Exchange Commission regulations thereunder, to and 40.5 thereunder, a request for Commission (‘‘SEC’’)). See also Securities Exchange impose market and large trader approval of rules and rule amendments Act Release No. 61483 (February 3, 2010), 75 FR reporting requirements under that would enable OCC (1) to clear and 6753 (February 10, 2010)(SEC approval of securities Commission regulations to the trading settle contracts called ‘‘options’’ exchanges’ listing and trading options on ETFS (‘‘Options’’) on Gold and Silver Products Gold Trust and ETFS Silver Trust). and clearing of the options in order to 10 Section 4(c)(1) of the CEA, 7 U.S.C. 6(c)(1), assist the Commission in monitoring traded on national securities exchanges, provides in full that: and addressing, among other things, the in its capacity as a registered securities In order to promote responsible economic or effect on designated contract markets of clearing agency (and not in its capacity financial innovation and fair competition, the trading in such products.3 as a DCO) and (2) to clear and settle Commission by rule, regulation, or order, after notice and opportunity for hearing, may (on its own contracts called ‘‘security futures’’ initiative or on application of any person, including 1 7 U.S.C. 1 et seq. (‘‘Security Futures’’) on Gold and Silver any board of trade designated or registered as a 2 7 U.S.C. 6(c). Products traded on designated contract contract market or derivatives transaction execution 3 The Commission has provided exemptions for markets 7 registered with the SEC as facility for transactions for future delivery in any gold and silver products on two prior occasions. commodity under section 7 of this title) exempt any See Order Exempting the Trading and Clearing of limited purpose national securities agreement, contract, or transaction (or class thereof) Certain Products Related to SPDR® Gold Trust exchanges pursuant to Section 6(g) of that is otherwise subject to subsection (a) of this Shares, 73 FR 31981 (June 5, 2008), Order the ’34 Act 8 (‘‘DCMs’’) as security section (including any person or class of persons Exempting the Trading and Clearing of SPDR Gold offering, entering into, rendering advice or Futures Contracts, 73 FR 31979 (June 5, 2008), and rendering other services with respect to, the 4 7 U.S.C. 7a–1. Order Exempting the Trading and Clearing of agreement, contract, or transaction), either 5 Certain Products Related to iShares® COMEX Gold 15 U.S.C. 78q–l. unconditionally or on stated terms or conditions or Trust Shares and iShares® Silver Trust Shares, 73 6 7 U.S.C. 7a–2(c), 17 CFR 39.4(a), 40.5. for stated periods and either retroactively or FR 79830 (December 30, 2008) (collectively, the 7 See Section 5 of the CEA, 7 U.S.C. 7. prospectively, or both, from any of the requirements ‘‘Previous Orders.’’). 8 15 U.S.C. 78f(g). Continued

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may grant such an exemption by rule, Section 1a(31) of the CEA.13 During the fair competition among boards of trade, regulation or order, after notice and legislative process leading to the other markets and market opportunity for hearing, and may do so enactment of Section 4(c) of the CEA, participants.’’16 It may be consistent on application of any person or on its the House-Senate Conference with these and the other purposes of the own initiative. Committee noted that: CEA, with the public interest, with the In enacting Section 4(c), Congress The Conferees do not intend that the CFTC–SEC Memorandum of noted that the goal of the provision ‘‘is exercise of exemptive authority by the Understanding of March 11, 2008, and to give the Commission a means of Commission would require any with the addendum thereto, for the providing certainty and stability to determination beforehand that the agreement, mode of trading and clearing the existing and emerging markets so that instrument, or transaction for which an Options and Security Futures on Gold financial innovation and market exemption is sought is subject to the Act. and Silver Products—whether the mode development can proceed in an effective Rather, this provision provides flexibility for applicable to options on securities or and competitive manner.’’ 11 Permitting the Commission to provide legal certainty to novel instruments where the determination commodities, or to security futures or Options and Security Futures on Gold as to jurisdiction is not straightforward. futures—to be determined by and Silver Products to trade on national Rather than making a finding as to whether competitive market forces. Accordingly, securities exchanges (as to Options) and a product is or is not a futures contract, the the Commission proposes to use its DCMs (as to Security Futures) and in Commission in appropriate cases may authority under Section 4(c) of the Act either case to be cleared by OCC in its proceed directly to issuing an exemption.14 to exempt the trading of Options on capacity as a securities clearing agency, The Options and Security Futures on Gold and Silver Products on national as discussed above, may foster both Gold and Silver Products described securities exchanges and clearing financial innovation and competition. In above raise questions involving their thereof by OCC in its capacity as a accordance with the Memorandum of nature and the appropriate resulting registered securities clearing agency Understanding entered into between the jurisdiction over them. Given their from the CEA and the Commission’s CFTC and the SEC on March 11, 2008, potential usefulness to the market, regulations thereunder to the extent and in particular the addendum thereto however, the Commission believes that necessary to permit them to be so traded concerning Principles Governing the this may be an appropriate case for and cleared. In addition, the Review of Novel Derivative Products, the issuing an exemption without making a Commission proposes to use its Commission has permitted novel finding as to the nature of these authority under Section 4(c) of the Act derivative products that implicate areas particular instruments. to exempt the trading and clearing of of potential overlapping regulatory Section 4(c)(2) provides that the Security Futures on Gold and Silver concern to be permitted to trade in Commission may grant exemptions only Products from those provisions of the either or both a CFTC- or SEC-regulated when it determines: That the Act and the Commission’s regulations environment, in a manner consistent requirements for which an exemption is thereunder that, if the underlying were with laws and regulations (including the being provided should not be applied to considered to be a commodity that is appropriate use of all available the agreements, contracts or transactions not a security, would be inconsistent exemptive and interpretive authority). at issue, and the exemption is consistent with the trading and clearing of Security The CFTC is requesting comment on with the public interest and the Futures on Gold and Silver Products as whether it should exempt Options and purposes of the CEA; that the security futures. The proposed Security Futures on Gold and Silver agreements, contracts or transactions exemption would require that Products, as described above, that are will be entered into solely between transactions in such contracts comply traded on a national securities exchange appropriate persons; and that the with the requirements established for or a DCM, respectively, and cleared exemption will not have a material transactions in security futures by the through OCC in its capacity as a adverse effect on the ability of the CEA and the Commission’s regulations registered securities clearing agency, Commission or any contract market or thereunder. The CFTC is requesting from the CEA and the Commission’s derivatives transaction execution comment as to whether these regulations thereunder, to the extent facility to discharge its regulatory or exemptions from the requirements of necessary to permit them to be so traded self-regulatory responsibilities under the the CEA and regulations thereunder and cleared. The CFTC previously 15 CEA. should be granted in the context of these granted exemptions for similar Options The purposes of the CEA include transactions. and Security Futures on June 5 and ‘‘promot[ing] responsible innovation and 12 Section 4(c)(3) includes within the December 30, 2008. term ‘‘appropriate persons’’ a number of In proposing this exemption, the 13 7 U.S.C. 1a(31). specified categories of persons, and also CFTC need not—and does not—find 14 4(c) Conf. Report at 3214–3215. in subparagraph (K) thereof ‘‘such other that Options on the Gold and Silver 15 Section 4(c)(2) of the CEA, 7 U.S.C. 6(c)(2), persons that the Commission Products are (or are not) options subject provides in full that: determines to be appropriate in light of to the CEA, or find that Security Futures The Commission shall not grant any exemption under paragraph (1) from any of the requirements * * * the applicability of appropriate on the Gold and Silver Products are (or of subsection (a) of this section unless the ’’ are not) security futures as defined in regulatory protections. National Commission determines that— securities exchanges and OCC, as well (A) The requirement should not be applied to the of subsection (a) of this section, or from any other agreement, contract, or transaction for which the as their members who will intermediate provision of this chapter (except subparagraphs exemption is sought and that the exemption would Options on Gold and Silver Products, (c)(ii) and (D) of section 2(a)(1) of this title, except be consistent with the public interest and the are subject to extensive and detailed that the Commission and the Securities and purposes of this Act; and regulation by the SEC under the ’34 Act. Exchange Commission may by rule, regulation, or (B) The agreement, contract, or transaction— Similarly, DCMs and OCC, as well as order jointly exclude any agreement, contract, or (i) Will be entered into solely between transaction from section 2(a)(1)(D) of this title), if appropriate persons; and their members who will intermediate the Commission determines that the exemption (ii) Will not have a material adverse effect on the would be consistent with the public interest. ability of the Commission or any contract market or 16 CEA 3(b), 7 U.S.C. 5(b). See also CEA 4(c)(1), 11 House Conf. Report No. 102–978, 1992 derivatives transaction execution facility to 7 U.S.C. 6(c)(1) (purpose of exemptions is ‘‘to U.S.C.C.A.N. 3179, 3213 (‘‘4(c) Conf. Report’’). discharge its regulatory or self-regulatory duties promote responsible economic or financial 12 See footnote 3, above. under this Act. innovation and fair competition.’’).

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Security Futures on Gold and Silver regulated markets, it may be that collection of information from any Products, are subject to regulation by national securities exchanges that list entities that would be subject to the the SEC and CFTC. The CFTC is the options should comply with market proposed order. requesting comment as to whether all reporting requirements and brokers and B. Cost-Benefit Analysis persons trading Options and Security traders that carry accounts or trade in Futures on Gold and Silver Products on options on gold and silver products Section 15(a) of the CEA,20 as national securities exchanges and should comply with large trader amended by Section 119 of the DCMs, respectively, and clearing such reporting requirements.17 Positions on Commodity Futures Modernization Act products on OCC, are appropriate security futures contracts on gold and of 2000, requires the Commission to persons. silver products are currently required to consider the costs and benefits of its The Commission held a public be reported to the Commission by DCMs action before issuing an order under the meeting on March 25, 2010 to examine and intermediaries.18 However, there is CEA. By its terms, Section 15(a) as the trading of futures and options in the no such reporting requirement with amended does not require the precious and base metals market and respect to options on gold and silver Commission to quantify the costs and analyze how the Commission regulates products that are exempted from being benefits of an order or to determine futures and options markets on treated as commodity options. Thus, the whether the benefits of the order commodities of finite supply. The Commission seeks comment as to outweigh its costs. Rather, Section 15(a) Commission is considering the views whether such reporting should be simply requires the Commission to expressed at that meeting. For the time required. Such information might ‘‘consider the costs and benefits’’ of its being, the Commission continues to enhance the Commission’s ability to action. decline to determine whether certain collect and analyze market data Section 15(a) of the CEA further products underlain by physical concerning trading in the markets for specifies that costs and benefits shall be commodities, such as the subject Gold gold and silver, and its ability evaluated in light of five broad areas of and Silver Products, are subject to the effectively to monitor the trading market and public concern: Protection Commission’s jurisdiction as activity and financial risk exposure of of market participants and the public; commodity options and futures market participants and thus the risk efficiency, competitiveness, and contracts. However, the Commission exposure of any DCO, such as OCC, financial integrity of futures markets; may make such jurisdictional clearing as central counterparty price discovery; sound risk management determinations in the future, and such (although in its capacity as a registered practices; and other public interest determinations may inform the securities clearing agency). If the considerations. Accordingly, the Commission’s approach to Commission determines to impose such Commission could in its discretion give consideration of exemptive orders, and requirements as to the gold and silver greater weight to any one of the five of assessing the rules of registered products that are the subject of the enumerated areas and could in its entities. current proposed order, or those that discretion determine that, III. Large Trader Reporting; Market were the subjects of the Previous notwithstanding its costs, a particular and Financial Surveillance Orders, a separate notice and request for order was necessary or appropriate to comments will be issued setting forth protect the public interest or to The Commission is considering the proposed specifics of such effectuate any of the provisions or to question of whether exemptions such as requirements. accomplish any of the purposes of the the one discussed herein, as well as IV. Request for Comment CEA. those issued previously on substantially The Commission is considering the similar options and futures on gold and The Commission requests comment costs and benefits of this proposed order silver products, may interfere with the on all aspects of the issues presented by in light of the specific provisions of Commission’s ability to discharge its this proposed order. Section 15(a) of the CEA, as follows: 21 regulatory responsibilities under the 1. Protection of market participants CEA or with the self-regulatory duties of V. Related Matters and the public. National securities contract markets. Options and Security A. Paperwork Reduction Act exchanges, OCC, and their members Futures on gold and silver products can who would intermediate the above- be used by those trading them for the The Paperwork Reduction Act of 1995 ‘‘ ’’ 19 described Options and Security Futures same economic purposes served by ( PRA ) imposes certain requirements on Gold and Silver Products are subject entering into commodity options and on Federal agencies (including the to extensive regulatory oversight. security futures on gold and silver. As Commission) in connection with their 2. Efficiency, competition, and a result of highly interconnected conducting or sponsoring any collection financial integrity. The proposed physical and derivatives gold and silver of information as defined by the PRA. exemption may enhance market markets, the trading of Gold and Silver The proposed exemptive order would efficiency and competition since it Products that are options on national not, if approved, require a new could encourage potential trading of securities exchanges, if traded in 17 See Parts 15 through 21 of the Commission’s Options and Security Futures on Gold sufficient volumes, can significantly regulations. and Silver Products through modes affect the price discovery function of 18 Under Commission Regulation Section other than those normally applicable; related commodity futures and option 15.03(b), 17 CFR § 15.03(b), the number of contracts that is, designated contract markets or contracts. In addition, the pools of that constitute a reportable level for security futures derivatives transaction execution physical gold and silver aggregated by products on an individual equity security is 1,000. In the instant case, when measured in terms of facilities. Financial integrity will not be these funds can materially affect ounces, reporting levels for Security Futures on affected since the Options and Security supplies that are deliverable under the Gold and Silver Products would be significantly Futures on Gold and Silver Products terms and conditions of related less than that for futures contracts on gold and commodity futures and options silver currently trading on Comex. Thus, visibility with respect to the Security Futures may be greater 20 7 U.S.C. 19(a). contracts. In order to preserve the than it would under large trader reporting 21 See also Previous Orders, 73 FR at 31982 (June integrity of the price discovery and risk requirements. 5, 2008), 73 FR at 3 FR at 31980 (June 5, 2008), and management functions of Commission 19 44 U.S.C. 3507(d). 73 FR at 79832 (December 30, 2008).

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will be cleared by OCC, a DCO and SEC- Dated: April 13, 2010. House Committee on Oversight and registered clearing agency, Todd A. Stevenson, Government Reform, the Senate intermediated by SEC-registered broker- Secretary. Committee on Governmental Affairs, dealers. [FR Doc. 2010–8805 Filed 4–13–10; 4:15 pm] and the Office of Management and 3. Price discovery. Price discovery BILLING CODE 6355–01–P Budget (OMB) pursuant to paragraph 4c may be enhanced through market of Appendix I to OMB Circular No. A– competition. 130, ‘‘Federal Agency Responsibilities DEPARTMENT OF DEFENSE for Maintaining Records About 4. Sound risk management practices. Individuals’’ dated February 8, 1996 The Options and Security Futures on (February 20, 1996; 61 FR 6427). Gold and Silver Products will be subject Office of the Secretary to OCC’s current risk-management [Docket ID DOD–2010–OS–0048] Dated: April 12, 2010. practices including its margining Mitchell S. Bryman, system. Privacy Act of 1974; System of Alternate OSD Federal Register Liaison Records Officer, Department of Defense. 5. Other public interest considerations. The proposed AGENCY: Defense Security Cooperation DSCA 01 exemption may encourage development Agency, DoD. SYSTEM NAME: of derivative products through market ACTION: Notice to alter a system of International Affairs Personnel competition without unnecessary records. regulatory burden. Initiatives Database. (November 23, 2005; 70 FR 70789). After considering these factors, the SUMMARY: The Office of the Secretary of Commission has determined to seek Defense proposes to alter a system of CHANGES: records to its inventory of record comment on the proposed order as * * * * * discussed above. The Commission systems subject to the Privacy Act of invites public comment on its 1974 (5 U.S.C. 552a), as amended. CATEGORIES OF INDIVIDUALS COVERED BY THE application of the cost-benefit provision. DATES: This proposed action would be SYSTEM: Delete entry and replace with Issued in Washington, DC, on April 9, 2010 effective without further notice on May by the Commission. 17, 2010 unless comments are received ‘‘Civilians and military personnel employed with the Department of David A. Stawick, which result in a contrary determination. Defense who wish to become certified Secretary of the Commission. by the DoD International Affairs ADDRESSES: You may submit comments, [FR Doc. 2010–8630 Filed 4–14–10; 8:45 am] Certification Program, a voluntary identified by docket number and title, BILLING CODE P program sponsored by the Defense by any of the following methods: Security Cooperation Agency and • Federal Rulemaking Portal: http:// Departments of the Army, Navy and Air www.regulations.gov. Follow the Force.’’ CONSUMER PRODUCT SAFETY instructions for submitting comments. COMMISSION • Mail: Federal Docket Management CATEGORIES OF RECORDS IN THE SYSTEM: System Office, 1160 Defense Pentagon, Delete entry and replace with ‘‘Full Sunshine Act Meetings Washington, DC 20301–1160. name; e-mail address; work mailing Instructions: All submissions received address, telephone and fax numbers. TIME AND DATE: Wednesday, April 21, must include the agency name and Employment and education 2010, 9 a.m.–11 a.m. docket number for this Federal Register information that includes if individual document. The general policy for PLACE: Hearing Room 420, Bethesda is civilian or military; major command comments and other submissions from Towers, 4330 East West Highway, and mailing address, name of members of the public is to make these Bethesda, Maryland. organization, office symbol/code, job submissions available for public title, job function, grade/rank, job series, STATUS: Commission Meeting—Open to viewing on the Internet at http:// military specialty, start date, total the Public. www.regulations.gov as they are months in International Affairs related received without change, including any MATTERS TO BE CONSIDERED: Pending work, billet information, current personal identifiers or contact Decisional Matters: Testing and certification level, highest education information. Labeling to Product Certification— completed, and field of study. Notice of Proposed Rulemaking (NPR) FOR FURTHER INFORMATION CONTACT: Ms. Supervisor Information that consists of and Testing Component Parts—Notice Cindy Allard at (703) 588–6830. first and last name, e-mail address, organization, office symbol, work phone of Proposed Rulemaking (NPR). SUPPLEMENTARY INFORMATION: The Office and fax number.’’ A live webcast of the Meeting can be of the Secretary of Defense notices for viewed at http://www.cpsc.gov/webcast/ systems of records subject to the Privacy AUTHORITY FOR MAINTENANCE OF THE SYSTEM: index.html. Act of 1974 (5 U.S.C. 552a), as amended, Delete entry and replace with ‘‘10 have been published in the Federal For a recorded message containing the U.S.C. 134, Under Secretary of Defense Register and are available from the latest agenda information, call (301) for Policy and DoD Directive 5105.65, Chief, OSD/JS Privacy Office, Freedom 504–7948. Defense Security Cooperation Agency.’’ of Information Directorate, Washington CONTACT PERSON FOR MORE INFORMATION: Headquarters Services, 1155 Defense PURPOSE(S): Todd A. Stevenson, Office of the Pentagon, Washington DC 20301–1155. Delete entry and replace with Secretary, U.S. Consumer Product The proposed system report, as ‘‘International Affairs Personnel Safety Commission, 4330 East West required by 5 U.S.C. 552a(r) of the Initiatives Database (IAPID) is a single Highway, Bethesda, MD 20814, (301) Privacy Act of 1974, as amended, was central facility with the Department of 504–7923. submitted on March 31, 2010, to the Defense (DoD) that maintains and

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verifies information provided by CONTESTING RECORD PROCEDURES: ROUTINE USES OF RECORDS MAINTAINED IN THE individuals seeking international affairs Delete entry and replace with ‘‘The SYSTEM, INCLUDING CATEGORIES OF USERS AND certification based on their current Office of the Secretary of Defense rules THE PURPOSES OF SUCH USES: experience and training. for accessing records for contesting In addition to those disclosures * * * * * contents and appealing initial agency generally permitted under 5 U.S.C. determinations are published in Office 552a(b) of the Privacy Act of 1974, these SAFEGUARDS: of the Secretary of Defense records contained therein may Delete entry and replace with Administrative Instruction 81; 32 CFR specifically be disclosed outside the ‘‘Records are maintained in controlled part 311; or may be obtained from the DoD as a routine use pursuant to 5 areas accessible only to authorized system manager.’’ U.S.C. 552a(b)(3) as follows: personnel. Government computers * * * * * The DoD ‘Blanket Routine Uses’ set requiring a Common Access Card to forth at the beginning of OSD’s access personal information is further DSCA 01 compilation of systems of records restricted by the use of passwords that SYSTEM NAME: notices apply to this system. are changed periodically. Physical entry International Affairs Personnel POLICIES AND PRACTICES FOR STORING, is restricted by the locks, security Initiatives Database. RETRIEVING, ACCESSING, RETAINING, AND personnel and administrative DISPOSING OF RECORDS IN THE SYSTEM: procedures.’’ SYSTEM LOCATION: Defense Institute of Security STORAGE: RETENTION AND DISPOSAL: Assistance Management, Research Records are maintained on electronic Delete entry and replace with Directorate, 2475 K Street, Wright- storage media. ‘‘ Disposition is pending until the Patterson AFB, OH 45433–7641. National Archives and Records RETRIEVABILITY: Administration approves the retention CATEGORIES OF INDIVIDUALS COVERED BY THE Records are retrieved by the and disposal schedule, records will be SYSTEM: individual’s name, organization, and treated as permanent.’’ Civilians and military personnel level of certification. employed with the Department of SAFEGUARDS: SYSTEM MANAGER(S) AND ADDRESS: Defense who wish to become certified Delete entry and replace with ‘‘U.S. by the DoD International Affairs Records are maintained in controlled Army Personnel: Deputy Assistant Certification Program, a voluntary areas accessible only to authorized Secretary of the Army for Defense program sponsored by the Defense personnel. Government computers Exports (DASA DE&C), 1777 North Kent Security Cooperation Agency and requiring a Common Access Card to Street, Rosslyn, VA 22209–2185. Departments of the Army, Navy and Air access personal information is further U.S. Navy/U.S. Marine Corps Force. restricted by the use of passwords that Personnel: Navy International Programs are changed periodically. Physical entry Office, 2521 S. Clark Street, Suite 800, CATEGORIES OF RECORDS IN THE SYSTEM: is restricted by the locks, security Arlington, VA 22202–3928. Full name; e-mail address; work personnel and administrative U.S. Air Force Personnel: Security mailing address, telephone and fax procedures. Assistance Policy and International numbers. Training and Education Division (SAF/ Employment and education RETENTION AND DISPOSAL: IAPX), 1550 Wilson Blvd., Suite 900, information that includes if individual Disposition is pending until the Arlington VA 22209–1080. is civilian or military; major command National Archives and Records Other Defense Personnel: Defense and mailing address, name of Administration approves the retention Institute of Security Assistance organization, office symbol/code, job and disposal schedule, records will be Management (DISAM), Project Manager, title, job function, grade/rank, job series, treated as permanent. Building 52, 2475 K Street, Wright- military specialty, start date, total SYSTEM MANAGER(S) AND ADDRESS: Patterson AFB, Ohio 45433–7641.’’ months in International Affairs related work; billet information, current U.S. Army Personnel: Deputy NOTIFICATION PROCEDURE: certification level, highest education Assistant Secretary of the Army for Delete entry and replace with completed, and field of study. Defense Exports (DASA DE&C), 1777 ‘‘Individuals seeking to determine Supervisor Information that consists of North Kent Street, Rosslyn, VA 22209– whether information about themselves first and last name, e-mail address, 2185. is contained in this system should organization, office symbol, work phone U.S. Navy/U.S. Marine Corps address written request to the and fax number. Personnel: Navy International Programs appropriate system manager listed Office, 2521 S. Clark Street, Suite 800, above. AUTHORITY FOR MAINTENANCE OF THE SYSTEM: Arlington, VA 22202–3928. Written requests should include the 10 U.S.C. 134, Under Secretary of U.S. Air Force Personnel: Security full name, organization, job series and Defense for Policy and DoD Directive Assistance Policy and International title and be signed.’’ 5105.65, Defense Security Cooperation Training and Education Division (SAF/ Agency. IAPX), 1550 Wilson Blvd., Suite 900, RECORD ACCESS PROCEDURES: Arlington VA 22209–1080. Delete entry and replace with PURPOSE(S): Other Defense Personnel: Defense ‘‘Individuals seeking access to records International Affairs Personnel Institute of Security Assistance about themselves contained in this Initiatives Database (IAPID) is a single Management (DISAM), Project Manager, system should address written request central facility with the Department of Building 52, 2475 K Street, Wright- to the appropriate system manager listed Defense (DoD) that maintains and Patterson AFB, Ohio 45433–7641. above. verifies information provided by Written requests should include the individuals seeking international affairs NOTIFICATION PROCEDURE: full name, organization, job series and certification based on their current Individuals seeking to determine title and be signed.’’ experience and training. whether information about themselves

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is contained in this system should Instructions: All submissions received STORAGE: address written request to the must include the agency name and Delete entry and replace with appropriate system manager listed docket number for this Federal Register ‘‘Records are maintained on paper and above. document. The general policy for electronic storage media.’’ Written requests should include the comments and other submissions from * * * * * full name, organization, job series and members of the public is to make these title and be signed. submissions available for public NOTIFICATION PROCEDURE: viewing on the Internet at http:// Delete entry and replace with RECORD ACCESS PROCEDURES: www.regulations.gov as they are ‘‘Individuals seeking to determine Individuals seeking access to records received without change, including any whether information about themselves about themselves contained in this personal identifiers or contact is contained in this system should system should address written request information. address written inquiries to the Privacy to the appropriate system manager listed Act Office, Headquarters, Defense above. FOR FURTHER INFORMATION CONTACT: Ms. Logistics Agency, Attn: DGA, 8725 John Written requests should include the Jody Sinkler at (703) 767–5045. J. Kingman Road, Suite 1644, Fort full name, organization, job series and SUPPLEMENTARY INFORMATION: The Belvoir, VA 22060–6221.’’ title and be signed. Defense Logistics Agency’s system of RECORD ACCESS PROCEDURES: record notices subject to the Privacy Act CONTESTING RECORD PROCEDURES: Delete entry and replace with of 1974 (5 U.S.C. 552a), as amended, ‘‘Individuals seeking access to The Office of the Secretary of Defense have been published in the Federal information about themselves contained rules for accessing records for contesting Register and are available from the in this system should address written contents and appealing initial agency Chief Privacy and FOIA Officer, inquiries to the Privacy Act Office, determinations are published in Office Headquarters Defense Logistics Agency, Headquarters, Defense Logistics Agency, of the Secretary of Defense Attn: DGA, 8725 John J. Kingman Road, Attn: DGA, 8725 John J. Kingman Road, Administrative Instruction 81; 32 CFR Suite 1644, Fort Belvoir, VA 22060– Suite 1644, Fort Belvoir, VA 22060– part 311; or may be obtained from the 6221. system manager. 6221. The specific changes to the record Individuals must supply their name RECORD SOURCE CATEGORIES: system being amended are set forth and the DLA facility or activity where Information is obtained from the below followed by the notice, as employed at the time they requested to individual and immediate supervisors. amended, published in its entirety. The participate in the Alternate Worksite proposed amendment is not within the Program.’’ EXEMPTIONS CLAIMED FOR THE SYSTEM: purview of subsection (r) of the Privacy None. Act of 1974 (5 U.S.C. 552a), as amended, CONTESTING RECORD PROCEDURES: [FR Doc. 2010–8653 Filed 4–14–10; 8:45 am] which requires the submission of new Delete entry and replace with ‘‘The BILLING CODE 5001–06–P or altered systems reports. DLA rules for accessing records, for Dated: April 12, 2010. contesting contents, and appealing initial agency determinations are Mitchell S. Bryman, DEPARTMENT OF DEFENSE contained in 32 CFR part 323, or may Alternate OSD Federal Register Liaison be obtained from the Privacy Act Office, Officer, Department of Defense. Office of the Secretary Headquarters, Defense Logistics Agency, [Docket ID DOD–2010–OS–0045] S330.10 Attn: DGA, 8725 John J. Kingman Road, Suite 1644, Fort Belvoir, VA 22060– Privacy Act of 1974; System of SYSTEM NAME: 6221.’’ Records DLA Telework Program Records (May * * * * * 5, 2006; 71 FR 26476). AGENCY: Defense Logistics Agency, DoD. S375.80 ACTION CHANGES: : Notice to amend a system of SYSTEM NAME: records. SYSTEM ID NUMBER: Alternate Worksite Records.

SUMMARY: The Defense Logistics Agency Delete entry and replace with SYSTEM LOCATION: is proposing to amend a system of ‘‘S375.80’’. Office of the Director, Human records notice in its existing inventory Resources, Headquarters, Defense SYSTEM NAME: of record systems subject to the Privacy Logistics Agency, 8725 John J. Kingman Act of 1974 (5 U.S.C. 552a), as amended. Delete entry and replace with Road, Suite 6231, Fort Belvoir, VA DATES: The proposed action will be ‘‘Alternate Worksite Records’’. 22060–6221, and heads of the DLA effective without further notice on May Primary Level Field activities. Official 17, 2010 unless comments are received SYSTEM LOCATION: mailing addresses are published as an which would result in a contrary Delete entry and replace with ‘‘Office appendix to DLA’s compilation of determination. of the Director, Human Resources, systems of records notices. ADDRESSES Headquarters, Defense Logistics Agency, : You may submit comments, CATEGORIES OF INDIVIDUALS COVERED BY THE 8725 John J. Kingman Road, Suite 6231, identified by docket number and title, SYSTEM: Fort Belvoir, VA 22060–6221, and heads by any of the following methods: Individuals who have been granted * Federal Rulemaking Portal: http:// of the DLA Primary Level Field activities. Official mailing addresses are and/or denied participation in the DLA www.regulations.gov. Follow the Telework Program. instructions for submitting comments. published as an appendix to DLA’s * Mail: Federal Docket Management compilation of systems of records CATEGORIES OF RECORDS IN THE SYSTEM: System Office, 1160 Defense Pentagon, notices.’’ Records include individual’s name; Washington, DC 20301–1160. * * * * * position title, grade, and job series; last

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performance evaluation rating; duty 552a(b) of the Privacy Act of 1974, these is contained in this system should station address and telephone number; records or information contained address written inquiries to the Privacy approved alternative worksite address, therein may specifically be disclosed Act Office, Headquarters, Defense telephone number(s), telephone outside the DOD as a routine use Logistics Agency, Attn: DGA, 8725 John installation and local fees (if pursuant to 5 U.S.C. 552a(b)(3) as J. Kingman Road, Suite 1644, Fort applicable); Telework request forms follows: Belvoir, VA 22060–6221. (Telework Request and Approval Form, Home address, home safety checklists, RECORD ACCESS PROCEDURES: Telework Agreement, Self-Certification and home safety reports may be Home Safety Checklist, and Supervisor- disclosed to the Department of Labor Individuals seeking access to Employee Checklist); approvals/ when an employee is injured while information about themselves contained disapprovals; home safety reports; working at home. in this system should address written description of government owned To the American Federation of inquiries to the Privacy Act Office, equipment and software provided to the Government Employees Council 169 to Headquarters, Defense Logistics Agency, Attn: DGA, 8725 John J. Kingman Road, Teleworker; and the digital identifier of provide raw statistical data on the DLA Suite 1644, Fort Belvoir, VA 22060– the individual used to authenticate telework program. Data to be disclosed 6221. document approvals. includes number of positions designated as eligible for Telework by job title, Individuals must supply their name AUTHORITY FOR MAINTENANCE OF THE SYSTEM: series and grade; number of employees and the DLA facility or activity where Pub. L. 106–346, section 359, requesting Telework; and the number employed at the time they requested to Department of Transportation and approved for Telework by the local participate in the Alternate Worksite Related Agencies Appropriations Act activity. No personal identifiers or Program. 2001; 5 U.S.C. 6120, Telecommuting in personally identifying data is provided. CONTESTING RECORD PROCEDURES: The DoD ‘Blanket Routine Uses’ set Executive Agencies; Under Secretary of The DLA rules for accessing records, forth at the beginning of DLA’s Defense for Personnel and Readiness for contesting contents, and appealing compilation of systems of records Memorandum, Department of Defense initial agency determinations are Telework Policy and Guide for Civilian notices apply to this system. Policies and practices for storing, contained in 32 CFR part 323, or may Employees, October 22, 2001; and DoD be obtained from the Privacy Act Office, Directive 1035.1, Telework Policy for retrieving, accessing, retaining, and disposing of records in the system: Headquarters, Defense Logistics Agency, Department of Defense. Attn: DGA, 8725 John J. Kingman Road, STORAGE: Suite 1644, Fort Belvoir, VA 22060– PURPOSE(S): Records are maintained on paper and 6221. Records are used by supervisors and electronic storage media. program coordinators for managing, RECORD SOURCE CATEGORIES: evaluating, and reporting DLA Telework RETRIEVABILITY: Data is supplied by participants, Program activity/participation. Data on Records are retrieved by name. supervisors, and information technology participation in the DLA Telework offices. Program, minus personal identifiers, is SAFEGUARDS: EXEMPTIONS CLAIMED FOR THE SYSTEM: provided to the DoD for a consolidated Access to the database is limited to DoD response to the Office of Personnel those who require the records in the None. Management (OPM) Telework Survey. performance of their official duties. [FR Doc. 2010–8654 Filed 4–14–10; 8:45 am] Portions of the files are used by Access is further restricted by the use of BILLING CODE 5001–06–P Information Technology offices for passwords, which are changed determining equipment and software periodically. Physical entry is restricted needs; for ensuring appropriate by the use of locks, guards, and DEPARTMENT OF DEFENSE administrative procedures. Employees technical safeguards are in use at Office of the Secretary alternative work sites; and for are periodically briefed on the evaluating and mitigating vulnerabilities consequences of improperly accessing [Docket ID: DOD–2010–OS–0047] associated with connecting to DLA restricted databases. Privacy Act of 1974; Systems of computer systems from remote RETENTION AND DISPOSAL: Records locations. Records are destroyed 1 year after Portions of the files may be used by employee’s participation in the program AGENCY: Defense Logistics Agency, DoD. Information Security offices for ends. Unapproved requests are ACTION: Notice to delete a system of determining equipment and software destroyed 1 year after the request is records. needs; for ensuring appropriate rejected. technical safeguards are in use at SUMMARY: The Defense Logistics Agency alternative work sites; and for SYSTEM MANAGER(S) AND ADDRESS: proposes to delete a system of records evaluating and mitigating vulnerabilities Director, Human Resources, notice in its existing inventory of associated with connecting to DLA Headquarters, Defense Logistics Agency, records systems subject to the Privacy computer systems from remote 8725 John J. Kingman Road, Suite 6231, Act of 1974, (5 U.S.C. 552a), as locations. Portions of the records may Fort Belvoir, VA 22060–6221; and the amended. also be used by telephone control offices heads of DLA Primary Level Field DATES: This proposed action will be to validate and reimburse participants activities. Official mailing addresses are effective without further notice on May for costs associated with telephone use. published as an appendix to DLA’s 17, 2010 unless comments are received compilation of systems of records which result in a contrary ROUTINE USES OF RECORDS MAINTAINED IN THE notices. SYSTEM, INCLUDING CATEGORIES OF USERS AND determination. THE PURPOSES OF SUCH USES: NOTIFICATION PROCEDURE: ADDRESSES: You may submit comments, In addition to those disclosures Individuals seeking to determine identified by dock number and title, by generally permitted under 5 U.S.C. whether information about themselves any of the following methods:

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• Federal Rulemaking Portal: http:// DEPARTMENT OF DEFENSE Dated: April 12, 2010. www.regulations.gov. Follow the Mitchell S. Bryman, instructions for submitting comments. Office of the Secretary Alternate OSD Federal Register Liaison Officer, Department of Defense. • Mail: Federal Docket Management [Docket ID: DOD–2010–OS–0046] System Office, 1160 Defense Pentagon, Deletion: Washington, DC 20301–1160. Privacy Act of 1974; Systems of Records S900.10. Instructions: All submissions received SYSTEM NAME: must include the agency name and AGENCY: Defense Logistics Agency, DoD. Personnel Roster/Locator Files docket number for this Federal Register ACTION: Notice to delete a system of document. The general policy for records. (December 26, 2002; 67 FR 78780). comments and other submissions from REASON: SUMMARY: The Defense Logistics Agency members of the public is to make these Records are now being maintained submissions available for public proposes to delete a system of records notice in its existing inventory of under a DoD-wide system of records viewing on the Internet at http:// identified as DPR 39 DoD, entitled ‘‘DoD www.regulations.gov as they are records systems subject to the Privacy Act of 1974, (5 U.S.C. 552a), as Personnel Accountability and received without change, including any ’’ amended. Assessment System. personal identifiers or contact [FR Doc. 2010–8656 Filed 4–14–10; 8:45 am] information. DATES: This proposed action will be BILLING CODE 5001–06–P effective without further notice on May FOR FURTHER INFORMATION CONTACT: Jody 17, 2010 unless comments are received Sinkler at (703) 767–5045. which result in a contrary DEPARTMENT OF DEFENSE SUPPLEMENTARY INFORMATION: The determination. Defense Logistics Agency systems of ADDRESSES: You may submit comments, Department of the Navy records notices subject to the Privacy identified by dock number and title, by Notice of Intent To Grant Exclusive any of the following methods: Act of 1974, (5 U.S.C. 552a), as Patent License: SciTech Medical Inc. amended, have been published in the • Federal Rulemaking Portal: http:// Federal Register and are available from www.regulations.gov. Follow the AGENCY: Department of the Navy, DoD. the Chief Privacy and FOIA Officer, instructions for submitting comments. ACTION: Notice. Headquarters, Defense Logistics Agency, • Mail: Federal Docket Management ATTN: DGA, 8725 John J. Kingman System Office, 1160 Defense Pentagon, SUMMARY: The Department of the Navy Road, Suite 1644, Fort Belvoir, VA Washington, DC 20301–1160. hereby gives notice of its intent to grant 22060–6221. Instructions: All submissions received a partially exclusive license to SciTech must include the agency name and Medical Inc. The proposed license is a The Agency proposes to delete a docket number for this Federal Register revocable, nonassignable, partially system of records notice in its inventory document. The general policy for exclusive license to practice several of record systems subject to the Privacy comments and other submissions from inventions throughout the United Act of 1974 (5 U.S.C. 552a), as amended. members of the public is of make these States, the District of Columbia, the The proposed deletion is not within the submissions available for public Commonwealth of Puerto Rico, and all purview of subsection (r) of the Privacy viewing on the Internet at http:// other United States territories and Act of 1974, (5 U.S.C. 552a), as www.regulations.gov as they are possessions and throughout the world amended, which requires the received without change, including any as covered by all related filings. The submission of a new or altered system personal identifiers or contact Secretary of the Navy has an ownership report. information. interest in these inventions, and they are covered by U.S. Patent No. Dated: April 12, 2010. FOR FURTHER INFORMATION CONTACT: Jody 7,128,714: Non-Contact Waveform Sinkler at (703) 767–5045. Mitchell S. Bryman, Monitor; U.S. Patent App. Ser. No. 12/ Alternate OSD Federal Register Liaison SUPPLEMENTARY INFORMATION: The 131,472: Remote Blood Pressure Sensing Officer, Department of Defense. Defense Logistics Agency systems of Method and Apparatus; and, U.S. records notices subject to the Privacy Deletion: Provisional Patent App. Ser. No. 61/ Act of 1974, (5 U.S.C. 552a), as 255,258: Non-Contact System and amended, have been published in the S340.20 CAHS Method For Monitoring A Physiological Federal Register and are available from Condition and various related foreign SYSTEM NAME: the Chief Privacy and FOIA Officer, applications. Headquarters Defense Logistics Agency, Official Records for Host Enrollee ATTN: DGA, 8725 John J. Kingman DATES: Anyone wishing to object to the Programs (November 16, 2004; 69 FR Road, Suite 1644, Fort Belvoir, VA grant of this license has fifteen (15) days 67112). 22060–6221. from the date of this notice to file The Agency proposes to delete a written objections along with REASON: system of records notice in its inventory supporting evidence, if any. ADDRESSES: Written objections are to be System notice is no longer needed. of record systems subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended. filed with the Naval Undersea Warfare The program has been discontinued and The proposed deletion is not within the Center Division, Newport, 1176 Howell records have been destroyed. purview of subsection (r) of the Privacy St., Bldg 990, Code 07TP, Newport, RI [FR Doc. 2010–8655 Filed 4–14–10; 8:45 am] Act of 1974, (5 U.S.C. 552a), as 02841. BILLING CODE 5001–06–P amended, which requires the FOR FURTHER INFORMATION CONTACT: Dr. submission of a new or altered system Theresa A. Baus, Head, Technology report. Partnership Enterprise Office, Naval

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Undersea Warfare Center Division, Individuals desiring to participate records notice subject to the Privacy Act Newport, 1176 Howell St., Bldg 990, remotely via teleconference or webinar of 1974, (5 U.S.C. 552a), as amended, Code 07TP, Newport, RI 02841, must submit their contact information has been published in the Federal telephone 401–832–8728, or e-mail (to include e-mail address) to Ms. Register and is available from Mrs. [email protected]. Hartlage via the below address. There Miriam Brown-Lam, HEAD, FOIA/ Authority: 35 U.S.C. 207, 37 CFR part 404. will be limited availability to participate Privacy Act Policy Branch, the remotely and requests will be handled Department of the Navy, 2000 Navy Dated: April 7, 2010. on a first-come, first-served basis. Pentagon, Washington, DC 20350–2000. A.M. Vallandingham, To contact the Designated Federal The specific changes to the record Lieutenant Commander, Judge Advocate Officer, write to Executive Director, system being amended are set forth General’s Corps, U.S. Navy, Federal Register CNO Executive Panel (N00K), 4825 below followed by the notice, as Liaison Officer. Mark Center Drive, 2nd Floor, amended, published in its entirety. The [FR Doc. 2010–8657 Filed 4–14–10; 8:45 am] Alexandria, VA 22311–1846. proposed amendment is not within the BILLING CODE 3810–FF–P Dated: April 7, 2010. purview of subsection (r) of the Privacy A.M. Vallandingham, Act of 1974 (5 U.S.C. 552a), as amended, which requires the submission of new DEPARTMENT OF DEFENSE Lieutenant Commander, Judge Advocate General’s Corps, U.S. Navy, Federal Register or altered systems reports. Department of the Navy Liaison Officer. Dated: April 12, 2010. [FR Doc. 2010–8661 Filed 4–14–10; 8:45 am] Mitchell S. Bryman, Meeting of the Chief of Naval BILLING CODE 3810–FF–P Alternate OSD Federal Register Liaison Operations (CNO) Executive Panel Officer, Department of Defense. AGENCY: Department of the Navy, DoD. DEPARTMENT OF DEFENSE N01070–3 ACTION: Notice of open meeting. Department of the Navy SYSTEM NAME: SUMMARY: The CNO Executive Panel Navy Military Personnel Records will deliberate on the findings and [Docket ID USN–2010–0008] System (January 29, 2007; 72 FR 3981). proposed recommendations of the Subcommittee on Improved Concept Privacy Act of 1974; System of CHANGES: Generation Development. The matters to Records * * * * * be discussed include: Navy’s concept AGENCY: Department of the Navy, DoD. CATEGORIES OF RECORDS IN THE SYSTEM: generation and concept development ACTION: Notice to amend a system of Delete entry and replace with ‘‘Full processes and procedures. records. DATES: The meeting will be held on name, Social Security Number (SSN), April 30, 2010, at 10 a.m. and last no SUMMARY: The Department of the Navy enlisted service number, or officer file longer than two hours. proposes to amend a system of records number, personnel service jackets and service records, correspondence and ADDRESSES: The meeting will be held in in its inventory of record systems records concerning classification, the Boardroom, CNA, 4825 Mark Center subject to the Privacy Act of 1974 (5 assignment, distribution, promotion, Drive, Alexandria, VA 22311–1846. U.S.C. 552a), as amended. advancement, performance, recruiting, Some members of the Executive Panel DATES: The changes will be effective on retention, reenlistment, separation, may participate remotely via May 17, 2010 unless comments are training, education, morale, personal teleconference and webinar. received that would result in a contrary determination. affairs, benefits, entitlements, discipline FOR FURTHER INFORMATION CONTACT: Ms. and administration of naval personnel.’’ Bree A. Hartlage, CNO Executive Panel, ADDRESSES: You may submit comments, * * * * * 4825 Mark Center Drive, Alexandria, VA identified by docket number and title, 22311–1846, 703–681–4907. by any of the following methods: • SYSTEM MANAGER(S) AND ADDRESS: SUPPLEMENTARY INFORMATION: Federal Rulemaking Portal: http:// www.regulations.gov. Follow the Delete entry and replace with Individuals or interested groups may ‘‘Commander, Navy Personnel submit written statements for instructions for submitting comments. • Mail: Federal Docket Management Command (PERS–31), 5720 Integrity consideration by the Chief of Naval System Office, 1160 Defense Pentagon, Drive, Millington, TN 38055–3130: Operations Executive Panel at any time Washington, DC 20301–1160. Commanding Officers, Officers in or in response to the agenda of the Instructions: All submissions received Charge, and Heads of Department of the scheduled meeting. All requests or must include the agency name and Navy activities. statements must be submitted to the docket number for this Federal Register Official mailing addresses are Designated Federal Officer at the document. The general policy for published as an appendix to the Navy’s address detailed below at least five days comments and other submissions from compilation of systems of records prior to the meeting to allow adequate members of the public is to make these notices.’’ time for consideration. Requests or submissions available for public statements will not be allowed during NOTIFICATION PROCEDURE: viewing on the Internet at http:// the meeting that is the subject of this Delete entry and replace with www.regulations.gov as they are notice. ‘‘Individuals seeking to determine received without change, including any The Designated Federal Officer will whether this system of records contains personal identifiers or contact review all timely submissions with the information about themselves should information. CNO Executive Panel Chairperson and address written inquiries to: will ensure they are provided to FOR FURTHER INFORMATION CONTACT: Mrs. For permanent records of all active members of the CNO Executive Panel Miriam Brown-Lam (202) 685–6545. duty and reserve members (except before the meeting that is the subject of SUPPLEMENTARY INFORMATION: The Individual Ready Reserve (IRR)), former this notice. Department of the Navy systems of members discharged, deceased, or

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retired since 1995, should be addressed notarized signature as a means of AUTHORITY FOR MAINTENANCE OF THE SYSTEM: to the Commander, Navy Personnel proving the identity of the individual 10 U.S.C. 5013, Secretary of the Navy; Command (PERS–312), 5720 Integrity requesting access to the records. 42 U.S.C. 10606 as implemented by DoD Drive, Millington, TN 38055–3120. Current members, active and reserve, Instruction 1030.1, Victim and Witness Inquiries regarding records of former may visit the Navy Personnel Assistance Procedures; and E.O. 9397 members discharged, deceased, or Command, Records Review Room, Bldg (SSN), as amended. retired before 1995 should be addressed 769, Room 109, Millington, TN 38055– to the Director, National Personnel 3130, for assistance with records located PURPOSE(S): Records Center, Military Personnel in that building; or the individual may To assist officials and employees of Records, 9700 Page Avenue, St. Louis, visit the local activity to which attached the Navy in the management, MO 63132–5100. for access to locally maintained records. supervision and administration of Navy Inquiries regarding field service Proof of identification will consist of personnel (officer and enlisted) and the records of current members should be Military Identification Card for persons operations of related personnel affairs addressed to the Personnel Office or having such cards, or other picture- and functions. Personnel Support Detachment bearing identification.’’ ROUTINE USERS OF RECORDS MAINTAINED IN THE providing administrative support to the * * * * * SYSTEM, INCLUDING CATEGORIES OF USERS AND local activity to which the individual is THE PURPOSES OF SUCH USES: assigned. N01070–3 In addition to those disclosures Official mailing addresses are generally permitted under 5 U.S.C. published as an appendix to the Navy’s SYSTEM NAME: 552a(b) of the Privacy Act of 1974, these compilation of systems of records Navy Military Personnel Records records contained therein may notices. System. The request should contain first, specifically be disclosed outside the SYSTEM LOCATION: middle, and last name and the last four DoD as a routine use pursuant to 5 of the Social Security Number (SSN) Primary locations: Navy Personnel U.S.C. 552a(b)(3) as follows: (and/or enlisted service number/officer Command (PERS–312), 5720 Integrity To officials and employees of the file number), rank/rate, designator, Drive, Millington, TN 38055–3120 for National Research Council in military status, address, and signature of records of all active duty Navy and Cooperative Studies of the National the requester. The system manager may reserve members (including Individual History of Disease, of Prognosis and of require an original signature or a Ready Reserve (IRR)); and for records of Epidemiology. Each study in which the notarized signature as a means of members that were retired, discharged, records of members and former proving the identity of the individual or died while in service since 1995. members of the naval service are used requesting access to the records.’’ Write to the National Personnel Records must be approved by the Chief of Naval Center, Military Personnel Records, Personnel. RECORD ACCESS PROCEDURES: 9700 Page Avenue, St. Louis, MO To officials and employees of the Delete entry and replace with 63132–5100, for records of members Department of Health and Human ‘‘Individuals seeking access to records that were retired, discharged, or died Services, in the performance of their about themselves contained in this while in service prior to 1995. official duties related to eligibility, system of records should address Secondary locations: Personnel notification and assistance in obtaining written inquiries to Commander, Navy Offices and Personnel Support health and medical benefits by members Personnel Command (PERS–312), 5720 Detachments providing administrative and former members of the Navy. Integrity Drive, Millington, TN 38055– support for the local activity where the To the U.S. Citizenship and 3120, for records of all active duty and individual is assigned. Immigration Services for use in alien reserve members (including Individual Official mailing addresses are admission and naturalization inquiries. Ready Reserve (IRR)). published as an appendix to the Navy’s To the Office of Personnel Director, National Personnel Records compilation of systems of records Management for verification of military Center, Military Personnel Records, notices. service for benefits, leave, or reduction- 9700 Page Avenue, St. Louis, MO in-force purposes, and to establish Civil 63132–5100, for records of former CATEGORIES OF INDIVIDUALS COVERED BY THE Service employee tenure and leave members discharged, deceased, or SYSTEM: accrual rate. retired before 1995. All Navy military personnel: Officers, To the Director of Selective Service The Personnel Office or Personnel enlisted, active, inactive, reserve, fleet System in the performance of official Support Detachment providing reserve, retired, midshipmen, officer duties related to registration with the administrative support to the local candidates, and Naval Reserve Officer Selective Service System. activity to which the individual is Training Corps personnel. To the Social Security Administration assigned for field service records of to obtain or verify Social Security current members. CATEGORIES OF RECORDS IN THE SYSTEM: Numbers or to substantiate applicant’s Official mailing addresses are Full name, Social Security Number credit for Social Security compensation. published as an appendix to the Navy’s (SSN), enlisted service number, or To officials and employees of the compilation of systems of records officer file number, personnel service Department of Veterans Affairs in the notices. jackets and service records, performance of their duties relating to The request should contain first, correspondence and records concerning approved research projects, and for middle, and last name and the last four classification, assignment, distribution, processing and adjudicating claims, of the Social Security Number (SSN) promotion, advancement, performance, benefits, and medical care. (and/or enlisted service number/officer recruiting, retention, reenlistment, To officials of the U.S. Coast Guard file number), rank/rate, designator, separation, training, education, morale, (USCG) for the purpose of creating military status, address, and signature of personal affairs, benefits, entitlements, service records for current USCG the requester. The system manager may discipline and administration of naval members that had prior service with the require an original signature or a personnel. Navy.

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To officials and employees of Navy limited to, state and federal licensing Commanding Officers, Officers in Relief and the American Red Cross in authorities and ecclesiastical endorsing Charge, and Heads of Department of the the performance of their duties relating organizations. Navy activities. to the assistance of the members and To governmental entities or private Official mailing addresses are their dependents and relatives, or organizations under government published as an appendix to the Navy’s related to assistance previously contract to perform random analytical compilation of systems of records furnished such individuals, without research into specific aspects of military notices. regard to whether the individual personnel management and assisted or his/her sponsor continues to administrative procedures. NOTIFICATION PROCEDURE: be a member of the Navy. Access will To Federal agencies, their contractors Individuals seeking to determine be limited to those portions of the and grantees, and to private whether this system of records contains member’s record required to effectively organizations, such as the National information about themselves should assist the member. Academy of Sciences, for the purposes address written inquiries to: To duly appointed Family of conducting personnel and/or health- For permanent records of all active Ombudsmen in the performance of their related research in the interest of the duty and reserve members (except duties related to the assistance of the Federal government and the public. Individual Ready Reserve (IRR)), former members and their families. When not considered mandatory, the members discharged, deceased, or To state and local agencies in the names and other identifying data will be retired since 1995, should be addressed performance of their official duties eliminated from records used for such to the Commander, Navy Personnel related to verification of status for research studies. Command (PERS–312), 5720 Integrity determination of eligibility for Veterans The DoD ‘Blanket Routine Uses’ that Drive, Millington, TN 38055–3120. Bonuses and other benefits and appear at the beginning of the Navy’s Inquiries regarding records of former entitlements. compilation of system of record notices members discharged, deceased, or To officials and employees of the also apply to this system. retired before 1995 should be addressed Office of the Sergeant at Arms of the Policies and practices for storing, to the Director, National Personnel United States House of Representatives retrieving, accessing, retaining, and Records Center, Military Personnel in the performance of their official disposing of records in the system: Records, 9700 Page Avenue, St. Louis, duties related to the verification of the MO 63132–5100. active duty naval service of Members of STORAGE: Inquiries regarding field service Congress. Access is limited to those Paper records and electronic storage records of current members should be portions of the Member’s record media. addressed to the Personnel Office or required to verify service time. RETRIEVABILITY: Personnel Support Detachment To provide information and support providing administrative support to the By name, Social Security Number to victims and witnesses in compliance local activity to which the individual is (SSN), enlisted service number or officer with the Victim and Witness Assistance assigned. Program, the Sexual Assault Prevention file number. Official mailing addresses are and Response Program, and the Victims’ SAFEGUARDS: published as an appendix to the Navy’s Rights and Restitution Act of 1990. Computer facilities and terminals are compilation of systems of records Information as to current military located in restricted areas accessible notices. addresses and assignments may be only to authorized persons that are The request should contain first, provided to military banking facilities properly screened, cleared and trained. middle, and last name and the last four who provide banking services overseas Manual records and computer printouts of the Social Security Number (SSN) and who are reimbursed by the are available only to authorized (and/or enlisted service number/officer Government for certain checking and personnel having a need-to-know. file number), rank/rate, designator, loan losses. For personnel separated, military status, address, and signature of discharged or retired from the Armed RETENTION AND DISPOSAL: the requester. The system manager may Forces information as to last known Those documents that are designated require an original signature or a residential or home of record address as temporary in the prescribing notarized signature as a means of may be provided to the military banking regulations remain in the record until proving the identity of the individual facility upon certification by a banking their obsolescence, or the member is requesting access to the records. facility officer that the facility has a separated from the Navy, then are returned or dishonored check negotiated removed and provided to the RECORD ACCESS PROCEDURES: by the individual or the individual has individual. Those documents Individuals seeking access to records defaulted on a loan and that if designated as permanent are submitted about themselves contained in this restitution is not made by the individual to Navy Personnel Command at system of records should address the United States Government will be predetermined times to form a single written inquiries to Commander, Navy liable for the losses the facility may personnel record in the Electronic Personnel Command (PERS–312), 5720 incur. Military Personnel Records System Integrity Drive, Millington, TN 38055– To Federal, state, local, and foreign (EMPRS), and remain in EMPRS 3120, for records of all active duty and (within Status of Forces agreements) law permanently. Permanent records are reserve members (including Individual enforcement agencies or their transferred to the National Archives and Ready Reserve (IRR)). authorized representatives in Records Administration 62 years after Director, National Personnel Records connection with litigation, law the completion of the service member’s Center, Military Personnel Records, enforcement, or other matters under the obligated service. 9700 Page Avenue, St. Louis, MO jurisdiction of such agencies. 63132–5100, for records of former Information relating to professional SYSTEM MANAGER(S) AND ADDRESS: members discharged, deceased, or qualifications of chaplains may be Commander, Navy Personnel retired before 1995. provided to civilian certification boards Command (PERS–31), 5720 Integrity The Personnel Office or Personnel and committees, including, but not Drive, Millington, TN 38055–3130: Support Detachment providing

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administrative support to the local following consultation with the 104–13), the Federal Energy Regulatory activity to which the individual is Committee Management Secretariat, Commission (Commission or FERC) is assigned for field service records of General Services Administration, notice soliciting public comment on the current members. is hereby given that the Environmental proposed information collection Official mailing addresses are Management Site-Specific Advisory described below. published as an appendix to the Navy’s Board will be renewed for a two-year DATES: Comments in consideration of compilation of systems of records period beginning April 11, 2010. the collection of information are due 60 notices. The Board provides the Assistant days after publication of this Notice in The request should contain first, Secretary for Environmental the Federal Register. middle, and last name and the last four Management (EM) with information, ADDRESSES: Comments may be filed of the Social Security Number (SSN) advice, and recommendations either electronically (eFiled) or in paper (and/or enlisted service number/officer concerning issues affecting the EM format, and should refer to Docket No. file number), rank/rate, designator, program at various sites. These site- IC10–80–000. Documents must be military status, address, and signature of specific issues include clean-up prepared in an acceptable filing format the requester. The system manager may standards and environmental and in compliance with Commission require an original signature or a restoration; waste management and submission guidelines at http:// notarized signature as a means of disposition; stabilization and www.ferc.gov/help/submission- proving the identity of the individual disposition of non-stockpile nuclear guide.asp. eFiling instructions are requesting access to the records. materials; excess facilities; future land available at: http://www.ferc.gov/docs- Current members, active and reserve, use and long-term stewardship; risk filing/efiling.asp. First time users must may visit the Navy Personnel assessment and management; and clean- follow eRegister instructions at: http:// Command, Records Review Room, Bldg up science and technology activities. www.ferc.gov/docs-filing/ 769, Room 109, Millington, TN 38055– Additionally, the renewal of the eregistration.asp, to establish a user 3130, for assistance with records located Environmental Management Site- name and password before eFiling. The in that building; or the individual may Specific Advisory Board has been Commission will send an automatic visit the local activity to which attached determined to be essential to conduct acknowledgement to the sender’s e-mail for access to locally maintained records. Department of Energy business and to address upon receipt of eFiled Proof of identification will consist of be in the public interest in connection comments. Commenters making an Military Identification Card for persons with the performance of duties imposed eFiling should not make a paper filing. having such cards, or other picture- on the Department of Energy by law and Commenters that are not able to file bearing identification. agreement. The Board will operate in electronically must send an original and accordance with the provisions of the two (2) paper copies of their comments CONTESTING RECORD PROCEDURES: Federal Advisory Committee Act, and to: Federal Energy Regulatory The Navy’s rules for accessing rules and regulations issued in Commission, Secretary of the records, and for contesting contents and implementation of that Act. Further Commission, 888 First Street, NE., appealing initial agency determinations information regarding this Advisory Washington, DC 20426. are published in Secretary of the Navy Board may be obtained from Ms. Users interested in receiving Instruction 5211.5; 32 CFR part 701; or Catherine Alexander Brennan, automatic notification of activity in this may be obtained from the system Designated Federal Officer, at (202) docket may do so through eSubscription manager. 586–7711. at http://www.ferc.gov/docs-filing/ esubscription.asp. In addition, all RECORD SOURCE CATEGORIES: Issued in Washington, DC, on April 11, 2010. comments and FERC issuances may be Correspondence; educational viewed, printed or downloaded institutions; federal, state, and local Carol A. Matthews, remotely through FERC’s eLibrary at: court documents; civilian and military Committee Management Officer. http://www.ferc.gov/docs-filing/ investigatory reports; general [FR Doc. 2010–8658 Filed 4–14–10; 8:45 am] elibrary.asp, by searching on Docket No. correspondence concerning the BILLING CODE 6450–01–P IC10–80. For user assistance, contact individual; official records of FERC Online Support by e-mail at professional qualifications; Navy Relief [email protected], or by and American Red Cross requests for DEPARTMENT OF ENERGY phone, at: (866) 208–3676 (toll-free), or verification of status. Federal Energy Regulatory (202) 502–8659 for TTY. FOR FURTHER INFORMATION CONTACT EXEMPTIONS CLAIMED FOR THE SYSTEM: Commission : Ellen Brown may be reached by None. [Docket No. IC10–80–000] telephone at (202) 502–8663, by fax at [FR Doc. 2010–8652 Filed 4–14–10; 8:45 am] (202) 273–0873, and by e-mail at BILLING CODE 5001–06–P Commission Information Collection [email protected]. Activities (FERC Form 80); Comment Request; Extension SUPPLEMENTARY INFORMATION: The information collected on the FERC Form DEPARTMENT OF ENERGY April 8, 2010. 80 (also known as ‘‘FERC–80,’’ OMB Environmental Management Site- AGENCY: Federal Energy Regulatory Control No. 1902–0106), ‘‘Licensed Specific Advisory Board Charter Commission. Hydropower Development Recreation Renewal ACTION: Notice of proposed information Report,’’ is used by the Commission to collection and request for comments. implement the statutory provisions of Pursuant to Section 14(a)(2)(A) of the sections 4(a), 10(a), 301(a), 304 and 309 Federal Advisory Committee Act (Pub. SUMMARY: In compliance with the of the Federal Power Act (FPA), 16 L. No. 92–463), and in accordance with requirements of section 3506(c)(2)(A) of U.S.C. sections 797, 803, 825c & 8254. Title 41 of the Code of Federal the Paperwork Reduction Act of 1995, The authority for the Commission to Regulations, section 102–3.65(a), and 44 U.S.C. 3506(c)(2)(A) (2006), (Pub. L. collect this information comes from

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section 10(a) of the FPA which requires identifying recreational facilities at • Stating that paper filings, if any, the Commission to be responsible for hydropower projects. should be submitted to FERC’s Office of ensuring that hydro projects subject to The data required by FERC Form 80 the Secretary 1 (rather than the FERC its jurisdiction are consistent with the are specified by Title 18 of the Code of Regional Office) comprehensive development of the Federal Regulations (CFR) under 18 CFR • Providing the current contact nation’s waterway for recreation and 8.11 and 141.14 (and are discussed at information for both FERC and OMB other beneficial public uses. In the http://www.ferc.gov/docs-filing/ • Indicating the need and timing for interest of fulfilling these objectives, the forms.asp#80). The FERC Form 80 is initial Form No. 80 filings, in Commission expects licensees subject to collected once every six years. The last accordance with 18 CFR 8.11(b). its jurisdiction, to recognize the collection was due on April 1, 2009, for The proposed updates to the general resources that are affected by their data compiled during the calendar year information, instructions, and title of activities and to play a role in protecting ending December 31, 2008. The next Schedule 1 are attached. The remainder such resources. collection of the FERC Form 80 is due of the form, instructions, and glossary FERC Form 80 is a report on the use on April 1, 2015, with subsequent remain unchanged and are not attached. and development of recreational collections due every sixth year, for data facilities at hydropower projects compiled during the previous calendar Action: The Commission is requesting licensed by the Commission. year. a three-year extension of the FERC–80 Applications for amendments to The current OMB clearance expires reporting requirements, with the licenses and/or changes in land rights on 9/30/2010. With the next collection indicated updates and corrections to the frequently involve changes in resources due in 2015, FERC Form 80 will not be general and identifying instructions. available for recreation. Commission collected during the requested These updates do not affect the data staff utilizes FERC Form 80 data when upcoming three-year OMB clearance collected or regulations, which are not analyzing the adequacy of existing cycle. Because the requirements for being revised. public recreational facilities and when Form 80 are contained in the Burden Statement: For the collection processing and reviewing possible Commission’s regulations, FERC plans cycle, which occurs every sixth year, the amendments to help determine the to submit FERC Form 80 to the Office estimated public reporting burden is: (a) impact of such changes. In addition, the of Management and Budget (OMB) for 400 respondents, (b) 1 response/ Commission’s regional office staff uses review, to ensure the OMB clearance respondent, and (c) 3 hours per the FERC Form 80 data when remains continuous and current. response, giving a total of 1,200 burden conducting inspections of licensed Updates and corrections to the hours. The estimated annual burden projects. The Commission’s inspectors instructions include: figures and costs (provided below and to use the data in evaluating compliance • Reflecting the FERC preference for be submitted to OMB) are averaged over with various license conditions and in electronic filing the six-year collection cycle.

Average Number of Average FERC–80 Number of reponses per burden hours Total burden respondents respondent per response hours (1) (2) (3) (1) × (2) × (3)

Annual, estimates—averaged and spread over the 6-year collection cycle ... 400/6 = 66.67 1/6 = 0.167 3/6 = 0.5 1200/6 = 200

The total estimated annual cost and (7) transmitting, or otherwise the proposed collection of information, burden to respondents (spread over the disclosing the information. including the validity of the 6-year collection cycle) is $13,257.11 The estimate of cost for respondents methodology and assumptions used; (3) (200 hours/2080 hours 2 per year, times is based upon salaries for professional ways to enhance the quality, utility and $137,874 3). and clerical support, as well as direct clarity of the information to be collected; and (4) ways to minimize the The reporting burden includes the and indirect overhead costs. Direct costs burden of the collection of information total time, effort, or financial resources include all costs directly attributable to providing this information, such as on those who are to respond, including expended to generate, maintain, retain, the use of appropriate automated, disclose, or provide the information administrative costs and the cost for information technology. Indirect or electronic, mechanical, or other including: (1) Reviewing instructions; technological collection techniques or (2) developing, acquiring, installing, and overhead costs are costs incurred by an organization in support of its mission. other forms of information technology, utilizing technology and systems for the These costs apply to activities which e.g., permitting electronic submission of purposes of collecting, validating, benefit the whole organization rather responses. verifying, processing, maintaining, than any one particular function or Kimberly D. Bose, disclosing and providing information; activity. (3) adjusting the existing ways to Secretary. comply with any previously applicable Comments are invited on: (1) Whether the proposed collection of information FERC Form 80, Licensed Hydropower instructions and requirements; (4) is necessary for the proper performance Development Recreation Report training personnel to respond to a of the functions of the Commission, General Information collection of information; (5) searching including whether the information will data sources; (6) completing and have practical utility; (2) the accuracy of This form collects data on recreational reviewing the collection of information; the agency’s estimate of the burden of resources at projects licensed by the

1 Filings submitted to the FERC’s Office of the more quickly to both the public and staff, and the 2 Number of hours an employee works each year. Secretary (similar to other forms) will be available processing costs will be reduced. 3 Estimated average annual cost per employee.

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Federal Energy Regulatory Commission services located within the 247,000 acre-feet with a normal (Commission) under the Federal Power development/project boundary. maximum water surface elevation of 767 Act (16 U.S.C. 791a–825r). This form b. To ensure a common understanding feet above mean sea level (msl). must be submitted by licensees of all of terms, please refer to the Glossary. The three alternatives for the upper projects except those specifically c. Report actual data for each item. If reservoir are described below. actual data are unavailable, then please exempted under 18 CFR 8.11 (c). Iron Mountain Alternative For regular, periodic filings, submit estimate. (1) A proposed 235-foot-high, 1,250- this form on or before April 1, 2015. Schedule 1. General Data Submit subsequent filings of this form foot-long upper dam located 3 miles on or before April 1, every 6th year Note: The remainder of the FERC Form 80 north of San Vicente reservoir; (2) a thereafter (for example, 2021, 2027, (form, instructions, and glossary) are proposed reservoir with a surface area of etc.). unchanged and are not included here.] 93 acres having a storage capacity of For initial Form No. 80 filings (18 [FR Doc. 2010–8584 Filed 4–14–10; 8:45 am] 8,070 acre-feet and a normal maximum CFR 8.11(b)), each licensee of an BILLING CODE 6717–01–P water surface elevation of 2,110 feet unconstructed project shall file an above msl; (3) a proposed 12,300-foot- initial Form No. 80 after such project long, 20-foot-diameter concrete power has been in operation for a full calendar DEPARTMENT OF ENERGY tunnel; (4) two proposed 500-foot-long, year prior to the filing deadline. Each steel-lined penstocks; (5) a proposed licensee of an existing (constructed) Federal Energy Regulatory powerhouse containing two generating project shall file an initial Form No. 80 Commission units having a total installed capacity of after such project has been licensed for [Project No. 12747–001] 500 megawatts; (6) a proposed 3,300- a full calendar year prior to the filing foot-long, 24-foot-diameter concrete deadline. San Diego County Water Authority; tailrace; (7) a proposed 14,000-foot-long, Filing electronically is the preferred Notice of Preliminary Permit 230-kilovolt transmission line; and (8) manner of filing. (See http:// Application Accepted for Filing and appurtenant facilities. www.ferc.gov for more information.) If Soliciting Comments, Motions To Foster Canyon Alternative you cannot file electronically, submit an Intervene, and Competing Applications original and two copies of the form to (1) A proposed upper dam the: Federal Energy Regulatory April 7, 2010. approximately one half mile north of Commission, Office of the Secretary, On March 1, 2010, San Diego County San Vicente reservoir; (2) a proposed 888 First St., NE., Washington, DC Water Authority filed an application for upper reservoir with a surface area of 20426. a preliminary permit, pursuant to 100 acres normal maximum water The public burden estimated for this section 4(f) of the Federal Power Act, surface elevation of 1,490 feet above form is three hours per response, proposing to study the feasibility of the msl; (3) a proposed 3,000-foot-long, 20- including the time for reviewing San Vicente Pumped Storage Water foot-long, concrete power tunnel; (4) instructions, searching existing data Power Project No. 13747. The proposed two proposed 300-foot-long, steel-lined sources, gathering and maintaining the project would be located at the existing penstocks; (5) a proposed powerhouse data needed, and completing the San Vicente dam and reservoir on San containing two generating units having collection of information. Send Vicente Creek in San Diego County, a total installed capacity of 480 comments regarding the burden California. The project would consist of megawatts; (6) a proposed 2,700-foot- estimate or any aspect of this collection the existing San Vicente reservoir long, 24-foot-diameter concrete tailrace; of information, including suggestions functioning as the lower reservoir of the (7) a proposed 9,000-foot-long, 230- for reducing burden, to the: project and one of three alternatives as kilovolt transmission line; and (8) • Federal Energy Regulatory an upper reservoir: the Iron Mountain appurtenant facilities. Commission (FERC), e-mail to Alternative, the Foster Canyon The East Reservoir Alternative [email protected]; or mail to Alternative, and the East Reservoir FERC, 888 First Street NE., Washington, Alternative. Specific details about each (1) A proposed upper dam DC 20426 (Attention: Information of these alternatives are described approximately 0.8 miles east of San Clearance Officer), and below. The sole purpose of a Vicente Reservoir; (2) a proposed upper • Office of Management and Budget preliminary permit, if issued, is to grant reservoir with a surface area of 60 acres (OMB), e-mail to the permit holder priority to file a and a normal maximum water surface [email protected]; or mail license application during the permit elevation of 1,600 feet above msl; (3) a to OMB, Office of Information and term. A preliminary permit does not proposed 6,000-foot-long, 20-foot-long Regulatory Affairs, Attention: Desk authorize the permit holder to perform concrete power tunnel; (4) two proposed Officer for the Federal Energy any land-disturbing activities or 300-foot-long, steel-lined penstocks; (5) Regulatory Commission, Washington, otherwise enter upon lands or waters a proposed powerhouse containing two DC 20503. Include OMB Control owned by others without the owners’ generating units having a total installed Number 1902–0106 as a point of express permission. capacity of 570 megawatts; (6) a reference. All three of the alternatives would use proposed 2,600-foot-long, 24-foot- No person shall be subject to any the San Vicente reservoir as the lower diameter concrete tailrace; (7) a penalty for failing to comply with a reservoir of the pumped storage project. proposed 15,000-foot-long, 230-kilovolt collection of information if the The San Vicente reservoir portion of the transmission line; and (8) appurtenant collection of information does not project would consist of: facilities. display a valid control number (44 (1) an existing dam, currently being The proposed project would have a U.S.C. 3512 (a)). raised to a dam height of 337 feet, and maximum estimated annual generation a length of 1,442 feet; and (2) an existing of up to 1,000 gigawatt-hours, which Instructions impoundment, that upon completion of would be sold to a local utility. a. All data reported on this form must the dam raise will have a surface area Applicant Contact: Frank Belock, represent recreational facilities and of 1,600 acres, and storage capacity of Deputy General Manager, San Diego

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County Water Authority, 4677 Overland Comment Date: 5 p.m. Eastern Time Docket Numbers: ER10–1021–000. Avenue, San Diego, CA 92123; phone: on Wednesday, April 28, 2010. Applicants: Connecticut Yankee (858) 522–67881. Docket Numbers: EG10–30–000. Atomic Power Company. FERC Contact: Joseph P. Hassell, 202– Applicants: Juniper Canyon Wind Description: Connecticut Yankee 502–8079 Power LLC. Atomic Power Co submits petition for Deadline for filing comments, motions Description: Notice of Self- waiver of tariff provision. to intervene, competing applications Certification of Exempt Wholesale Filed Date: 04/06/2010. (without notices of intent), or notices of Generator Status of Juniper Canyon Accession Number: 20100407–0213. intent to file competing applications: 60 Wind Power LLC. Comment Date: 5 p.m. Eastern Time days from the issuance of this notice. Filed Date: 04/07/2010. on Tuesday, April 27, 2010. Competing applications and notices of Accession Number: 20100407–5040. Docket Numbers: ER10–1022–000. intent must meet the requirements of 18 Comment Date: 5 p.m. Eastern Time Applicants: Just Energy Texas LP. CFR 4.36. Comments, motions to on Wednesday, April 28, 2010. Description: Just Energy Texas LP intervene, notices of intent, and Take notice that the Commission submits notice of cancellation of its competing applications may be filed received the following electric rate market-based rate tariff designated as electronically via the Internet. See 18 filings: First Revised Rate Schedule FERC No 1, CFR 385.2001(a)(1)(iii) and the Docket Numbers: ER99–1435–022; Original Volume No 1. instructions on the Commission’s Web ER10–390–001; ER00–1814–010. Filed Date: 04/06/2010. site (http://www.ferc.gov/docs-filing/ Applicants: Avista Corporation; Accession Number: 20100407–0211. ferconline.asp) under the ‘‘eFiling’’ link. Avista Turbine Power, Inc.; Avista Comment Date: 5 p.m. Eastern Time For a simpler method of submitting text Turbine Power, Inc. on Tuesday, April 27, 2010. ‘‘ only comments, click on Quick Description: Request for Waiver of Docket Numbers: ER10–1023–000. ’’ Comment. For assistance, please Avista Corporation. Applicants: Just Energy, LLC. contact FERC Online Support at Filed Date: 04/02/2010. Description: Just Energy, LLC submits [email protected]; call toll- Accession Number: 20100402–5073. Notice of Cancellation of its market- free at (866) 208–3676; or, for TTY, Comment Date: 5 p.m. Eastern Time based rate tariff designated as Second contact (202) 502–8659. Although the on Friday, April 23, 2010. Revised Rate Schedule FERC 1, Original Commission strongly encourages Docket Numbers: ER10–822–001. Volume 1. electronic filing, documents may also be Applicants: Southwest Power Pool, Filed Date: 04/06/2010. paper-filed. To paper-file, mail an Inc. Accession Number: 20100407–0210. original and eight copies to: Kimberly D. Description: Southwest Power Pool, Comment Date: 5 p.m. Eastern Time Bose, Secretary, Federal Energy Inc submits an errata to their Meter on Tuesday, April 27, 2010. Regulatory Commission, 888 First Agent Service Agreement filed on Docket Numbers: ER10–1024–000. Street, NE., Washington, DC 20426. March 2, 2010. Applicants: Midwest Independent More information about this project, Filed Date: 04/06/2010. Transmission System Operator, Inc. including a copy of the application, can Accession Number: 20100407–0208. Description: Midwest Independent be viewed or printed on the ‘‘eLibrary’’ Comment Date: 5 p.m. Eastern Time Transmission System Operator, Inc link of Commission’s Web site at on Tuesday, April 27, 2010. submits Commission acceptance and http://www.ferc.gov/docs-filing/ Docket Numbers: ER10–1016–000. approval of the proposed classification elibrary.asp. Enter the docket number for certain Grandfathered Agreement of (P–12747) in the docket number field to Applicants: Duke Energy Indiana, Inc. Description: Duke Energy Indiana, Inc Big Rivers Electric Corp. etc. access the document. For assistance, Filed Date: 04/06/2010. contact FERC Online Support. submits updated summary schedules for the Transmission and Local Facilities Accession Number: 20100407–0209. Kimberly D. Bose, Agreement for the Calendar Year 2008 Comment Date: 5 p.m. Eastern Time Secretary. with Wabash Valley Power Association, on Tuesday, April 27, 2010. [FR Doc. 2010–8590 Filed 4–14–10; 8:45 am] Inc. Docket Numbers: ER10–1025–000. BILLING CODE 6717–01–P Filed Date: 04/06/2010. Applicants: Just Energy Ohio, LLC. Accession Number: 20100406–0207. Description: Just Energy Ohio, LLC Comment Date: 5 p.m. Eastern Time submits Notice of Cancellation of its DEPARTMENT OF ENERGY on Tuesday, April 27, 2010. market-based rate tariff designated as Docket Numbers: ER10–1018–000. First Revised Rate Schedule FERC 1, Federal Energy Regulatory Applicants: PacifiCorp. Original Volume 1. Commission Description: PacifiCorp submits First Filed Date: 04/06/2010. Revised Sheet 9 et al. to First Revised Accession Number: 20100407–0207. Combined Notice of Filings No. 1 Rate Schedule FERC 239. Comment Date: 5 p.m. Eastern Time April 07, 2010. Filed Date: 04/06/2010. on Tuesday, April 27, 2010. Take notice that the Commission Accession Number: 20100406–0211. Docket Numbers: ER10–1026–000. received the following exempt Comment Date: 5 p.m. Eastern Time Applicants: Just Energy New York, wholesale generator filings: on Tuesday, April 27, 2010. LLC. Docket Numbers: EG10–29–000. Docket Numbers: ER10–1019–000. Description: Just Energy New York, Applicants: Big Horn Wind Project Applicants: PacifiCorp. LLC submits Notice of Cancellation of LLC. Description: PacifiCorp submits their market-based rate tariff, designated Description: Notice of Self- Revision 8 to Appendix A of First as First Revised Rate Schedule FERC No Certification of Exempt Wholesale Revised Schedule FERC 297. 1, Original Volume No 1. Generator Status of Big Horn II Wind Filed Date: 04/06/2010. Filed Date: 04/06/2010. Project LLC. Accession Number: 20100406–0212. Accession Number: 20100407–0206. Filed Date: 04/07/2010. Comment Date: 5 p.m. Eastern Time Comment Date: 5 p.m. Eastern Time Accession Number: 20100407–5039. on Tuesday, April 27, 2010. on Tuesday, April 27, 2010.

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Docket Numbers: ER10–1027–000. eRegistration account using the Applicants: Kern River Gas Applicants: Southern California eRegistration link. Select the eFiling Transmission Company. Edison Company. link to log on and submit the Description: Kern River Gas Description: Southern California intervention or protests. Transmission Company submits a report Edison Company submits a Small Persons unable to file electronically supporting its gas compressor fuel Generator Interconnection Agreement should submit an original and 14 copies factors and los and unaccounted-for gas and a Service Agreement for Wholesale of the intervention or protest to the factors for calendar year 2009. Distribution Service between the Federal Energy Regulatory Commission, Filed Date: 03/31/2010. Transmission Distribution Business 888 First St., NE., Washington, DC Accession Number: 20100331–0224. Unit of SCE. 20426. Comment Date: 5 p.m. Eastern Time Filed Date: 04/06/2010. The filings in the above proceedings on Monday, April 12, 2010. Accession Number: 20100407–0205. are accessible in the Commission’s Docket Numbers: RP10–527–000. Comment Date: 5 p.m. Eastern Time eLibrary system by clicking on the Applicants: Natural Gas Pipeline on Tuesday, April 27, 2010. appropriate link in the above list. They Company of America. Docket Numbers: ER10–1028–000. are also available for review in the Description: Natural Gas Pipeline Applicants: Madison Paper Industries. Commission’s Public Reference Room in Company of America, LLC submits First Description: Madison Paper Industries Washington, DC. There is an Revised Sheet 34L et al. to its FERC Gas submits tariff filing per 35.12: Baseline eSubscription link on the Web site that Tariff, Seventh Revised Volume 1 to be Filing to be effective 3/1/2009. enables subscribers to receive e-mail effective 4/1/10. Filed Date: 04/07/2010. notification when a document is added Filed Date: 03/31/2010. Accession Number: 20100407–5029. to a subscribed dockets(s). For Accession Number: 20100331–0255. Comment Date: 5 p.m. Eastern Time assistance with any FERC Online Comment Date: 5 p.m. Eastern Time on Wednesday, April 28, 2010. service, please e-mail on Monday, April 12, 2010. Take notice that the Commission [email protected]. or call Docket Numbers: RP10–528–000. received the following open access (866) 208–3676 (toll free). For TTY, call Applicants: Natural Gas Pipeline transmission tariff filings: (202) 502–8659. Company of America. Description: Natural Gas Pipeline Docket Numbers: OA10–3–000. Nathaniel J. Davis, Sr., Company of America, LLC submits Applicants: Crystal Lake Wind II, Deputy Secretary. LLC. Original Sheet 35C.13 et al. to its FERC [FR Doc. 2010–8612 Filed 4–14–10; 8:45 am] Description: Crystal Lake Wind, LLC Gas Tariff, Seventh Revised Volume 1 to Amendment to Petition for Waiver of BILLING CODE 6717–01–P be effective 4/1/10. Commission Rules. Filed Date: 03/31/2010. Accession Number: 20100331–0256. Filed Date: 04/05/2010. DEPARTMENT OF ENERGY Accession Number: 20100405–5109. Comment Date: 5 p.m. Eastern Time Comment Date: 5 p.m. Eastern Time Federal Energy Regulatory on Monday, April 12, 2010. on Thursday, April 15, 2010. Commission Docket Numbers: RP10–529–000. Any person desiring to intervene or to Applicants: Natural Gas Pipeline protest in any of the above proceedings Combined Notice of Filings Company of America. must file in accordance with Rules 211 Description: Natural Gas Pipeline and 214 of the Commission’s Rules of April 01, 2010. Company of America, LLC submits Practice and Procedure (18 CFR 385.211 Take notice that the Commission has Third Revised Sheet 33D.01 et al. to its and 385.214) on or before 5 p.m. Eastern received the following Natural Gas FERC Gas Tariff, Seventh Revised time on the specified comment date. It Pipeline Rate and Refund Report filings: Volume 1 to be effective 4/1/10. is not necessary to separately intervene Docket Numbers: RP10–524–000. Filed Date: 03/31/2010. again in a subdocket related to a Applicants: Trunkline Gas Company, Accession Number: 20100331–0257. compliance filing if you have previously LLC. Comment Date: 5 p.m. Eastern Time intervened in the same docket. Protests Description: Trunkline Gas Company, on Monday, April 12, 2010. will be considered by the Commission LLC submits Fourth Revised Sheet No. Docket Numbers: RP10–530–000. in determining the appropriate action to 28 et al. to FERC Gas Tariff, Third Applicants: Natural Gas Pipeline be taken, but will not serve to make Revised Volume No.1, to be effective Company of America. protestants parties to the proceeding. 4/1/10.c Description: Natural Gas Pipeline Anyone filing a motion to intervene or Filed Date: 03/31/2010. Company of America, LLC submits an protest must serve a copy of that Accession Number: 20100331–0218. amendment with a negotiated rate document on the Applicant. In reference Comment Date: 5 p.m. Eastern Time exhibit to an existing maximum to filings initiating a new proceeding, on Monday, April 12, 2010. recourse rate Storage Rate Schedule interventions or protests submitted on Docket Numbers: RP10–525–000. NNS agreement. or before the comment deadline need Applicants: National Fuel Gas Supply Filed Date: 03/31/2010. not be served on persons other than the Corporation. Accession Number: 20100331–0258. Applicant. Description: National Fuel Gas Supply Comment Date: 5 p.m. Eastern Time The Commission encourages Corporation submits the 134th Revised on Monday, April 12, 2010. electronic submission of protests and Sheet 9 to FERC Gas tariff, Fourth Docket Numbers: RP10–531–000. interventions in lieu of paper, using the Revised Volume 1, to become effective Applicants: Natural Gas Pipeline FERC Online links at http:// 4/1/10. Company of America. www.ferc.gov. To facilitate electronic Filed Date: 03/31/2010. Description: Natural Gas Pipeline service, persons with Internet access Accession Number: 20100331–0225. Company of America, LLC submits a who will eFile a document and/or be Comment Date: 5 p.m. Eastern Time new negotiated rate storage Rate listed as a contact for an intervenor on Monday, April 12, 2010. Schedule NNS agreement with must create and validate an Docket Numbers: RP10–526–000. Anadarko Energy Service Company.

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Filed Date: 03/31/2010. Description: Natural Gas Pipeline Docket Numbers: RP10–543–000. Accession Number: 20100331–0259. Company of America, LLC submits Applicants: Transwestern Pipeline Comment Date: 5 p.m. Eastern Time Third Revised Sheet 35C et al. to its Company, LLC. on Monday, April 12, 2010. FERC Gas Tariff, Seventh Revised Description: Transwestern Pipeline Docket Numbers: RP10–532–000. Volume 1 to be effective 4/1/10. Company LLC submits Seventh Revised Applicants: Natural Gas Pipeline Filed Date: 03/31/2010. Sheet No. 6 to FERC Gas Tariff, Third Company of America. Accession Number: 20100331–0265. Revised Volume No. 1, to be effective Description: Natural Gas Pipeline Comment Date: 5 p.m. Eastern Time 4/1/10. Company of America, LLC submits an on Monday, April 12, 2010. Filed Date: 03/31/2010. amendment with a negotiated rate Docket Numbers: RP10–538–000. Accession Number: 20100331–0238. exhibit to an existing maximum Applicants: Natural Gas Pipeline Comment Date: 5 p.m. Eastern Time recourse rate Storage Rate Schedule Company of America. on Monday, April 12, 2010. NNS agreement. Description: Natural Gas Pipeline Docket Numbers: RP10–544–000. Filed Date: 03/31/2010. Company of America, LLC submits Applicants: Northern Natural Gas Accession Number: 20100331–0260. report of the refunds of penalty Company. Comment Date: 5 p.m. Eastern Time revenues to its FERC Gas Tariff, Seventh Description: Northern Natural Gas on Monday, April 12, 2010. Revised Volume 1. Company submits Fifth Revised Sheet Docket Numbers: RP10–533–000. Filed Date: 03/31/2010. No. 66B.01b et al. to FERC Gas Tariff, Applicants: Natural Gas Pipeline Accession Number: 20100331–0266. Fifth Revised Volume No. 1, to effective Company of America. Comment Date: 5 p.m. Eastern Time 4/1/10. Description: Natural Gas Pipeline on Monday, April 12, 2010. Filed Date: 03/31/2010. Company of America, LLC submits First Docket Numbers: RP10–539–000. Accession Number: 20100331–0233. Revised Sheet 33I to its FERC Gas Tariff, Applicants: Discovery Gas Comment Date: 5 p.m. Eastern Time Seventh Revised Volume 1 to be Transmission LLC. on Monday, April 12, 2010. effective 4/1/10. Description: Discovery Gas Docket Numbers: RP10–545–000. Filed Date: 03/31/2010. Transmission LLC submits First Revised Applicants: Quest Pipelines (KPC). Accession Number: 20100331–0261. Sheet No. 1 et al. to FERC Gas Tariff, Description: Quest Pipelines (KPC) Comment Date: 5 p.m. Eastern Time Original Volume No. 1, to be effective 5/ submits First Revised Sheet No. 112 to on Monday, April 12, 2010. 1/10. FERC Gas Tariff, Second Revised Filed Date: 03/31/2010. Docket Numbers: RP10–534–000. Volume No. 1, to be effective 5/1/10. Accession Number: 20100331–0241. Filed Date: 03/31/2010. Applicants: Natural Gas Pipeline Comment Date: 5 p.m. Eastern Time Accession Number: 20100331–0239. Company of America. on Monday, April 12, 2010. Description: Natural Gas Pipeline Comment Date: 5 p.m. Eastern Time Company of America, LLC submits Docket Numbers: RP10–540–000. on Monday, April 12, 2010. Applicants: Natural Gas Pipeline Original Sheet 35C.14 to its FERC Gas Docket Numbers: RP10–546–000. Company of America. Tariff, Seventh Revised Volume 1 to be Description: Natural Gas Pipeline Applicants: Northern Natural Gas effective 4/1/10. Company of America LLC submits First Company. Filed Date: 03/31/2010. Revised Sheet No. 35C.08 to FERC Gas Description: Northern Natural Gas Accession Number: 20100331–0262. Tariff, Seventh Revised Volume No. 1, Company submits Fourteenth Revised Comment Date: 5 p.m. Eastern Time to be effective 4/1/10. Sheet No. 66B.01a et al. to FERC Gas on Monday, April 12, 2010. Filed Date: 03/31/2010. Tariff, Fifth Revised Volume No. 1, to be Docket Numbers: RP10–535–000. Accession Number: 20100331–0235. effective 5/1/10. Applicants: Natural Gas Pipeline Comment Date: 5 p.m. Eastern Time Filed Date: 03/31/2010. Company of America. on Monday, April 12, 2010. Accession Number: 20100331–0234. Comment Date: 5 p.m. Eastern Time Description: Natural Gas Pipeline Docket Numbers: RP10–541–000. on Monday, April 12, 2010. Company of America LLS submits First Applicants: Natural Gas Pipeline Revised Sheet 33J et al. to FERC Gas Company of America. Docket Numbers: RP10–547–000. Tariff, Seventh revised Volume 1, to Description: Natural Gas Pipeline Applicants: Rockies Express Pipeline become effective 4/1/10. Company of America LLC submits LLC. Filed Date: 03/31/2010. Original Sheet No. 35C.10 to FERC Gas Description: Rockies Express Pipeline Accession Number: 20100331–0263. Tariff, Seventh Revised Volume No. 1, LLC submits Eighteenth Revised Sheet Comment Date: 5 p.m. Eastern Time to be effective 4/1/10. No. 10 to FERC Gas Tariff, Second on Monday, April 12, 2010. Filed Date: 03/31/2010. Revised Volume No. 1, to be effective Docket Numbers: RP10–536–000. Accession Number: 20100331–0236. 4/1/10. Applicants: Natural Gas Pipeline Comment Date: 5 p.m. Eastern Time Filed Date: 03/31/2010. Company of America. on Monday, April 12, 2010. Accession Number: 20100331–0240. Description: Natural Gas Pipeline Docket Numbers: RP10–542–000. Comment Date: 5 p.m. Eastern Time Company of America, LLC submits Applicants: Trailblazer Pipeline on Monday, April 12, 2010. Original Sheet 34C.06 et al. to its FERC Company LLC. Docket Numbers: RP10–548–000. Gas Tariff, Seventh Revised Volume 1 to Description: Trailblazer Pipeline Applicants: East Tennessee Natural be effective 4/1/10. Company LLC submits Third Revised Gas, LLC. Filed Date: 03/31/2010. Sheet No. 11 to FERC Gas Tariff, Fourth Description: East Tennessee Natural Accession Number: 20100331–0264. Revised Volume No. 1, to be effective 5/ Gas, LLC submits its cashout report for Comment Date: 5 p.m. Eastern Time 1/10. November 2008 through October 2009. on Monday, April 12, 2010. Filed Date: 03/31/2010. Filed Date: 03/31/2010. Docket Numbers: RP10–537–000. Accession Number: 20100331–0237. Accession Number: 20100401–0223. Applicants: Natural Gas Pipeline Comment Date: 5 p.m. Eastern Time Comment Date: 5 p.m. Eastern Time Company of America. on Monday, April 12, 2010. on Monday, April 12, 2010.

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Docket Numbers: RP10–549–000. Accession Number: 20100401–0219. Accession Number: 20100401–0229. Applicants: Equitrans, LP. Comment Date: 5 p.m. Eastern Time Comment Date: 5 p.m. Eastern Time Description: Equitrans, LP submits on Monday, April 12, 2010. on Monday, April 12, 2010. First Revised Sheet 319 et al. to its FERC Docket Numbers: RP10–555–000. Docket Numbers: RP10–561–000. Gas Tariff, Original Volume 1, to be Applicants: ANR Pipeline Company. Applicants: Dominion Transmission, effective 4/1/10. Description: ANR Pipeline Company Inc. Filed Date: 03/31/2010. submits amendments to the negotiated Description: Dominion Transmission, Accession Number: 20100401–0224. rate agreements, Rate Schedule ETS, LLC submits Eighteenth Revised Sheet Comment Date: 5 p.m. Eastern Time Rate Schedule NNS et al., to be effective 1300 et al. to FERC Gas Tariff, Third on Monday, April 12, 2010. 4/1/10. Revised Volume 1, to be effective 4/30/ Docket Numbers: RP10–550–000. Filed Date: 03/31/2010. 10. Applicants: Gas Transmission Accession Number: 20100401–0220. Filed Date: 03/31/2010. Northwest Corporation. Comment Date: 5 p.m. Eastern Time Accession Number: 20100401–0230. Description: Gas Transmission on Monday, April 12, 2010. Comment Date: 5 p.m. Eastern Time Northwest Corporation submits First Docket Numbers: RP10–556–000. on Monday, April 12, 2010. Revised Sheet 0 et al. to its FERC Gas Applicants: ANR Pipeline Company. Any person desiring to intervene or to Tariff, Original Volume 1, to be effective Description: ANR Pipeline Company protest in any of the above proceedings 4/30/10. submits Rate Schedule FSS, Rate must file in accordance with Rules 211 Filed Date: 03/31/2010. Schedule ETS, and Rate Schedule FTS– and 214 of the Commission’s Rules of Accession Number: 20100401–0215. 1 negotiated rate service agreements, to Practice and Procedure (18 CFR 385.211 Comment Date: 5 p.m. Eastern Time be effective 4/1/10. and 385.214) on or before 5 p.m. Eastern on Monday, April 12, 2010. Filed Date: 03/31/2010. time on the specified comment date. It Docket Numbers: RP10–551–000. Accession Number: 20100401–0221. is not necessary to separately intervene Applicants: Northern Border Pipeline Comment Date: 5 p.m. Eastern Time again in a subdocket related to a Company. on Monday, April 12, 2010. compliance filing if you have previously Description: Northern Border Pipeline Docket Numbers: RP10–557–000. intervened in the same docket. Protests Company submits Fifteenth Revised will be considered by the Commission Sheet 99 et al. to its FERC Gas Tariff, Applicants: ANR Pipeline Company. Description: ANR Pipeline Company in determining the appropriate action to First Revised Volume 1, to be effective be taken, but will not serve to make 5/1/10. submits Seventeenth Revised Sheet 17A et al. to its FERC Gas Tariff, Second protestants parties to the proceeding. Filed Date: 03/31/2010. Anyone filing a motion to intervene or Accession Number: 20100401–0216. Revised Volume 1, to be effective 5/1/ 10. protest must serve a copy of that Comment Date: 5 p.m. Eastern Time document on the Applicant. In reference on Monday, April 12, 2010. Filed Date: 03/31/2010. Accession Number: 20100401–0222. to filings initiating a new proceeding, Docket Numbers: RP10–552–000. Comment Date: 5 p.m. Eastern Time interventions or protests submitted on Applicants: Tuscarora Gas on Monday, April 12, 2010. or before the comment deadline need Transmission Company. not be served on persons other than the Description: Tuscarora Gas Docket Numbers: RP10–558–000. Applicant. Transmission Company submits First Applicants: Kinder Morgan Interstate The Commission encourages Revised Sheet No. 0, 66, 120, 204, 213, Gas Transmission. electronic submission of protests and 222, and 229 to FERC Gas Tariff, First Description: Kinder Morgan Interstate interventions in lieu of paper, using the Revised Volume No. 1, to be effective 4/ Gas Transmission LLC submits Sixth FERC Online links at http:// 30/10. Revised Sheet 4O to FERC Gas Tariff, www.ferc.gov. To facilitate electronic Filed Date: 03/31/2010. Fourth Revised Volume 1A, to be service, persons with Internet access Accession Number: 20100401–0217. effective 4/1/10. who will eFile a document and/or be Comment Date: 5 p.m. Eastern Time Filed Date: 03/31/2010. listed as a contact for an intervenor on Monday, April 12, 2010. Accession Number: 20100401–0228. must create and validate an Docket Numbers: RP10–553–000. Comment Date: 5 p.m. Eastern Time eRegistration account using the Applicants: Midcontinent Express on Monday, April 12, 2010. eRegistration link. Select the eFiling Pipeline LLC. Docket Numbers: RP10–559–000. link to log on and submit the Description: Midcontinent Express Applicants: Tuscarora Gas intervention or protests. Pipeline, LLC submits Second Revised Transmission Company. Persons unable to file electronically Sheet 7 et al. to its FERC Gas Tariff, Description: Tuscarora Gas should submit an original and 14 copies Original Volume 1, to be effective 5/1/ Transmission Company submits of the intervention or protest to the 10. Original Sheet 7 et al. to FERC Gas Federal Energy Regulatory Commission, Filed Date: 03/31/2010. Tariff, First Revised Volume 1, to be 888 First St., NE., Washington, DC Accession Number: 20100401–0218. effective 4/30/10. 20426. Comment Date: 5 p.m. Eastern Time Filed Date: 03/31/2010. The filings in the above proceedings on Monday, April 12, 2010. Accession Number: 20100401–0227. are accessible in the Commission’s Docket Numbers: RP10–554–000. Comment Date: 5 p.m. Eastern Time eLibrary system by clicking on the Applicants: Transcontinental Gas on Monday, April 12, 2010. appropriate link in the above list. They Pipe Line Company. Docket Numbers: RP10–560–000. are also available for review in the Description: Transcontinental Gas Applicants: North Baja Pipeline, LLC. Commission’s Public Reference Room in Pipe Line Company, LLC submits Fifth Description: North Baja Pipeline, LLC Washington, DC. There is an Revised Sheet 81 et al. to its FERC Gas submits Second Revised Sheet 9A to eSubscription link on the Web site that Tariff, Fourth Revised Volume 1, to be FERC Gas Tariff, Original Volume 1, to enables subscribers to receive e-mail effective 5/1/10. be effective 4/30/10. notification when a document is added Filed Date: 03/31/2010. Filed Date: 03/31/2010. to a subscribed dockets(s). For

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assistance with any FERC Online Applicants: Elba Express Company, DEPARTMENT OF ENERGY service, please e-mail LLC. Federal Energy Regulatory [email protected]. or call Description: Elba Express Company, Commission (866) 208–3676 (toll free). For TTY, call LLC submits Substitute Original Sheet (202) 502–8659. 143 et al. to FERC Gas Tariff, Original Combined Notice of Filings No. 1 Nathaniel J. Davis, Sr., Volume 1, to be effective 3/1/10. Deputy Secretary. Filed Date: 03/29/2010. March 31, 2010. [FR Doc. 2010–8611 Filed 4–14–10; 8:45 am] Take notice that the Commission has Accession Number: 20100330–0203. received the following Natural Gas BILLING CODE 6717–01–P Comment Date: 5 p.m. Eastern Time Pipeline Rate and Refund Report filings: on Monday, April 12, 2010. Docket Numbers: RP10–520–000. DEPARTMENT OF ENERGY Docket Numbers: RP10–386–001. Applicants: Vector Pipeline, L.P. Description: Vector Pipeline L.P. Federal Energy Regulatory Applicants: Elba Express Company, submits the annual fuel use report. Commission LLC. Filed Date: 03/30/2010. Description: Elba Express Company, Accession Number: 20100330–0241. Combined Notice of Filings No. 2 LLC submits EEC Service Agreement No Comment Date: 5 p.m. Eastern Time March 31, 2010. EEC–1 dated 10/5/07 with Shell NA on Monday, April 12, 2010. Take notice that the Commission has LNG LLC, to be effective 3/1/2010. Docket Numbers: RP10–521–000. received the following Natural Gas Filed Date: 03/29/2010. Applicants: Saltville Gas Storage Company LLC. Pipeline Rate and Refund Report filings: Accession Number: 20100330–0202. Docket Numbers: RP08–426–013. Description: Saltville Gas Storage Comment Date: 5 p.m. Eastern Time Applicants: El Paso Natural Gas Company LLC submits First Revised Company. on Monday, April 12, 2010. Sheet 22D to FERC Gas Tariff, Original Description: El Paso Natural Gas Any person desiring to protest this Volume 1, reflecting an effective date of Company submits Thirty-Second filing must file in accordance with Rule 4/1/10. Filed Date: 03/30/2010. Revised Sheet 28 et al. to its FERC Gas 211 of the Commission’s Rules of Accession Number: 20100330–0243. Tariff, Second Revised Volume 1A, to be Practice and Procedure (18 CFR Comment Date: 5 p.m. Eastern Time effective 5/1/10. 385.211). Protests to this filing will be on Monday, April 12, 2010. Filed Date: 03/25/2010. considered by the Commission in Accession Number: 20100329–0209. determining the appropriate action to be Docket Numbers: RP10–522–000. Comment Date: 5 p.m. Eastern Time taken, but will not serve to make Applicants: Columbia Gas on Tuesday, April 06, 2010. protestants parties to the proceeding. Transmission, LLC. Docket Numbers: RP10–481–001. Such protests must be filed on or before Description: Columbia Gas Applicants: Eastern Shore Natural Gas 5 p.m. Eastern Time on the specified Transmission, LLC submits its FTS Company. comment date. Anyone filing a protest Service Agreement No 15260, Ninth Revised Sheet No 503.01 to FERC Gas Description: Eastern Shore Natural must serve a copy of that document on Tariff, Third Revised Volume No 1, to Gas Company submits FERC Gas Tariff, all the parties to the proceeding. Second Revised Volume 1 of Sub 71st be effective April 1, 2010. Revised Sheet 7, to be effective 4/1/10. The Commission encourages Filed Date: 03/30/2010. Filed Date: 03/25/2010. electronic submission of protests in lieu Accession Number: 20100331–0204. Accession Number: 20100325–0227. of paper using the ‘‘eFiling’’ link at Comment Date: 5 p.m. Eastern Time Comment Date: 5 p.m. Eastern Time http://www.ferc.gov. Persons unable to on Monday, April 12, 2010. on Tuesday, April 06, 2010. file electronically should submit an Docket Numbers: RP10–523–000. Docket Numbers: RP10–271–001. original and 14 copies of the protest to Applicants: Columbia Gas RP10–350–001. the Federal Energy Regulatory Transmission, LLC. Applicants: Southern LNG, Inc. Commission, 888 First Street, NE., Description: Columbia Gas Description: Southern LNG, Inc Washington, DC 20426. Transmission, LLC submits its FTS submits Substitute Original Sheet No This filing is accessible on-line at Service Agreement No 15245 to FERC 32E et al., to be effective 3/1/2010. http://www.ferc.gov, using the Gas Tariff, Third Revised Volume No 1, Filed Date: 03/29/2010. ‘‘eLibrary’’ link and is available for to be effective 4/1/2010. Accession Number: 20100330–0205. review in the Commission’s Public Filed Date: 03/30/2010. Comment Date: 5 p.m. Eastern Time Reference Room in Washington, DC. Accession Number: 20100331–0205. on Monday, April 12, 2010. There is an ‘‘eSubscription’’ link on the Comment Date: 5 p.m. Eastern Time Docket Numbers: RP10–271–002; Web site that enables subscribers to on Monday, April 12, 2010. RP10–350–002. receive e-mail notification when a Any person desiring to intervene or to Applicants: Southern LNG, Inc. document is added to a subscribed protest in any of the above proceedings Description: Southern LNG, Inc docket(s). For assistance with any FERC must file in accordance with Rules 211 submits SLNG–1 Service Agreement No Online service, please e-mail and 214 of the Commission’s Rules of SLNG11 dated 5/27/03 and SLNG–3 [email protected], or call Practice and Procedure (18 CFR 385.211 Service Agreement No SLNG25 dated (866) 208–3676 (toll free). For TTY, call and 385.214) on or before 5 p.m. Eastern 10/5/07. (202) 502–8659. time on the specified comment date. It Filed Date: 03/29/2010. is not necessary to separately intervene Accession Number: 20100330–0204. Nathaniel J. Davis, Sr., again in a subdocket related to a Comment Date: 5 p.m. Eastern Time Deputy Secretary. compliance filing if you have previously on Monday, April 12, 2010. [FR Doc. 2010–8610 Filed 4–14–10; 8:45 am] intervened in the same docket. Protests Docket Numbers: RP10–342–001. BILLING CODE 6717–01–P will be considered by the Commission

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in determining the appropriate action to Original Volume 1 to be effective document on the Applicant. In reference be taken, but will not serve to make 5/1/10. to filings initiating a new proceeding, protestants parties to the proceeding. Filed Date: 03/26/2010. interventions or protests submitted on Anyone filing a motion to intervene or Accession Number: 20100326–0204. or before the comment deadline need protest must serve a copy of that Comment Date: 5 p.m. Eastern Time not be served on persons other than the document on the Applicant. In reference on Wednesday, April 07, 2010. Applicant. to filings initiating a new proceeding, Docket Numbers: RP10–515–000. The Commission encourages interventions or protests submitted on Applicants: Algonquin Gas electronic submission of protests and or before the comment deadline need Transmission, LLC. interventions in lieu of paper, using the not be served on persons other than the Description: Algonquin Gas FERC Online links at http:// Applicant. Transmission LLC submits Third www.ferc.gov. To facilitate electronic The Commission encourages Revised Sheet No. 625 to FERC Gas service, persons with Internet access electronic submission of protests and Tariff, Fifth Revised Volume No. 1, to be who will eFile a document and/or be interventions in lieu of paper, using the effective 3/26/10. listed as a contact for an intervenor FERC Online links at http:// Filed Date: 03/26/2010. must create and validate an www.ferc.gov. To facilitate electronic Accession Number: 20100326–0205. eRegistration account using the service, persons with Internet access Comment Date: 5 p.m. Eastern Time eRegistration link. Select the eFiling who will eFile a document and/or be on Wednesday, April 07, 2010. link to log on and submit the listed as a contact for an intervenor Docket Numbers: RP10–516–000. intervention or protests. Persons unable to file electronically must create and validate an Applicants: Guardian Pipeline, LLC. eRegistration account using the Description: Guardian Pipeline, LLC should submit an original and 14 copies eRegistration link. Select the eFiling submits Third Revised Sheet 9 to its of the intervention or protest to the link to log on and submit the Tariff, to be effective 4/1/10. Federal Energy Regulatory Commission, intervention or protests. Filed Date: 03/26/2010. 888 First St. NE., Washington, DC Persons unable to file electronically Accession Number: 20100326–0207. 20426. The filings in the above proceedings should submit an original and 14 copies Comment Date: 5 p.m. Eastern Time are accessible in the Commission’s of the intervention or protest to the on Wednesday, April 07, 2010. eLibrary system by clicking on the Federal Energy Regulatory Commission, Docket Numbers: RP10–518–000. 888 First St., NE., Washington, DC appropriate link in the above list. They Applicants: Trunkline LNG Company, are also available for review in the 20426. LLC. The filings in the above proceedings Commission’s Public Reference Room in Description: Trunkline LNG are accessible in the Commission’s Washington, DC. There is an Company, LLC submits Sixth Revised eLibrary system by clicking on the eSubscription link on the Web site that Sheet No. 6 to FERC Gas Tariff, Second appropriate link in the above list. They enables subscribers to receive e-mail Revised Volume No. 1–A, to be effective are also available for review in the notification when a document is added 3/11/2010. Commission’s Public Reference Room in to a subscribed docket(s). For assistance Filed Date: 03/26/2010. Washington, DC. There is an with any FERC Online service, please e- Accession Number: 20100329–0208. mail [email protected] or eSubscription link on the Web site that Comment Date: 5 p.m. Eastern Time call (866) 208–3676 (toll free). For TTY, enables subscribers to receive e-mail on Wednesday, April 07, 2010. notification when a document is added call (202) 502–8659. Docket Numbers: RP10–519–000. to a subscribed dockets(s). For Nathaniel J. Davis, Sr., assistance with any FERC Online Applicants: Northern Border Pipeline Deputy Secretary. service, please e-mail Company. [email protected]. or call Description: Northern Border Pipeline [FR Doc. 2010–8608 Filed 4–14–10; 8:45 am] (866) 208–3676 (toll free). For TTY, call Company submits Twenty-Fourth BILLING CODE 6717–01–P (202) 502–8659. Revised Sheet 99A et al., to its FERC Gas Tariff, First Revised Volume 1, to be Nathaniel J. Davis, Sr., effective 4/1/10. DEPARTMENT OF ENERGY Deputy Secretary. Filed Date: 03/29/2010. Federal Energy Regulatory [FR Doc. 2010–8609 Filed 4–14–10; 8:45 am] Accession Number: 20100329–0218. Commission BILLING CODE 6717–01–P Comment Date: 5 p.m. Eastern Time on Monday, April 12, 2010. Combined Notice of Filings # 1 Any person desiring to intervene or to DEPARTMENT OF ENERGY protest in any of the above proceedings April 08, 2010. must file in accordance with Rules 211 Take notice that the Commission Federal Energy Regulatory and 214 of the Commission’s Rules of received the following electric corporate Commission Practice and Procedure (18 CFR 385.211 filings: and 385.214) on or before 5 p.m. Eastern Combined Notice of Filings Docket Numbers: EC10–59–000. time on the specified comment date. It Applicants: EquiPower Resources March 30, 2010. is not necessary to separately intervene Corp., BG Dighton Power, LLC, Lake Take notice that the Commission has again in a subdocket related to a Road Generating Co LP, Masspower. received the following Natural Gas compliance filing if you have previously Description: Joint Application for Pipeline Rate and Refund Report filings: intervened in the same docket. Protests Authorization of Transaction under Docket Numbers: RP10–514–000. will be considered by the Commission Section 203 of the PFA, and Requests Applicants: Southern Star Central Gas in determining the appropriate action to for Waivers of Filing Requirements, Pipeline, Inc. be taken, but will not serve to make Confidential Treatment of Transaction Description: Southern Star Central protestants parties to the proceeding. Documents, Shortened Comment Period Gas Pipeline, Inc., submits Fifth Revised Anyone filing a motion to intervene or and Expedited Consideration. Sheet 2 et al., to its FERC Gas Tariff, protest must serve a copy of that Filed Date: 04/08/2010.

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Accession Number: 20100408–5098. Comment Date: 5 p.m. Eastern Time The Commission encourages Comment Date: 5 p.m. Eastern Time on Wednesday, April 28, 2010. electronic submission of protests and on Thursday, April 29, 2010. Docket Numbers: ER10–1031–000. interventions in lieu of paper, using the Take notice that the Commission Applicants: Crestwood Energy, LP. FERC Online links at http:// received the following exempt Description: Crestwood Energy LP www.ferc.gov. To facilitate electronic wholesale generator filings: submits FERC Electric Tariff, Original service, persons with Internet access Docket Numbers: EG10–31–000. Volume No 1 effective 4/8/2010. who will eFile a document and/or be Applicants: Loraine Windpark Filed Date: 04/07/2010. listed as a contact for an intervenor Project, LLC. Accession Number: 20100407–0215. must create and validate an Description: Notice of Self- Comment Date: 5 p.m. Eastern Time eRegistration account using the Certification of Exempt Wholesale on Wednesday, April 28, 2010. eRegistration link. Select the eFiling Generator Status of Loraine Windpark Docket Numbers: ER10–1033–000. link to log on and submit the Project, LLC. Applicants: Beaver Ridge Wind, LLC. intervention or protests. Filed Date: 04/08/2010. Description: Beaver Ridge Wind, LLC Persons unable to file electronically Accession Number: 20100408–5097. submits tariff filing per 35.12: Market should submit an original and 14 copies Comment Date: 5 p.m. Eastern Time Based Rate Authorization to be effective of the intervention or protest to the on Thursday, April 29, 2010. 7/1/2008. Federal Energy Regulatory Commission, 888 First St., NE., Washington, DC Take notice that the Commission Filed Date: 04/08/2010. Accession Number: 20100408–5106. 20426. received the following electric rate The filings in the above proceedings filings: Comment Date: 5 p.m. Eastern Time on Thursday, April 29, 2010. are accessible in the Commission’s Docket Numbers: ER99–2948–020; eLibrary system by clicking on the ER00–2918–019; ER01–1654–022; Docket Numbers: ER10–1034–000. appropriate link in the above list. They ER01–556–018; ER02–2567–019; ER04– Applicants: Competitive Energy. are also available for review in the 485–017; ER05–261–012; ER07–244– Description: Competitive Energy Commission’s Public Reference Room in 011; ER05–728–012; ER07–245–011; submits tariff filing per 35.12: Washington, DC. There is an ER07–247–011; ER08–860–001; ER10– Competitive Energy Tariff to be effective eSubscription link on the Web site that 346–005. 8/1/2001. enables subscribers to receive e-mail Applicants: Constellation Energy Filed Date: 04/08/2010. notification when a document is added Commodities Group, R.E. Ginna Nuclear Accession Number: 20100408–5109. to a subscribed docket(s). For assistance Power Plant, LLC, Baltimore Gas and Comment Date: 5 p.m. Eastern Time with any FERC Online service, please e- Electric Company, Constellation Pwr on Thursday, April 29, 2010. mail [email protected] or Source Generation LLC, Constellation Take notice that the Commission call (866) 208–3676 (toll free). For TTY, NewEnergy, Inc., Nine Mile Point received the following electric securities call (202) 502–8659. Nuclear Station, LLC, CER Generation II, filings: Nathaniel J. Davis, Sr., LLC, Handsome Lake Energy, LLC, Docket Numbers: ES10–32–000. Constellation Energy Commodities Applicants: NSTAR Electric Deputy Secretary. Group M, Calvert Cliffs Nuclear Power Company. [FR Doc. 2010–8607 Filed 4–14–10; 8:45 am] Plant LLC, Raven One, LLC, Raven Description: Application of NSTAR BILLING CODE 6717–01–P Three, LLC, Raven Two, LLC. Electric Company for Authority to Issue Description: Update to Notice of Short-Term Debt Securities. Change in Status of Constellation MBR Filed Date: 04/08/2010. DEPARTMENT OF ENERGY Entities. Accession Number: 20100408–5085. Filed Date: 04/08/2010. Federal Energy Regulatory Comment Date: 5 p.m. Eastern Time Commission Accession Number: 20100408–5012. on Thursday, April 29, 2010. Comment Date: 5 p.m. Eastern Time Any person desiring to intervene or to Combined Notice of Filings on Thursday, April 29, 2010. protest in any of the above proceedings Docket Numbers: ER10–1029–000 must file in accordance with Rules 211 April 5, 2010. Applicants: West Oaks Energy, LP. and 214 of the Commission’s Rules of Take notice that the Commission has Description: West Oaks Energy NY/ Practice and Procedure (18 CFR 385.211 received the following Natural Gas NE, LP submits Application for Market- and 385.214) on or before 5 p.m. Eastern Pipeline Rate and Refund Report filings: Based Rate Authorization, designation time on the specified comment date. It Docket Numbers: RP10–562–000. of Category 1 Status, and Request for is not necessary to separately intervene Applicants: Wisconsin Electric Power waivers and Blanket Approvals. again in a subdocket related to a Company, Wisconsin Gas LLC. Filed Date: 04/07/2010. compliance filing if you have previously Description: Request of Wisconsin Accession Number: 20100407–0238. intervened in the same docket. Protests Electric Power Company and Wisconsin Comment Date: 5 p.m. Eastern Time will be considered by the Commission Gas LLC for Temporary Waiver and on Wednesday, April 28, 2010. in determining the appropriate action to Expedited Action. Docket Numbers: ER10–1030–000. be taken, but will not serve to make Filed Date: 04/01/2010. Applicants: West Oaks Energy NY/ protestants parties to the proceeding. Accession Number: 20100401–5093. NE, LP. Anyone filing a motion to intervene or Comment Date: 5 p.m. Eastern Time Description: West Oaks Energy NY/ protest must serve a copy of that on Friday, April 9, 2010. NE, LP submits Application for Market- document on the Applicant. In reference Docket Numbers: RP10–563–000. Based Rate Authorization, designation to filings initiating a new proceeding, Applicants: Alliance Pipeline L.P. of Category 1 Status, and Request for interventions or protests submitted on Description: Alliance Pipeline L.P. waivers and Blanket Approvals. or before the comment deadline need submits tariff filing per 154.203: Filed Date: 04/07/2010. not be served on persons other than the Baseline Filing to be effective 4/1/2010. Accession Number: 20100407–0237. Applicant. Filed Date: 04/01/2010.

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Accession Number: 20100401–5101. Applicants: CenterPoint Energy Gas Filed Date: 04/01/2010. Comment Date: 5 p.m. Eastern Time Transmission Company. Accession Number: 20100402–0202. on Tuesday, April 13, 2010. Description: CenterPoint Energy Gas Comment Date: 5 p.m. Eastern Time Docket Numbers: RP10–564–000. Transmission Company submits on Tuesday, April 13, 2010. Applicants: Gulf South Pipeline negotiated rate agreements with Laclede Docket Numbers: RP10–577–000. Company, LP. Energy Resources, Inc., et al. to be Applicants: Columbia Gas Description: Gulf South Pipeline effective 4/1/10. Transmission, LLC. Company, LP submits a capacity release Filed Date: 04/01/2010. Description: Columbia Gas agreement containing negotiated rate Accession Number: 20100402–0206. Transmission, LLC submits First provisions. Comment Date: 5 p.m. Eastern Time Revised Sheet 278 et al. to its FERC Gas Filed Date: 04/01/2010. on Tuesday, April 13, 2010. Tariff, Third Revised Volume 1, to be Accession Number: 20100401–0251. Docket Numbers: RP10–572–000. effective 5/1/10. Comment Date: 5 p.m. Eastern Time Applicants: CenterPoint Energy Gas Filed Date: 04/01/2010. on Tuesday, April 13, 2010. Transmission Company. Accession Number: 20100402–0201. Docket Numbers: RP10–565–000. Description: CenterPoint Energy Gas Comment Date: 5 p.m. Eastern Time Applicants: Gulf South Pipeline Transmission Company submits the on Tuesday, April 13, 2010. Company, LP. Amended and Restated Firm (Rate Docket Numbers: RP10–578–000. Description: Gulf South Pipeline Schedule FT) Transportation Service Applicants: Gulf Crossing Pipeline Company, LP submits a capacity release Agreement. Company, LLC. agreement containing negotiated rate Filed Date: 04/01/2010. Description: Gulf Crossing Pipeline provisions. Accession Number: 20100402–0205. Company, LLC submits amendment to a Filed Date: 04/01/2010. Comment Date: 5 p.m. Eastern Time negotiated rate letter agreement Accession Number: 20100401–0250. on Tuesday, April 13, 2010. executed by their customers in relation Comment Date: 5 p.m. Eastern Time Docket Numbers: RP10–573–000. to the Gulf Crossing Project. on Tuesday, April 13, 2010. Applicants: CenterPoint Energy Gas Filed Date: 04/02/2010. Docket Numbers: RP10–566–000. Transmission Company. Accession Number: 20100402–0212. Comment Date: 5 p.m. Eastern Time Applicants: Texas Gas Transmission, Description: CenterPoint Energy Gas on Wednesday, April 14, 2010. LLC. Transmission Company submits new Description: Texas Gas Transmission, negotiated rate agreement to provide Docket Numbers: RP10–579–000. LLC submits Second Revised Sheet 52 firm transportation services under Rate Applicants: CenterPoint Energy Gas to FERC Gas Tariff, Third Revised Schedule EFT to Southwestern Electric Transmission Company. Volume 1. Power Company. Description: CenterPoint Energy Gas Filed Date: 04/01/2010. Filed Date: 04/01/2010. Transmission Company submits an Accession Number: 20100402–0204. Accession Number: 20100401–0249. amended Rate Schedule FT negotiated Comment Date: 5 p.m. Eastern Time Comment Date: 5 p.m. Eastern Time rate agreement with XTO Energy, Inc. on Tuesday, April 13, 2010. on Tuesday, April 13, 2010. Filed Date: 04/02/2010. Docket Numbers: RP10–574–000. Accession Number: 20100402–0213. Docket Numbers: RP10–567–000. Applicants: CenterPoint Energy Gas Comment Date: 5 p.m. Eastern Time Applicants: CenterPoint Energy Gas Transmission Company. on Wednesday, April 14, 2010. Transmission Company. Description: CenterPoint Energy Gas Description: CenterPoint Energy Gas Docket Numbers: RP10–580–000. Transmission Company submits Third Applicants: Dauphin Island Gathering Transmission Company submits Tenth Revised Sheet 686 of its FERC Gas Partners. Revised Sheet No. 1 et al. to FERC Gas Tariff, Sixth Revised Volume 1, to be Description: Dauphin Island Tariff, Sixth Revised Volume No. 1. effective 4/1/2010. Gathering Partners submits Fifty-Second Filed Date: 04/01/2010. Filed Date: 04/01/2010. Revised Sheet 9 et al. to FERC Gas Accession Number: 20100401–0273. Accession Number: 20100402–0209. Tariff, First Revised Volume 1, to be Comment Date: 5 p.m. Eastern Time Comment Date: 5 p.m. Eastern Time effective 4/3/10. on Tuesday, April 13, 2010. on Tuesday, April 13, 2010. Filed Date: 04/02/2010. Docket Numbers: RP10–568–000. Docket Numbers: RP10–575–000. Accession Number: 20100402–0225. Applicants: Transcontinental Gas Applicants: Columbia Gas Comment Date: 5 p.m. Eastern Time Pipe Line Company, LLC. Transmission Company. on Wednesday, April 14, 2010. Description: Transcontinental Gas Description: Columbia Gas Any person desiring to intervene or to Pipe Line Company, LLC submits Transmission Company submits First protest in any of the above proceedings negotiated rate agreement containing Sheet No. 187 et al. to FERC Gas Tariff, must file in accordance with Rules 211 non-conforming provisions. Second Revised Volume No. 1, to be and 214 of the Commission’s Rules of Filed Date: 04/01/2010. effective 5/1/10. Practice and Procedure (18 CFR 385.211 Accession Number: 20100401–0268. Filed Date: 04/01/2010. and 385.214) on or before 5 p.m. Eastern Comment Date: 5 p.m. Eastern Time Accession Number: 20100402–0203. time on the specified comment date. It on Tuesday, April 13, 2010. Comment Date: 5 p.m. Eastern Time is not necessary to separately intervene Docket Numbers: RP10–570–000. on Tuesday, April 13, 2010. again in a subdocket related to a Applicants: ANR Pipeline Company. Docket Numbers: RP10–576–000. compliance filing if you have previously Description: ANR Pipeline Company Applicants: Columbia Gas intervened in the same docket. Protests submits negotiated rate agreements. Transmission, LLC. will be considered by the Commission Filed Date: 04/01/2010. Description: Columbia Gas in determining the appropriate action to Accession Number: 20100401–0267. Transmission, LLC submits Original be taken, but will not serve to make Comment Date: 5 p.m. Eastern Time Sheet No. 503.02 to FERC Gas Tariff, protestants parties to the proceeding. on Tuesday, April 13, 2010. Third Revised Volume No. 1, to be Anyone filing a motion to intervene or Docket Numbers: RP10–571–000. effective 5/1/10. protest must serve a copy of that

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document on the Applicant. In reference facilities by Empire Pipeline, Inc. and how to participate in the to filings initiating a new proceeding, (Empire) in Tioga County, Pennsylvania Commission’s proceedings. interventions or protests submitted on and Steuben and Ontario Counties, New Summary of the Planned Project or before the comment deadline need York. This EA will be used by the not be served on persons other than the Commission in its decision-making Empire plans to construct and operate Applicant. process to determine whether the approximately 16 miles of 24-inch- The Commission encourages project is in the public convenience and diameter pipeline and replace electronic submission of protests and necessity. approximately 1.3 miles of existing 24- interventions in lieu of paper, using the This notice announces the opening of inch-diameter pipeline. According to FERC Online links at http:// the scoping process the Commission Empire, its project would enable Empire www.ferc.gov. To facilitate electronic will use to gather input from the public to provide firm transportation services service, persons with Internet access and interested agencies on the project. requested by producers connecting who will eFile a document and/or be Your input will help the Commission extensive Marcellus Shale production listed as a contact for an intervenor staff determine what issues need to be along the proposed pipeline corridor. must create and validate an evaluated in the EA. Please note that the The Tioga County Extension Project eRegistration account using the scoping period will close on May 7, would provide about 350,000 eRegistration link. Select the eFiling 2010. dekatherms per day of capacity to link to log on and submit the Comments may be submitted in various market areas in New York, New intervention or protests. written form or verbally. Further details England, and eastern Canada along the Persons unable to file electronically on how to submit written comments are Millenium Pipeline, Tennessee Gas should submit an original and 14 copies provided in the Public Participation Pipeline Company 200 Line, of the intervention or protest to the section of this notice. In lieu of or in TransCanada Pipeline, and Empire’s Federal Energy Regulatory Commission, addition to sending written comments, existing systems. 888 First St. NE., Washington, DC we invite you to attend the public The Tioga County Extension Project scoping meetings scheduled as follows: would consist of the following facilities: 20426. • The filings in the above proceedings Construction of 16 miles of 24-inch- are accessible in the Commission’s Date and time Location diameter pipeline from Tioga County, eLibrary system by clicking on the Pennsylvania to Steuben County, New appropriate link in the above list. They April 27, 2010, 7 p.m. Radisson Hotel—Cor- York; local time. ning, 125 Denison • are also available for review in the Replacement of 1.3 miles of existing Parkway East, Cor- 24-inch-diameter pipeline in Victor, Commission’s Public Reference Room in ning, New York Washington, DC. There is an Ontario County, New York; 14830. 607–962– • Construction of a new interconnect eSubscription link on the Web site that 5000. with Tennessee Gas Pipeline Company enables subscribers to receive e-mail April 28, 2010, 7 p.m. Hampton Inn, 7637 in the Town of Canandaigua, Ontario notification when a document is added local time. New York State County, New York; and to a subscribed dockets(s). For Rte 96, Victor, New • Miscellaneous modifications at assistance with any FERC Online York 14564. 585– existing measurement and compressor service, please e-mail 924–4400. stations. [email protected]. or call This notice is being sent to the The general location of the project (866) 208–3676 (toll free). For TTY, call Commission’s current environmental facilities is shown in appendix 1.1 (202) 502–8659. mailing list for this project. State and Land Requirements for Construction Nathaniel J. Davis, Sr., local government representatives are Deputy Secretary. asked to notify their constituents of this Construction of the planned facilities planned project and encourage them to would disturb about 223 acres of land [FR Doc. 2010–8606 Filed 4–14–10; 8:45 am] for the aboveground facilities and the BILLING CODE 6717–01–P comment on their areas of concern. If you are a landowner receiving this pipeline. Following construction, about notice, you may be contacted by a 113 acres would be maintained for DEPARTMENT OF ENERGY pipeline company representative about permanent operation of the project’s the acquisition of an easement to facilities; the remaining acreage would Federal Energy Regulatory construct, operate, and maintain the be restored and allowed to revert to Commission planned facilities. The company would former uses. About 31 percent of the seek to negotiate a mutually acceptable planned pipeline route parallels an [Docket No. PF10–5–000] agreement. However, if the project is existing pipeline right-of-way. Empire Pipeline, Inc.; Notice of Intent approved by the Commission, that The EA Process To Prepare an Environmental approval conveys with it the right of eminent domain. Therefore, if easement The National Environmental Policy Assessment for the Planned Tioga Act (NEPA) requires the Commission to County Extension Project, Request for negotiations fail to produce an agreement, the pipeline company could take into account the environmental Comments on Environmental Issues, impacts that could result from an action and Notice of Public Scoping Meeting initiate condemnation proceedings in accordance with State law. whenever it considers the issuance of a April 7, 2010. A fact sheet prepared by the FERC entitled ‘‘An Interstate Natural Gas 1 The appendices referenced in this notice are not The staff of the Federal Energy being printed in the Federal Register. Copies of Regulatory Commission (FERC or Facility On My Land? What Do I Need appendices were sent to all those receiving this Commission) will prepare an To Know?’’ is available for viewing on notice in the mail and are available at http:// environmental assessment (EA) that will the FERC Web site (http:// www.ferc.gov using the link called ‘‘eLibrary’’ or www.ferc.gov). This fact sheet addresses from the Commission’s Public Reference Room, 888 discuss the environmental impacts of First Street, NE., Washington, DC 20426, or call the Tioga County Extension Project, a number of typically-asked questions, (202) 502–8371. For instructions on connecting to involving construction and operation of including the use of eminent domain eLibrary, refer to the last page of this notice.

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Certificate of Public Convenience and participate once they have evaluated the and newspapers. This list also includes Necessity. NEPA also requires us 2 to proposal relative to their all affected landowners (as defined in discover and address concerns the responsibilities. Agencies that would the Commission’s regulations) who are public may have about proposals. This like to request cooperating agency status potential right-of-way grantors, whose process is referred to as scoping. The should follow the instructions for filing property may be used temporarily for main goal of the scoping process is to comments provided under the Public project purposes, or who own homes focus the analysis in the EA on the Participation section of this notice. within certain distances of aboveground facilities, and anyone who submits important environmental issues. By this Public Participation notice, the Commission requests public comments on the project. We will comments on the scope of the issues to You can make a difference by update the environmental mailing list as address in the EA. All comments providing us with your specific the analysis proceeds to ensure that we received will be considered during the comments or concerns about the project. send the information related to this preparation of the EA. Your comments should focus on the environmental review to all individuals, In the EA we will discuss impacts that potential environmental effects, organizations, and government entities could occur as a result of the reasonable alternatives, and measures to interested in and/or potentially affected construction and operation of the avoid or lessen environmental impacts. by the planned project. planned project under these general The more specific your comments, the If the EA is published for distribution, headings: more useful they will be. To ensure that copies will be sent to the environmental • and soils; your comments are timely and properly mailing list for public review and • Land use; recorded, please send your comments so comment. If you would prefer to receive • Water resources, fisheries, and that they will be received in a paper copy of the document instead of wetlands; Washington, DC on or before May 7, the CD version or would like to remove • Cultural resources; 2010. your name from the mailing list, please • Vegetation and wildlife; For your convenience, there are three return the attached Information Request • Air quality and noise; and methods you can use to submit your (appendix 2). • Endangered and threatened species. comments to the Commission. The Becoming an Intervenor We will also evaluate possible Commission encourages electronic filing alternatives to the planned project or of comments and has expert eFiling staff Once Empire files its application with portions of the project, and make available to assist you at (202) 502–8258 the Commission, you may want to recommendations on how to lessen or or [email protected]. become an ‘‘intervenor’’, which is an avoid impacts on the various resource (1) You may file your comments official party to the Commission’s areas. electronically by using the Quick proceeding. Intervenors play a more Although no formal application has Comment feature, which is located at formal role in the process and are able been filed, we have already initiated our http://www.ferc.gov under the link to file briefs, appear at hearings, and be NEPA review under the Commission’s called Documents and Filings. A Quick heard by the courts if they choose to pre-filing process. The purpose of the Comment is an easy method for appeal the Commission’s final ruling. pre-filing process is to encourage early interested persons to submit text-only An intervenor formally participates in involvement of interested stakeholders comments on a project; the proceeding by filing a request to and to identify and resolve issues before (2) You may file your comments intervene. Instructions for becoming an an application is filed with the FERC. electronically by using the ‘‘eFiling’’ intervenor are included in the User’s As part of our pre-filing review, we have feature that is listed under the Guide under the ‘‘e-filing’’ link on the begun to contact some Federal and State Documents and Filings link. eFiling Commission’s Web site. Please note that agencies to discuss their involvement in involves preparing your submission in you may not request intervenor status at the scoping process and the preparation the same manner as you would if filing this time. You must wait until a formal of the EA. on paper, and then saving the file on application for the project is filed with Our independent analysis of the your computer’s hard drive. You will the Commission. issues will be presented in the EA. The attach that file to your submission. New Additional Information EA will be placed in the public record eFiling users must first create an and, depending on the comments account by clicking on the links called Additional information about the received during the scoping process, Sign up or eRegister. You will be asked project is available from the may be published and distributed to the to select the type of filing you are Commission’s Office of External Affairs, public. A comment period will be making. A comment on a particular at (866) 208–FERC, or on the FERC Web allotted if the EA is published for project is considered a ‘‘Comment on a site (http://www.ferc.gov) using the review. We will consider all comments Filing’’; or eLibrary link. Click on the eLibrary link, on the EA before we make our (3) You may file a paper copy of your click on ‘‘General Search’’ and enter the recommendations to the Commission. comments at the following address: docket number, excluding the last three To ensure your comments are Kimberly D. Bose, Secretary, Federal digits in the Docket Number field (i.e., considered, please carefully follow the Energy Regulatory Commission, 888 PF10–5). Be sure you have selected an instructions in the Public Participation First Street, NE., Room 1A, Washington, appropriate date range. For assistance, section below. DC 20426. please contact FERC Online Support at [email protected] or toll free With this notice, we are asking Environmental Mailing List agencies with jurisdiction and/or at (866) 208–3676, or for TTY, contact special expertise with respect to The environmental mailing list (202) 502–8659. The eLibrary link also environmental issues to formally includes Federal, State, and local provides access to the texts of formal cooperate with us in the preparation of government representatives and documents issued by the Commission, the EA. These agencies may choose to agencies; elected officials; such as orders, notices, and environmental and public interest rulemakings. 2 ‘‘We’’, ‘‘us’’, and ‘‘our’’ refer to the environmental groups; Native American Tribes; other In addition, the Commission offers a staff of the Commission’s Office of Energy Projects. interested parties; and local libraries free service called eSubscription which

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allows you to keep track of all formal 888 First Street, NE., Washington, DC who will eFile a document and/or be issuances and submittals in specific 20426. listed as a contact for an intervenor dockets. This can reduce the amount of This filing is accessible online at must create and validate an time you spend researching proceedings http://www.ferc.gov, using the eRegistration account using the by automatically providing you with ‘‘eLibrary’’ link and is available for eRegistration link. Select the eFiling notification of these filings, document review in the Commission’s Public link to log on and submit the summaries, and direct links to the Reference Room in Washington, DC. intervention or protests. documents. Go to http://www.ferc.gov/ There is an ‘‘eSubscription’’ link on the Persons unable to file electronically esubscribenow.htm. Web site that enables subscribers to should submit an original and 14 copies Finally, public meetings or site visits receive e-mail notification when a of the intervention or protest to the will be posted on the Commission’s document is added to a subscribed Federal Energy Regulatory Commission, calendar located at http://www.ferc.gov/ docket(s). For assistance with any FERC 888 First St., NE., Washington, DC EventCalendar/EventsList.aspx along Online service, please e-mail 20426. with other related information. [email protected], or call The filings in the above-referenced (866) 208–3676 (toll free). For TTY, call proceeding are accessible in the Kimberly D. Bose, (202) 502–8659. Commission’s eLibrary system by Secretary. Comment Date: 5 p.m. Eastern Time clicking on the appropriate link in the [FR Doc. 2010–8591 Filed 4–14–10; 8:45 am] on April 26, 2010. above list. They are also available for BILLING CODE 6717–01–P review in the Commission’s Public Kimberly D. Bose, Reference Room in Washington, DC. Secretary. There is an eSubscription link on the DEPARTMENT OF ENERGY [FR Doc. 2010–8589 Filed 4–14–10; 8:45 am] Web site that enables subscribers to BILLING CODE 6717–01–P Federal Energy Regulatory receive e-mail notification when a Commission document is added to a subscribed docket(s). For assistance with any FERC [Docket No. EL10–23–002] DEPARTMENT OF ENERGY Online service, please e-mail [email protected]. or call Sagebrush, a California Partnership; Federal Energy Regulatory Commission (866) 208–3676 (toll free). For TTY, call Notice of Filing (202) 502–8659. [Docket No. ER10–1031–000] April 7, 2010. Kimberly D. Bose, Take notice that on April 5, 2010, Crestwood Energy LP; Supplemental Secretary. Sagebrush, a California partnership Notice That Initial Market-Based Rate [FR Doc. 2010–8583 Filed 4–14–10; 8:45 am] (Sagebrush) submits for filing a revised Filing Includes Request for Blanket BILLING CODE 6717–01–P open access transmission tariff (OATT) Section 204 Authorization to govern the terms of new interconnection and transmission April 8, 2010. DEPARTMENT OF ENERGY service on Sagebrush’s existing This is a supplemental notice in the transmission line, pursuant to the above-referenced proceeding of Federal Energy Regulatory Commission’s February 4, 2010, Order Crestwood Energy LP’s application for Commission Accepting in Part and Rejecting in Part market-based rate authority, with an [Docket No. ER10–1029–000] Tariff Filing and Directing Compliance accompanying rate tariff, noting that Filing, 130 FERC ¶ 61,093 (2010). such application includes a request for West Oaks Energy LP; Supplemental Any person desiring to intervene or to blanket authorization, under 18 CFR Notice That Initial Market-Based Rate protest this filing must file in part 34, of future issuances of securities Filing Includes Request for Blanket accordance with Rules 211 and 214 of and assumptions of liability. Section 204 Authorization the Commission’s Rules of Practice and Any person desiring to intervene or to Procedure (18 CFR 385.211, 385.214). protest should file with the Federal April 8, 2010. Protests will be considered by the Energy Regulatory Commission, 888 This is a supplemental notice in the Commission in determining the First Street, NE., Washington, DC 20426, above-referenced proceeding of West appropriate action to be taken, but will in accordance with Rules 211 and 214 Oaks Energy LP’s application for not serve to make protestants parties to of the Commission’s Rules of Practice market-based rate authority, with an the proceeding. Any person wishing to and Procedure (18 CFR 385.211 and accompanying rate tariff, noting that become a party must file a notice of 385.214). Anyone filing a motion to such application includes a request for intervention or motion to intervene, as intervene or protest must serve a copy blanket authorization, under 18 CFR appropriate. Such notices, motions, or of that document on the Applicant. part 34, of future issuances of securities protests must be filed on or before the Notice is hereby given that the and assumptions of liability. comment date. On or before the deadline for filing protests with regard Any person desiring to intervene or to comment date, it is not necessary to to the applicant’s request for blanket protest should file with the Federal serve motions to intervene or protests authorization, under 18 CFR part 34, of Energy Regulatory Commission, 888 on persons other than the Applicant. future issuances of securities and First Street, NE., Washington, DC 20426, The Commission encourages assumptions of liability, is April 28, in accordance with Rules 211 and 214 electronic submission of protests and 2010. of the Commission’s Rules of Practice interventions in lieu of paper using the The Commission encourages and Procedure (18 CFR 385.211 and ‘‘eFiling’’ link at http://www.ferc.gov. electronic submission of protests and 385.214). Anyone filing a motion to Persons unable to file electronically interventions in lieu of paper, using the intervene or protest must serve a copy should submit an original and 14 copies FERC Online links at http:// of that document on the Applicant. of the protest or intervention to the www.ferc.gov. To facilitate electronic Notice is hereby given that the Federal Energy Regulatory Commission, service, persons with Internet access deadline for filing protests with regard

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to the applicant’s request for blanket Any person desiring to intervene or to DEPARTMENT OF ENERGY authorization, under 18 CFR part 34, of protest should file with the Federal future issuances of securities and Energy Regulatory Commission, 888 Federal Energy Regulatory assumptions of liability, is April 28, First Street, NE., Washington, DC 20426, Commission 2010. in accordance with Rules 211 and 214 Notice of FERC Staff Attendance at the The Commission encourages of the Commission’s Rules of Practice electronic submission of protests and Entergy Regional State Committee and Procedure (18 CFR 385.211 and Meeting interventions in lieu of paper, using the 385.214). Anyone filing a motion to FERC Online links at http:// intervene or protest must serve a copy April 8, 2010. www.ferc.gov. To facilitate electronic of that document on the Applicant. The Federal Energy Regulatory service, persons with Internet access Commission hereby gives notice that who will eFile a document and/or be Notice is hereby given that the deadline for filing protests with regard members of its staff may attend the listed as a contact for an intervenor meeting noted below. Their attendance to the applicant’s request for blanket must create and validate an is part of the Commission’s ongoing authorization, under 18 CFR part 34, of eRegistration account using the outreach efforts. eRegistration link. Select the eFiling future issuances of securities and link to log on and submit the assumptions of liability, is April 28, Entergy Regional State Committee intervention or protests. 2010. Meeting Persons unable to file electronically The Commission encourages April 22, 2010 (8:30 a.m.–5 p.m.), W should submit an original and 14 copies electronic submission of protests and Hotel New Orleans, 333 Poydras Street, of the intervention or protest to the interventions in lieu of paper, using the New Orleans, LA 70130, 504–525–9444. Federal Energy Regulatory Commission, FERC Online links at http:// The discussions may address matters 888 First St., NE., Washington, DC www.ferc.gov. To facilitate electronic at issue in the following proceedings: 20426. service, persons with Internet access The filings in the above-referenced Docket No. Entergy Services, Inc. proceeding are accessible in the who will eFile a document and/or be OA07–32. Commission’s eLibrary system by listed as a contact for an intervenor Docket No. Entergy Services, Inc. clicking on the appropriate link in the must create and validate an OA08–59. above list. They are also available for eRegistration account using the Docket No. Louisiana Public Service review in the Commission’s Public eRegistration link. Select the eFiling EL00–66. Commission v. Entergy link to log on and submit the Services, Inc. Reference Room in Washington, DC. Docket No. Louisiana Public Service There is an eSubscription link on the intervention or protests. EL01–88. Commission v. Entergy Web site that enables subscribers to Persons unable to file electronically Services, Inc. receive e-mail notification when a should submit an original and 14 copies Docket No. Arkansas Electric Coopera- document is added to a subscribed of the intervention or protest to the EL05–15. tive Corp. v. Entergy Ar- docket(s). For assistance with any FERC Federal Energy Regulatory Commission, kansas, Inc. Online service, please e-mail Docket No. Louisiana Public Service 888 First St., NE., Washington, DC EL07–52. Commission v. Entergy [email protected]. or call 20426. (866) 208–3676 (toll free). For TTY, call Services, Inc. Docket No. Louisiana Public Service (202) 502–8659. The filings in the above-referenced proceeding are accessible in the EL08–51. Commission v. Entergy Kimberly D. Bose, Services, Inc. Commission’s eLibrary system by Docket No. Ameren Services Co. v. Secretary. clicking on the appropriate link in the EL08–60. Entergy Services, Inc. [FR Doc. 2010–8586 Filed 4–14–10; 8:45 am] above list. They are also available for Docket No. Arkansas Public Service BILLING CODE 6717–01–P review in the Commission’s Public EL09–43. Commission v. Entergy Reference Room in Washington, DC. Services, Inc. There is an eSubscription link on the Docket No. Louisiana Public Service DEPARTMENT OF ENERGY Web site that enables subscribers to EL09–61. Commission v. Entergy Services, Inc. Federal Energy Regulatory receive e-mail notification when a Docket No. South Mississippi Electric Commission document is added to a subscribed EL09–78. Power Association v. docket(s). For assistance with any FERC Entergy Services, Inc. [Docket No. ER10–1030–000] Online service, please e-mail Docket No. Louisiana Public Service EL10–55. Commission v. Entergy West Oaks Energy NY/NE, LP; [email protected] or call (866) 208–3676 (toll free). For TTY, call Services, Inc. Supplemental Notice That Initial Docket No. Entergy Services, Inc. Market-Based Rate Filing Includes (202) 502–8659. ER05–1065. Request for Blanket Section 204 Kimberly D. Bose, Docket No. Entergy Services, Inc. Authorization ER07–682. Secretary. Docket No. Entergy Services, Inc. April 8, 2010. [FR Doc. 2010–8582 Filed 4–14–10; 8:45 am] ER07–956. This is a supplemental notice in the BILLING CODE 6717–01–P Docket No. Entergy Services, Inc. above-referenced proceeding of West ER08–767. Oaks Energy NY/NE LP’s application for Docket No. Entergy Services, Inc. ER08–1056. market-based rate authority, with an Docket No. Entergy Services, Inc. accompanying rate tariff, noting that ER08–1057. such application includes a request for Docket No. Entergy Services, Inc. blanket authorization, under 18 CFR ER09–636. part 34, of future issuances of securities Docket No. Entergy Services, Inc. and assumptions of liability. ER09–833.

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Docket No. Entergy Services, Inc. serve motions to intervene or protests when a document is added to a ER09–877. on persons other than the Applicant. subscribed docket(s). For assistance Docket No. Entergy Services, Inc. The Commission encourages with any FERC Online service please e- ER09–882. electronic submission of protests and Docket No. Entergy Services, Inc. mail [email protected], or ER09–1214. interventions in lieu of paper using the call (866) 208–3676 (toll free). For TTY, Docket No. Entergy Services, Inc. ‘‘eFiling’’ link at http://www.ferc.gov. call (202) 502–8659. ER09–1224. Persons unable to file electronically Please note that the review of Denali’s Docket No. Entergy Services, Inc. should submit an original and 14 copies Alaska’s Open Season Plan is being ER10–794. of the protest or intervention to the done as part of the pre-filing phase of Docket No. Entergy Services, Inc. Federal Energy Regulatory Commission, Denali’s Alaska Project. Docket No. ER10–879. 888 First Street, NE., Washington, DC PF08–26–001 has been reserved for the Docket No. Entergy Services, Inc. 20426. Open Season Plan and commenters ER10–984. This filing is accessible on-line at should use the –001 sub-docket for These meetings are open to the http://www.ferc.gov, using the filings regarding the Open Season Plan. ‘‘ ’’ public. eLibrary link and is available for The Commission’s Web page for For more information, contact Patrick review in the Commission’s Public eSubscription allows for subscription Clarey, Office of Energy Market Reference Room in Washington, DC. only to this specific sub-docket, Docket Regulation, Federal Energy Regulatory There is an ‘‘eSubscription’’ link on the No. PF08–26–001 or, for those Commission at (317) 249–5937 or Web site that enables subscribers to interested in the entire pre-filing [email protected]. receive e-mail notification when a process to, ‘‘Subscribe to root docket and document is added to a subscribed all existing and new sub-dockets.’’ Kimberly D. Bose, docket(s). For assistance with any FERC Denali states that, when completed, Secretary. Online service, please e-mail the Alaska Project will consist of two [FR Doc. 2010–8585 Filed 4–14–10; 8:45 am] [email protected], or call FERC-jurisdictional transmission lines BILLING CODE 6717–01–P (866) 208–3676 (toll free). For TTY, call on the North Slope of Alaska, a FERC- (202) 502–8659. jurisdictional gas treatment plant that Comment Date: 5 p.m. Eastern Time will treat North Slope gas for pipeline DEPARTMENT OF ENERGY on Wednesday April 21, 2010. transportation, and a FERC- jurisdictional gas mainline that will Kimberly D. Bose, Federal Energy Regulatory extend from the Alaska North Slope to Commission Secretary. the border between Alaska and Canada. [Docket No. PR10–14–000] [FR Doc. 2010–8588 Filed 4–14–10; 8:45 am] Pursuant to section 157.38 of the BILLING CODE 6717–01–P Commission’s Regulations, the Enterprise Texas Pipeline LLC; Notice Commission plans to act on the Denali of Petition for Rate Approval proposed Open Season Plan by June 7, DEPARTMENT OF ENERGY 2010. Denali states that if its Open April 7, 2010. Season Plan is approved by the Take notice that on April 1, 2010, Federal Energy Regulatory Enterprise Texas Pipeline LLC Commission Commission, the Open Season will commence on July 6, 2010, and (Enterprise Texas) filed a petition for [Docket No. PF08–26–001] rate approval pursuant to section conclude on October 4, 2010. Any questions regarding this Request 284.123(b)(2) of the Commission’s Denali—The Alaska Gas Pipeline LLC; regulations. Enterprise Texas proposes for Approval of Denali’s Open Season Notice of Request for Approval of Plan Plan may be directed to: rates of $0.6090 per MMBtu for Rate for Conducting an Open Season Zone 1—Legacy Assets and $0.6744 for James F. Moriarty, Locke Lord Bissell & Rate Zone 2—Sherman Extension April 8, 2010. Liddell LLP, 701 8th Street, NW.— Facilities. Take notice that on April 7, 2010, Suite 700, Washington, DC 20001. Any person desiring to participate in pursuant to section 157.38 of the (202) 220–6915. this rate proceeding must file a motion Commission’s Regulations governing [email protected]. to intervene or to protest this filing must Open Seasons for Alaska Natural Gas Patrick J. Coughlin, Vice President & file in accordance with Rules 211 and Transportation Projects, Denali—The General Counsel, Denali—The Alaska 214 of the Commission’s Rules of Alaska Gas Pipeline LLC (Denali) filed Gas Pipeline LLC, 188 West Northern Practice and Procedure (18 CFR 385.211 a Request for Commission Approval of Lights Blvd., P.O. Box 241747, and 385.214). Protests will be its Plan for Conducting an Open Season. Anchorage, AK 99524–1747. (907) considered by the Commission in The proposed Open Season is being 865–4709. determining the appropriate action to be held to solicit binding commitments for [email protected]. taken, but will not serve to make gas treatment plant services (treating Any person desiring to comment on protestants parties to the proceeding. and compression) and firm natural gas this filing or file a motion to intervene Any person wishing to become a party transportation provided by Denali’s in this phase of the project must file in must file a notice of intervention or proposed Alaska Project, which is more accordance with the Rule 212 of motion to intervene, as appropriate. fully described in the filing. Commission’s Rules of Practice and Such notices, motions, or protests must This filing is accessible online at Procedure. All comments will be be filed on or before 5 p.m. Eastern time http://www.ferc.gov, using the considered by the Commission in on the date as indicated below. Anyone ‘‘eLibrary’’ link and is available for determining the appropriate action to be filing an intervention or protest must review in the Commission’s Public taken. In addition to the filing of serve a copy of that document on the Reading Room in Washington, DC. comments, the Commission will permit Applicant. Anyone filing an There is an ‘‘eSubscription’’ link on the the filing of reply comments pursuant to intervention or protest on or before the Commission’s Web site that enables its authority under Rule 213 of the intervention or protest date need not subscribers to receive e-mail notification Commission’s Rules of Practice and

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Procedure. The due dates for motions to Natural Gas Act (NGA). Creole Trail of intervention and, pursuant to section intervene, comments and reply seeks authorization to construct and 157.205 of the Commission’s comments are listed below. operate approximately 550 feet of 12- Regulations under the NGA (18 CFR The Commission strongly urges inch diameter pipe (no above ground 157.205) a protest to the request. If no electronic filings of comments and reply facilities will be constructed) from an protest is filed within the time allowed, comments in lieu of paper using the existing tap on Segment 1 of Creole the proposed activity shall be deemed to ‘‘eFiling’’ link at http://www.ferc.gov. Trail’s system to an existing meter be authorized effective the day after the Persons unable to file electronically station at Cameron Meadows Processing time allowed for protest. If a protest is should submit an original and 7 copies Plant, owned by PSI Midstream filed and not withdrawn within 30 days of their comments or reply comments to: Partners, L.P., all located in Johnson after the time allowed for filing a Federal Energy Regulatory Commission, Bayou, Cameron Parish, Louisiana, to protest, the instant request shall be 888 First Street, NE., Washington, DC enable the delivery of up to 250 MMcf treated as an application for 20426. (Label cover letter or first page per day of re-gasified LNG to the plant authorization pursuant to section 7 of with case name, Denali—The Alaska for processing. The cost is estimated to the NGA. Gas Pipeline LLC—Docket No. PF08– be $450,000. Creole Trail proposes to 26–001) The Commission strongly encourages perform these activities under its electronic filings of comments, protests, Comment Date: April 30, 2010. blanket certificate issued in Docket No. Reply Comment Date: May 13, 2010. and interventions via the Internet in lieu CP05–358–000 [115 FERC ¶ 61,331 of paper. See 18 CFR 385.2001(a)(1)(iii) Kimberly D. Bose, (2006)], all as more fully set forth in the and the instructions on the Secretary. application which is on file with the Commission’s Web site (http:// Commission and open to public [FR Doc. 2010–8581 Filed 4–14–10; 8:45 am] www.ferc.gov) under the ‘‘e-Filing’’ link. inspection. BILLING CODE 6717–01–P Persons unable to file electronically The filing may be viewed on the Web should submit an original and 14 copies at http://www.ferc.gov using the of the protest or intervention to the ‘‘eLibrary’’ link. Enter the docket number DEPARTMENT OF ENERGY Federal Energy Regulatory Commission, excluding the last three digits in the 888 First Street, NE., Washington, DC Federal Energy Regulatory docket number field to access the 20426. Commission document. For assistance, contact FERC at [email protected] or call [Docket No. CP10–118–000] Kimberly D. Bose, toll-free, (886) 208–3676 or TYY, (202) Secretary. Cheniere Creole Trail Pipeline, L.P.; 502–8659. [FR Doc. 2010–8592 Filed 4–14–10; 8:45 am] Any questions regarding this Notice of Request Under Blanket BILLING CODE 6717–01–P Authorization application may be directed to Karri Mahmoud, Manager, Regulatory and April 7, 2010. Compliance, Cheniere Energy, Inc., 700 DEPARTMENT OF ENERGY Take notice that on April 2, 2010, Milam, Suite 800, Houston, Texas Cheniere Creole Trail Pipeline, L.P. 77002, or phone at (713) 375–5000. Federal Energy Regulatory (Creole Trail), 700 Milam, Suite 800, Any person or the Commission’s Staff Commission Houston, Texas 77002, filed in Docket may, within 60 days after the issuance No. CP10–118–000, a prior notice of the instant notice by the Commission, Notice of Revocation of Market-Based request pursuant to sections 157.205, file pursuant to Rule 214 of the Rate Tariff 157.208, and 157.212 of the Commission’s Procedural Rules (18 CFR Commission’s regulations under the 385.214) a motion to intervene or notice April 8, 2010.

Electric Quarterly Reports ...... Docket No. ER02–2001–014. G&G Energy, Inc ...... Docket No. ER07–514–000. NCSU Energy, Inc ...... Docket No. ER07–177–000. Primary Power Marketing LLC ...... Docket No. ER98–4333–000. WASP Energy, LLC ...... Docket No. ER05–1020–000.

On March 18, 2010, the Commission including power marketers, to file In the March 18 Order, the issued an order announcing its intent to Electric Quarterly Reports summarizing Commission directed G&G Energy, Inc.; revoke the market-based rate authority the contractual terms and conditions in NCSU Energy, Inc.; Primary Power of the above captioned public utilities, their agreements for all jurisdictional Marketing LLC. and WASP Energy, LLC which had failed to file their required services (including market-based power to file the required Electric Quarterly Electric Quarterly Reports.1 The sales, cost-based power sales, and Reports within 15 days of the date of Commission provided the utilities transmission service) and providing issuance of the order or face revocation fifteen days in which to file their transaction information (including rates) of their authority to sell power at overdue Electric Quarterly Reports or for short-term and long-term power market-based rates and termination of 3 face revocation of their market-based sales during the most recent calendar their electric market-based rate tariffs. rate tariffs. quarter.2 The time period for compliance with In Order No. 2001, the Commission the March 18 Order has elapsed. The revised its public utility filing 2 Revised Public Utility Filing Requirements, four companies identified in the March requirements and established a Order No. 2001, 67 FR 31,043, FERC Stats. & Regs. 18 Order (G&G Energy, Inc.; NCSU requirement for public utilities, ¶ 31,127, reh’g denied, Order No. 2001–A, 100 FERC ¶ 61,074, reconsideration and clarification ¶ 61,314 (2002), order directing filing, Order No. 1 Electric Quarterly Reports, 130 FERC ¶ 61,187 denied, Order No. 2001–B, 100 FERC ¶ 61,342, 2001–D, 102 FERC ¶ 61,334 (2003). (2010) (March 18 Order). order directing filings, Order No. 2001–C, 101 FERC 3 March 18 Order at Ordering Paragraph A.

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Energy, Inc.; Primary Power Marketing FEDERAL RESERVE SYSTEM Act (‘‘PRA’’). The FTC is seeking public LLC. and WASP Energy, LLC) have comments on its proposal to extend failed to file their delinquent Electric Federal Open Market Committee; through May 31, 2013, the current PRA Quarterly Reports. Domestic Policy Directive of March 16, clearance for information collection The Commission hereby revokes the 2010 requirements contained in its Contact Lens Rule. That clearance expires on market-based rate authority and In accordance with § 271.25 of its May 31, 2010. terminates the electric market-based rate rules regarding availability of tariffs of the above-captioned public information (12 CFR part 271), there is DATES: Comments must be received on utilities. set forth below the domestic policy or before May 17, 2010. Kimberly D. Bose, directive issued by the Federal Open ADDRESSES: Interested parties are Secretary. Market Committee at its meeting held invited to submit written comments on March 16, 2010.1 electronically or in paper form, by [FR Doc. 2010–8580 Filed 4–14–10; 8:45 am] The Federal Open Market Committee following the instructions in the BILLING CODE 6717–01–P seeks monetary and financial conditions Request for Comments part of the that will foster price stability and SUPPLEMENTARY INFORMATION section promote sustainable growth in output. below. Comments in electronic form To further its long–run objectives, the FEDERAL ELECTION COMMISSION should be submitted by using the Committee seeks conditions in reserve following Web link: (https:// Sunshine Act Notices markets consistent with federal funds public.commentworks.com/ftc/ trading in a range from 0 to 1⁄4 percent. contactlensrulepra2) (and following the AGENCY: Federal Election Commission. The Committee directs the Desk to instructions on the web-based form). complete the execution of its purchases Comments in paper form should be Cancellation of about $1.25 trillion of agency MBS mailed or delivered to the following and of about $175 billion in housing– address: Federal Trade Commission, DATE AND TIME: Wednesday, April 14, related agency debt by the end of March. Office of the Secretary, Room H–135 2010, at 11 a.m. The Committee directs the Desk to (Annex J), 600 Pennsylvania Avenue, PLACE: 999 E Street, NW., Washington, engage in dollar roll transactions as NW, Washington, DC 20580, in the DC (Ninth Floor). necessary to facilitate settlement of the manner detailed in the SUPPLEMENTARY Federal Reserve’s agency MBS INFORMATION below. STATUS: This hearing has been canceled. transactions. The System Open Market FOR FURTHER INFORMATION CONTACT: AUDIT HEARING: Biden For President, Inc. Account Manager and the Secretary will Requests for copies of the collection of * * * * * keep the Committee informed of information and supporting ongoing developments regarding the documentation should be addressed to DATE AND TIME: Thursday, April 15, System’s balance sheet that could affect 2010, at 10 a.m. Karen Jagielski, Attorney, Division of the attainment over time of the Advertising Practices, Bureau of PLACE: 999 E Street, NW., Washington, Committee’s objectives of maximum Consumer Protection, Federal Trade DC (Ninth Floor). employment and price stability. Commission, 600 Pennsylvania Avenue, By order of the Federal Open Market NW., NJ– 3212, Washington, DC 20580, STATUS: This Meeting Will Be Open To Committee, April 8, 2010. The Public. (202) 326-2509. Brian F. Madigan, SUPPLEMENTARY INFORMATION: Items To Be Discussed Secretary, Federal Open Market Committee. Background Correction and Approval of Minutes. [FR Doc. 2010–8593 Filed 4–14–10; 8:45 am] Under the PRA, 44 U.S.C. 3501-3520, Report of the Audit Division on the BILLING CODE 6210–01–S federal agencies must obtain approval Tennessee Democratic Party (TDP). from OMB for each collection of Report of the Audit Division on Friends FEDERAL TRADE COMMISSION information they conduct or sponsor. for Menor Committee. ‘‘Collection of information’’ means 2010 Rulemaking Schedule. Agency Information Collection agency requests or requirements that Management and Administrative Activities; Submission for OMB members of the public submit reports, Matters. Review; Comment Request keep records, or provide information to a third party. 44 U.S.C. 3502(3); 5 CFR Individuals who plan to attend and AGENCY: Federal Trade Commission 1320.3(c). (‘‘FTC’’ or ‘‘Commission’’). require special assistance, such as sign On December 24, 2009, the FTC language interpretation or other ACTION: Notice and request for comment. sought comment on the information reasonable accommodations, should collection requirements associated with SUMMARY: The information collection contact Darlene Harris, Acting the Contact Lens Rule (the Rule), 16 requirements described below will be Commission Secretary, at (202) 694– CFR part 315. No comments were submitted to the Office of Management 1040, at least 72 hours prior to the received. Pursuant to the OMB and Budget (‘‘OMB’’) for review, as hearing date. regulations, 5 CFR Part 1320, that required by the Paperwork Reduction PERSON TO CONTACT FOR INFORMATION: implement the PRA, the FTC is Judith Ingram, Press Officer, Telephone: 1 Copies of the Minutes of the Federal Open providing this second opportunity for (202) 694–1220. Market Committee at its meeting held on March 16, public comment while seeking OMB 2010, which includes the domestic policy directive approval to renew the pre-existing Darlene Harris, issued at the meeting, are available upon request to clearance for the Rule (OMB Control No. Acting Secretary of the Commission. the Board of Governors of the Federal Reserve System, Washington, D.C. 20551. The minutes are 3084-0095). All comments should be [FR Doc. 2010–8452 Filed 4–14–10; 8:45 am] published in the Federal Reserve Bulletin and in filed as prescribed in the ADDRESSES BILLING CODE 6715–01–M the Board’s annual report. section above and in the Request for

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Comments (found below), and must be Because comments will be made should be submitted via facsimile to received on or before May 17, 2010. public, they should not include any (202) 395-5167 because U.S. postal mail The Rule was promulgated by the FTC sensitive personal information, such as at the OMB is subject to delays due to pursuant to the Fairness to Contact Lens an individual’s Social Security Number; heightened security precautions. Consumers Act (‘‘FCLCA’’), Pub. L. 108– date of birth; driver’s license number or The FTC Act and other laws the 164 (December 6, 2003), which was other state identification number, or Commission administers permit the enacted to enable consumers to foreign country equivalent; passport collection of public comments to purchase contact lenses from the seller number; financial account number; or consider and use in this proceeding as of their choice. The Rule became credit or debit card number. Comments appropriate. The Commission will effective on August 2, 2004. As also should not include any sensitive consider all timely and responsive mandated by the FCLCA, the Rule health information, such as medical public comments that it receives, requires the release and verification of records or other individually whether filed in paper or electronic contact lens prescriptions and contains identifiable health information. In form. Comments received will be recordkeeping requirements applying to addition, comments should not include available to the public on the FTC’s Web both prescribers and sellers of contact any ‘‘[t]rade secret or any commercial or site, to the extent practicable, at (http:// lenses. financial information which is obtained www.ftc.gov/os/publiccomments.shtm). Specifically, the Rule requires that from any person and which is privileged As a matter of discretion, the prescribers provide a copy of the or confidential. . .,’’ as provided in Commission makes every effort to prescription to the consumer upon the Section 6(f) of the Federal Trade remove home contact information for completion of a contact lens fitting and Commission Act (‘‘FTC Act’’), 15 U.S.C. individuals from the public comments it verify or provide prescriptions to 46(f), and Commission Rule 4.10(a)(2), receives before placing those comments authorized third parties. The Rule also 16 CFR 4.10(a)(2). Comments containing on the FTC’s Web site. More information, including routine uses mandates that a contact lens seller may material for which confidential permitted by the Privacy Act, may be sell contact lenses only in accordance treatment is requested must be filed in found in the FTC’s privacy policy at with a prescription that the seller either: paper form, must be clearly labeled ‘‘ ’’ (http://www.ftc.gov/ftc/privacy.shtm). (a) Has received from the patient or Confidential, and must comply with prescriber; or (b) has verified through FTC Rule 4.9(c). Burden Statement Because paper mail addressed to the direct communication with the FTC is subject to delay due to Commission staff estimates the prescriber. In addition, the Rule heightened security screening, please paperwork burden of the FCLCA and imposes recordkeeping requirements on consider submitting your comments in Rule based on its knowledge of the eye contact lens prescribers and sellers. For electronic form. Comments filed in care industry. Staff believes there will example, the Rule requires prescribers electronic form should be submitted by be some burden on individual to document in their patients’ records using the following Web link: (https:// prescribers to provide contact lens the medical reasons for setting a contact public.commentworks.com/ftc/ prescriptions, although it involves lens prescription expiration date of less contactlensrulepra2) (and following the merely writing a few items of than one year. The Rule requires contact instructions on the web-based form). If information onto a slip of paper and lens sellers to maintain records for three this Notice appears at (http:// handing it to the patient, or perhaps years of all direct communications www.regulations.gov), you may also file mailing or faxing it to a third party. In involved in obtaining verification of a an electronic comment through that addition, there will be some contact lens prescription, as well as Web site. The Commission will consider recordkeeping burden on contact lens prescriptions, or copies thereof, which all comments that regulations.gov sellers—including retaining they receive directly from customers or forwards to it. prescriptions or records of ‘‘direct prescribers. A comment filed in paper form communications’’—pertaining to each The information retained under the should include the ‘‘Contact Lens Rule: sale of contact lenses to consumers who Rule’s recordkeeping requirements is FTC File No. P054510’’ reference both in received their original prescription from used by the Commission to substantiate the text and on the envelope, and a third party prescriber. compliance with the Rule and may also should be mailed or delivered to the Estimated total annual hours burden: provide a basis for the Commission to following address: Federal Trade 850,000 hours (rounded to the nearest bring an enforcement action. Without Commission, Office of the Secretary, thousand). Based upon staff knowledge the required records, it would be Room H–135 (Annex J), 600 of the industry, this figure is derived by difficult either to ensure that entities are Pennsylvania Avenue, NW, Washington, adding approximately 567,000 complying with the Rule’s requirements DC 20580. The FTC is requesting that disclosure hours for contact lens or to bring enforcement actions based on any comment filed in paper form be sent prescribers to approximately 283,000 violations of the Rule. by courier or overnight service, if recordkeeping hours for contact lens sellers, for a combined industry total of Request for Comments possible, because U.S. postal mail in the Washington area and at the Commission 850,000 hours. This is slightly lower Interested parties are invited to is subject to delay due to heightened than the estimates previously submitted submit written comments electronically security precautions. to OMB (the similar figure was 950,000 or in paper form. Comments should Comments on any proposed hours in 2006); and is due to a drop in refer to ‘‘Contact Lens Rule: FTC File recordkeeping, or disclosure the estimated number of contact lens No. P054510’’ to facilitate the requirements that are subject to wearers from 36 million (2006) to 34 organization of comments. Please note Paperwork Reduction Act review by the million (2008). that your comment — including your Office of Management and Budget No provisions in the Rule have been name and your state — will be placed should additionally be submitted to: amended since staff’s prior submission on the public record of this proceeding, Office of Information and Regulatory to OMB. The Rule’s disclosure and including on the publicly accessible Affairs, Office of Management and recordkeeping requirements, therefore, FTC Web site, at (http://www.ftc.gov/os/ Budget, Attention: Desk Officer for remain the same. As noted above, the publiccomments.shtm). Federal Trade Commission. Comments number of contact lens wearers in the

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United States is estimated to be as they are the entities in the industry 566,666.7 hours) + ($12.90 × 283,333.3 approximately 34 million.1 Therefore, most reliant on obtaining or verifying hours) = $32,317,000] assuming an annual contact lens exam contact lens prescriptions. Based on The contact lens market is a for each contact lens wearer, 34 million conversations with the industry, staff multibillion dollar market; one recent people would receive a copy of their estimates that these entities currently survey estimates that contact lens sales prescription each year under the Rule. account for approximately 10% of sales totaled $2.37 billion from Jan 1, 2006 to At an estimated one minute per in the contact lens market2 and, by Dec 31, 2006.4 Thus, the total labor cost prescription, the annual time spent by extension, that approximately 3.4 burden estimate of $32.3 million prescribers complying with the million consumers—10% of the 34 represents approximately 1.5% of the disclosure requirement would be a million contact lens wearers in the overall market. maximum of 567,000 hours. [(34 million United States—purchase their lenses Estimated annual non-labor cost × 1 minute)/60 minutes = 566,667 from them. burden: $0 or minimal. hours] At an estimated five minutes per sale Staff believes that the Rule’s As required by the FCLCA, the Rule to each of 3.4 million consumers, disclosure and recordkeeping also imposes two recordkeeping contact lens sellers will spend a total of requirements impose negligible capital requirements. First, prescribers must 283,300 burden hours complying with or other non-labor costs, as the affected document the specific medical reasons the recordkeeping requirement. [(3.4 entities are likely to have the necessary for setting a contact lens prescription million × 5 minutes)/60 minutes = supplies and/or equipment already (e.g., expiration date shorter than the one year 283,333.3 hours] This estimate likely prescription pads, patients’ medical minimum established by the FCLCA. overstates the actual burden, however, charts, facsimile machines and paper, This burden is likely to be nil because because it includes the time spent by telephones, and recordkeeping facilities the requirement applies only in cases sellers who already keep records such as filing cabinets or other storage). when the prescriber invokes the medical pertaining to contact lens sales in the Willard Tom, judgment exception, which is expected ordinary course of business. In addition, General Counsel. to occur infrequently, and prescribers the estimate may overstate the time are likely to record this information in [FR Doc. 2010–8647 Filed 4–14–10: 8:45 am] spent by sellers to the extent that BILLING CODE: 6750–01–S the ordinary course of business as part records (e.g., verification requests) are of their patients’ medical records. The generated and stored automatically and OMB regulation that implements the electronically, which staff understands PRA defines ‘‘burden’’ to exclude any DEPARTMENT OF HEALTH AND is the case for some larger online sellers. HUMAN SERVICES effort that would be expended Estimated labor costs: $32,317,000 regardless of a regulatory requirement. 5 (rounded to the nearest thousand). Health Resources and Services CFR 1320.3(B)(3)(2). Commission staff derived labor costs Administration Second, the Rule requires contact lens by applying appropriate hourly cost sellers to maintain certain documents figures to the burden hours described Agency Information Collection relating to contact lens sales. As noted above. Staff estimates, based on its Activities: Submission for OMB above, a seller may sell contact lenses knowledge of the industry, that Review; Comment Request only in accordance with a prescription optometrists account for approximately Periodically, the Health Resources that the seller either (a) has received 75% of prescribers. Consequently, for and Services Administration (HRSA) from the patient or prescriber, or (b) has simplicity, staff will focus on their publishes abstracts of information verified through direct communication average hourly wage in estimating collection requests under review by the with the prescriber. The FCLCA requires prescribers’ labor cost burden. Office of Management and Budget sellers to retain prescriptions and According to Bureau of Labor (OMB), in compliance with the records of communications with Statistics from May 2008, salaried Paperwork Reduction Act of 1995 (44 prescribers relating to prescription optometrists earn an average wage of U.S.C. Chapter 35). To request a copy of verification for three years. $50.58 per hour and general office Staff believes that the burden of the clearance requests submitted to clerical personnel earn an average of complying with this requirement is low. OMB for review, call the HRSA Reports $12.90 per hour.3 Sellers who seek verification of contact Clearance Office on (301) 443–0371. With these categories of personnel, lens prescriptions must retain one or The following request has been respectively, likely to perform the brunt two records for each contact lens sale: submitted to the Office of Management of the disclosure (for optometrists) and Either the relevant prescription itself, or and Budget for review under the recordkeeping (for office clerks) aspects the verification request and any Paperwork Reduction Act of 1995: of the Rule, estimated total labor cost response from the prescriber. Staff attributable to the Rule would be Proposed Project: HRSA AIDS estimates that such recordkeeping will approximately $32.8 million. [($50.58 × Education and Training Centers entail a maximum of five minutes per Evaluation Activities (OMB No. 0915– sale, including time spent preparing a 2 The FTC’s February 2005 study, ‘‘The Strength 0281)—Revision file and actually filing the record(s). of Competition in the Rx Sale of Contact Lenses: An Staff also believes that, based on its FTC Study,’’ cites various data that, averaged The AIDS Education and Training knowledge of the industry, this burden together, suggests that approximately 10% of Centers (AETC) Program, under the Title will fall primarily on mail order and contact lens sales are by online and mail-order XXVI of the Public Health Service Act, sellers. The report is available online at (http:// as amended, Ryan White HIV/AIDS Internet-based sellers of contact lenses, www.ftc.gov/reports/contactlens/ 050214contactlensrpt.pdf). Program legislation, supports a network 1 See Contact Lenses, Frequently Asked 3 Mean and median worker hourly wages for Questions, Nov. 2009, available at (http:// optometrists and general office clerks are drawn 4 The Vision Council of America and Jobson www.allaboutvision.com/faq/contactlens.htm.) See from the Bureau of Labor Statistics (BLS) Optical Research have conducted large scale also Nichols, J. ‘‘Annual Report: Contact Lenses Occupational Employment and Statistics Survey, continuous consumer research under the name 2008,’’ Contact Lens Spectrum, Jan. 2009, available May 2008, based on BLS-sampled data it collected VisionWatch, which reports on the vision care at (http://www.clspectrum.com/ over a 3-year period. See (http://www.bls.gov/ industry. The basis for this statistic is on file with article.aspx?article=102473). news.release/pdf/ocwage.pdf) (Table 1). the Federal Trade Commission.

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of regional and cross-cutting national forms on AETC training events, and the achieved through training events. centers that conduct targeted, multi- centers are required to report aggregate Collection of this information allows disciplinary education and training data on their activities to HRSA and the HRSA and HAB to provide information programs for health care providers HIV/AIDS Bureau (HAB). This data on training activities and types of treating persons with HIV/AIDS. The collection provides information on the education and training provided to Ryan AETCs’ purpose is to increase the number of training events, including White HIV/AIDS Program Grantees, number of health care providers who are clinical trainings and consultations, as resource allocation, and capacity effectively educated and motivated to well as technical assistance activities expansion. counsel, diagnose, treat, and medically conducted by each regional center, the manage individuals with HIV infection, number of health care providers Trainees are asked to complete the and to help prevent high risk behaviors receiving professional training or Participant Information Form (PIF) for that lead to HIV transmission. consultation, and the time and effort each activity they complete, and As part of an ongoing effort to expended on different levels of training trainers, are asked to complete the Event evaluate AETC activities, information is and consultation activities. In addition, Record (ER). The estimated annual needed on AETC training sessions, information is obtained on the response burden to trainers as well as consultations, and technical assistance populations served by the AETC attendees of training programs is as activities. Each regional center collects trainees, and the increase in capacity follows:

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

PIF ...... 116,624 1 116,624 0.167 19,476 .2 ER ...... 18,070 1 18,070 0.2 3,614

Total ...... 134,694 ...... 134,694 ...... 23,090.2

The estimated annual burden to AETCs is as follows:

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

Aggregate data set ...... 12 2 24 32 768

The total burden hours are 23,858.2. States Code, as amended by the Proposed Project: Scholarships for Written comments and Paperwork Reduction Act of 1995 Disadvantaged Students Program (OMB recommendations concerning the Public Law 104–13, the Health No. 0915–0149) Extension proposed information collection should Resources and Services Administration The Scholarships for Disadvantaged be sent within 30 days of this notice to (HRSA) will publish periodic Students (SDS) Program has as its the desk officer for HRSA, either by e- summaries of proposed projects being purpose the provision of funds to mail to [email protected] developed for submission to the Office eligible schools to provide scholarships or by fax to 202–395–6974. Please direct of Management and Budget (OMB) to full-time students with financial need all correspondence to the ‘‘attention of under the Paperwork Reduction Act of from disadvantaged backgrounds the desk officer for HRSA.’’ 1995. To request more information on enrolled in health professions and Dated: April 7, 2010. the proposed project or to obtain a copy nursing programs. Sahira Rafiullah, of the data collection plans, call HRSA To qualify for participation in the SDS Director, Division of Policy and Information Reports Clearance Officer at 301–443– program, a school must be carrying out Coordination. 1129. a program for recruiting and retaining [FR Doc. 2010–8622 Filed 4–14–10; 8:45 am] Comments are invited on: (a) Whether students from disadvantaged BILLING CODE 4165–15–P the proposed collection of information backgrounds, including students who is necessary for the proper performance are members of racial and ethnic of the functions of the agency, including minority groups (section 737(d)(1)(B) of DEPARTMENT OF HEALTH AND the Public Health Service (PHS) Act). A HUMAN SERVICES whether the information shall have practical utility; (b) the accuracy of the school must meet the eligibility criteria to demonstrate that the program has agency’s estimate of the burden of the Health Resources and Services achieved success based on the number proposed collection of information; (c) Administration and/or percentage of disadvantaged ways to enhance the quality, utility, and Agency Information Collection students who graduate from the school. clarity of the information to be collected In awarding SDS funds to eligible Activities: Proposed Collection: and; (d) ways to minimize the burden of Comment Request schools, funding priorities must be the collection of information on given to schools based on the proportion In compliance with the requirement respondents, including through the use of graduating students going into for opportunity for public comment on of automated collection techniques of primary care, the proportion of proposed data collection projects other forms of information technology. underrepresented minority students, (section 350(c)(2)(A) of Title 44, United and the proportion of graduates working

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in medically underserved communities The estimated response burden is as (section 737(c) of the PHS Act). follows:

Responses Form Number of per Hours per Total burden respondents respondents response hours

SDS Application ...... 600 1 13 7,800 SDS Report ...... 600 1 1 600

Total ...... 600 1 14 8,400

E-mail comments to DATES: Fax written comments on the communicate (either directly or through [email protected] or mail to the collection of information by May 17, a business associate in the foreign HRSA Reports Clearance Officer, Room 2010. country) with a representative of the 10–33, Parklawn Building, 5600 Fishers ADDRESSES: To ensure that comments on foreign government to which they seek Lane, Rockville, MD 20857. Written the information collection are received, exportation, and written authorization comments should be received within 60 OMB recommends that written must be obtained from the appropriate days of this notice. comments be faxed to the Office of office within the foreign government Dated: April 6, 2010. Information and Regulatory Affairs, approving the importation of the medical device. An alternative to Sahira Rafiullah, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or e-mailed to obtaining written authorization from the Director, Division of Policy and Information _ foreign government is to accept a Coordination. oira [email protected]. All comments should be identified with the notarized certification from a [FR Doc. 2010–8623 Filed 4–14–10; 8:45 am] OMB control number 0910–0264. Also responsible company official in the BILLING CODE 4165–15–P include the FDA docket number found United States that the product is not in in brackets in the heading of this conflict with the foreign country’s laws. document. This certification must include a DEPARTMENT OF HEALTH AND statement acknowledging that the FOR FURTHER INFORMATION CONTACT: HUMAN SERVICES responsible company official making the Daniel Gittleson, Office of Information certification is subject to the provisions Management, Food and Drug Food and Drug Administration of 18 U.S.C. 1001. This statutory Administration, 1350 Piccard Dr., PI50– provision makes it a criminal offense to 400B, Rockville, MD 20850, 301–796– [Docket No. FDA–2010–N–0031] knowingly and willingly make a false or 5156, [email protected]. fraudulent statement, or make or use a SUPPLEMENTARY INFORMATION: Agency Information Collection In false document, in any manner within Activities; Submission for Office of compliance with 44 U.S.C. 3507, FDA the jurisdiction of a department or Management and Budget Review; has submitted the following proposed agency of the United States. The collection of information to OMB for Comment Request; Export of Medical respondents to this collection of review and clearance. Devices-Foreign Letters of Approval information are companies that seek to Export of Medical Devices-Foreign export medical devices. FDA’s estimate AGENCY: Food and Drug Administration, Letters of Approval (OMB Control of the reporting burden is based on the HHS. Number 0910–0264)—Extension experience of FDA’s medical device ACTION: Notice. Section 801(e)(2) of the Federal Food, program personnel. Drug, and Cosmetic Act (the act) (21 In the Federal Register of January 26, SUMMARY: The Food and Drug U.S.C. 381(e)(2)) provides for the 2010 (75 FR 4086), FDA published a 60- Administration (FDA) is announcing exportation of an unapproved device day notice requesting public comment that a proposed collection of under certain circumstances if the on the proposed collection of information has been submitted to the exportation is not contrary to the public information. No comments were Office of Management and Budget health and safety and it has the approval received. (OMB) for review and clearance under of the foreign country to which it is FDA estimates the burden of this the Paperwork Reduction Act of 1995. intended for export. Requesters collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Section of the Total Operating Federal Food, No. of Annual Frequency Total Annual Hours Total Hours and Maintenance Drug, and Respondents per Response Responses per Response 2 Cosmetic Act Costs

801(e)(2) 38 1 38 3 114 $6,250 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2Due to a clerical error, the operating and maintenance costs that appeared in the notice issued in the FEDERAL REGISTER of January 26, 2010, were reported as zero. The correct figure is in Table 1 of this document.

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Dated: April 9, 2010. DEPARTMENT OF HEALTH AND location(s) at the lowest geographical Leslie Kux, HUMAN SERVICES level possible for use in the designation Acting Assistant Commissioner for Policy. process, with the objective of Health Resources and Services [FR Doc. 2010–8572 Filed 4–14–10; 8:45 am] minimizing the level of effort required Administration on the part of States and communities BILLING CODE 4160–01–S seeking designations. Privacy Act of 1974; Report of an DATES: HRSA filed an altered system Altered System of Records DEPARTMENT OF HEALTH AND report with the Chair of the House HUMAN SERVICES AGENCY: Department of Health and Committee on Government Reform and Human Services (HHS), Health Oversight, the Chair of the Senate Health Resources and Services Resources & Services Administration Committee on Homeland Security and Administration (HRSA). Governmental Affairs, and the Administrator, Office of Information ACTION: Notice of an Altered System of and Regulatory Affairs, Office of National Advisory Council on Migrant Records (SOR). Health; Notice of Meeting Management and Budget (OMB) on SUMMARY: In accordance with the March 1, 2010. To ensure all parties In accordance with section 10(a)(2) of requirements of the Privacy Act of 1974, have adequate time in which to the Federal Advisory Committee Act the Health Resources and Services comment, the altered system, including (Pub. L. 92–463), notice is hereby given Administration (HRSA) is publishing the routine uses, will become effective of the following meeting: notice of a proposal to alter an existing 30 days from the publication of the System of Records. The existing system notice or 40 days from the date it was Name: National Advisory Council on of records, ‘‘State-Provided Physician submitted to OMB and Congress, Migrant Health. Records for the Application Submission whichever is later, unless HRSA Dates and Times: May 3, 2010, 8:30 a.m. & Processing System (ASAPS), Office of receives comments that require to 5 p.m. May 4, 2010, 8:30 a.m. to 5 p.m. Shortage Designation (OSD), Bureau of alterations to this notice. Place: Hard Rock Hotel San Diego, 207 5th Health Professions (BHPr), HRSA,’’ ADDRESSES: Please address comments to Avenue, San Diego, California 92101, SORN #09–15–0066, originally the Application Submission & Telephone: 619–702–3000, Fax: 877–344– published on January 10, 2005, covers Processing System (ASAP) System 7625. Manager, Office of Shortage Status: The meeting will be open to the health care practitioners who are the subjects of databases collected and Designation, Bureau of Health public. Professions, Health Resources and Purpose: The purpose of the meeting is to maintained by State Primary Care Offices/Associations. Such health care Services Administration, 5600 Fishers discuss services and issues related to the Lane, Room 8A–08, Rockville, Maryland health of migrant and seasonal farmworkers practitioners include physicians (both M.D.s and D.O.s), licensed or otherwise 20857; telephone (301) 594–4473. This and their families and to formulate is not a toll-free number. Comments recommendations for the Secretary of Health authorized by a State to provide health received will be available for inspection and Human Services. care services, dentists, and mental at this same address from 9 a.m. to 3 Agenda: The agenda includes an overview health professionals. This State p.m., (Eastern Standard ), of the Council’s general business activities. collected data may now also be made Monday through Friday. The Council will also hear presentations available to contractors employed by the from experts on farmworker issues, including OSD to assist in the application review FOR FURTHER INFORMATION CONTACT: the status of farmworker health at the local process. The States affected have signed Please contact the ASAPS, System and national levels. a Data Use Agreement permitting the Manager, Office of Shortage The Council meeting is being held in contractors to have access to their data. Designation, Bureau of Health conjunction with the National Farmworker The purposes of these alterations are Professions, Health Resources and Conference sponsored by the National to update the system manager location, Services Administration (HRSA), 5600 Association of Community Health Centers, authority for maintenance of the system, Fishers Lane, Room 8A–08, Rockville, which is being held in San Diego, California, categories of individuals covered by the Maryland 20857; telephone (301) 594– May 5–7, 2010. system and categories of records in the 4473. This is not a toll-free number. Agenda items are subject to change as system. Additionally, HRSA is adding SUPPLEMENTARY INFORMATION: The priorities indicate. FOR FURTHER INFORMATION new routine uses numbers 4 and 5, to following changes/additions are being CONTACT: Gladys Cate, Office of Minority and include the reviewing and processing made to the current System of Records Special Populations, Bureau of Primary assistance from contractors and the Routine Uses: (4) The Office of Shortage Health Care, Health Resources and Services breach notification language. This Designation (OSD) has contracted with Administration, 5600 Fishers Lane, Maryland system of records is required to comply a vendor to assist OSD in the review and 20857; telephone (301) 594–0367. with the implementation directives of processing of the HPSA and/or MUA/P Dated: April 7, 2010. Section 332 of the Public Health Service applications received by the State Act. The records will be used to support offices. Such access will only be granted Sahira Rafiullah, the ASAPS electronic application for to the contractors with the States’ Director, Division of Policy and Information the development, submission, and written permission, and all such Coordination. review of applications for HPSAs and contractors shall be required to sign a [FR Doc. 2010–8624 Filed 4–14–10; 8:45 am] MUPs. The most critical requirement for Rules of Behavior document, maintain BILLING CODE 4165–15–P accurate designation determinations is Privacy Act safeguards with respect to accurate data on the location of health such records, and return all records to care providers relative to the HRSA; (5) The SORN will now include population. To this end, OSD specific language to appropriate Federal continually tries to obtain the latest data agencies and Department contractors on primary care, dental, and mental that have a need to know the health providers and their practice information for the purpose of assisting

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the Department’s efforts to respond to a • Provider Status. of Health and Human Services shall suspected or confirmed breach of the • First Name. designate health professional shortage security or confidentiality of • Middle Name. areas, or HPSAs, and/or Medically information maintained in this system • Last Name. Underserved Populations, or MUPs, of records, and the information • Suffix. based on criteria established by • disclosed is relevant and necessary for Physician License Number. regulation. The authority for designation • Specialty Code. that assistance. Also being modified • of HPSAs is delegated to the Bureau of with this Altered System of Records Visa Status. Health Professions Office of Shortage • Federal Employee Status. Notice is the room number and program • Designation (OSD). Criteria and the name for the location of the system National Health Service Corps process used for designation of HPSAs manager. The room number is being Status. and/or MUPs were developed in • MD/DO/DDS. changed from 8C–26 to 8A–08 and the accordance with the requirements of • AMA ID. program name is being changed from • AOA ID. Section 332. Designation as a HPSA is the Shortage Designation Branch to the • Hospital Privileges Status. a prerequisite to application for Office of Shortage Designation. Lastly, • Gender. National Health Service Corps the authority for the maintenance of the • Source Type. recruitment assistance. To accomplish system has been changed from 42 CFR, • Address 1. this task, the OSD relies on data chapter 1, part 5—Designation of Health • Address 2. specified in 42 CFR Part 5, which Professional Shortage Areas and section • Address 3. implements Section 332, and HPSA 332 of the Public Health Service (PHS) • City. and/or MUP guidelines, to review Act to just section 332 of the Public • State. applications submitted by State Primary Health Service (PHS) Act. • Zip. Care Offices (PCO) and their affiliates • Dated: March 24, 2010. FIPS State. for designation status. • FIPS County. Mary K. Wakefield, • Census Tract. PURPOSE(S): Administrator. • Minor Civil Division. The sole purpose of the system is to • Longitude. SYSTEM NUMBER: 09–15–0066 support the Application Submission • Latitude. and Processing System electronic SYSTEM NAME: • Address FTE. State-Provided Physician Records for • Office Visits (Per Year). application for the development, the Application Submission & • New Patients Waiting Time For submission, and review of applications Processing System, OSD, BHPr, HRSA. Appointments (days). for HPSAs and MUPs. The most critical • Current Patients Waiting Time For requirement for accurate designation SECURITY CLASSIFICATION: Appointments (days). determinations is accurate data on the None. • Average Wait for New Patient location of health care providers relative to the population. To this end, Office of SYSTEM LOCATION: (hours). • Average Wait for Current Patient Shortage Designation continually tries The Application Submission and (hours). to obtain the latest data on health care Processing System (ASAPS) System • Patient Percent—Homeless. providers and their practice location(s) Manager is located in Office of Shortage • Patient Percent—Medicaid. at the lowest geographical level possible Designation, Bureau of Health • Patient Percent—Migrant for use in the designation process, with Professions, Health Resources and Farmworker. the objective of minimizing the level of Services Administration, 5600 Fishers • Patient Percent—Native American. effort required on the part of States and Lane, Room 8A–08, Rockville, Maryland • Patient Percent—Sliding Fee Scale. communities seeking designations. 20857. The actual computer server is • Patient Percent—Language Barrier located in Office of Information Present. ROUTINE USES OF RECORDS MAINTAINED IN THE Technology, Health Resources and • Patient Percent—Migrant/Seasonal SYSTEM, INCLUDING CATEGORIES OF USERS AND Services Administration, 5600 Fishers Farmworker. THE PURPOSES OF SUCH USES: Lane, Room 10A–08, Rockville, • Patient Percent—Other Population. 1. Each State Primary Care Office (and Maryland 20857. • Medicaid Claims. a few Primary Care Associations) may • Hours Given Include Time Spent in have access to provider data within CATEGORIES OF INDIVIDUALS COVERED BY THE Hospital. SYSTEM: their own State for Medically • Accepts New Patients. Underserved Population/Area (MUA/P) Health care practitioners who are the • Tour Hours in Direct Patient Care and/or Health Professional Shortage subjects of databases collected and for this Address. Area (HPSA) applications. These users maintained by State Primary Care • Sub Specialty. will also have access to bordering Offices/Associations. Such health care • Sub Specialty Percent. States’ data (one county-deep) at an practitioners include physicians (both • Language 1. aggregate level only. M.D.s and D.O.s), dentists, and mental • Language 1 Percent. 2. Disclosure may be made to health care providers, licensed or • Language 2. otherwise authorized by a State to • Language 2 Percent. contractors engaged by the Department provide health care services. • Language 3. to geocode the physicians’ address so • Language 3 Percent. that it may be seen on a computerized CATEGORIES OF RECORDS IN THE SYSTEM: • /Date of Birth (Dentists only). map, or to load the provider data into The system will include records that • Number of Auxillaries (Dentists the Application Submission and show a value for each of the following only). Processing Systems. All such fields for all of the physicians that are contractors shall be required to maintain included in each States’ database: AUTHORITY FOR MAINTENANCE OF THE SYSTEM: Privacy Act safeguards with respect to • Provider ID (System-Assigned). Section 332 of the Public Health such records and return all records to • Provider Type. Service Act provides that the Secretary HRSA.

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3. Disclosure may be made to area. All authorized users sign a ‘‘Rules RECORD SOURCE CATEGORIES: contractors engaged by the Department of Behavior’’ document. All passwords, Data are collected from the State to assist OSD in the review and keys and/or combinations are changed Primary Care Offices and a few State processing of the HPSA and/or MUA/P when a person leaves or no longer has Primary Care Associations. applications received by the State authorized duties. Access to records is [FR Doc. 2010–8620 Filed 4–14–10; 8:45 am] offices. Such access will only be made limited to those authorized personnel BILLING CODE 4160–15–P with the State’s permission (through a trained in accordance with the Privacy Data Use Agreement) and all such Act and ADP security procedures. The contractors shall be required to sign a safeguards described above were DEPARTMENT OF HOMELAND Rules of Behavior document, maintain established in accordance with DHHS SECURITY Privacy Act safeguards with respect to Chapter 45–13 and supplementary such records, and return all records to chapter PHS hf:45–13 of the General U.S. Customs and Border Protection HRSA. Administration Manual; and the DHHS Agency Information Collection 4. To appropriate Federal agencies Information Resources Management Activities: Customs-Trade Partnership and Department contractors that have a Manual, Part 6, ‘‘ADP Systems Security.’’ Against Terrorism (C–TPAT) need to know the information for the RETENTION AND DISPOSAL: purpose of assisting the Department’s AGENCY: U.S. Customs and Border efforts to respond to a suspected or HRSA is working with the Records Protection, Department of Homeland confirmed breach of the security or Officer and NARA to obtain the Security. confidentiality of information appropriate retention value. ACTION: 30-Day notice and request for maintained in this system of records, SYSTEM MANAGER(S) AND ADDRESS: comments; extension of an existing and the information disclosed is Application Submission & Processing information collection: 1651–0077. relevant and necessary for that System System Manager, Office of assistance. SUMMARY: U.S. Customs and Border Shortage Designation, Bureau of Health Protection (CBP) of the Department of POLICIES AND PRACTICES FOR STORING, Professions, Health Resources and Homeland Security has submitted the RETRIEVING, ACCESSING, RETAINING, AND Services Administration, 5600 Fishers following information collection request DISPOSING OF RECORDS IN THE SYSTEM: Lane, Room 8A–08, Rockville, Maryland to the Office of Management and Budget STORAGE: 20857. (OMB) for review and approval in Records are maintained in file folders NOTIFICATION PROCEDURE: accordance with the Paperwork and in computer data files. Write to the Application Submission Reduction Act: Customs-Trade & Processing System System Manager to Partnership Against Terrorism (C– RETRIEVABILITY: determine if a record exists. The TPAT). This is a proposed extension of Retrieval of physician records is by requester must also verify his or her an information collection that was use of personal identifiers used when identity by providing either a previously approved. CBP is proposing entering the system. notarization of the request or a written that this information collection be extended with no change to the burden SAFEGUARDS: certification that the requester is who he hours. This document is published to 1. Authorized users: Access to records or she claims to be and understands that the knowing and willful request for obtain comments from the public and is limited to designated HRSA, HRSA affected agencies. This proposed hired contractors, and PCO/A staff. acquisition of a record pertaining to an individual under false pretenses is a information collection was previously These employees are the only published in the Federal Register (75 authorized users. HRSA maintains criminal offense under the Act, subject to a fine. FR 6678) on February 10, 2010, allowing current lists of authorized users. for a 60-day comment period. This 2. Physical Safeguards: All computer RECORD ACCESS PROCEDURE: notice allows for an additional 30 days equipment and files are stored in areas To obtain access to a record, contact for public comments. This process is where fire and life safety codes are the Application Submission and conducted in accordance with 5 CFR strictly enforced. All automated and Processing System (ASAPS) System 1320.10. non-automated documents are protected Manager at the address specified above. on a 24-hour basis. Perimeter security DATES: Written comments should be Requesters should provide the same received on or before May 17, 2010. includes intrusion alarms, on-site guard information as is required under the ADDRESSES: Interested persons are force, random guard patrol, key/ Notification Procedures above. invited to submit written comments on passcard/combination controls, and Individuals may also request listings of this proposed information collection to receptionist controlled area. Hard copy accountable disclosures that have been the Office of Information and Regulatory files are maintained in a file room used made of their records, if any. solely for this purpose with access Affairs, Office of Management and limited by combination lock to CONTESTING RECORD PROCEDURES: Budget. Comments should be addressed authorized users identified above. Write to the official specified under to the OMB Desk Officer for Customs Computer files are password protected Notification Procedures above, and and Border Protection, Department of and are accessible only by use of reasonably identify the record and Homeland Security, and sent via computers which are password specify the information being contested, electronic mail to protected. the corrective action sought, and your [email protected] or faxed 3. Procedural Safeguards: A password reasons for requesting the correction, to (202) 395–5806. is required to access computer files. All along with supporting information to SUPPLEMENTARY INFORMATION: U.S. users of personal information in show how the record is inaccurate, Customs and Border Protection (CBP) connection with the performance of incomplete, untimely, or irrelevant. The encourages the general public and their jobs protect information from right to contest records is limited to affected Federal agencies to submit public view and from unauthorized information which is incomplete, written comments and suggestions on personnel entering an unsupervised incorrect, untimely, or irrelevant. proposed and/or continuing information

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collection requests pursuant to the Dated: April 12, 2010. Avenue, NW.; Room 5.2–A, Paperwork Reduction Act (Pub. L.104– Tracey Denning, Washington, DC 20229. 13). Your comments should address one Agency Clearance Officer, U.S. Customs and Instructions: All submissions received of the following four points: Border Protection. must include the words ‘‘Department of (1) Evaluate whether the proposed [FR Doc. 2010–8632 Filed 4–14–10; 8:45 am] Homeland Security’’ and the docket collection of information is necessary BILLING CODE 9111–14–P number for this action. Comments for the proper performance of the received will be posted without functions of the agency/component, alteration at http://www.regulations.gov, including whether the information will DEPARTMENT OF HOMELAND including any personal information have practical utility; SECURITY provided. Docket: For access to the docket to (2) Evaluate the accuracy of the U.S. Customs and Border Protection read background documents or agencies/components estimate of the [Docket No. USCBP–2010–0013] comments received by COAC, go to burden of the proposed collection of http://www.regulations.gov. information, including the validity of Notice of Meeting of the Advisory FOR FURTHER INFORMATION CONTACT: Ms. the methodology and assumptions used; Committee on Commercial Operations Wanda Tate, Office of Trade Relations, (3) Enhance the quality, utility, and of Customs and Border Protection U.S. Customs and Border Protection, clarity of the information to be (COAC) Department of Homeland Security, 1300 collected; and Pennsylvania Avenue, NW., Room 5.2– AGENCY: U.S. Customs and Border A, Washington, DC 20229; (4) Minimize the burden of the Protection, Department of Homeland [email protected]; telephone 202– collections of information on those who Security (DHS). are to respond, including the use of 344–1440; facsimile 202–325–4290. ACTION: Notice of Federal Advisory appropriate automated, electronic, SUPPLEMENTARY INFORMATION: Pursuant Committee meeting. mechanical, or other technological to the Federal Advisory Committee Act techniques or other forms of SUMMARY: The Advisory Committee on (5 U.S.C. App.), DHS hereby announces information. Commercial Operations of U.S. Customs the meeting of the Advisory Committee Title: Customs-Trade Partnership and Border Protection (COAC) will meet on Commercial Operations of Customs Against Terrorism (C–TPAT). on May 11, 2010 in Philadelphia, and Border Protection (COAC). COAC is tasked with providing advice to the OMB Number: 1651–0077. Pennsylvania. The meeting will be open to the public. Secretary of Homeland Security, the Form Number: None. DATES: COAC will meet Tuesday, May Secretary of the Treasury, and the Abstract: The Customs-Trade 11, 2010 from 1 p.m.–5 p.m. Please note Commissioner of U.S. Customs and Partnership Against Terrorism (C– that the meeting may close early if the Border Protection (CBP) on matters TPAT) Program is designed to provide committee completes its business. If you pertaining to the commercial operations expedited processing to participants in plan on attending, please register either of CBP and related functions within this Program at certain, high-risk online at https://apps.cbp.gov/ DHS or the Department of the Treasury. locations by prescreening participants. te_registration/?w=18, or by e-mail to The fifth meeting of the eleventh term The C–TPAT Program applies to air, [email protected] by close-of- of COAC will be held at the date, time land and sea. This Program was business on May 6, 2010. and location specified above. A tentative agenda for the meeting is set mandated by the SAFE Port Act. This ADDRESSES: The meeting will be held at forth below. information collection is an on-line the Loews Philadelphia Hotel, 1200 application that must be completed by Market Street, Regency Ballroom A, Tentative Agenda companies or individuals wishing to Philadelphia, Pennsylvania 19107. The participate in the C–TPAT program. 1. Importer Security Filing (‘‘10+2’’). public is invited to submit comments 2. Intellectual Property Rights This application can be found on and/or written material on any of the www.cbp.gov. Enforcement Subcommittee. identified agenda items as set forth 3. Agriculture Subcommittee. Current Actions: There are no changes below. Please note that any comments 4. Air Cargo Security Subcommittee. to the information collection. This or written materials that are mailed 5. Automation Subcommittee. submission is being made to extend the should reach the contact person at the 6. Import Safety. expiration date. address listed below before May 6, 2010, 7. Bond Subcommittee. Type of Review: Extension (without so that copies of your submitted 8. Trade Facilitation Subcommittee. materials can be distributed to change). Procedural committee members prior to the Affected Public: Businesses, meeting. Comments must be identified This meeting is open to the public; Individuals. by USCBP–2010–0013 and may be however, participation in COAC Estimated Number of Respondents: submitted by one of the following deliberations is limited to committee 6,500. methods: members, Department of Homeland Estimated Time per Respondent: 5 • Federal eRulemaking Portal: http:// Security officials, and persons invited to hours. www.regulations.gov. Follow the attend the meeting for special instructions for submitting comments. presentations. Please note that the Estimated Total Annual Burden • E-mail: [email protected]. meeting may close early if all business Hours: 32,500. Include the docket number in the is finished. If additional information is required subject line of the message. All visitors must check-in at the contact: Tracey Denning, U.S. Customs • Fax: 202–325–4290. Loews Philadelphia Hotel at the and Border Protection, Office of • Mail: Ms. Wanda Tate, Office of Regency Ballroom A with CBP officials Regulations and Rulings, 799 9th Street, Trade Relations, U.S. Customs and at the registration desk. NW., 7th Floor, Washington, DC 20229– Border Protection, Department of Since seating is limited, all persons 1177, at 202–325–0265. Homeland Security, 1300 Pennsylvania attending this meeting should provide

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notice by close-of-business on May 6, Group No. 840, was accepted February ACTION: Notice of receipt of applications 2010, by registering online at https:// 2, 2010. for permit. apps.cbp.gov/te_registration/?w=18 or, The plat, in five (5) sheets, alternatively, by contacting Ms. Wanda representing the dependent resurvey of SUMMARY: We, the U.S. Fish and Tate, Office of Trade Relations, U.S. portions of the south and north Wildlife Service, invite the public to Customs and Border Protection, boundaries and a portion of the comment on the following applications Department of Homeland Security, 1300 subdivisional lines, metes-and-bounds to conduct certain activities with Pennsylvania Avenue, NW., surveys of Tracts 37 and 38, and metes- endangered species. With some Washington, DC 20229; and-bounds surveys of the easterly and exceptions, the Endangered Species Act [email protected]; telephone 202– westerly right-of-way lines of the (ESA) prohibit activities with listed 344–1440; facsimile 202–325–4290. Nevada Northern Railway through species unless a Federal permit is issued sections 1, 12, 13, 24, 25 and 36, that allows such activities. The ESA Information on Services for Individuals Township 19 North, Range 63 East, laws require that we invite public With Disabilities Mount Diablo Meridian, Nevada, under comment before issuing these permits. For information on facilities or Group No. 840, was accepted February DATES: We must receive requests for services for individuals with disabilities 2, 2010. documents or comments on or before or to request special assistance at the These surveys were executed to meet May 17, 2010. meeting, contact Ms. Wanda Tate as certain administrative needs of the ADDRESSES: Brenda Tapia, Division of soon as possible. Bureau of Land Management. Management Authority, U.S. Fish and Dated: April 9, 2010. 2. The Plat of Survey of the following Wildlife Service, 4401 North Fairfax Kimberly Marsho, described lands was officially filed at Drive, Room 212, Arlington, VA 22203; Director, Office of Trade Relations, U.S. the Nevada State Office, Reno, Nevada, fax (703) 358-2280; or e-mail Customs and Border Protection. on February 19, 2010: [email protected]. [FR Doc. 2010–8597 Filed 4–14–10; 8:45 am] The plat, in six (6) sheets, representing the dependent resurvey of FOR FURTHER INFORMATION CONTACT: BILLING CODE 9111–14–P the Fourth Standard Parallel North, Brenda Tapia, (703) 358-2104 through a portion of Range 63 East, a (telephone); (703) 358-2280 (fax); portion of the east boundary and a [email protected] (e-mail). DEPARTMENT OF THE INTERIOR portion of the subdivisional lines, the SUPPLEMENTARY INFORMATION: Bureau of Land Management subdivision of sections 24 and 25, and I. Public Comment Procedures metes-and-bounds surveys of portions of [LLNV952000 L14200000.BJ0000 241A; 10– the easterly and westerly right-of-way A. How Do I Request Copies of 08807; MO# 4500012873; TAS: 14X1109] lines of the Nevada Northern Railway, Applications or Comment on Submitted Applications? Filing of Plats of Survey; Nevada Township 20 North, Range 63 East, Mount Diablo Meridian, Nevada, under Send your request for copies of AGENCY: Bureau of Land Management, Group No. 856, was accepted February applications or comments and materials Interior. 18, 2010. concerning any of the applications to ACTION: Notice. This survey was executed to meet the contact listed under ADDRESSES. certain administrative needs of the Please include the Federal Register SUMMARY: The purpose of this notice is Bureau of Land Management. notice publication date, the PRT- to inform the public and interested State 3. The above-listed surveys are now number, and the name of the applicant and local government officials of the the basic record for describing the lands in your request or submission. We will filing of Plats of Survey in Nevada. for all authorized purposes. These not consider requests or comments sent DATES: Effective Dates: Filing is effective surveys have been placed in the open to an e-mail or address not listed under at 10 a.m. on the dates indicated below. files in the BLM Nevada State Office ADDRESSES. If you provide an email FOR FURTHER INFORMATION CONTACT: and are available to the public as a address in your request for copies of David D. Morlan, Chief, Branch of matter of information. Copies of the applications, we will attempt to respond Geographic Sciences, Bureau of Land surveys and related field notes may be to your request electronically. Management (BLM), Nevada State furnished to the public upon payment of Please make your requests or Office, 1340 Financial Blvd., P.O. Box the appropriate fees. comments as specific as possible. Please 12000, Reno, Nevada 89520, 775–861– Dated: April 7, 2010. confine your comments to issues for 6541. David D. Morlan, which we seek comments in this notice, SUPPLEMENTARY INFORMATION: Chief Cadastral Surveyor, Nevada. and explain the basis for your comments. Include sufficient 1. The Plats of Survey of the following [FR Doc. 2010–8602 Filed 4–14–10; 8:45 am] described lands were officially filed at information with your comments to BILLING CODE 4310–HC–P the Nevada State Office, Reno, Nevada, allow us to authenticate any scientific or on February 4, 2010: commercial data you include. The plat, in two (2) sheets, DEPARTMENT OF THE INTERIOR The comments and recommendations representing the dependent resurvey of that will be most useful and likely to a portion of the east boundary and a Fish and Wildlife Service influence agency decisions are: (1) portion of the subdivisional lines, the Those supported by quantitative subdivision of section 12 and metes- [FWS-R9-IA-2010-N079] information or studies; and (2) Those and-bounds surveys of the easterly and that include citations to, and analyses westerly right-of-way lines of the [96300-1671-0000-P5] of, the applicable laws and regulations. Nevada Northern Railway through Receipt of Applications for Permit We will not consider or include in our section 1 and a portion of section 12, administrative record comments we Township 18 North, Range 63 East, AGENCY: Fish and Wildlife Service, receive after the close of the comment Mount Diablo Meridian, Nevada, under Interior. period (see DATES) or comments

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delivered to an address other than those sea turtles (Lepidochelys olivacea), Commission, 500 E Street SW., listed above (see ADDRESSES). obtained from six wild females for the Washington, DC 20436. Hearing- purpose of scientific research. This B. May I Review Comments Submitted impaired persons can obtain notification covers activities to be by Others? information on this matter by contacting conducted by the applicant over a 5– the Commission’s TDD terminal on 202– Comments, including names and year period. 205–1810. Persons with mobility street addresses of respondents, will be The following applicants each request impairments who will need special available for public review at the a permit to import the sport-hunted assistance in gaining access to the address listed under ADDRESSES. The trophy of one male bontebok Commission should contact the Office public may review documents and other (Damaliscus pygargus pygargus) culled of the Secretary at 202–205–2000. information applicants have sent in from a captive herd maintained under General information concerning the support of the application unless our the management program of the Commission may also be obtained by allowing viewing would violate the Republic of South Africa, for the accessing its Internet server (http:// Privacy Act or Freedom of Information purpose of enhancement of the survival Act. Before including your address, of the species. www.usitc.gov). The public record for phone number, e-mail address, or other this review may be viewed on the personal identifying information in your Applicant: Wilton Hardesty, Okmulgee, Commission’s electronic docket (EDIS) comment, you should be aware that OK; PRT-07800A at http://edis.usitc.gov. your entire comment—including your Applicant: Roger Jarvis, Cypress, TX; SUPPLEMENTARY INFORMATION: On personal identifying information—may PRT-07801A October 5, 2009, the Commission be made publicly available at any time. determined that it should proceed to a Dated: April 09, 2010 While you can ask us in your comment full review in the subject five-year to withhold your personal identifying Brenda Tapia review pursuant to section 751(c)(5) of information from public review, we Program Analyst, Branch of Permits, Division the Act. The Commission found that the cannot guarantee that we will be able to of Management Authority domestic interested party group do so. [FR Doc. 2010–8651 Filed 4–14–10; 8:45 am] response to its notice of institution (74 BILLING CODE 4310–55–S II. Background FR 31757, July 2, 2009) was adequate To help us carry out our conservation and that the respondent interested party group response was inadequate. The responsibilities for affected species, the INTERNATIONAL TRADE Endangered Species Act of 1973, section COMMISSION Commission also found that other 10(a)(1)(A), as amended (16 U.S.C. 1531 circumstances warranted conducting a et seq.), and our regulations in the Code [Investigation No. 731–TA–149 (Third full review.1 A record of the of Federal Regulations (CFR) at 50 CFR Review)] Commissioners’ votes, the 17 require that we invite public Barium Chloride From China Commission’s statement on adequacy, comment before final action on these and any individual Commissioner’s permit applications. AGENCY: United States International statements will be available from the III. Permit Applications Trade Commission. Office of the Secretary and at the ACTION: Notice of Commission Commission’s Web site. Applicant: Jean Dubach, Ph.D., Wildlife determination to conduct a full five-year Genetics Lab, Loyola University Authority: This review is being conducted review concerning the antidumping under authority of title VII of the Tariff Act Medical Center, Maywood, IL; PRT- duty order on barium chloride from 06638A of 1930; this notice is published pursuant to China. section 207.62 of the Commission’s rules. The applicant requests a permit to SUMMARY: By order of the Commission. import biological specimens from up to The Commission hereby gives 4 captive held Sumatran orangutans notice that it will proceed with a full Issued: October 14, 2009. (Pongo abelii) from the Toronto Zoo, review pursuant to section 751(c)(5) of Marilyn R. Abbott, the Tariff Act of 1930 (19 U.S.C. Ontario, Canada, for the purpose of Secretary to the Commission. enhancement of the survival of the 1675(c)(5)) to determine whether species. revocation of the antidumping duty Editorial Note: This document was order on barium chloride from China received in the Office of the Federal Register Applicant: New England Wild Flower would be likely to lead to continuation on April 9, 2010. Society (NEWFS), Framingham, MA; or recurrence of material injury within [FR Doc. 2010–8568 Filed 4–14–10; 8:45 am] PRT-06998A a reasonably foreseeable time. A BILLING CODE 7020–02–P schedule for the review will be The applicant requests a permit to established and announced at a later export leaf cuttings from Jesup’s milk- date. For further information concerning vetch (Astragalus robbinsii var. jesupi) the conduct of this review and rules of to the Canadian Museum of Nature, general application, consult the Ottawa, Ontario, Canada for the purpose Commission’s Rules of Practice and of enhancement of the species through Procedure, part 201, subparts A through scientific research. This notification E (19 CFR part 201), and part 207, covers activities conducted by the subparts A, D, E, and F (19 CFR part applicant for a 5–year period. 207). Applicant: Western Connecticut State DATES: Effective Date: October 5, 2009. University, Danbury, CT; PRT-234773 1 Commissioners Charlotte R. Lane, Irving A. FOR FURTHER INFORMATION CONTACT: Williamson, and Dean A. Pinkert found that no The applicant requests a permit to Mary Messer (202–205–3193), Office of other circumstances warranted conducting a full import blood samples from Olive Ridley Investigations, U.S. International Trade review and voted for an expedited review.

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INTERNATIONAL TRADE STATUS: Open to the public. Written comments and suggestions COMMISSION MATTERS TO BE CONSIDERED: from the public and affected agencies 1. Agenda for future meetings: none. concerning the proposed collection of [Investigation Nos. 731–TA–776–779 (Second Review)] 2. Minutes. information are encouraged. Your 3. Ratification List. comments should address one or more Preserved Mushrooms From Chile, 4. Inv. No. 731–TA–1070A (Review) of the following four points: China, India, and Indonesia; (Crepe Paper Products from China)— • Evaluate whether the proposed Determinations briefing and vote. (The Commission is collection of information is necessary currently scheduled to transmit its for the proper performance of the On the basis of the record 1 developed determination and Commissioners’ functions of the agency, including in the subject five-year reviews, the opinions to the Secretary of Commerce whether the information will have United States International Trade on or before April 30, 2010.) practical utility; Commission (Commission) determines, 5. Outstanding action jackets: • Evaluate the accuracy of the pursuant to section 751(c) of the Tariff (1) Document No. GC–10–028 agencies estimate of the burden of the Act of 1930 (19 U.S.C. 1675(c)), that concerning Inv. No. 337–TA–644 proposed collection of information, revocation of the antidumping duty (Certain Composite Wear Components including the validity of the orders on preserved mushrooms from and Products Containing Same). methodology and assumptions used; Chile, China, India, and Indonesia In accordance with Commission • Enhance the quality, utility, and would be likely to lead to continuation policy, subject matter listed above, not clarity of the information to be or recurrence of material injury to an disposed of at the scheduled meeting, collected; and industry in the United States within a may be carried over to the agenda of the • Minimize the burden of the reasonably foreseeable time.2 following meeting. Earlier collection of information on those who announcement of this meeting was not Background are to respond, including through the possible. use of appropriate automated, The Commission instituted these Issued: April 12, 2010. electronic, mechanical, or other reviews on October 1, 2009 (74 FR By order of the Commission. technological collection techniques or 50818) and determined on January 4, William R. Bishop, other forms of information technology, 2010 that it would conduct expedited e.g., permitting electronic submission of reviews (75 FR 3756, January 22, 2010). Hearings and Meetings Coordinator. responses. The Commission transmitted its [FR Doc. 2010–8697 Filed 4–13–10; 11:15 am] determinations in these reviews to the BILLING CODE 7020–02–P Overview of Information Collection Secretary of Commerce on April 9, 2010. 1117–0042 The views of the Commission are (1) Type of Information Collection: DEPARTMENT OF JUSTICE contained in USITC Publication 4135 Extension of a currently approved (April 2010), entitled Preserved Drug Enforcement Administration collection. Mushrooms from Chile, China, India, (2) Title of the Form/Collection: and Indonesia: Investigation Nos. 731– [OMB Number 1117–0042] National Clandestine Laboratory Seizure TA–776–779 (Second Review). Report. By order of the Commission. Agency Information Collection (3) Agency form number, if any and Issued: April 9, 2010. Activities: Proposed Collection; the applicable component of the Comments Requested: National William R. Bishop, Department sponsoring the collection: Clandestine Laboratory Seizure Report Acting Secretary to the Commission. Form number: EPIC Form 143. Component: El Paso Intelligence [FR Doc. 2010–8598 Filed 4–14–10; 8:45 am] ACTION: 60-Day Notice of Information Center, Drug Enforcement BILLING CODE 7020–02–P Collection Under Review. Administration, U.S. Department of The Department of Justice (DOJ), Drug Justice. INTERNATIONAL TRADE Enforcement Administration (DEA), will (4) Affected public who will be asked COMMISSION be submitting the following information or required to respond, as well as a brief collection request to the Office of abstract: [USITC SE–10–009] Management and Budget (OMB) for Primary: State, Local or Tribal Government. Government in the Sunshine Act review and approval in accordance with Other: None. Meeting Notice the Paperwork Reduction Act of 1995. The proposed information collection is Abstract: Records in this system are AGENCY HOLDING THE MEETING: United published to obtain comments from the used to provide clandestine laboratory States International Trade Commission. public and affected agencies. Comments seizure information to the El Paso Intelligence Center, Drug Enforcement TIME AND DATE: April 21, 2010, at 9:30 are encouraged and will be accepted Administration, and other Law a.m. until June 14, 2010. This process is conducted in accordance with 5 CFR enforcement agencies, in the discharge PLACE: Room 101, 500 E Street, SW., of their law enforcement duties and Washington, DC 20436, Telephone: 1320.10. If you have comments, especially on responsibilities. (202) 205–2000. the estimated public burden or (5) An estimate of the total number of associated response time, suggestions, respondents and the amount of time 1 The record is defined in sec. 207.2(f) of the Commission’s Rules of Practice and Procedure (19 or need a copy of the proposed estimated for an average respondent to CFR § 207.2(f)). information collection instrument with respond: There are one thousand 2 Vice Chairman Daniel R. Pearson determines instructions or additional information, twenty-seven (1027) total respondents that revocation of the antidumping duty order on please contact Clark R. Fleming, Field for this information collection. Three preserved mushrooms from Indonesia would not be likely to lead to continuation or recurrence of Division Counsel, El Paso Intelligence thousand seven hundred fifty-four material injury to an industry in the United States Center, 11339 SSG Sims Blvd., El Paso, (3754) responded using paper at 1 hour within a reasonably foreseeable time. TX 79908. a response and five thousand four

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hundred seven (5407) responded information are encouraged. Your Actual preparation time is dependent on electronically at 1 hour a response, for comments should address one or more the number of nominees per nine thousand one hundred sixty-one of the following four points: application. (9161) annual responses. —Evaluate whether the proposed (5) An estimate of the total public (6) An estimate of the total public collection of information is necessary burden (in hours) associated with the burden (in hours) associated with the for the proper performance of the collection is 83 hours. × collection: It is estimated that there are functions of the agency, including Total Annual Reporting Burden: 200 9161 annual burden hours associated whether the information will have 25 minutes = 5,000 minutes/60 = 83.33 with this collection. practical utility; hours for each award category. If additional information is required —Evaluate the accuracy of the agency’s If additional information is required, contact: Lynn Bryant, Department estimate of the burden of the proposed please contact, Clearance Officer, Clearance Officer, United States collection of information, including the United States Department of Justice, Department of Justice, Justice validity of the methodology and Justice Management Division, Policy Management Division, Policy and assumptions used; and Planning Staff, Patrick Henry Planning Staff, Patrick Henry Building, —Enhance the quality, utility, and Building, Suite 1600, 601 D Street, NW., Suite 1600, 601 D Street, NW., clarity of the information to be Washington, DC 20530. Washington, DC 20530. collected; and Dated: April 12, 2010. Dated: April 12, 2010. —Minimize the burden of the collection Lynn Bryant, Lynn Bryant, of information on those who are to Department Clearance Officer, PRA, United Department Clearance Officer, PRA, U.S. respond, including through the use of States Department of Justice. Department of Justice. appropriate automated, electronic, [FR Doc. 2010–8635 Filed 4–14–10; 8:45 am] mechanical, or other technological [FR Doc. 2010–8633 Filed 4–14–10; 8:45 am] BILLING CODE 4410–18–P BILLING CODE 4410–09–P collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. DEPARTMENT OF LABOR DEPARTMENT OF JUSTICE Overview of This Information Office of the Secretary of Labor Office of Justice Programs Collection (1) Type of information collection: [OMB Number 1121–NEW] Request for Information on Business New collection. Practices To Reduce the Likelihood of Bureau of Justice Assistance; Agency (2) The title of the form/collection: Forced Labor or Child Labor in the Information Collection Activities: Federal Law Enforcement Officers Production of Goods Proposed Collection; Comments Congressional Badge of Bravery. AGENCY: Bureau of International Labor Requested (3) The agency form number, if any, and the applicable component of the Affairs, Labor. ACTION: 60-Day Notice of Information Department sponsoring the collection: ACTION: Request for information. Collection Under Review: New None. Bureau of Justice Assistance, SUMMARY: The Department of Labor Collection Bureau of Justice Assistance Office of Justice Programs, United States Application Form: Federal Law Department of Justice. (DOL) is seeking information on current Enforcement Officers Congressional (4) Affected public who will be asked practices of firms, business associations, Badge of Bravery. or required to respond, as well as a brief and other private sector groups to abstract: reduce the likelihood of child labor and The Department of Justice, Office of Primary: Law Enforcement officials. forced labor in the production of goods. Justice Programs, Bureau of Justice Abstract: The information collected This information will aid DOL in Assistance, will be submitting the on this application will provide for the fulfilling its mandate under the following information collection request nomination of law enforcement officers Trafficking Victims Protection to the Office of Management and Budget for the Federal, and the State and Local Reauthorization Act of 2005 to work for review and clearance in accordance Congressional Badge of Bravery awards. with persons who are involved in the with the Paperwork Reduction Act of The awards will recognize law production of goods made with forced 1995. This proposed information enforcement officers who (1) were labor or child labor to create a standard collection is published to obtain injured while engaged in lawful duties set of practices that will reduce the comments from the public and affected and performing an act of bravery that likelihood that such persons will agencies. Comments are encouraged and put such officer at personal risk; or (2) produce goods using such labor. will be accepted for ‘‘sixty days’’ until though not injured; performed an act of DATES: Information should be submitted June 14, 2010. If you have additional bravery that placed such officer at risk to the Office of Child Labor, Forced comments, suggestions, or need a copy of serious physical injury or death. Labor and Human Trafficking (OCFT) of the proposed information collection Others: None. within the Bureau of International Labor instrument with instructions or (5) An estimate of the total number of Affairs (ILAB) via one of the methods additional information, please contact respondents and the amount of time described below by 5 p.m., on June 14, M. Berry at 202–616–6500/1–866–268– needed for an average respondent to 2010. 0079, Bureau of Justice Assistance, respond is as follows: An estimated 200 To Submit Information, or for Further Office of Justice Programs, U.S. applications/nominations for each Information, Contact: ILAB/OCFT, U.S. Department of Justice, 810 7th Street, Board has been adopted from a similar Department of Labor, at (202) 693–4843 NW., Washington, DC 20531 via awards program and will be used for the (this is not a toll free number). facsimile at 202–305–1367 or by e-mail Federal Law Enforcement Officers Comments, identified as ‘‘Docket No. at [email protected]. Congressional Badge of Bravery. The DOL–2010–0002,’’ may be submitted by Written comments and suggestions applicant should take approximately 25 any of the following methods: from the public and affected agencies minutes to gather the required • Federal eRulemaking Portal: http:// concerning the proposed collection of information and complete the form. www.regulations.gov. The portal

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includes instructions for submitting Government to reduce forced and child by the competent authority, and does comments. Parties submitting responses labor internationally and ensure that not prejudice children’s attendance in electronically are encouraged not to products made by forced labor and child school or their capacity to benefit from submit paper copies. labor in violation of international the instruction received. • Facsimile (fax): OCFT at 202–693– standards are not imported into the ‘‘Forced Labor’’—‘‘Forced labor’’ under 4830. United States. international standards means all work • Mail, Express Delivery, Hand Pursuant to part (D) of the TVPRA of or service which is exacted from any Delivery, and Messenger Service (2 2005 mandate, ILAB is seeking person under the menace of any penalty copies): Charita Castro or Rachel Rigby information on current practices of for its nonperformance and for which at U.S. Department of Labor, ILAB/ firms, business associations, and other the worker does not offer himself OCFT, 200 Constitution Avenue, NW., private sector groups to reduce the voluntarily, and includes indentured Room S–5317, Washington, DC 20210. likelihood of child labor and forced labor. ‘‘Forced labor’’ includes work Note that security-related screening may labor in the production of goods. Many provided or obtained by force, fraud, or result in significant delays in receiving firms have policies, activities and/or coercion, including: materials by regular mail. systems in place to monitor labor rights (1) By threats of serious harm to, or • E-mail: [email protected]. in their supply chains and remediate physical restraint against any person; All submissions should clearly violations. Such policies, activities and (2) By means of any scheme, plan, or identify the person and/or organization systems vary depending on location, pattern intended to cause the person to filing the submission and should be industry, and many other factors. ILAB believe that, if the person did not signed and dated. seeks to identify practices that have perform such labor or services, that In addition to these formal been effective in specific contexts, person or another person would suffer submission methods, the public will be analyze their replicability, and serious harm or physical restraint; or able to view this notice via DOL’s disseminate those that have potential to (3) By means of the abuse or Facebook page at http:// be effective on a broader scale. For threatened abuse of law or the legal www.facebook.com/departmentoflabor further details see the ‘‘Information process. For purposes of this definition, and Twitter account at http:// Requested’’ section of this notice. forced labor does not include work twitter.com/usdol. specifically authorized by national laws II. Definitions of Forced Labor and SUPPLEMENTARY INFORMATION: where such work is carried out in Child Labor accordance with conditions prescribed I. Background ‘‘Child Labor’’—‘‘Child labor’’ under by the competent authority, including: Section 105(b)(1) of the Trafficking international standards means all work any work or service required by Victims Protection Reauthorization Act performed by a person below the age of compulsory military service laws for of 2005 (‘‘TVPRA of 2005’’), Public Law 15. It also includes all work performed work of a purely military character; 109–164 (2006), directed the Secretary by a person below the age of 18 in the work or service which forms part of the of Labor, acting through the Bureau of following practices: normal civic obligations of the citizens International Labor Affairs, to ‘‘carry out (A) All forms of slavery or practices of a fully self-governing country; work additional activities to monitor and similar to slavery, such as the sale or or service exacted from any person as a combat forced labor and child labor in trafficking of children, debt bondage consequence of a conviction in a court foreign countries.’’ Section 105(b)(2) of and serfdom, or forced or compulsory of law, provided that the said work or the TVPRA of 2005, 22 U.S.C. labor, including forced or compulsory service is carried out under the 7112(b)(2), listed these activities as: recruitment of children for use in armed supervision and control of a public (A) Monitor the use of forced labor conflict; authority and that the said person is not and child labor in violation of (B) The use, procuring, or offering of hired to or placed at the disposal of international standards; a child for prostitution, for the private individuals, companies or (B) Provide information regarding production of pornography or for associations; work or service required in trafficking in persons for the purpose of pornographic purposes; cases of emergency, such as in the event forced labor to the Office to Monitor and (C) The use, procuring, or offering of of war or of a calamity or threatened Combat Trafficking of the Department of a child for illicit activities in particular calamity, fire, flood, famine, earthquake, State for inclusion in [the] trafficking in for the production and trafficking of violent epidemic or epizootic diseases, persons report required by section drugs; and invasion by animal, insect or vegetable 110(b) of the Trafficking Victims (D) Work which, by its nature or the pests, and in general any circumstance Protection Act of 2000 (22 U.S.C. circumstances in which it is carried out, that would endanger the existence or 7107(b)); is likely to harm the health, safety, or the well-being of the whole or part of (C) Develop and make available to the morals of children. The work referred to the population; and minor communal public a list of goods from countries that in subparagraph (D) is determined by services of a kind which, being the Bureau of International Labor Affairs the laws, regulations, or competent performed by the members of the has reason to believe are produced by authority of the country involved, after community in the direct interest of the forced labor or child labor in violation consultation with the organizations of said community, can therefore be of international standards; employers and workers concerned, and considered as normal civic obligations (D) Work with persons who are taking into consideration relevant incumbent upon the members of the involved in the production of goods on international standards. This definition community, provided that the members the list described in subparagraph (C) to will not apply to work specifically of the community or their direct create a standard set of practices that authorized by national laws, including representatives have the right to be will reduce the likelihood that such work done by children in schools for consulted in regard to the need for such persons will produce goods using the general, vocational or technical services. labor described in such subparagraph; education or in other training and institutions, where such work is carried III. Information Requested (E) Consult with other departments out in accordance with international ILAB is seeking general information and agencies of the United States standards under conditions prescribed on the practices of business entities to

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reduce the likelihood of child labor and Signed at Washington, DC this 12th day of compensation benchmark amount for forced labor in the production of goods. April, 2010. certain executives established by ILAB welcomes any and all information, Sandra Polaski, Section 39 limits the allowability of which could include, e.g., codes of Deputy Undersecretary, Bureau of compensation costs under Government conduct, standards used to implement International Labor Affairs. contracts as implemented at FAR such codes of conduct, auditing/ [FR Doc. 2010–8642 Filed 4–14–10; 8:45 am] 31.205–6(p), limiting the amount of monitoring systems, supply-chain BILLING CODE 4510–28–P reimbursable executive compensation. management practices designed to The benchmark compensation amount monitor informal workplaces, for certain executives does not limit the homework, and other challenging work OFFICE OF MANAGEMENT AND compensation that an executive may environments, training modules, BUDGET otherwise receive. This amount is based reporting practices, collaborative upon a review of commercially available Determination of Benchmark surveys of executive compensation that practices and strategies, grassroots Compensation Amount for Certain analyze the relevant data made available projects, or other relevant information. Executives by the Securities and Exchange ILAB is also seeking information on Commission. More specifically, as AGENCY: government practices to collaborate Office of Federal Procurement required by Section 39 of the OFPP Act, with private sector entities to reduce Policy, OMB. the determination is made on the child labor and forced labor in the ACTION: Notice. median (50th percentile) amount of production of goods. Submissions may compensation over a recent 12-month SUMMARY: The Office of Management include documents in various formats, period for the five most highly and Budget is publishing the attached such as policy statements, reports, and compensated employees in management memorandum to the Heads of Executive case studies. However, the specific positions at each home office and each Departments and Agencies concerning format of any submission is not segment of all publicly-owned the determination of the benchmark important provided that the document companies with annual sales over $50 compensation amount for certain presents and/or evaluates practices million. Compensation for the fiscal executives that will be allowable under implemented by business entities, or year means the total amount of wages, Government contracts during salary, bonuses and deferred governments in partnership with contractors’ Fiscal Year 2010— compensation for the year, whether business entities, to reduce the $693,951. This determination is paid, earned, or otherwise accruing, as likelihood of child labor and forced required under Section 39 of the Office recorded in the employer’s cost labor in the production of goods. of Federal Procurement Policy Act, 41 accounting records for the year. After Information should be submitted to U.S.C. 435, as amended. The benchmark consultation with the Director of the the addresses and within the time compensation amount applies equally to Defense Contract Audit Agency, we both defense and civilian procurement period set forth above. DOL seeks have determined pursuant to the agencies. information that can be used to inform requirements of Section 39 that the the development of tools and resources FOR FURTHER INFORMATION CONTACT: benchmark compensation amount for to be disseminated publicly on the DOL Raymond Wong, Office of Federal certain executives for the contractors’ Web site and/or in other publications. Procurement Policy, Office of Fiscal Year (FY) 2010 is $693,951. This Internal documents or confidential Management and Budget, telephone at amount is for contractors’ FY 2010 and documents that cannot be shared with 202–395–6805 and e-mail: subsequent contractor fiscal years, the public will not be used. [email protected]. unless and until revised by OFPP. The Submissions containing confidential or Daniel I. Gordon, benchmark compensation amount for personal information may be redacted certain executives applies to contract Administrator, Office of Federal Procurement by DOL before being made available to Policy. costs incurred after January 1, 2010, the public, in accordance with under covered contracts of both the applicable laws and regulations. DOL Memorandum for the Heads of defense and civilian procurement does not intend to respond directly to a Executive Departments and Agencies agencies as specified in Section 39 of submission or to return a submission to From: Daniel I. Gordon, the OFPP Act, 41 U.S.C. 435, as a submitter, but DOL may communicate Administrator, Office of Federal amended. with the submitter regarding any Procurement Policy. Questions concerning this matters relating to the submission. Subject: Determination of Benchmark memorandum may be addressed to Compensation Amount for Certain Raymond Wong, OFPP, at 202–395– DOL will compile and analyze 6805. submissions pursuant to this Notice, Executives, Pursuant to Section 39 of and of many other practices as the Office of Federal Procurement [FR Doc. 2010–8641 Filed 4–14–10; 8:45 am] Policy Act, 41 U.S.C. 435, as amended. BILLING CODE P described above, in coordination with a This memorandum sets forth the contractor, the Center for Reflection, benchmark compensation amount for Education, and Action (CREA). For certain executives as required by NATIONAL AERONAUTICS AND more information about CREA’s contract Section 39 of the Office of Federal SPACE ADMINISTRATION with DOL, or to discuss relevant Procurement Policy (OFPP) Act, as practices directly with CREA, please amended. Under Section 39, the [Notice (10–044)] contact Project Director Ruth benchmark compensation amount for _ NASA Advisory Council; Science Rosenbaum at ruth rosenbaum@crea- certain executives is the median amount inc.org. Committee; Planetary Protection of the compensation provided for all Subcommittee; Meeting senior executives of all benchmark corporations for the most recent year for AGENCY: National Aeronautics and which data is available. The benchmark Space Administration.

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ACTION: Notice of meeting. Dated: April 12, 2010. meeting. Verbal presentations and P. Diane Rausch, written comments should be limited to SUMMARY: The National Aeronautics and Advisory Committee Management Officer, the subject of safety in NASA. Attendees Space Administration (NASA) National Aeronautics and Space will be requested to sign a register and announces a meeting of the Planetary Administration. to comply with NASA security Protection Subcommittee of the NASA [FR Doc. 2010–8659 Filed 4–14–10; 8:45 am] requirements, including the Advisory Council (NAC). This BILLING CODE 7510–13–P presentation of a valid picture ID, before Subcommittee reports to the Science receiving an access badge. Foreign Committee of the NAC. The meeting nationals attending this meeting will be will be held for the purpose of soliciting NATIONAL AERONAUTICS AND required to provide a copy of their from the scientific community and other SPACE ADMINISTRATION passport, visa, or green card in addition persons scientific and technical [Notice (10–043)] to providing the following information information relevant to program no less than 10 working days prior to planning. Aerospace Safety Advisory Panel; the meeting: Full name; gender; date/ DATES: Thursday, May 13, 2010, 9 a.m. Meeting place of birth; citizenship; visa/green to 4:30 p.m., and Friday, May 14, 2010, card information (number, type, 9 a.m. to 4 p.m. EDT. AGENCY: National Aeronautics and expiration date); passport information Space Administration (NASA). ADDRESSES: NASA Headquarters, 300 E (number, country, expiration date); Street, SW., Room 3H46, Washington, ACTION: Notice of meeting. employer/affiliation information (name of institution, address, country, DC 20546. SUMMARY: In accordance with the telephone); title/position of attendee. To FOR FURTHER INFORMATION CONTACT: Ms. Federal Advisory Committee Act, Public expedite admittance, attendees with Marian Norris, Science Mission Law 92–463, as amended, the National U.S. citizenship can provide identifying Directorate, NASA Headquarters, Aeronautics and Space Administration information 3 working days in advance Washington, DC 20546, (202) 358–4452, announce a forthcoming meeting of the by contacting Susan Burch via e-mail at fax (202) 358–4118, or Aerospace Safety Advisory Panel. [email protected] or by telephone [email protected]. DATES: Friday, April 30, 2010, 12:30 at (202) 358–0550. It is imperative that SUPPLEMENTARY INFORMATION: The p.m. to 2:30 p.m. the meeting be held on this date to meeting will be open to the public up ADDRESSES: NASA Headquarters, 300 E. accommodate the scheduling priorities to the capacity of the room. The agenda Street, SW., Room 9H40, Washington, of the key participants. for the meeting includes the following DC 20546. Dated: April 9, 2010. topics: FOR FURTHER INFORMATION CONTACT: Ms. P. Diane Rausch, —Review European Space Agency- Kathy Dakon, Aerospace Safety Advisory Committee Management Officer, NASA Coordination on Planetary Advisory Panel Executive Director, National Aeronautics and Space Protection. National Aeronautics and Space Administration. —Update on National Research Council Administration, Washington, DC 20546, [FR Doc. 2010–8569 Filed 4–14–10; 8:45 am] Studies on Planetary Protection. (202) 358–0732. BILLING CODE P —Implications for Planetary Protection SUPPLEMENTARY INFORMATION: The of Changes in the Human Spaceflight Aerospace Safety Advisory Panel will Program. hold its 2nd Quarterly Meeting for 2010. It is imperative that the meeting be This discussion is pursuant to carrying NATIONAL ARCHIVES AND RECORDS held on these dates to accommodate the out its statutory duties for which the ADMINISTRATION scheduling priorities of the key Panel reviews, identifies, evaluates, and participants. Attendees will be advises on those program activities, Advisory Committee on Presidential requested to sign a register and to systems, procedures, and management Libraries Meeting comply with NASA security activities that can contribute to program AGENCY: requirements, including the risk. Priority is given to those programs National Archives and Records presentation of a valid picture ID, before that involve the safety of human flight. Administration. receiving an access badge. Foreign The agenda will include: Space Shuttle ACTION: Notice of meeting. nationals attending this meeting will be and International Space Station SUMMARY: required to provide a copy of their Updates; Commercial Space; Mishap In accordance with the passport, visa, or green card in addition Investigation Process and Metrics; Federal Advisory Committee Act, as to providing the following information Industrial Safety Metrics. amended (5 U.S.C. appendix 2), the no less than 10 working days prior to The meeting will be open to the National Archives and Records the meeting: Full name; gender; date/ public up to the seating capacity of the Administration (NARA) announces a place of birth; citizenship; visa/green room. Seating will be on a first-come meeting of the Advisory Committee on card information (number, type, basis. Photographs will only be Presidential Libraries. The meeting will expiration date); passport information permitted during the first 10 minutes of be held to discuss the Presidential (number, country, expiration date); the meeting. During the first 30 minutes Library program and topics related to employer/affiliation information (name of the meeting, members of the public the public-private partnership between of institution, address, country, may make a 5-minute verbal the Presidential Libraries and their telephone); title/position of attendee. To presentation to the Panel on the subject Presidential Foundations. expedite admittance, attendees with of safety in NASA. To do so, please DATES: The meeting will be held on May U.S. citizenship can provide identifying contact Ms. Susan Burch at 11, 2010 from 10 a.m. to 1 p.m. information 3 working days in advance [email protected] at least 48 hours ADDRESSES: Southern Methodist by contacting Marian Norris via e-mail in advance. Any member of the public University, Hughes Trigg Student at [email protected] or by telephone at is permitted to file a written statement Center, 3140 Dyer Street, Ballroom (202) 358–4452. with the Panel at the time of the West, Dallas, Texas 75206.

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FOR FURTHER INFORMATION CONTACT: appraisal is completed. Requesters will administrative use by the agency of Sharon Fawcett, Assistant Archivist for be given 30 days to submit comments. origin, the rights of the Government and Presidential Libraries, at the National ADDRESSES: You may request a copy of of private persons directly affected by Archives and Records Administration, any records schedule identified in this the Government’s activities, and 8601 Adelphi Road, College Park, notice by contacting the Life Cycle whether or not they have historical or Maryland 20740, telephone number Management Division (NWML) using other value. (301) 837–3250. Contact the Presidential one of the following means: Besides identifying the Federal Libraries staff at Mail: NARA (NWML), 8601 Adelphi agencies and any subdivisions [email protected]. Road, College Park, MD 20740–6001. requesting disposition authority, this SUPPLEMENTARY INFORMATION: The E-mail: [email protected]. public notice lists the organizational meeting will be open to the public. Fax: 301–837–3698. unit(s) accumulating the records or Requesters must cite the control Meeting attendees may park at the indicates agency-wide applicability in number, which appears in parentheses Binkley Parking Garage, located at 3101 the case of schedules that cover records after the name of the agency which Binkley Ave. The garage’s hourly rates that may be accumulated throughout an submitted the schedule, and must will apply. agency. This notice provides the control provide a mailing address. Those who number assigned to each schedule, the Dated: April 12, 2010. desire appraisal reports should so total number of schedule items, and the Mary Ann Hadyka, indicate in their request. number of temporary items (the records Committee Management Officer. FOR FURTHER INFORMATION CONTACT: proposed for destruction). It also [FR Doc. 2010–8787 Filed 4–14–10; 8:45 am] Laurence Brewer, Director, Life Cycle includes a brief description of the BILLING CODE 7515–01–P Management Division (NWML), temporary records. The records National Archives and Records schedule itself contains a full Administration, 8601 Adelphi Road, description of the records at the file unit NATIONAL ARCHIVES AND RECORDS College Park, MD 20740–6001. level as well as their disposition. If ADMINISTRATION Telephone: 301–837–1539. E-mail: NARA staff has prepared an appraisal [email protected]. memorandum for the schedule, it too Records Schedules; Availability and includes information about the records. Request for Comments SUPPLEMENTARY INFORMATION: Each year Federal agencies create billions of Further information about the AGENCY: National Archives and Records records on paper, film, magnetic tape, disposition process is available on Administration (NARA). and other media. To control this request. ACTION: Notice of availability of accumulation, agency records managers Schedules Pending proposed records schedules; request for prepare schedules proposing retention comments. periods for records and submit these 1. Department of the Army, Agency- schedules for NARA’s approval, using wide (N1–AU–10–1, 1 item, 1 temporary SUMMARY: The National Archives and the Standard Form (SF) 115, Request for item). Master files of an electronic Records Administration (NARA) Records Disposition Authority. These information system that contains publishes notice at least once monthly schedules provide for the timely transfer information on military family members of certain Federal agency requests for into the National Archives of enrolled in special needs programs. records disposition authority (records historically valuable records and Included are eligibility documentation, schedules). Once approved by NARA, authorize the disposal of all other evaluations, and treatment plans. records schedules provide mandatory records after the agency no longer needs 2. Department of the Army, Agency- instructions on what happens to records them to conduct its business. Some wide (N1–AU–10–14, 1 item, 1 when no longer needed for current schedules are comprehensive and cover temporary item). Master files of an Government business. They authorize all the records of an agency or one of its electronic information system that is the preservation of records of major subdivisions. Most schedules, used to account for the status of Army continuing value in the National however, cover records of only one personnel and their families following a Archives of the United States and the office or program or a few series of natural or man-made disaster. destruction, after a specified period, of records. Many of these update 3. Department of Defense, Defense records lacking administrative, legal, previously approved schedules, and Logistics Agency (N1–361–10–1, 2 research, or other value. Notice is some include records proposed as items, 2 temporary items). Master files published for records schedules in permanent. and outputs of a web-based electronic which agencies propose to destroy The schedules listed in this notice are information system used by agencies to records not previously authorized for media neutral unless specified order goods and services. disposal or reduce the retention period otherwise. An item in a schedule is 4. Department of Health and Human of records already authorized for media neutral when the disposition Services, Office of the Secretary (N1– disposal. NARA invites public instructions may be applied to records 468–09–1, 2 items, 2 temporary items). comments on such records schedules, as regardless of the medium in which the Master files of a learning management required by 44 U.S.C. 3303a(a). records are created and maintained. system that contains agency training DATES: Requests for copies must be Items included in schedules submitted course materials and student training received in writing on or before May 17, to NARA on or after December 17, 2007, records. 2010. Once the appraisal of the records are media neutral unless the item is 5. Department of Homeland Security, is completed, NARA will send a copy of limited to a specific medium. (See 36 U.S. Customs and Border Protection the schedule. NARA staff usually CFR 1225.12(e).) (N1–568–09–2, 1 item, 1 temporary prepare appraisal memorandums that No Federal records are authorized for item). Master files of an electronic contain additional information destruction without the approval of the information system used for inventory concerning the records covered by a Archivist of the United States. This management and tracking maintenance proposed schedule. These, too, may be approval is granted only after a and repair activities relating to agency requested and will be provided once the thorough consideration of their marine vessels.

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6. Department of Homeland Security, are master files and reports associated NATIONAL FOUNDATION ON THE U.S. Customs and Border Protection with an electronic information system ARTS AND THE HUMANITIES (N1–568–09–3, 1 item, 1 temporary that contains data gathered by multiple item). Master files of an electronic Federal agencies in connection with the National Endowment for the Arts; Arts information system used to process Community Reinvestment Act. Advisory Panel permit applications and fees for 15. Challenge multiple border crossings. Pursuant to Section 10(a)(2) of the 7. Department of Homeland Security, Corporation, Agency-wide (N1–561–08– Federal Advisory Committee Act (Pub. U.S. Customs and Border Protection 1, 94 items, 66 temporary items). L. 92–463), as amended, notice is hereby (N1–568–09–5, 1 item, 1 temporary Records relating to routine given that four meetings of the Arts item). Master files of an electronic housekeeping matters, such as Advisory Panel to the National Council information system that contains images procurement, meeting management, and on the Arts will be held at the Nancy of cars, trucks, packages, luggage and fiscal accounting, informal , Hanks Center, 1100 Pennsylvania their contents that is used at ports of working papers and drafts, case files Avenue, NW., Washington, DC 20506 as entry into the United States to detect and other records relating to routine follows (ending times are approximate): contraband. grants, donor case files, international AccessAbility (application review): 8. Department of Housing and Urban relations files, files of committees May 6, 2010 by teleconference. This Development, Office of the Chief dealing with routine matters, meeting, from 2 p.m. to 4 p.m. EDT, will Information Officer (N1–207–09–2, 1 environmental assessments, and other be closed. item, 1 temporary item). Master files of records that do not document significant AccessAbility (application review): an electronic information system used or precedent setting policies, May 11, 2010 by teleconference. This to analyze the agency’s baseline and procedures, or actions. Proposed for meeting, from 2 p.m. to 3:30 p.m. EDT, target enterprise architecture. permanent retention are such records as will be closed. 9. Department of the Interior, National Literature (application review): May Business Center (N1–48–09–9, 2 items, files accumulated by the Board of Directors and senior level officials, case 19–20, 2010 in Room 714. A portion of 2 temporary items). Case files this meeting, from 12 p.m. to 12:30 p.m. accumulated by the Federal Consulting files relating to precedent setting grants, congressional correspondence, files of on May 20th, will be open to the public Group which provides consulting for policy discussion. The remainder of significant committees, publications, services, such as executive coaching and the meeting, from 9 a.m. to 6:30 p.m. on and reports. leadership assessment, aimed at May 19th and from 9 a.m. to 12 p.m. overcoming organizational challenges. 16. National Indian Gaming and from 12:30 p.m. to 4 p.m. on May Also included are reports generated for Commission, Administrative Division 20th, will be closed. clients from the American Customer (N1–220–09–3, 3 items, 3 temporary Literature (application review): May Satisfaction Index. items). Master files of three electronic 21, 2010 in Room 714. This meeting, 10. Department of Justice, Office of information systems that deal with such from 9 a.m. to 5:15 p.m., will be closed. the Inspector General (N1–60–09–72, 1 matters as invoices and billings, budget The closed portions of meetings are item, 1 temporary item). Master files of and financial operations, and payments for the purpose of Panel review, an electronic information system used relating to contractor background discussion, evaluation, and for management and tracking of audits. 11. Department of Justice, Bureau of investigations. recommendations on financial Prisons (N1–129–09–26, 1 item, 1 17. National Indian Gaming assistance under the National temporary item). Master files of an Commission, Audit Division (N1–220– Foundation on the Arts and the electronic information system used to 09–4, 2 items, 2 temporary items). Humanities Act of 1965, as amended, track budget allocations and spending. Master files of electronic information including information given in 12. Department of Justice, Bureau of system that maintains data on audits confidence to the agency. In accordance with the determination of the Chairman Prisons (N1–129–09–27, 1 item, 1 conducted at Indian gaming operations. of November 10, 2009, these sessions temporary item). Master files of an Also included are master files of a will be closed to the public pursuant to electronic information system used to system that contains financial subsection (c)(6) of section 552b of Title track contracts with outside specialists statements and other financial data. involved in drug abuse treatment 5, United States Code. programs. 18. National Indian Gaming Any person may observe meetings, or 13. Department of Justice, Bureau of Commission, Office of General Counsel portions thereof, of advisory panels that Prisons (N1–129–09–28, 1 item, 1 (N1–220–09–2, 2 items, 2 temporary are open to the public, and if time temporary item). Master files of an items). Master files of an electronic allows, may be permitted to participate electronic information system which information system that contains in the panel’s discussions at the contains data relating to the analyses and other records relating to discretion of the panel chairman. If you construction of new facilities during the Indian lands, opinions, and data need any accommodation due to a pre-construction phase. concerning tribal operations. Also disability, please contact the Office of 14. Board of Governors of the Federal included are master files of an AccessAbility, National Endowment for Reserve System, Agency-wide (N1–82– electronic tracking system that the Arts, 1100 Pennsylvania Avenue, 09–2, 9 items, 4 temporary items). Web documents the status of cases assigned NW., Washington, DC 20506, 202/682– site records relating to nominees for the to the office. 5532, TDY–TDD 202/682–5496, at least agency’s Consumer Advisory Council, seven (7) days prior to the meeting. Dated: April 9, 2010. including data on nominees and Web- Further information with reference to generated letters confirming receipt of Sharon Thibodeau, these meetings can be obtained from Ms. nominations and rejections of nominees. Deputy Assistant Archivist for Records Kathy Plowitz-Worden, Office of Also included are data files summarized Services—Washington, DC. Guidelines & Panel Operations, National or extracted from research function data [FR Doc. 2010–8788 Filed 4–14–10; 8:45 am] Endowment for the Arts, Washington, bases. Proposed for permanent retention BILLING CODE 7515–01–P DC 20506, or call 202/682–5691.

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Dated: April 12, 2010. be performed. Where generally 0001. The PDR can also be reached by Kathy Plowitz-Worden, recognized codes and standards are telephone at (301) 415–4737 or (800) Panel Coordinator, Panel Operations, used, they shall be identified and 397–4205, by fax at (301) 415–3548, and National Endowment for the Arts. evaluated to determine their by e-mail to [email protected]. [FR Doc. 2010–8613 Filed 4–14–10; 8:45 am] applicability, adequacy, and sufficiency Regulatory guides are not BILLING CODE 7537–01–P and shall be supplemented or modified copyrighted, and Commission approval as necessary to ensure a quality product is not required to reproduce them. in keeping with the required safety Dated at Rockville, Maryland, this 8 day of NUCLEAR REGULATORY function.’’ April, 2010. ‘‘ COMMISSION GDC 30, Quality of Reactor Coolant For the Nuclear Regulatory Commission. Pressure Boundary,’’ requires, in part, Andrea D. Valentin, [NRC–2009–0166] that ‘‘[c]omponents that are part of the reactor coolant pressure boundary shall Chief, Regulatory Guide Development Branch, Final Regulatory Guide: Issuance, Division of Engineering, Office of Nuclear be designed, fabricated, erected, and Regulatory Research. Availability tested to the highest practical quality [FR Doc. 2010–8650 Filed 4–14–10; 8:45 am] standards.’’ AGENCY: Nuclear Regulatory GDC 31, ‘‘Fracture Prevention of BILLING CODE 7590–01–P Commission. Reactor Coolant Pressure Boundary,’’ ACTION: Notice of Issuance and requires, in part, that ‘‘[t]he reactor Availability of Regulatory Guide (RG) coolant pressure boundary shall be SMALL BUSINESS ADMINISTRATION 1.65, Revision 1, ‘‘Materials and designed with sufficient margin to Inspections for Reactor Vessel Closure assure that when stressed under Notice of Action Subject to Studs.’’ operating, maintenance, testing, and Intergovernmental Review Under postulated accident conditions (1) the Executive Order 12372 FOR FURTHER INFORMATION CONTACT: boundary behaves in a nonbrittle Wallace Norris, U.S. Nuclear Regulatory AGENCY: U.S. Small Business manner and (2) the probability of Administration. Commission, Washington, DC 20555– rapidly propagating fracture is 0001, telephone: (301) 251–7650 or minimized.’’ ACTION: Notice of Action Subject to e-mail [email protected]. Appendix B, ‘‘Quality Assurance Intergovernmental Review Under SUPPLEMENTARY INFORMATION: Criteria for Nuclear Power Plants and Executive Order 12372. ’’ I. Introduction Fuel Reprocessing Plants, to 10 CFR SUMMARY: The Small Business part 50 requires, in part, that Administration (SBA) is notifying the The U.S. Nuclear Regulatory ‘‘[m]easures be established to assure that Commission (NRC) is issuing a guide in public that it intends to grant the special processes, including welding, pending applications of 22 existing the agency’s ‘‘Regulatory Guide’’ series. heat treating, and nondestructive This series was developed to describe Small Business Development Centers testing, are controlled and accomplished (SBDCs) for refunding on October 1, and make available to the public by qualified personnel using qualified information such as methods that are 2010, subject to the availability of funds. procedures in accordance with Nine states do not participate in the EO acceptable to the NRC staff for applicable codes, standards, implementing specific parts of the 12372 process; therefore, their addresses specifications, criteria, and other special are not included. A short description of agency’s regulations, techniques that the requirements.’’ staff uses in evaluating specific the SBDC program follows in the problems or postulated accidents, and II. Further Information supplementary information below. data that the staff needs in its review of In April 2009, DG–1211 was issued The SBA is publishing this notice at applications for permits and licenses. for public comment. The public least 90 days before the expected RG 1.65, Revision 1, ‘‘Materials and comment period closed on June 12, refunding date. The SBDCs and their Inspections for Reactor Vessel Closure 2009. The staff’s responses to the public mailing addresses are listed below in Studs,’’ was issued with a temporary comments received are located in the the address section. A copy of this identification as Draft Regulatory Guide, NRC’s Agencywide Documents Access notice also is being furnished to the DG–1211. General Design Criterion and Management System under respective State single points of contact (GDC) 1, ‘‘Quality Standards and Accession Number ML092050752. designated under the Executive Order. Records,’’ of Appendix A, ‘‘General Electronic copies of RG 1.65, Revision 1 Each SBDC application must be Design Criteria for Nuclear Power are available through the NRC’s public consistent with any area-wide small Plants,’’ to Title 10, of the Code of Web site under ‘‘Regulatory Guides’’ at business assistance plan adopted by a Federal Regulations, part 50, ‘‘Domestic http://www.nrc.gov/reading-rm/doc- State authorized agency. Licensing of Production and Utilization collections/. DATES: A State single point of contact Facilities’’ (10 CFR part 50), requires, in In addition, regulatory guides are and other interested State or local part, that ‘‘[s]tructures, systems, and available for inspection at the NRC’s entities may submit written comments components important to safety shall be Public Document Room (PDR) located at regarding an SBDC refunding within 30 designed, fabricated, erected, and tested 11555 Rockville Pike, Rockville, days from the date of publication of this to quality standards commensurate with Maryland. The PDR’s mailing address is notice to the SBDC. the importance of the safety function to USNRC PDR, Washington, DC 20555– ADDRESSES:

ADDRESSES OF RELEVANT SBDC STATE DIRECTORS

Mr. Al Salgado, Region Director, Univ. of Texas at San Antonio, 501 Ms. Kristina Oliver, State Director, West Virginia Development Office, West Durango Blvd., San Antonio, TX 78207, (210) 458–2450. 1900 Kanawha Boulevard, East Building 6, Room 504, Charleston, WV 25305, (304) 957–2087.

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ADDRESSES OF RELEVANT SBDC STATE DIRECTORS—Continued Mr. Clinton Tymes, State Director, University of Delaware, One Innova- Ms. Carmen Marti, SBDC Director, Inter American University of Puerto tion Way, Suite 301, Newark,DE 19711, (302) 831–2747. Rico, Ponce de Leon Avenue, #416, Edificio Union Plaza, Seventh Floor, Hato Rey, PR 00918, (787) 763–6811. Mr. Michael Young, Region Director, University of Houston, 2302 Ms. Becky Naugle, State Director, University of Kentucky, 225 Gatton Fannin, Suite 200, Houston, TX 77002, (713) 752–8425. College of Business Economics, Lexington, KY 40506–0034, (859) 257–7668. Ms. Liz Klimback, Region Director, Dallas Community College, 1402 Ms. Rene Sprow, State Director, Univ. of Maryland @ College Park, Corinth Street, Dallas, TX 75212, (214) 860–5835. 7100 Baltimore Avenue, Suite 401, Baltimore, MD 20742–1815, (301) 403–8300. Mr. Craig Bean, Region Director, Texas Tech University, 2579 South Ms. Leonor Dottin, SBDC Director, University of the Virgin Islands, Loop 289, Suite 114, Lubbock, TX 79423–1637, (806) 745–3973. 8000 Nisky Center, Suite 720, St. Thomas, USVI 00802–5804, (340) 776–3206. Mr. Max Summers, State Director, University of Missouri, 1205 Univer- Mr. Jim Heckman, State Director, Iowa State University, 340 Gerdin sity Avenue, Suite 300, Columbia, MO 65211, (573) 882–1348. Business Building, Ames, IA 50011–1350, (515) 294–2037. Ms. Lenae Quillen-Blume, State Director, Vermont Technical College, P.O. Box 188, Randolph Center, VT 05061–0188, (802) 728–9101.

FOR FURTHER INFORMATION CONTACT: operations, depending upon local needs, ACTION: Notice. Antonio Doss, Associate Administrator SBA priorities and SBDC program for SBDCs, U.S. Small Business objectives. Services include training and SUMMARY: This is a Notice of the Administration, 409 Third Street, SW., counseling to existing and prospective Presidential declaration of a major Sixth Floor, Washington, DC 20416. small business owners in management, disaster for Public Assistance Only for the State of Rhode Island (FEMA–1894– SUPPLEMENTARY INFORMATION: marketing, finance, operations, planning, taxes, and any other general DR), dated 04/08/2010. Description of the SBDC Program or technical area of assistance that Incident: Severe Storms and Flooding. A partnership exists between SBA supports small business growth. Incident Period: 03/12/2010 and and an SBDC. SBDCs offer training, The SBA district office and the SBDC continuing. counseling and other business must agree upon the specific mix of Effective Date: 04/08/2010. development assistance to small services. They should give particular Physical Loan Application Deadline businesses. Each SBDC provides attention to SBA’s priority and special Date: 06/07/2010. services under a negotiated Cooperative emphasis groups, including veterans, Economic Injury (EIDL) Loan Agreement with SBA, the general women, exporters, the disabled, and Application Deadline Date: 01/04/2011. management and oversight of SBA, and minorities. ADDRESSES: Submit completed loan applications to: Small Business a state plan initially approved by the SBDC Program Requirements Governor. Non-Federal funds must Administration, Processing and match Federal funds. An SBDC must An SBDC must meet programmatic Disbursement Center, 14925 Kingsport operate according to law, the and financial requirements imposed by Road, Fort Worth, TX 76155. Cooperative Agreement, SBA’s statute, regulations or its Cooperative FOR FURTHER INFORMATION CONTACT: A. regulations, the annual Program Agreement. The SBDC must: Escobar, Office of Disaster Assistance, Announcement, and program guidance. (a) Locate service centers so that they U.S. Small Business Administration, are as accessible as possible to small 409 3rd Street, SW., Suite 6050, Program Objectives businesses; Washington, DC 20416. (b) Open all service centers at least 40 The SBDC program uses Federal SUPPLEMENTARY INFORMATION: Notice is funds to leverage the resources of states, hours per week, or during the normal business hours of its state or academic hereby given that as a result of the academic institutions and the private President’s major disaster declaration on sector to: Host Organization, throughout the year; (c) Develop working relationships 04/08/2010, Private Non-Profit (a) Strengthen the small business organizations that provide essential community; with financial institutions, the investment community, professional services of governmental nature may file (b) Increase economic growth; disaster loan applications at the address (c) Assist more small businesses; and associations, private consultants and small business groups; and listed above or other locally announced (d) Broaden the delivery system to locations. more small businesses. (d) Maintain lists of private consultants at each service center. The following areas have been SBDC Program Organization determined to be adversely affected by Dated: April 6, 2010. the disaster: The lead SBDC operates a statewide Antonio Doss, or regional network of SBDC service Primary Counties: Bristol, Kent, Associate Administrator for Small Business Newport, Providence, Washington. centers. An SBDC must have a full-time Development Centers. Director. SBDCs must use at least 80 [FR Doc. 2010–8444 Filed 4–14–10; 8:45 am] The Interest Rates are: percent of the Federal funds to provide BILLING CODE M services to small businesses. SBDCs use Percent volunteers and other low cost resources For Physical Damage: as much as possible. SMALL BUSINESS ADMINISTRATION Non-Profit Organizations With SBDC Services [Disaster Declaration #12116 and #12117] Credit Available Elsewhere ... 3.625 Non-Profit Organizations With- An SBDC must have a full range of Rhode Island Disaster #RI–00007 out Credit Available Else- business development and technical where ...... 3.000 assistance services in its area of AGENCY: Small Business Administration. For Economic Injury:

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Percent Percent (Catalog of Federal Domestic Assistance Numbers 59002 and 59008) Non-Profit Organizations With- Businesses and Small Agricultural James E. Rivera, out Credit Available Else- Cooperatives without Credit where ...... 3.000 Available Elsewhere ...... 4.000 Associate Administrator for Disaster Assistance. [FR Doc. 2010–8616 Filed 4–14–10; 8:45 am] The number assigned to this disaster The number assigned to this disaster BILLING CODE 8025–01–P for physical damage is 121166 and for for economic injury is 12115. economic injury is 121176. The States which received an EIDL (Catalog of Federal Domestic Assistance Declaration # are Oklahoma, Texas. Numbers 59002 and 59008) (Catalog of Federal Domestic Assistance SECURITIES AND EXCHANGE James E. Rivera, Number 59002) COMMISSION Associate Administrator for Disaster Dated: April 8, 2010. Assistance. [Release No. 34–61877; File No. SR–DTC– Karen G. Mills, [FR Doc. 2010–8615 Filed 4–14–10; 8:45 am] 2010–06] Administrator. BILLING CODE 8025–01–P [FR Doc. 2010–8617 Filed 4–14–10; 8:45 am] Self-Regulatory Organizations; The BILLING CODE 8025–01–P Depository Trust Company; Notice of SMALL BUSINESS ADMINISTRATION Filing and Immediate Effectiveness of Proposed Rule Change Relating to the [Disaster Declaration #12115] SMALL BUSINESS ADMINISTRATION Elective Dividends Service

Oklahoma Disaster # OK–00036 April 8, 2010. Declaration of Economic Injury [Disaster Declaration # 12070 and # 12071] Pursuant to Section 19(b)(1) of the AGENCY: Small Business Administration. Oklahoma Disaster Number OK–00035 Securities Exchange Act of 1934 1 ACTION: Notice. (‘‘Act’’), notice is hereby given that on AGENCY: U.S. Small Business March 22, 2010, The Depository Trust SUMMARY: This is a notice of an Administration. Company (‘‘DTC’’) filed with the Economic Injury Disaster Loan (EIDL) Securities and Exchange Commission ACTION: Amendment 2. declaration for the State of Oklahoma, (‘‘Commission’’) the proposed rule dated 04/09/2010. change as described in Items I, II, and SUMMARY: Incident: Severe Freezing Rain, Ice This is an amendment of the III below, which Items have been and Snowstorms. Presidential declaration of a major prepared primarily by DTC. DTC filed Incident Period: 01/28/2010 through disaster for Public Assistance Only for the proposed rule change pursuant to 02/18/2010. the State of Oklahoma (FEMA–1883– Section 19(b)(3)(A)(iii) of the Act 2 and Effective Date: 04/09/2010. DR), dated 03/05/2010. Rule 19b–4(f)(4) 3 thereunder so that the EIDL Loan Application Deadline Date: Incident: Severe Winter Storm. proposal was effective upon filing with 01/10/2011. Incident Period: 01/28/2010 through the Commission. The Commission is ADDRESSES: Submit completed loan 01/30/2010. publishing this notice to solicit applications to: Small Business comments on the proposed rule change DATES: Administration, Processing and Effective Date: 04/08/2010. from interested persons. Disbursement Center, 14925 Kingsport Physical Loan Application Deadline I. Self-Regulatory Organization’s Road, Fort Worth, TX 76155. Date: 05/04/2010. Statement of the Terms of Substance of FOR FURTHER INFORMATION CONTACT: A. Economic Injury (EIDL) Loan the Proposed Rule Change Escobar, Office of Disaster Assistance, Application Deadline Date: 12/06/2010. U.S. Small Business Administration, The proposed rule change will ADDRESSES: Submit completed loan 409 3rd Street, SW., Suite 6050, provide various technical updates to applications to: U.S. Small Business Washington, DC 20416. DTC’s Elective Dividend service. Administration, Processing and SUPPLEMENTARY INFORMATION: Notice is Disbursement Center, 14925 Kingsport II. Self-Regulatory Organization’s hereby given that as a result of the Road, Fort Worth, TX 76155. Statement of the Purpose of, and Administrator’s EIDL declaration, Statutory Basis for, the Proposed Rule applications for economic injury FOR FURTHER INFORMATION CONTACT: Change disaster loans may be filed at the Alan Escobar, Office of Disaster In its filing with the Commission, address listed above or other locally Assistance, U.S. Small Business DTC included statements concerning announced locations. Administration, 409 3rd Street, SW., the purpose of and basis for the The following areas have been Suite 6050, Washington, DC 20416. proposed rule change and discussed any determined to be adversely affected by SUPPLEMENTARY INFORMATION: The notice comments it received on the proposed the disaster: of the President’s major disaster rule change. The text of these statements Primary Counties: Comanche, declaration for Private Non-Profit may be examined at the places specified Greer, Jackson, Jefferson, Stephens. organizations in the State of Oklahoma, in Item IV below. DTC has prepared Contiguous Counties: Oklahoma dated 03/05/2010, is hereby amended to summaries, set forth in sections A, B, Beckham, Caddo, Carter, Cotton, include the following areas as adversely and C below, of the most significant Garvin, Grady, Harmon, Kiowa, affected by the disaster. aspects of such statements. Love, Tillman. Texas Primary Counties: Tillman. 1 15 U.S.C. 78s(b)(1). Clay, Hardeman, Montague Wilbarger. All other information in the original 2 15 U.S.C. 78s(b)(3)(A)(iii). The Interest Rates are: declaration remains unchanged. 3 17 CFR 240.19b–4(f)(4).

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A. Self-Regulatory Organization’s thereunder because it promotes Paper Comments Statement of the Purpose of, and efficiencies in the clearance and • Send paper comments in triplicate Statutory Basis for, the Proposed Rule settlement of securities transactions by to Elizabeth M. Murphy, Secretary, Change providing participants with a Securities and Exchange Commission, In 1991, DTC filed a rule change with streamlined, electronic means of 100 F Street, NE., Washington, DC the Commission to establish the Elective internally reviewing and approving 20549–1090. 4 election instructions. Dividends (‘‘EDS’’) function. The EDS All submissions should refer to File No. function allows participants to use B. Self-Regulatory Organization’s SR–DTC–2010–06. This file number DTC’s Participant Terminal System Statement on Burden on Competition should be included on the subject line (‘‘PTS’’) or Participant Browser System DTC does not believe that the if e-mail is used. To help the (‘‘PBS’’) instead of hard copy for their Commission process and review your instructions concerning distributions on proposed rule change will have any impact or impose any burden on comments more efficiently, please use certain issues of securities. only one method. The Commission will At the request of its participants, DTC competition. post all comments on the Commission’s has created an automated election C. Self-Regulatory Organization’s Internet Web site (http://www.sec.gov/ instruction approval process accessible Statement on Comments on the rules/sro.shtml). Copies of the through PBS (‘‘EDS approval process’’).5 Proposed Rule Change Received From submission, all subsequent The EDS approval process will provide Members, Participants, or Others amendments, all written statements participants with a streamlined, with respect to the proposed rule electronic means of internally reviewing DTC has not solicited or received change that are filed with the and approving election instructions and written comments relating to the Commission, and all written will be used for the following EDS proposed rule change. DTC will notify services: Cash-in Lieu/Round Up, the Commission of any written communications relating to the Dividend Reinvestment Program, comments it receives. proposed rule change between the Commission and any person, other than Foreign Currency Payments, Optional III. Date of Effectiveness of the Dividend Distribution, and Tax Relief. those that may be withheld from the Proposed Rule Change and Timing for public in accordance with the Participants that chose to use the EDS Commission Action approval process will be required to provisions of 5 U.S.C. 552, will be assign an administrator in their firm to The foregoing rule change has become available for Web site viewing and enable or disable the EDS approval effective upon filing pursuant to Section printing in the Commission’s Public 8 process at the firm. The EDS approval 19(b)(3)(A)(iii) of the Act and Rule Reference Room, 100 F Street, NE., 9 process will have three basic 19b–4(f)(4) thereunder because the Washington, DC 20549, on official entitlements to allow for the creation proposed rule change effects a change in business days between the hours of 10 and approval of instructions: (i) Creator, an existing service of DTC that (i) does a.m. and 3 p.m. Copies of such filings which allows the user to only create not adversely affect the safeguarding of also will be available for inspection and instructions, (ii) approver, which allows securities or funds in DTC’s custody or copying at DTC’s principal office and the user to approve instructions created control or for which it is responsible DTC’s Web site at http://www.dtc.org/ by others and (iii) creator/approver, and (ii) does not significantly affect the impNtc/mor/index.html. All comments which allows the user to create its own respective rights of DTC or persons received will be posted without change; instructions that are automatically using the service. At any time within the Commission does not edit personal approved. Once an instruction is sixty days of the filing of such rule identifying information from created, it will appear with a status of change, the Commission may summarily submissions. You should submit only ‘‘Pending’’ for the approver to approve or abrogate such rule change if it appears information that you wish to make reject. Once approved, the instruction to the Commission that such action is available publicly. All submissions becomes an approved election that will necessary or appropriate in the public should refer to File No. SR–DTC–2010– appear in the election window and will interest, for the protection of investors, 06 and should be submitted on or before be processed in the same way that DTC or otherwise in furtherance of the May 6, 2010. currently processes such elections.6 purposes of the Act. For the Commission by the Division of Additionally, DTC is making IV. Solicitation of Comments Trading and Markets, pursuant to delegated technical updates to its procedures in authority.10 order to properly reflect DTC contact Interested persons are invited to Florence E. Harmon, information and the input methods submit written data, views, and Deputy Secretary. arguments concerning the foregoing, available to participants. [FR Doc. 2010–8614 Filed 4–14–10; 8:45 am] DTC states that the proposed rule including whether the proposed rule change is consistent with the change is consistent with the Act. BILLING CODE 8011–01–P requirements of Section 17A of the Act 7 Comments may be submitted by any of and the rules and regulations the following methods: DEPARTMENT OF STATE

4 Electronic Comments Securities Exchange Release Act No. 29814 (Oct. [Public Notice 6955] 11, 1991), 56 FR 55563 (Oct. 21, 1991). • Use the Commission’s Internet 5 When the EDS approval process is enabled for comment form (http://www.sec.gov/ a given service, a participant will be required to Culturally Significant Objects Imported rules/sro.shtml) or for Exhibition Determinations: ‘‘From create and update its instructions in PBS for that • service; PTS may not be used. Send an e-mail to rule- Xanadu to Dadu: The World of Khubilai 6 If left unapproved, the instruction will remain [email protected]. Please include File Khan’’ pending until the cutoff date. If the instruction is No. SR–DTC–2010–06 on the subject pending on the cutoff date, it will be deleted from SUMMARY: Notice is hereby given of the the EDS system at the end of the day, and the line. instruction will revert to the last approved election following determinations: Pursuant to or if one does not exist, to the default for the event. 8 15 U.S.C. 78s(b)(3)(A)(iii). 7 15 U.S.C. 78q–1. 9 17 CFR 240.19b–4(f)(4). 10 17 CFR 200.30–3(a)(12).

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the authority vested in me by the Act of ATPA. (See 19 U.S.C. 3203(b)(6)(B).) 2. Requirements for Submissions October 19, 1965 (79 Stat. 985; 22 U.S.C. This information will be used in the 2459), Executive Order 12047 of March preparation of a report to the Congress Persons submitting comments must 27, 1978, the Foreign Affairs Reform and on the operation of the program. do so in English and must identify (on Restructuring Act of 1998 (112 Stat. the first page of the submission) the DATES: Public comments are due no 2681, et seq.; 22 U.S.C. 6501 note, et ‘‘USTR Report on Operation of the later than 5 p.m., May 12, 2010. seq.), Delegation of Authority No. 234 of Andean Trade Preference Act.’’ In order October 1, 1999, Delegation of Authority ADDRESSES: Submissions via on-line: to be assured of consideration, No. 236 of October 19, 1999, as http://www.regulations.gov. For comments should be submitted by May amended, and Delegation of Authority alternatives to on-line submissions, 12, 2010. No. 257 of April 15, 2003 [68 FR 19875], please contact Gloria Blue, Executive In order to ensure the timely receipt I hereby determine that the objects to be Secretary, Trade Policy Staff Committee and consideration of comments, USTR included in the exhibition ‘‘From (TPSC), at (202) 395–3475. strongly encourages commenters to Xanadu to Dadu: The World of Khubilai make on-line submissions, using the FOR FURTHER INFORMATION CONTACT: For Khan,’’ imported from abroad for http://www.regulations.gov Web site. procedural questions concerning written temporary exhibition within the United Comments should be submitted under comments, please contact Gloria Blue at States, are of cultural significance. The the following docket: USTR–2010–0012. the above number. All other questions objects are imported pursuant to a loan To find the docket, enter the docket regarding the ATPA should be directed agreement with the foreign owners or number in the ‘‘Enter Keyword or ID’’ to Bennett Harman, Deputy Assistant custodians. I also determine that the window at the http:// USTR for Latin America, at (202) 395– exhibition or display of the exhibit www.regulations.gov home page and objects at The Metropolitan Museum of 9446. click ‘‘Search.’’ The site will provide a Art, New York, NY, from on or about SUPPLEMENTARY INFORMATION: search-results page listing all documents September 28, 2010, until on or about associated with this docket. Find a 1. Background Information January 2, 2011, and at possible reference to this notice by selecting additional exhibitions or venues yet to The ATPA, as amended by the ‘‘Notices’’ under ‘‘Document Type’’ on be determined, is in the national Andean Trade Promotion and Drug the search-results page, and click on the interest. I have ordered that Public Eradication Act of 2002 (ATPDEA) in link entitled ‘‘Submit a Comment.’’ (For Notice of these Determinations be the Trade Act of 2002, 19 U.S.C. 3201 further information on using the published in the Federal Register. et seq., provides trade benefits for http://www.regulations.gov Web site, FOR FURTHER INFORMATION CONTACT: For eligible Andean countries. In please consult the resources provided further information, including a list of Proclamation 7616 of October 31, 2002, on the Web site by clicking on the the exhibit objects, contact Julie the President designated Bolivia, ‘‘Help’’ tab.) Simpson, Attorney-Adviser, Office of Colombia, Ecuador, and Peru as The http://www.regulations.gov Web the Legal Adviser, U.S. Department of ATPDEA beneficiary countries. In site provides the option of making State (telephone: 202–632–6467). The Proclamation 8323 of November 25, submissions by filling in a comments mailing address is U.S. Department of 2008, the President determined that field, or by attaching a document. USTR State, SA–5, L/PD, Fifth Floor (Suite Bolivia no longer satisfies the eligibility prefers submissions to be provided in an 5H03), Washington, DC 20522–0505. criteria related to counternarcotics and attached document. If a document is Dated: April 8, 2010. suspended Bolivia’s status as a attached, it is sufficient to type ‘‘See Maura M. Pally, beneficiary country for purposes of the attached’’ in the ‘‘Type comment & Deputy Assistant Secretary for Professional ATPA and ATPDEA. In a June 30, 2009 Upload File’’ field. USTR prefers and Cultural Exchanges, Bureau of report to Congress the President did not submissions in Microsoft Word (.doc) or Educational and Cultural Affairs, Department determine that Bolivia satisfies the Adobe Acrobat (.pdf). If the submission of State. requirements set forth in section 203(c) is in an application other than those [FR Doc. 2010–8638 Filed 4–14–10; 8:45 am] of the ATPA (19 U.S.C. 3202(c)) for two, please indicate the name of the BILLING CODE 4710–05–P being designated as a beneficiary application in the ‘‘Comments’’ field. country. Therefore, as provided for in For any comments submitted section 208(a)(3) of the Act (19 U.S.C. electronically containing business OFFICE OF THE UNITED STATES 3206(a)(3)), no duty free treatment or confidential information, the file name TRADE REPRESENTATIVE other preferential treatment extended of the business confidential version under the ATPA remained in effect with should begin with the characters ‘‘BC’’. Andean Trade Preference Act (ATPA), respect to Bolivia after June 30, 2009. Any page containing business as Amended: Request for Public Section 203(f) of the ATPA (19 U.S.C. confidential information must be clearly Comments Regarding Beneficiary 3202(f)) requires the USTR, not later marked ‘‘BUSINESS CONFIDENTIAL’’ Countries than June 30, 2010, to submit to on the top of that page. Filers of AGENCY: Office of the United States Congress a report on the operation of the submissions containing business Trade Representative. ATPA. Before submitting such report, confidential information must also ACTION: Notice; request for comments. USTR is required to request comments submit a public version of their on whether beneficiary countries are comments. The file name of the public SUMMARY: In compliance with section meeting the criteria set forth in 19 version should begin with the character 203(f) of the ATPA, as amended, 19 U.S.C. 3203(b)(6)(B) (which incorporates ‘‘P’’. The ‘‘BC’’ and ‘‘P’’ should be U.S.C. 3202(f)(2), the Office of the by reference the criteria set forth in followed by the name of the person or United States Trade Representative sections 3202(c) and (d)). USTR refers entity submitting the comments or reply (USTR) is requesting the views of interested parties to the Federal comments. Filers submitting comments interested parties on whether the Register notice published on August 15, containing no business confidential designated beneficiary countries are 2002 (67 FR 53379), for a full list of the information should name their file using meeting the eligibility criteria under the eligibility criteria. the character ‘‘P’’, followed by the name

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of the person or entity submitting the DEPARTMENT OF TRANSPORTATION demands including improved access comments. between I–65 and US 31W; and Please do not attach separate cover Federal Highway Administration improved roadway capacity and safety letters to electronic submissions; rather, [FHWA–KY–EIS–04–2–F, NH 65–1 (73)] conditions. include any information that might Authority: 23 U.S.C. 315; 49 CFR 1.48. appear in a cover letter in the comments Notice of Availability of the Record of Issued on April 6, 2010. themselves. Similarly, to the extent Decision for the I–65 to US 31W possible, please include any exhibits, Access Improvement Final Mr. Jose Sepulveda, annexes, or other attachments in the Environmental Impact Statement Division Administrator, FHWA–Kentucky same file as the submission itself, not as (FEIS) Division. separate files. [FR Doc. 2010–8437 Filed 4–14–10; 8:45 am] AGENCY: Federal Highway USTR strongly urges submitters to file BILLING CODE M Administration. comments through http:// www.regulations.gov, if at all possible. ACTION: Notice of Availability of Record DEPARTMENT OF TRANSPORTATION Any alternative arrangements must be of Decision (ROD). made with Ms. Blue in advance of SUMMARY: In accordance with the Federal Highway Administration transmitting a comment. Ms. Blue National Environmental Policy Act should be contacted at (202) 395–3475. (NEPA) and Federal Highway Notice of Final Federal Agency Actions General information concerning USTR Administration (FHWA) procedures, the on a Proposed New Road Connecting is available at http://www.ustr.gov. FHWA announces the availability of the I–65 and U.S. 31W in Kentucky Carmen Suro-Bredie, ROD to implement the I–65 to US 31W AGENCY: Federal Highway Chairman, Trade Policy Staff Committee. Access Improvement project in Warren Administration (FHWA), DOT. County, Kentucky. The Division [FR Doc. 2010–8629 Filed 4–14–10; 8:45 am] ACTION: Notice of limitation on claims Administrator, FHWA–Kentucky BILLING CODE P for judicial review of actions by FHWA, Division signed the ROD on March 23, Army Corps of Engineers (USACE), 2010. DoD, and other Federal agencies. ADDRESSES: The FHWA ROD for the I– DEPARTMENT OF TRANSPORTATION 65 to US 31W Access Improvement SUMMARY: This notice announces actions project can be viewed and downloaded taken by the FHWA that are final within Maritime Administration from the project Web site at http:// the meaning of 23 U.S.C. 139(l)(1). The www.transportation.ky.gov/d3/I6531w, actions relate to a proposed highway Marine Highway Projects or viewed at public libraries in the project: a new connector road from I–65 project area. to US 31W in Warren County, Kentucky ACTION: Solicitation of applications for FOR FURTHER INFORMATION: Mr. Anthony [Kentucky Transportation Cabinet Marine highway projects. Goodman, Environmental Specialist, (KYTC) Item No. 3–16.00]. SUMMARY: The Department of Federal Highway Administration, DATES: By this notice, the FHWA is Transportation is soliciting applications Kentucky Division; 330 West Broadway, advising the public of final agency for Marine Highway Projects as Frankfort, Kentucky, 40601; normal actions subject to 23 U.S.C. 139(l)(1). A specified in the America’s Marine business hours Monday–Friday, 8 a.m.– claim seeking judicial review of the Highway Program Final Rule, MARAD– 4:30 p.m. Eastern Standard Time; Phone Federal agency actions on the highway 2010–0035, published in the Federal 502–223–6742, E-mail project will be barred unless the claim Register on April 9, 2010. These [email protected]. is filed on or before October 5, 2010. If applications must comply with the SUPPLEMENTARY INFORMATION: The I–65 the Federal law that authorizes judicial requirements of the referenced to US 31W Access Improvement ROD review of a claim provides a time period America’s Marine Highway Program was developed through preparation of of less than 180 days for filing such Final Rule, and be submitted in the Final Environmental Impact claim, then that shorter time period still accordance with the instructions Statement for I–65 to US 31W Access applies. contained in that Final Rule. This Improvement, prepared in accordance FOR FURTHER INFORMATION CONTACT: For application period begins immediately with the National Environmental Policy FHWA: Mr. Anthony Goodman, upon publication of this notice and is Act (NEPA). The decision is hereby Environmental Specialist, Federal open through June 11, 2010. made to implement the project that Highway Administration, Kentucky Division; 330 West Broadway, Frankfort, FOR FURTHER INFORMATION CONTACT: involves the construction of a new road Kentucky, 40601; normal business hours Michael Gordon, Office of Intermodal linking I–65 and US 31W, construction Monday–Friday, 8 a.m.–4:30 p.m. System Development, Marine Highways of a full interchange with I–65 and a Eastern Standard Time; Phone 502–223– and Passenger Services, at (202) 366– partial interchange with US 68/KY 80, 6742, E-mail 5468, via e-mail at and reconstruction of US 31W as it [email protected]. For KYTC: [email protected], or by writing approaches the intersection of the new Mr. David Waldner, P.E., Director, to the Office of Marine Highways and corridor. The project, which is Division of Environmental Analysis, Passenger Services, MAR–520, Suite approximately 3.8 miles in length, is Kentucky Transportation Cabinet; 200 W21–315, 1200 New Jersey Avenue, SE., northeast of the city of Bowling Green, Mero Street, 5 Floor, Frankfort, Washington, DC 20590. in Warren County, Kentucky. The road will be six lanes with a depressed Kentucky, 40622; regular business hours Dated: April 9, 2010. median from I–65 to US 68/KY 80, and Monday–Friday, 8 a.m.–4:30 p.m. Christine Gurland, four lanes with a depressed median Eastern Standard Time; Phone 502–564– Secretary, Maritime Administration. from US 68/KY 80 to US 31W. The 5655, E-mail [email protected]. [FR Doc. 2010–8619 Filed 4–14–10; 8:45 am] purpose of the project is to meet the SUPPLEMENTARY INFORMATION: Notice is BILLING CODE 4910–81–P existing and future transportation hereby given that the FHWA has taken

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final agency actions subject to 23 U.S.C. 6. Social and Economic: Civil Rights http://www.phmsa.dot.gov/hazrnat/ 139(0)(1) by issuing licenses, permits, Act of 1964 [42 U.S.C. 2000(d)– regs/international. and approvals for the following highway 2000(d)(1)]; Uniform Relocation FOR FURTHER INFORMATION CONTACT: Mr. project in the State of Kentucky: The Assistance and Real Property Duane Pfund, Acting Director, Office of project [FHWA–KY–EIS–04–2–F, Acquisition Act of 1970 (42 U.S.C. 4601 Hazardous Materials Technology or Mr. NH65–1(73)] involves the construction et seq., Pub. L. 91–646) as amended by Shane Kelley, International of a new road linking I–65 and US 31W, the Uniform Relocation Act Transportation Specialist, Office of construction of a full interchange with Amendments of 1987 (Pub. L. 100–17); Hazardous Materials Safety, Department I–65 and a partial interchange with US Executive Order 12898, Federal Actions of Transportation, Washington, DC 68/KY 80, and reconstruction of US to Address Environmental Justice in 20590; (202) 366–0656. 31W as it approaches the intersection of Minority Populations and Low Income SUPPLEMENTARY INFORMATION: The the new corridor. The project, which is Populations, February 11, 1994. primary purpose of this meeting will be approximately 3.8 miles in length, is (Catalog of Federal Domestic Assistance to prepare for the 37th session of the northeast of the city of Bowling Green, Program Number 20.205, Highway Planning UNSCOE TDG. The 37th session of the in Warren County. The road will be six and Construction. The regulations UNSCOE TDG is the third of four lanes with a depressed median from I– implementing Executive Order 12372 meetings scheduled for the current 65 to US 68/KY 80, and four lanes with regarding intergovernmental consultation on 2009–2010 biennium. The UNSCOE will a depressed median from US 68/KY 80 Federal programs and activities apply to this consider proposals for the 17th Revised to US 31W. The purpose of the project program.) Edition of the United Nations is to meet the existing and future Authority: 23 U.S.C. 139(l)(1) Recommendations on the Transport of transportation demands including Issued on: April 6, 2010. improved access between I–65 and US Dangerous Goods Model Regulations Jose Sepulveda, 31W; and improved roadway capacity which will come into force in the and safety conditions. Division Administrator, FHWA–Kentucky international regulations from January 1, The actions by the Federal agencies, Division. 2013. Topics on the agenda for the [FR Doc. 2010–8438 Filed 4–14–10; 8:45 am] UNSCOE TDG meeting include: and the laws under which such actions Æ were taken, are described in the Final BILLING CODE 4910–RY–M Explosives and related matters. Æ Listing, classification and packing. Environmental Impact Statement (FEIS) Æ for the project, approved on July 22, Electric storage systems. DEPARTMENT OF TRANSPORTATION Æ 2009 (FHWA) and July 21, 2009 (KYTC); Miscellaneous proposals of in the FHWA Record of Decision (ROD) amendments to the Model Regulations Pipeline and Hazardous Materials on the Transport of Dangerous Goods. issued on March 23, 2010; and in other Safety Administration Æ documents in the FHWA project Electronic data interchange (EDI) for documentation purposes. records. The FEIS, ROD, and other International Standards on the Æ Cooperation with the International project records are available by Transport of Dangerous Goods; Public Atomic Energy Agency (IAEA). contacting FHWA or KYTC at the Meeting Æ addresses provided above. The FHWA Global harmonization of transport FEIS and ROD can be viewed and AGENCY: Pipeline and Hazardous of dangerous goods regulations with the Materials Safety Administration Model Regulations. downloaded from the project Web site at Æ [http://www.transportation.ky.gov/d3/ (PHMSA), Department of Guiding principles for the Model I6531w], or viewed at public libraries in Transportation. Regulations. Æ Issues relating to the Globally the project area. ACTION: Notice of public meeting. This notice applies to all Federal Harmonized System of Classification SUMMARY: This notice is to advise agency decisions as of the issuance date and Labelling of Chemicals (GHS). interested persons that PHMSA will Æ of this notice and all laws under which Other business. conduct a public meeting in preparation such actions were taken, including but In addition, PHMSA is soliciting for the 37th session of the United not limited to the following: comments on how to further enhance 1. General: National Environmental Nations Sub-Committee of Experts on harmonization for international Policy Act (NEPA) [42 U.S.C. 4321– the Transport of Dangerous Goods transport of hazardous materials. 4351]; Federal-Aid Highway Act [23 (UNSCOE TDG) to be held June 21–30, PHMSA has finalized a broad U.S.C. 109 and 23 U.S.C. 128]; Public 2010 in Geneva, Switzerland. During international strategic plan and Hearing [23 U.S.C. 128]. this meeting, PHMSA is also soliciting welcomes input on items which 2. Air: Clean Air Act [42 U.S.C. 7401– comments relative to potential new stakeholders believe should be included 7671(q)]. work items which may be considered as specific initiatives within this plan. 3. Wildlife: Endangered Species Act for inclusion in its international agenda. PHMSA’s Office of International [16 U.S.C. 1531–1544]. Information Regarding The UNSCOE Standards Strategic Plan can be 4. Historic and Cultural Resources: TDG Meeting: accessed at: http://www.phmsa.dot.gov/ Section 106 of the National Historic DATES: Wednesday, June 9, 2010; 9:30 hazmat/regs/international. Preservation Act of 1966, as amended a.m.–12:30 p.m. The public is invited to attend [16 U.S.C. 470(f) et seq.]; Archeological ADDRESSES: The meeting will be held at without prior notification. Due to the Resources Protection Act of 1977 [16 the DOT Headquarters, West Building, heightened security measures U.S.C. 470(aa)–470(ll)]; Archeological 1200 New Jersey Avenue, SE., participants are encouraged to arrive and Historic Preservation Act [16 U.S.C. Washington, DC 20590. early to allow time for security checks 469469(c)]. Conference Call Capability/Live necessary to obtain access to the 5. Land: Section 4(f) of The Meeting Information: Conference call-in building. Following the 37th session of Department of Transportation Act: 23 and ‘‘live meeting’’ capability will be the UNSCOE TDG, PHMSA will place a U.S.C. 138, 49 U.S.C. 303; Farmland provided for this meeting. Specific copy of the Sub-Committee’s report and Protection Policy Act (FPPA) [7 U.S.C. information on call-in and live meeting a summary of the results on PHMSA’s 4201–4209]. access will be posted when available at Hazardous Materials Safety Homepage

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at http://www.phmsa.dot.gov/hazmat/ • Hand Delivery: Bring comments to DEPARTMENT OF TRANSPORTATION regs/international. the Docket Management Facility in Federal Aviation Administration Documents Room W12–140 of the West Building Ground Floor at 1200 New Jersey [Summary Notice No. PE–2010–15] Copies of documents for the UNSCOE Avenue, SE., Washington, DC, between TDG meeting and the meeting agenda 9 a.m. and 5 p.m., Monday through Petition for Exemption; Summary of may be obtained from the United Friday, except Federal holidays. Petition Received Nations Transport Division’s Web site at: http://www.unece.org/trans/main/ Privacy: We will post all comments AGENCY: Federal Aviation dgdb/dgsubc/c30.html. PHMSA’s we receive, without change, to http:// Administration (FAA), DOT. www.regulations.gov, including any international standards Website at http: ACTION: Notice of petition for exemption //www.phmsa.dot.gov/hazmat/regs/ personal information you provide. received. international also provides additional Using the search function of our docket information regarding the UNSCOE TDG Web site, anyone can find and read the SUMMARY: This notice contains a and related matters such as summaries comments received into any of our summary petition seeking relief from of decisions taken at previous sessions dockets, including the name of the specified requirements of 14 CFR. The of the UNSCOE TDG. individual sending the comment (or purpose of this notice is to improve the Magdy El-Sibaie, signing the comment for an association, public’s awareness of, and participation in, this aspect of FAA’s regulatory Associate Administrator for Hazardous business, labor union, etc.). You may Materials Safety. review DOT’s complete Privacy Act activities. Neither publication of this notice nor the inclusion or omission of [FR Doc. 2010–8446 Filed 4–14–10; 8:45 am] Statement in the Federal Register information in the summary is intended BILLING CODE 4910–60–M published on April 11, 2000 (65 FR 19477–78). to affect the legal status of the petitions or their final disposition. Docket: To read background DATES: Comments on these petitions DEPARTMENT OF TRANSPORTATION documents or comments received, go to must identify the petition docket http://www.regulations.gov at any time Federal Aviation Administration number involved and must be received or to the Docket Management Facility in on or before May 5, 2010. [Summary Notice No. PE–2009–18] Room W12–140 of the West Building ADDRESSES: Ground Floor at 1200 New Jersey You may send comments Petition for Exemption; Summary of identified by Docket Number FAA– Avenue, SE., Washington, DC, between Petition Received 2009–0968 using any of the following 9 a.m. and 5 p.m., Monday through methods: AGENCY: Federal Aviation Friday, except Federal holidays. • Administration (FAA), DOT. Government-wide rulemaking Web FOR FURTHER INFORMATION CONTACT: site: Go to http://www.regulations.gov ACTION: Notice of petition for exemption and follow the instructions for sending received. Annette K. Kovite, ANM–113, (425) 227–1262, Federal Aviation your comments electronically. SUMMARY: This notice contains a Administration, 1601 Lind Avenue, • Mail: Send comments to the Docket summary of a petition seeking relief SW., Renton, WA 98057–3356, or Management Facility; U.S. Department from specified requirements of Title 14, Brenda Sexton, (202) 267–3664, Office of Transportation, 1200 New Jersey Code of Federal Regulations (14 CFR). of Rulemaking (ARM–1), Federal Avenue, SE., West Building Ground The purpose of this notice is to improve Aviation Administration, 800 Floor, Room W12–140, Washington, DC the public’s awareness of, and 20590. Independence Avenue, SW., • participation in, this aspect of FAA’s Washington, DC 20591. Fax: Fax comments to the Docket regulatory activities. Neither publication Management Facility at 202–493–2251. of this notice nor the inclusion or This notice is published pursuant to • Hand Delivery: Bring comments to omission of information in the summary 14 CFR 11.85. the Docket Management Facility in is intended to affect the legal status of Issued in Washington, DC, on April 9, Room W12–140 of the West Building the petition or its final disposition. 2010. Ground Floor at 1200 New Jersey DATES: Comments on this petition must Pamela Hamilton-Powell, Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through identify the petition docket number Director, Office of Rulemaking. involved and must be received on or Friday, except Federal holidays. before May 5, 2010. Petition for Exemption Privacy: We will post all comments ADDRESSES: You may send comments we receive, without change, to http:// identified by Docket Number FAA– Docket No.: FAA–2010–0288. www.regulations.gov, including any 2010–0288 using any of the following Petitioner: Aero Union Corporation. personal information you provide. Using the search function of our docket methods: Section of 14 CFR Affected: 14 CFR • Web site, anyone can find and read the Government-wide rulemaking Web 26.47. site: Go to http://www.regulations.gov comments received into any of our and follow the instructions for sending Description of Relief Sought: dockets, including the name of the your comments electronically. Exemption from the requirement to individual sending the comment (or • Mail: Send comments to the Docket develop damage tolerance data for STCs signing the comment for an association, Management Facility; U.S. Department ST00353LA and SA8009NM installed business, labor union, etc.). You may of Transportation, 1200 New Jersey on Lockheed 188A and 188C airplanes review DOT’s complete Privacy Act Avenue, SE., West Building Ground for the purpose of dispensing Statement in the Federal Register Floor, Room W12–140, Washington, DC firefighting materials. published on April 11, 2000 (65 FR 20590. [FR Doc. 2010–8594 Filed 4–14–10; 8:45 am] 19477–78). • Fax: Fax comments to the Docket Docket: To read background BILLING CODE 4910–13–P Management Facility at 202–493–2251. documents or comments received, go to

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http://www.regulations.gov at any time Policy, Fuel Economy and Consumer consists of an ultrasonic sensor and or to the Docket Management Facility in Programs, NHTSA, West Building, vehicle inclination sensor. Any attempt Room W12–140 of the West Building W43–443, 1200 New Jersey Avenue, SE., to enter the vehicle by means other than Ground Floor at 1200 New Jersey Washington, DC 20590. Ms. Mazyck’s the key will be detected by the VAS. Avenue, SE., Washington, DC, between telephone number is (202) 366–0846. Saab stated that when an unauthorized 9 a.m. and 5 p.m., Monday through Her fax number is (202) 493–2990. person has entered the vehicle after the Friday, except Federal holidays. SUPPLEMENTAL INFORMATION: In a petition system has been set, the signal lights FOR FURTHER INFORMATION CONTACT: dated March 1, 2010, Saab requested an will flash, and the horn and an Tyneka L. Thomas, 202–267–7626, or exemption from the parts-marking additional siren alarm will provide a Ralen Gao, 202–267–3168, Office of requirements of the Theft Prevention warning. The VAS monitors the doors, Rulemaking, Federal Aviation Standard (49 CFR part 541) for the MY engine hood and trunk lid. Administration, 800 Independence 2011 Saab 9–5 vehicle line. The petition Additionally, Saab stated that any Avenue, SW., Washington, DC 20591. requested an exemption from parts- attempt to access any of the system This notice is published pursuant to marking pursuant to 49 CFR part 543, components will activate the VAS. 14 CFR 11.85. Exemption from Vehicle Theft In addressing the specific content Prevention Standard, based on the requirements of 543.6, Saab provided a Issued in Washington, DC on April 9, 2010. detailed list of the tests conducted and Pamela Hamilton-Powell, installation of an antitheft device as standard equipment for the entire believes that the device is reliable and Director, Office of Rulemaking. durable since the device complied with vehicle line. its specified requirements for each test. Petition for Exemption Under § 543.5(a), a manufacturer may Specifically, Saab stated that the design petition NHTSA to grant exemptions for Docket No.: FAA–2009–0968. and assembly processes of the antitheft Petitioner: AirMed International, LLC. one vehicle line per model year. In its subsystems and components were Section of 14 CFR Affected: 135.364. petition, Saab provided a detailed validated for climatic, mechanical and description and diagram of the identity, Description of Relief Sought chemical environments under the design, and location of the components General Motors Corporation validation AirMed International, LLC (AirMed) of the antitheft device for the Saab 9– procedures. seeks relief from § 135.364 which would 5 vehicle line. Saab will install its allow AirMed to receive extended In support of its belief that its passive transponder-based, electronic antitheft device will be as effective as operations approval to operate its immobilizer antitheft device as standard Hawker Beechcraft on a planned route compliance with the parts marking equipment on its 9–5 vehicle line requirements in reducing and deterring that exceeds 180 minutes flying time beginning with MY 2011. Major outside the continental United States. vehicle theft, Saab referenced the components of the antitheft device will American Automobile Manufacturers [FR Doc. 2010–8579 Filed 4–14–10; 8:45 am] include a body control module (BCM), Association response to Docket 97–042; BILLING CODE 4910–13–P passive entry passive start module NHTSA Request for Comments on its (PEPS), intrusion/inclination sensor, an preliminary report to Congress on the immobilizer control module and a user effects of the Anti Car theft Act of 1984 DEPARTMENT OF TRANSPORTATION identification device (UID). Activation provides data supporting that the anti- of the immobilization device occurs theft device will be effective in reducing National Highway Traffic Safety when the ignition is turned to the ‘‘OFF’’ Administration and deterring motor vehicle theft. position. Saab will also install an Additionally, Saab stated that the 2011 Petition for Exemption From the audible and visual alarm system on the 9–5 antitheft device, which was Vehicle Theft Prevention Standard; 9–5 as standard equipment. Saab’s introduced on the 2003 Saab 9–3, has Saab submission is considered a complete been designed to enhance the petition as required by 49 CFR 543.7, in functionality and theft protection AGENCY: National Highway Traffic that it meets the general requirements provided by Saab’s first generation Safety Administration (NHTSA), contained in § 543.5 and the specific antitheft system. The Saab 9–3 was Department of Transportation (DOT). content requirements of § 543.6. formerly named the Saab 900. The ACTION: Grant of petition for exemption. Saab stated that before the vehicle can antitheft device installed on the Saab 9– operate, driver authentication must be 3 (Saab 900) was granted an exemption SUMMARY: This document grants in full performed by communication between from the parts-marking requirements. the Saab Cars North America, Inc.’s the PEPS and the BCM jointly with the (See 62 FR 55453). (Saab) petition for exemption of the 9– UID (key fob). Additionally, verification Saab provided data on the 5 vehicle line in accordance with 49 of the electronic code is required to effectiveness of the antitheft device CFR part 543, Exemption from the Theft allow the transmission shift lever to installed on its 9–3 vehicle line in Prevention Standard. This petition is unlock. When the Engine Start/Stop support of the belief that its device will granted because the agency has button on the instrument panel is be at least as effective as those determined that the antitheft device to pressed, the vehicle transmits a comparable devices previously granted be placed on the line as standard randomly generated 32-bit challenge exemptions by the agency. The agency’s equipment is likely to be as effective in and identifier. If the data matches the 2007 theft data showed that the theft reducing and deterring motor vehicle command and response values, rate for the 9–3 vehicle line has theft as compliance with the parts- authorizations are sent within the BCM remained consistently low. The average marking requirements of the Theft to allow the vehicle to operate. Saab theft rate using three MY’s data for the Prevention Standard (49 CFR part 541). stated that, if incorrect responses are 9–3 is 0.4690. Based on the theft rate DATES: The exemption granted by this received at any point in the process, or experience of the 9–3 vehicle line and notice is effective beginning with the if a response is not received, the system the additional advanced technology 2011 model year. will inhibit operation of the engine. utilized in the current 9–5 antitheft FOR FURTHER INFORMATION CONTACT: Ms. The Saab 9–5 is equipped with a system, Saab believes that the Saab 9– Deborah Mazyck, Office of International vehicle alarm system (VAS). The VAS 5 will be more effective in deterring

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theft than the parts-marking according to the requirements under 49 has concluded that granting these requirements of 49 CFR 541. CFR Parts 541.5 and 541.6 (marking of exemption renewals will provide a level Based on the supporting evidence major component parts and replacement of safety that is equivalent to, or greater submitted by Saab on the device, the parts). than, the level of safety maintained agency believes that the antitheft device NHTSA notes that if Saab wishes in without the exemptions for these for the 9–5 vehicle line is likely to be the future to modify the device on commercial motor vehicle (CMV) as effective in reducing and deterring which this exemption is based, the drivers. motor vehicle theft as compliance with company may have to submit a petition DATES: This decision is effective May the parts-marking requirements of the to modify the exemption. Part 543.7(d) 12, 2010. Comments must be received Theft Prevention Standard (49 CFR 541). states that a Part 543 exemption applies on or before May 17, 2010. The agency concludes that the device only to vehicles that belong to a line will provide the five types of exempted under this part and equipped ADDRESSES: You may submit comments performance listed in § 543.6(a)(3): with the anti-theft device on which the bearing the Federal Docket Management promoting activation; attracting line’s exemption is based. Further, Part System (FDMS) Docket ID FMCSA– attention to the efforts of unauthorized 543.9(c)(2) provides for the submission 1999–6480; FMCSA–2003–16564; persons to enter or operate a vehicle by of petitions ‘‘to modify an exemption to FMCSA–2005–23238; FMCSA–2005– means other than a key; preventing permit the use of an antitheft device 21254; FMCSA–2005–21711; FMCSA– defeat or circumvention of the device by similar to but differing from the one 2005–22727; FMCSA–2007–0017; unauthorized persons; preventing specified in that exemption.’’ FMCSA–2007–0071; FMCSA–2008– operation of the vehicle by The agency wishes to minimize the 0021, using any of the following unauthorized entrants; and ensuring the methods. administrative burden that Part • reliability and durability of the device. 543.9(c)(2) could place on exempted Federal eRulemaking Portal: Go to Pursuant to 49 U.S.C. 33106 and 49 vehicle manufacturers and itself. The http://www.regulations.gov. Follow the CFR 543.7(b), the agency grants a agency did not intend in drafting Part on-line instructions for submitting petition for exemption from the parts- comments. 543 to require the submission of a • marking requirements of part 541 either modification petition for every change Mail: Docket Management Facility; in whole or in part, if it determines that, to the components or design of an U.S. Department of Transportation, 1200 based upon substantial evidence, the antitheft device. The significance of New Jersey Avenue, SE., West Building standard equipment antitheft device is many such changes could be de Ground Floor, Room W12–140, likely to be as effective in reducing and minimis. Therefore, NHTSA suggests Washington, DC 20590–0001. • Hand Delivery or Courier: West deterring motor vehicle theft as that if the manufacturer contemplates Building Ground Floor, Room W12–140, compliance with the parts marking making any changes, the effects of 1200 New Jersey Avenue, SE., requirements of part 541. The agency which might be characterized as de Washington, DC, between 9 a.m. and 5 finds that Saab has provided adequate minimis, it should consult the agency p.m., Monday through Friday, except reasons for its belief that the antitheft before preparing and submitting a Federal Holidays. device for the Saab vehicle line is likely petition to modify. to be as effective in reducing and • Fax: 1–202–493–2251. deterring motor vehicle theft as Authority: 49 U.S.C. 33106; delegation of Each submission must include the authority at 49 CFR 1.50. compliance with the parts-marking Agency name and the docket number for requirements of the Theft Prevention Issued on: April 12, 2010. this Notice. Note that DOT posts all Standard (49 CFR part 541). This Stephen R. Kratzke, comments received without change to conclusion is based on the information Associate Administrator for Rulemaking. http://www.regulations.gov, including Saab provided about its device. [FR Doc. 2010–8660 Filed 4–14–10; 8:45 am] any personal information included in a For the foregoing reasons, the agency BILLING CODE 4910–59–P comment. Please see the Privacy Act hereby grants in full Saab’s petition for heading below. exemption for the Saab 9–5 vehicle line Docket: For access to the docket to from the parts-marking requirements of DEPARTMENT OF TRANSPORTATION read background documents or 49 CFR part 541, beginning with the comments, go to http:// 2011 model year vehicles. The agency Federal Motor Carrier Safety www.regulations.gov at any time or notes that 49 CFR part 541, Appendix Administration Room W12–140 on the ground level of A–1, identifies those lines that are [Docket No. FMCSA–1999–6480; FMCSA– the West Building, 1200 New Jersey exempted from the Theft Prevention 2003–16564; FMCSA–2005–23238; FMCSA– Avenue, SE., Washington, DC, between Standard for a given model year. 49 CFR 2005–21254; FMCSA–2005–21711; FMCSA– 9 a.m. and 5 p.m., Monday through part 543.7(f) contains publication 2005–22727; FMCSA–2007–0017; FMCSA– Friday, except Federal holidays. The requirements incident to the disposition 2007–0071; FMCSA–2008–0021] FDMS is available 24 hours each day, of all Part 543 petitions. Advanced 365 days each year. If you want listing, including the release of future Qualification of Drivers; Exemption acknowledgment that we received your product nameplates, the beginning Applications; Vision comments, please include a self- model year for which the petition is AGENCY: Federal Motor Carrier Safety addressed, stamped envelope or granted and a general description of the Administration (FMCSA), DOT. postcard or print the acknowledgement antitheft device is necessary in order to ACTION: Notice of renewal of page that appears after submitting notify law enforcement agencies of new exemptions; request for comments. comments on-line. vehicle lines exempted from the parts- Privacy Act: Anyone may search the marking requirements of the Theft SUMMARY: FMCSA announces its electronic form of all comments Prevention Standard. decision to renew the 29 individuals. received into any of our dockets by the If Saab decides not to use the FMCSA has statutory authority to name of the individual submitting the exemption for this line, it must formally exempt individuals from the vision comment (or of the person signing the notify the agency. If such a decision is requirement if the exemptions granted comment, if submitted on behalf of an made, the line must be fully marked will not compromise safety. The Agency association, business, labor union, etc.).

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You may review the DOT’s complete Kevin R. White for predicting each driver’s ability to Privacy Act Statement in the Federal These exemptions are extended continue to drive safely in interstate Register published on April 11, 2000 subject to the following conditions: (1) commerce. Therefore, FMCSA (65 FR 19476). This information is also That each individual has a physical concludes that extending the exemption available at http://www.regulations.gov. examination every year (a) by an for each renewal applicant for a period FOR FURTHER INFORMATION CONTACT: Dr. ophthalmologist or optometrist who of two years is likely to achieve a level Mary D. Gunnels, Director, Medical attests that the vision in the better eye of safety equal to that existing without Programs, (202)–366–4001, continues to meet the standard in 49 the exemption. [email protected], FMCSA, CFR 391.41(b)(10), and (b) by a medical Request for Comments Department of Transportation, 1200 examiner who attests that the individual New Jersey Avenue, SE., Room W64– is otherwise physically qualified under FMCSA will review comments 224, Washington, DC 20590–0001. 49 CFR 391.41; (2) that each individual received at any time concerning a Office hours are from 8:30 a.m. to 5 p.m. provides a copy of the ophthalmologist’s particular driver’s safety record and Monday through Friday, except Federal or optometrist’s report to the medical determine if the continuation of the holidays. examiner at the time of the annual exemption is consistent with the SUPPLEMENTARY INFORMATION: medical examination; and (3) that each requirements at 49 U.S.C. 31136(e) and individual provides a copy of the 31315. However, FMCSA requests that Background annual medical certification to the interested parties with specific data Under 49 U.S.C. 31136(e) and 31315, employer for retention in the driver’s concerning the safety records of these FMCSA may renew an exemption from qualification file and retain a copy of drivers submit comments by May 17, the vision requirements in 49 CFR the certification on his/her person while 2010. 391.41(b)(10), which applies to drivers driving for presentation to a duly FMCSA believes that the of CMVs in interstate commerce, for a authorized Federal, State, or local requirements for a renewal of an two-year period if it finds ‘‘such enforcement official. Each exemption exemption under 49 U.S.C. 31136(e) and exemption would likely achieve a level will be valid for two years unless 31315 can be satisfied by initially of safety that is equivalent to, or greater rescinded earlier by FMCSA. The than, the level that would be achieved exemption will be rescinded if: (1) The granting the renewal and then absent such exemption.’’ The procedures person fails to comply with the terms requesting and evaluating, if needed, for requesting an exemption (including and conditions of the exemption; (2) the subsequent comments submitted by renewals) are set out in 49 CFR part 381. exemption has resulted in a lower level interested parties. As indicated above, of safety than was maintained before it the Agency previously published Exemption Decision was granted; or (3) continuation of the notices of final disposition announcing This notice addresses 29 individuals exemption would not be consistent with its decision to exempt these 29 who have requested renewal of their the goals and objectives of 49 U.S.C. individuals from the vision requirement exemptions in accordance with FMCSA 31136(e) and 31315. in 49 CFR 391.41(b)(10). The final procedures. FMCSA has evaluated these decision to grant an exemption to each 29 applications for renewal on their Basis for Renewing Exemptions of these individuals was based on the merits and decided to extend each Under 49 U.S.C. 31315(b)(1), an merits of each case and only after exemption for a renewable two-year exemption may be granted for no longer careful consideration of the comments period. They are: than two years from its approval date received to its notices of applications. Gerald L. Anderson and may be renewed upon application The notices of applications stated in Leo G. Becker for additional two-year periods. In detail the qualifications, experience, Timothy W. Bickford accordance with 49 U.S.C. 31136(e) and and medical condition of each applicant Stanley W. Davis 31315, each of the 29 applicants has for an exemption from the vision Ray L. Emert satisfied the entry conditions for requirements. That information is Sean O. Feeny obtaining an exemption from the vision available by consulting the above cited Steven R. Felks requirements (64 FR 68195; 65 FR Federal Register publications. Marvin T. Fowler 20251; 67 FR 17102; 69 FR 17267; 71 FR Interested parties or organizations Michael J. Frein 16410; 73 FR 28188; 68 FR 74699; 69 FR possessing information that would Jimmy G. Hall 10503; 71 FR 6829; 71 FR 5105; 71 FR otherwise show that any, or all of these Hazel L. Hopkins, Jr. 19600; 70 FR 30999; 70 FR 46567; 72 FR drivers, are not currently achieving the Dennis R. Irvin 40360; 70 FR 48797; 70 FR 61493; 73 FR statutory level of safety should Mark L. LeBlanc 6246; 70 FR 71884; 71 FR 4632; 73 FR immediately notify FMCSA. The David A. Miller 5259; 72 FR 67340; 73 FR 1395; 73 FR Agency will evaluate any adverse Rick P. Moreno 6242; 73 FR 16950; 73 FR 15567; 73 FR evidence submitted and, if safety is Paul D. Schnautz 27015). Each of these 29 applicants has being compromised or if continuation of Steve J. Sherar requested renewal of the exemption and the exemption would not be consistent Robert F. Skinner, Jr. has submitted evidence showing that with the goals and objectives of 49 William T. Smiley the vision in the better eye continues to U.S.C. 31136(e) and 31315, FMCSA will Richard M. Smith meet the standard specified at 49 CFR take immediate steps to revoke the Robert A. Stoeckle 391.41(b)(10) and that the vision exemption of a driver. David N. Stubbs impairment is stable. In addition, a Issued on: April 6, 2010. Edward J. Sullivan review of each record of safety while Aaron S. Taylor driving with the respective vision Larry W. Minor, Martin L. Taylor deficiencies over the past two years Associate Administrator for Policy and Gary R. Thomas indicates each applicant continues to Program Development. William B. Thomas meet the vision exemption standards. [FR Doc. 2010–8646 Filed 4–14–10; 8:45 am] Michael J. Tisher These factors provide an adequate basis BILLING CODE 4910–EX–P

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DEPARTMENT OF TRANSPORTATION Conclusion FOR FURTHER INFORMATION CONTACT: Dr. The Agency has not received any Mary D. Gunnels, Director, Medical Federal Motor Carrier Safety adverse evidence on any of these drivers Programs, (202)–366–4001, Administration that indicates that safety is being [email protected], FMCSA, compromised. Based upon its Department of Transportation, 1200 [Docket No. FMCSA–2003–16241; FMCSA– evaluation of the 15 renewal New Jersey Avenue, SE., Room W64– 2003–16564; FMCSA–2005–22194; FMCSA– applications, FMCSA renews the 224, Washington, DC 20590–0001. 2007–27897] Federal vision exemptions for Lee A. Office hours are from 8:30 a.m. to 5 p.m. Burke, Barton C. Caldara, Allan Darley, Monday through Friday, except Federal Qualification of Drivers; Exemption holidays. Renewals; Vision Robin S. England, Charles D. Grady, Richard Hailey, Jr., Robert V. Hodges, SUPPLEMENTARY INFORMATION: AGENCY: Federal Motor Carrier Safety George R. Knavel, John R. Knott III, Administration (FMCSA), DOT. Timothy S. Miller, Roger D. Mollak, Electronic Access ACTION: Notice of final disposition. Edward D. Pickle, Ezequiel M. Ramirez, You may see all the comments online James L. Schmitt and James T. through the Federal Document SUMMARY: FMCSA previously Wortham, Jr. Management System (FDMS) at http:// announced its decision to renew the In accordance with 49 U.S.C. 31136(e) www.regulations.gov. exemptions from the vision requirement and 31315, each renewal exemption will in the Federal Motor Carrier Safety be valid for 2 years unless revoked Background earlier by FMCSA. The exemption will Regulations for 15 individuals. FMCSA Under 49 U.S.C. 31136(e) and 31315, be revoked if: (1) The person fails to has statutory authority to exempt FMCSA may grant an exemption for a 2- comply with the terms and conditions individuals from the vision requirement year period if it finds ‘‘such exemption of the exemption; (2) the exemption has if the exemptions granted will not would likely achieve a level of safety resulted in a lower level of safety than compromise safety. The Agency has that is equivalent to, or greater than, the was maintained before it was granted; or concluded that granting these level that would be achieved absent (3) continuation of the exemption would exemptions will provide a level of safety such exemption.’’ The statute also not be consistent with the goals and that will be equivalent to, or greater allows the Agency to renew exemptions objectives of 49 U.S.C. 31136 and 31315. than, the level of safety maintained at the end of the 2-year period. The without the exemptions for these Issued on: April 6, 2010. comment period ended on March 25, commercial motor vehicle (CMV) Larry W. Minor, 2010 (75 FR 8183). drivers. Associate Administrator for Policy and Discussion of Comments FOR FURTHER INFORMATION CONTACT: Dr. Program Development. Mary D. Gunnels, Director, Medical [FR Doc. 2010–8648 Filed 4–14–10; 8:45 am] FMCSA received no comments in this Programs, (202)–366–4001, BILLING CODE 4910–EX–P proceeding. [email protected], FMCSA, Conclusion Department of Transportation, 1200 New Jersey Avenue, SE., Room W64– DEPARTMENT OF TRANSPORTATION The Agency has not received any 224, Washington, DC 20590–0001. Federal Motor Carrier Safety adverse evidence on any of these drivers Office hours are from 8:30 a.m. to 5 p.m. Administration that indicates that safety is being Monday through Friday, except Federal compromised. Based upon its holidays. [Docket No. FMCSA–1999–5748; FMCSA– evaluation of the 5 renewal SUPPLEMENTARY INFORMATION: 1999–6156] applications, FMCSA renews the Federal vision exemptions for Dennis J. Qualification of Drivers; Exemption Electronic Access Lessard, Harry R. Littlejohn, James D. Renewals; Vision You may see all the comments online Simon, Robert J. Townsley and Jeffrey through the Federal Document AGENCY: Federal Motor Carrier Safety G. Wuensch. Management System (FDMS) at http:// Administration (FMCSA), DOT. In accordance with 49 U.S.C. 31136(e) www.regulations.gov. ACTION: Notice of final disposition. and 31315, each renewal exemption will Background be valid for 2 years unless revoked SUMMARY: FMCSA previously earlier by FMCSA. The exemption will Under 49 U.S.C. 31136(e) and 31315, announced its decision to renew the be revoked if: (1) The person fails to FMCSA may grant an exemption for a 2- exemptions from the vision requirement comply with the terms and conditions year period if it finds ‘‘such exemption in the Federal Motor Carrier Safety of the exemption; (2) the exemption has would likely achieve a level of safety Regulations for 5 individuals. FMCSA resulted in a lower level of safety than that is equivalent to, or greater than, the has statutory authority to exempt was maintained before it was granted; or level that would be achieved absent individuals from the vision requirement (3) continuation of the exemption would such exemption.’’ The statute also if the exemptions granted will not not be consistent with the goals and allows the Agency to renew exemptions compromise safety. The Agency has objectives of 49 U.S.C. 31136 and 31315. at the end of the 2-year period. The concluded that granting these comment period ended on March 25, exemptions will provide a level of safety Issued on: April 6, 2010. 2010 (75 FR 8184). that will be equivalent to, or greater Larry W. Minor, than, the level of safety maintained Associate Administrator for Policy and Discussion of Comments without the exemptions for these Program Development. FMCSA received no comments in this commercial motor vehicle (CMV) [FR Doc. 2010–8645 Filed 4–14–10; 8:45 am] proceeding. drivers. BILLING CODE 4910–EX–P

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Part II

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

42 CFR Parts 417, 422, 423, and 480 Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs; Final Rule

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DEPARTMENT OF HEALTH AND B. History and Overview 2. Beneficiary Communications Materials HUMAN SERVICES II. Provisions of the Proposed Rule and Under Parts C and D (§ 422.2260, Analysis and Responses to Public § 423.2262, § 423.2260, and § 423.2262) Centers for Medicare & Medicaid Comments 3. Required Use of Standardized Model Services A. Changes to Strengthen Our Ability To Materials Under Parts C and D Distinguish for Approval Stronger (§ 422.2262 and § 423.2262) Applicants for Part C and D Program 4. Involuntary Disenrollment for Failure to 42 CFR Parts 417, 422, 423, and 480 Participation and To Remove Pay Plan Premiums Under Parts C and D [CMS–4085–F] Consistently Poor Performers (§ 422.74 and § 423.44) 1. Require Notice of Intent to Apply Under 5. Maximum Allowable Out-of-Pocket Cost RIN 0938–AP77 Part C and D Within the Application Amount for Medicare Parts A and B Requirements (§ 422.501 and § 423.502) Services (§ 422.100) Medicare Program; Policy and 2. Application Requirements (§ 422.501(c) 6. Maximum Allowable Cost Sharing Technical Changes to the Medicare and § 423.502(c)) and Evaluation and Amount for Medicare Parts A and B Advantage and the Medicare Determination Procedures for Services and Prescription Drugs Prescription Drug Benefit Programs Determining Whether Applicants are (§ 422.100 and § 423.104) Qualified for a Contract Under Parts C 7. Prohibition on Prior Notification by AGENCY: Centers for Medicare & and D (§ 422.502 and § 423.503) PPO, PFFS, and MSA Plans Under Part Medicaid Services (CMS), HHS. 3. Deny Contract Qualification C (§ 422.2, § 422.4, and § 422.105) 8. Requirements for LIS Eligibility Under ACTION: Final rule. Applications Based on Past Contract Performance (§ 423.750 and § 422.750) Part D (§ 423.773) 9. Enrollment of Full Subsidy Eligible SUMMARY: 4. Use of Data to Evaluate Continued This final rule makes Individuals and Other Subsidy Eligible Ability to Act as a Qualified Sponsoring revisions to the regulations governing Individuals Under Part D (§ 423.34) Organization Under Parts C and D the Medicare Advantage (MA) program 10. Special Enrollment Periods Under Part (§ 422.504, and § 423.505) (Part C) and prescription drug benefit D (§ 423.380) 5. Compliance Programs Under Part C and program (Part D) based on our 11. Transition Process Under Part D D (§ 422.503(b)(4)(vi) and (§ 423.120(b)(3)) continued experience in the § 423.504(b)(4)(vi)) 12. Part D Sponsor Responsibility for administration of the Part C and D 6. Network Adequacy of Coordinated Care Retroactive Claims Adjustment programs. The revisions strengthen and Network-Based Private Fee-for- Reimbursements and Recoveries Under various program participation and exit Service Plans Under Part C (§ 422.112) Part D (§ 423.464) requirements; strengthen beneficiary 7. Deemable Program Requirements Under 13. Time Limits for Coordination of protections; ensure that plan offerings to Parts C and D (§ 422.156(b) (7), § 422.156 Benefits (§ 423.466) beneficiaries include meaningful (f), § 423.165(b), and § 423.165(f)) 14. Use of Standardized Technology Under differences; improve plan payment rules 8. Modify the Corrective Action Plan (CAP) Part D (§ 423.120) and processes; improve data collection Process as it Relates to Procedures for 15. Absence from Service Area for More for oversight and quality assessment, Termination and Nonrenewal of a Part C Than 12 Months Under Part D (§ 423.44) or D Contract By CMS (§ 422.506(b)(3), 16. Prohibition of Mid Year Mass implement new policies and clarify § 422.510(c)(1), § 423.507(b)(3), and existing program policy. Enrollment Changes by SPAPS Under § 423.509(c)(1)) Part D (§ 423.464(e)) DATES: Effective Date: These regulations 9. Procedures for Imposing Intermediate 17. Non-renewal Beneficiary Notification are effective on June 7, 2010. However, Sanctions and Civil Money Penalties Requirement Under Parts C and D we note that because health and drug Under Part C and D (§ 422.756 and (§ 422.506 and § 423.507) plans under the Part C and D programs 423.756) 18. Notice of Alternative Medicare Plans operate under contracts with CMS that 10. Termination of Contracts Under Parts C Available to Replace Non-Renewing are applicable on a calendar year basis, and D (§ 422.510(a) and § 423.509(a)) Plans Under Parts C and D 11. Request for Hearing Under Parts C and the provisions will not be applicable (§ 422.506(a)(2)(ii) and D (§ 422.662 and § 423.651) § 423.507(a)(2)(ii)) prior to contract year January 1, 2011, 12. Burden of Proof, Standard of Proof, except where otherwise noted. 19. Timeframes and Responsibilities for Standard of Review and Conduct of Making Redeterminations Under Part D FOR FURTHER INFORMATION CONTACT: Hearing (§ 422.660, § 423.650, § 422.676, (§ 423.590) Alissa Deboy, (410) 786–6041, General and § 423.658) 20. Requirements for Requesting information and Part D issues. 13. Expedited Contract Terminations Organization Determinations Under Part Sabrina Ahmed, (410) 786–7499, Part C Procedures (§ 422.510, § 423.509, C (§ 422.568) issues. § 422.664, § 423.652, § 422.644, and 21. Organization Determinations Under § 423.642) Under Parts C and D Terry Lied, (410) 786–8973, Collection Part C (§ 422.566 and § 422.568) 14. Time and Place of Hearing Under Parts of information requirements and 22. Representatives (§ 422.561, § 422.574, C and D (§ 422.670 and § 423.655) and § 422.624) regulatory impact analysis issues. 15. Discovery Under Parts C and D 23. Disclosure Requirements Under Parts C Kristy Nishimoto, (410) 786–8517, Part (§ 422.682 and § 423.661) and D (§ 422.111(g) and § 423.128(f)) C and D enrollment and appeals 16. Review by the Administrator Under 24. Definition of MA Plan Service Area issues. Parts C and D (§ 422.692(a) and (§ 422.2) Jennifer Smith, (410) 786–2987, Part C § 423.666(a)) C. Changes to Provide Plan Offerings With and D compliance and sanction 17. Reopening of an Initial Contract Meaningful Differences issues. Determination or Decision of a Hearing 1. Meaningful Differences in Bid Frank Szeflinski, (303) 844–7119, Part C Officer or the Administrator Under Parts Submissions and Bid Review (§ 422.254, payment issues. C and D (§ 422.696 and § 423.668) § 423.265, § 422.256, and 423.272) 18. Prohibition of MA and Part D 2. Transition Process in Cases of SUPPLEMENTARY INFORMATION: Applications for 2 Years after a Mutual Acquisitions and Mergers (§ 422.256 and Table of Contents Termination (§ 422.503(b)(6) and § 423.272) § 423.504(b)(5)) 3. Non-renewing Low-enrollment Plans I. Background B. Changes to Strengthen Beneficiary (§ 422.506(b)(1)(iv) and A. Overview of the Medicare Prescription Protections § 423.507(b)(1)(iii)) Drug, Improvement, and Modernization 1. Broker and Agent Requirements Under 4. Medicare Options Compare and Act of 2003 Parts C and D Medicare Prescription Drug Plan Finder

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D. Changes to Improve Payment Rules and 13. Cost Contract Program Revisions: T. ICRs Regarding Access to Covered Part Processes Appeals and Marketing Requirements D Drugs (§ 423.120) 1. Definitions Related to Risk Adjustment (§ 417.428, § 417.494, § 417.500, and U. ICRs Regarding Timeframes and Data Validation Appeals (§ 422.2) and § 417.640) Responsibility for Making Proposed Addition of Medicare a. Cost Contract Determinations (§ 417.492 Redeterminations (§ 423.590) Advantage Organization Risk and 417.494), Civil Money Penalties V. Annual Information Collection Burden Adjustment Data Validation—Dispute (§ 417.500), and Intermediate Sanctions V. Regulatory Impact Analysis and Appeal Procedures (§ 422.311) (§ 417.500) A. Need for Regulatory Action 2. Payments to Medicare Advantage b. Extending MA Marketing Requirements B. Overall Impact Organizations—Certification of Actuarial to Cost Program Plans (§ 417.428) C. Increase in Costs to MA Organizations Valuation (§ 422.254) 14. Out of Scope Comments and Part D Sponsors 3. Determination of Acceptable H. Changes to Implement Corrections and D. Expected Benefits Administrative Cost by HMO/CMP Cost Other Technical Changes E. Anticipated Effects—Effects of Cap on Contractors and Health Care Prepayment 1. Application of Subpart M to Health Care Out-of-Pocket Costs and Cost Sharing Plans (HCPPs) (§ 417.564) Prepayment Plans (§ 417.840) Amounts 4. Calculation of the Minimum Percentage 2. Generic Notice Delivery Requirements F. Alternatives Considered Increase Under Part C (§ 422.306) (§ 422.622 and 422.626) 1. Strengthening CMS’ Ability to Take E. Changes to Improve Data Collection for 3. Revision to Definition of Gross Covered Timely, Effective Contract Oversight and Quality Assessment Prescription Drug Costs (§ 423.308) Determinations or Intermediate 1. Requirements for Quality Improvement 4. Application Evaluation Procedures Sanctions (Part C & D) Programs Under Part C (§ 422.152, (§ 422.502(c and d) and § 423.503(c and 2. Changing the Standards of Review, § 422.153, and § 480.140) d)) Clarifying the Standard of Proof and a. Quality Improvement Programs 5. Intermediate Sanctions (§ 422.750(a) and Burden of Proof for Appeals, and b. New Quality Measures § 423.750(a)) Modifying the Conduct of Hearing for c. Use of Quality Improvement 6. Basis for Imposing Intermediate Contract Decisions (Including Denials of Organization Review Information Sanctions and Civil Money Penalties Initial Applications to Contract, Service 2. CAHPS Survey Administration Under (§ 422.752 and § 423.752) Area Expansions for Existing Contracts, Parts C and D (§ 417.472, § 422.152, and III. Provisions of the Final Rule Contract Non-Renewals and § 423.156) IV. Collection of Information Requirements Terminations, and Intermediate 3. Validation of Part C and Part D A. ICRs Regarding Basic Contract Sanctions) Reporting Requirements (§ 422.516 and Requirements (§ 417.472) 3. Clarify That CMS May Require a ‘‘Test § 423.514) B. ICRs Regarding Apportionment and Period’’ During an Enrollment/Marketing 4. Collection of Additional Part D Claims’ Allocation of Administrative and Sanction Elements for Nonpayment-Related General Costs (§ 417.564) 4. Right for CMS to Require an Purposes (§ 423.505) C. ICRs Regarding Medicare Secondary Independent Audit of Sponsoring F. Changes to Implement New Policy Payer (MSP) Procedure (§ 422.108 and Organizations under Intermediate 1. Protected Classes of Concern Under Part Sanction D (§ 423.120(b)(2)(v)) § 423.462) D. ICRs Regarding Disclosure Requirements 5. The Ability for CMS to Require Sponsors 2. Pro-rating the Plan Deductible for Part C to Disclose To Current and Potential MSA Enrollments Occurring During an (§ 422.111) E. ICRs Regarding Quality Improvement Enrollees Compliance and Performance Initial Coverage Election Period Deficiencies (§ 422.103) Program (§ 422.152) F. ICRs Regarding Application 6. Reducing Duplicative and Low G. Changes to Clarify Various Program Enrollment Plans (Parts C & D) Participation Requirements Requirements (§ 422.501 and § 423.502) G. ICRs Regarding General Provisions 7. Validation of Part C and Part D 1. Uniform Benefits Under Parts C and D Reporting Requirements (§ 422.100(d) and § 423.104)) (§ 422.503 and § 423.504) H. ICRs Regarding Contract Provisions G. Accounting Statement 2. Ensuring the Security of Protected H. Conclusion Health Information and Other Personally (§ 422.504 and 423.505) Regulations Text Identifiable Information (§ 422.504 and I. ICRs Regarding Nonrenewal of Contract § 423.505) (§ 422.506 and § 423.507) Acronyms 3. Requirement for Sponsoring J. ICRs Regarding Request for Hearing Organizations Under Parts C and D to (§ 422.662 and § 423.651) AO Accrediting Organization Report Other Payer Information to the K. ICRs Regarding Time and Place of ADS Dispensing System Coordination of Benefits Contractor Hearing (§ 422.670 and § 423.655) AEP Annual Enrollment Period (§ 422.108 and § 423.464) L. ICRs Regarding Review by the AHFS American Hospital Formulary 4. Visitor/Traveler Benefit Under Part C for Administrator (§ 422.692 and § 423.666) Service the Purpose of Extending Enrollment Up M. ICRs Regarding Procedures for Imposing AHFS–DI American Hospital Formulary to 12 Months (§ 422.74) Intermediate Sanctions and Civil Service—Drug Information 5. Medication Therapy Management Monetary Penalties (§ 422.756 and AHRQ Agency for Health Care Research Programs Under Part D (§ 423.153(d)) § 423.756) and Quality 6. Formulary Requirements—Development N. ICRs Regarding Disclosure of Part D ALJ Administrative Law Judge and Revision by a Pharmacy and Plan Information (§ 423.128) BBA Balanced Budget Act of 1997 (Pub. L. Therapeutics Committee (§ 423.120) O. ICRs Regarding Consumer Satisfaction 105–33) 7. Generic Equivalent Disclosure Under Surveys (§ 423.156) BBRA [Medicare, Medicaid and State Child Part D (§ 423.132) P. ICRs Regarding Validation of Part C and Health Insurance Program] Balanced 8. Access to Covered Part D drugs Part D Reporting Requirements Budget Refinement Act of 1999 (Pub. L. (§ 423.120) (§ 422.516 and § 423.514) 106–113) 9. Standard Timeframe and Notice Q. ICRs Regarding Drug Utilization BIPA Medicare, Medicaid, and SCHIP Requirements for Coverage Management, Quality Assurance, and Benefits Improvement Protection Act of Determinations Under Part D (§ 423.568) Medication Therapy Management 2000 (Pub. L. 106–554) 10. Expediting Certain Coverage Programs (MTMPs) (§ 423.153) CAHPS Consumer Assessment Health Determinations (§ 423.570) R. ICRs Regarding Timeframes and Notice Providers Survey 11. Timeframes and Notice Requirements Requirements for Standard Coverage CAP Corrective Action Plan for Expedited Coverage Determinations Determinations (§ 423.568) CCIP Chronic Care Improvement Program (§ 423.572) S. ICRs Regarding Timeframes and Notice CCS Certified Coding Specialist 12. Clarify Novation Agreements Under Requirements for Expedited Coverage CMR Comprehensive Medical Review Part D (§ 423.551) Determinations (§ 423.572) CMP Civil Money Penalties

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CMR Comprehensive Medical Review OPM Office of Personnel Management 22, 2005, 60 days after publication of CMS Centers for Medicare & Medicaid OTC Over the Counter the rule. Services PART C Medicare Advantage As we have gained experience with CMS–HCC CMS Hierarchal Condition PART D Medicare Prescription Drug Benefit Category Programs the MA program and the prescription CTM Complaints Tracking Module PPACA Patient Protection and Affordable drug benefit program, we periodically COB Coordination of Benefits Care Act (Pub. L. 111–148) have revised the Part C and D CORF Comprehensive Outpatient PBM Pharmacy Benefit Manager regulations to continue to improve or Rehabilitation Facility PDE Prescription Drug Event clarify existing policies and/or codify CPC Certified Professional Coder PDP Prescription drug plan current guidance for both programs. For CY Calendar year PFFS Private Fee For Service Plan example, in December 2007, we DOL U.S. Department of Labor POS Point of service published a final rule with comment on DRA Deficit Reduction Act of 2005 (Pub. L. PPO Preferred Provider Organization 109–171) PPS Prospective Payment System contract determinations involving EGWP Employer Group/Union-Sponsored P&T Pharmacy & Therapeutics Medicare Advantage (MA) organizations Waiver Plan QIO Quality Improvement Organization and Medicare Part D prescription drug EOB Explanation of Benefits QRS Quality Review Study plan sponsors (72 FR 68700). In April ESRD End-stage renal disease PACE Programs of All Inclusive Care for the 2008, we published a final rule to FACA Federal Advisory Committee Act Elderly address policy and technical changes to FDA Food and Drug Administration (HHS) RADV Risk Adjustment Data Validation the Part D program (73 FR 20486). In FEHBP Federal Employees Health Benefits RAPS Risk Adjustment Payment System September 2008 and January 2009, we Plan RHIA Registered Health Information FFS Fee-For-Service Administrator finalized revisions to both the Medicare FY Fiscal year RHIT Registered Health Information Advantage and prescription drug benefit GAO General Accounting Office Technician programs (73 FR 54226 and 74 FR 1494, HCPP Health Care Prepayment Plans SCHIP State Children’s Health Insurance respectively) to implement provisions in HEDIS HealthCare Effectiveness Data and Programs the Medicare Improvement for Patients Information Set SEP Special Enrollment Periods and Providers Act (MIPPA) (Pub. L. HHS [U.S. Department of] Health and SHIP State Health Insurance Assistance 110–275), which contained provisions Human Services Programs impacting both the Medicare Part C and SNF Skilled Nursing Facility HIPAA Health Insurance Portability and D programs, and make other policy Accountability Act of 1996 (Pub. L. 104– SNP Special Needs Plan 191) SPAP State Pharmaceutical Assistance clarifications based on experience with HMO Health Maintenance Organization Programs both programs (73 FR 54208, 73 FR HOS Health Outcome Survey SSI Supplemental Security Income 54226, and 74 FR 2881). TrOOP True Out Of Pocket HPMS Health Plan Management System B. History and Overview ICD–9–CM Internal Classification of U&C Usual and Customary Disease, 9th, Clinical Modification USP U.S. Pharmacopoeia The Balanced Budget Act of 1997 Guidelines SUPPLEMENTARY INFORMATION: (BBA) (Pub. L. 105–33) established a ICEP Initial Coverage Enrollment Period I. Background new ‘‘Part C’’ in the Medicare statute ICL Initial Coverage Limit (sections 1851 through 1859 of the ICR Information Collection Requirement A. Overview of the Medicare Social Security Act (the Act) which IVC Initial Validation Contractor Prescription Drug, Improvement, and LEP Late Enrollment Penalty provided for what was then called the LIS Low Income Subsidy Modernization Act of 2003 Medicare+Choice (M+C) program. LTC Long Term Care The Medicare Prescription Drug, Under section 1851(a)(1) of the Act, LTCF Long Term Care Facility Improvement, and Modernization Act of every individual entitled to Medicare MA Medicare Advantage 2003 (MMA) (Pub. L. 108–173) was Part A and enrolled under Medicare Part MAAA American Academy of Actuaries enacted on December 8, 2003. The B, except for most individuals with end- MAO Medicare Advantage Operations MMA established the Part D program stage renal disease (ESRD), could elect MA–PD Medicare Advantage-Prescription to receive benefits either through the Drug Plans and made revisions to the provisions in M+C Medicare+Choice program Part C of the Medicare statute governing original Medicare program or an M+C MPDPF Medicare Prescription Drug Plan the Medicare Advantage (MA) program. plan, if one was offered where he or she Finder The MMA directed that important lived. The primary goal of the M+C MIPPA Medicare Improvements for Patients aspects of the new Medicare program was to provide Medicare and Providers Act of 2008 prescription drug benefit program under beneficiaries with a wider range of MMA Medicare Prescription Drug, Part D be similar to and coordinated health plan choices. The M+C Improvement, and Modernization Act of with regulations for the MA program. provisions in Part C were amended by 2003 (Pub. L. 108–173) Generally, the provisions enacted in the Medicare, Medicaid, and SCHIP MSA Metropolitan statistical area Balanced Budget Refinement Act of MSAs Medical Savings Accounts the MMA took effect January 1, 2006. MSP Medicare Secondary Payer The final rules for the MA and Part D 1999 (BBRA) (Pub. L. 106–111), and MTM Medication Therapy Management prescription drug programs appeared in further amended by the Medicare, MTMP Medication Therapy Management the Federal Register on January 28, Medicaid, and State Children’s Health Programs 2005 (70 FR 4588–4741 and 70 FR Insurance Program SCHIP) Benefits NAIC National Association Insurance 4194–4585, respectively). While the Improvement Act of 2000 (BIPA) (Pub. Commissioners provisions of the final rule did not L. 106–554). NCPDP National Council for Prescription govern plan payment or benefits until As discussed above, the MMA, Drug Programs January 1, 2006, given the fact that enacted on December 8, 2003, added a NGC National Guideline Clearinghouse ‘‘ ’’ NIH National Institutes of Health provisions relating to applications, new Part D to the Medicare statute NOMNC Notice of Medicare Non-coverage marketing, contracts, and the new (sections 1860D–1 through 42 of the OEP Open Enrollment Period bidding process for the MA and Part D Act) creating the Medicare Prescription OIG Office of Inspector General programs, many provisions in these Drug Benefit Program, and made OMB Office of Management and Budget final rules became effective on March significant changes to the M+C program.

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Also as noted above, MIPPA, enacted structure choices for seniors to aid them beneficiary advocacy groups, on July 15, 2008, addressed a number of in making better plan choices, and will researchers, and others. provisions impacting the Part C and D continue to evaluate program changes in In this final rule, we address all programs, including provisions this area. timely comments and concerns on the impacting marketing under both We also proposed additional policies included in the proposed rule. programs which were implemented in provisions aimed at strengthening We note that there were several regulations published in the Federal existing beneficiary protections, comments submitted that were outside Register on September 18, 2008 (73 FR improving payment rules and processes, the scope of the proposals set forth in 54208), a final rule effective October 1, enhancing our ability to pursue data the proposed rule and, as such, we do 2008, that paralleled provisions in collection for oversight and quality not address them within this final rule. MIPPA, and in the same issue of the assessment, strengthening formulary Generally, the commenters supported Federal Register (73 FR 54226), a policy, and finalizing a number of our efforts to improve plan offerings by separate interim final rule that clarifications and technical corrections the same sponsor that are meaningfully addressed the other provisions of to existing policy. Except as noted or different from each other in order to MIPPA affecting the MA and Part D otherwise modified, we finalize these support improved beneficiary decision programs. We also clarified the MIPPA requirements in this rule. making and our efforts to clarify and marketing provisions in a November Section 902 of the Medicare codify existing policy through 2008 interim final rule (73 FR 67407 Prescription Drug, Improvement, and rulemaking. and issued a separate interim final rule Modernization Act of 2003 (MMA) in January 2009 to address MIPPA amended section 1871(a) of the Act and A. Changes to Strengthen Our Ability To provisions related to Part D plan requires the Secretary, in consultation Distinguish for Approval Strong formularies (74 FR 2881). with the Director of the Office of Applicants for Part C and D Program In October 22, 2009 Federal Register Management and Budget, to establish Participation and To Remove (74 FR 54634), we published a proposed and publish for the Consistently Poor Performers rule (file code CMS–4085–P), publication of Medicare final hereinafter referred to as the October 22, This section finalizes a number of regulations based on the previous proposed revisions designed to 2009 proposed rule) addressing publication of a Medicare proposed or additional policy clarifications under strengthen our ability to approve strong interim final regulation. Section 902 of applicants and remove poor performers the Part C and D programs. As noted the MMA also states that the timelines when issuing this proposed rule, we in the Part C and D programs. Since the for these regulations may vary but shall implementation of revisions to the MA believe that additional programmatic not exceed 3 years after publication of and operational changes are needed in and initial implementation of the the preceding proposed or interim final prescription drug programs in January order to further improve our oversight regulation except under exceptional and management of the Part C and D 2006, we have steadily enhanced our circumstances. ability to measure MAO and PDP programs and to further improve This final rule has been published beneficiary experience under MA or sponsor performance through efforts within the 3-year time limit imposed by such as the analysis of data provided Part D plans. section 902 of the MMA, and thus is in Indeed, one of the primary reasons set routinely by sponsors and by our accordance with the Congress’ intent to contractors, regular review of forth in the preamble for issuing the ensure timely publication of final October 22, 2009 proposed rule was to beneficiary complaints, marketing regulations. surveillance activities, and routine address beneficiary concerns associated On March 23, 2010, the Patient audits. This information, combined with with the annual task of selecting one Protection and Affordable Care Act feedback we have received from plan from so many options. We noted (Pub. L. 111–148) was enacted. Several beneficiary satisfaction surveys, HEDIS that while it is clear that the Medicare provisions of this public law affect the data, and information from MAOs and Part D program has improved access to Part C and D programs. In sections II.B. PDP sponsors themselves, has enabled drug coverage for elderly and offered and II.F. of this final rule, we provide us to develop a clearer sense of what beneficiaries a wide range of plans from a discussion of the effects of two of constitutes a successful Medicare which to choose, some have suggested these provisions on our proposed organization capable of providing that a significant numbers of policies regarding MA cost sharing and quality Part C and D services to beneficiaries are confused by the array ‘‘protected classes’’ of drugs under Part beneficiaries. Additionally, this of choices and find it difficult to make D, respectively. enrollment decisions that are best for information has also allowed us to them. Moreover, experience has shown II. Provisions of the Proposed Rule and identify and take appropriate action that organizations submitting bids under Analysis and Responses to Public against organizations that are not Part C and D to offer multiple plans Comments meeting program requirements and not have not consistently submitted plan We received approximately 114 items meeting the needs of beneficiaries. benefit designs that were significantly of timely correspondence containing As set forth below, we are finalizing different from each other, which can comments on the October 22, 2009 changes and clarifications to our add to beneficiary confusion. In this proposed rule. Commenters included regulations to make certain that all rule, we finalize a number of proposals health and drug plan organizations, current and potential MAOs and PDP to the way we administer the Part C and insurance industry trade groups, sponsors clearly understand and can D programs to promote beneficiaries pharmacy associations, pharmaceutical reasonably anticipate how we measure making the best plan choice that suits benefit manager (PBM) organizations, sponsor performance, determine when their needs. Although we believe these provider associations, representatives of there is noncompliance, and when provisions will go a long way to further hospital and long term care institutions, enforcement actions are warranted. that goal, we are committed to drug manufacturers, mental health and These provisions are described in additional explorations of ways to disease specific advocacy groups, detail in Table 1.

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TABLE 1—PROVISIONS STRENGTHENING OUR ABILITY TO DISTINGUISH FOR APPROVAL STRONG APPLICANTS AND TO REMOVE CONSISTENTLY POOR PERFORMERS

Part 422 Part 423 Provision Subpart Section Subpart Section

Notice of Intent to Apply ...... Subpart K ... § 422.501 ...... Subpart K ... § 423.502. Application Standards ...... Subpart K ... § 422.502 ...... Subpart K ... § 423.503. Compliance Measures/Analysis ...... Subpart K ... § 422.502 ...... Subpart K ... § 423.503. Compliance Programs ...... Subpart K ... § 422.503(b)(4)(vi) ..... Subpart K ... § 423.504(b)(4)(vi). Network Adequacy of Coordinated Care and Network-Based Pri- Subpart C .. § 422.112 ...... N/A ...... N/A. vate-Fee-For-Service plans under Part C. Clarify programmatic elements that are ‘‘deemable’’ ...... Subpart D .. § 422.156(b)(7), Subpart D .. § 423.165(b), § 422.156(f). § 423.165(f). Procedures for termination and Nonrenewals: Part C and D ...... Subpart K ... § 422.510(c)(1), Subpart K ... § 423.509(c)(1), § 422.506(b)(3). § 423.507(b)(3). Intermediate Sanctions: procedures for imposing civil and money Subpart O .. § 422.756 ...... Subpart O .. § 423.756. penalties. Contract Termination ...... Subpart K ... § 422.510(a) ...... Subpart K ... § 423.509(a). Proper request for hearings ...... Subpart N .. § 422.662 ...... Subpart N .. § 423.651. Burden of Proof, Standard of Proof, Standard of Review and Subpart N .. § 422.660, Subpart N .. § 423.650, Conduct of Hearing. § 422.676(d). § 423.658(d). Postponement of effective date of determination when a request Subpart N .. § 422.664 ...... Subpart N .. § 423.652. is being filed. Extending timeframe for contract determination hearings ...... Subpart N .. § 422.670 ...... Subpart N .. § 423.655. Appeal times: require each party provide witness list and docu- Subpart N .. § 422.682 ...... Subpart N .. § 423.661. ments 5 calendar days before hearing. Appeal times: require request for a review by the administrator Subpart N .. § 422.692(a) ...... Subpart N .. § 423.666(a). must be received with 15 days after receipt of hearing decision. § 422.692(a) Contract redeterminations and reopening ...... Subpart N .. § 422.696 ...... Subpart N .. § 423.668. Mutual termination of contract ...... Subpart K ... § 422.503(b)(6) ...... Subpart K ... § 423.504(b)(6).

1. Require Notice of Intent To Apply application for the following year. Apply does not bind the organization to Under Part C and D Within the However, without a pending contract submit an application. For this reason, Application Requirements (§ 422.501 number and completed CMS User ID we do not believe it is necessary to be and § 423.502) connectivity, an organization will not be flexible with the due date of the notice Under the authority of section able to access the appropriate modules of intent. Organizations are free to 1871(a)(1) of the Act, which authorizes in HPMS to complete the application submit a Notice of Intent to Apply and us to prescribe such regulations as may materials. then consider whether or not to submit be necessary to carry out the In this final rule, we address an application without risking any administration of the Medicare program, comments received and finalize this negative consequences from CMS. We we proposed an administrative provision with modification. As also believe that the notice of intent requirement in the October 22, 2009 explained below, we modified requirement will benefit applicants as it proposed rule for both the Part C and D § 422.503(b)(2) and § 423.502 (b)(2) to will serve as a 3-month advance programs related to the application clearly indicate that the decision not to reminder to begin preparation for their submission to qualify as MA and PDP submit an application after submission submission. We anticipate that the sponsor contractors. We specifically of a notice of intent will not result in additional lead time will result in more proposed in § 422.501 and § 423.502 to any compliance consequences. successful applications. codify our existing guidance that initial Comment: Several commenters Comment: One commenter questioned applicants and existing contractors supported this provision. whether the three month lead time is seeking to expand complete a Response: We appreciate the necessary, particularly for existing nonbinding Notice of Intent to Apply. commenters support of our proposal. sponsors, to ensure timely connectivity We noted that as a result of the fully Comment: Some commenters were to CMS systems. electronic submission process and concerned about the due date of the Response: Our preparation for the restrictions on access to the CMS Health Notice of Intent to Apply and wanted receipt of applications is a process that Plan Management System (HPMS), exceptions to allow CMS the flexibility can take up to 3 months. We encourage every applicant must complete a Notice to accept notice of intent after the due interested parties to see the October 2, of Intent to Apply as described in the date. Some commenters were 2009 HPMS memo for an example of the HPMS memo dated October 10, 2008. particularly concerned about special timeline from submission of the Notice This includes both initial applicants need plans offered in conjunction with of Intent to Apply to the application and current contractors seeking to Medicaid. Commenters also urged CMS submission. expand their organizations’ service area to provide organizations adequate time Comment: One commenter wanted and current contractors adding a Special to make the decision whether to apply CMS to add language indicating that for Needs Plan (SNP) or an Employer and stated that some organizations may those notices of intent that do not result Group/Union-Sponsored Waiver Plan not consider submitting an application in the submission of an application, lack (EGWP) to their existing contract. at the time notices are due. of submission would not be considered We also noted that submitting a Response: As stated in the proposed as part of any punitive evaluation. Notice of Intent to Apply does not bind regulation at § 422.503(b)(2) and Response: As we stated in the October that organization to submit an § 423.503(b)(2), the Notice of Intent to 2009 proposed rule, the Notice of Intent

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to Apply does not bind the organization regarding one applicant’s qualifications not anticipate the need to provide any to submit an application. We want to that we do not consider for others. flexibility on this particular matter. make clear that the submission of a We also proposed to clarify our Comment: One commenter stated that notice of intent without a subsequent authority to decline to consider the ‘‘all’’ standard is not practical given application submission would present application materials submitted after the that there is not a narrative of no risk of reprimand or sanction by us. expiration of the 10-day period requirements in the applications, but a For this reason, we are modifying following our issuance of a notice of series of attestations and tables (with § 422.503(b) and § 423.502 (b) to clearly intent to deny an organization’s contract detailed requirements stated in indicate that the decision not to submit qualification application. We clarified regulations and CMS subregulatory an application after submission of a § 422.502(c)(2) and § 423.503(c)(2) by guidance). notice of intent will not result in any proposing to add a new paragraph (iii) Response: We believe the ‘‘all’’ compliance consequences. to establish that if we do not receive a standard is practical. Applicants receive revised application within 10 days from enough information to successfully 2. Application Requirements (§ 422.501 the date of the intent to deny notice, or apply and are given two opportunities (c) and § 423.502 (c)) and Evaluation if after timely submission of a revised with instructions to cure deficiencies. and Determination Procedures for application the applicant still appears While we advise that applicants should Determining Whether Applicants Are unqualified to contract as an MA be familiar with Part C and D program Qualified for a Contract Under Parts C organization or Part D sponsor or has regulations and guidance, in most and D (§ 422.502 and § 423.503) not provided enough information to instances they are not required to In the October 2009 proposed rule, we allow us to evaluate the application, we describe how their organization will proposed a single clarification that will deny the application. meet a requirement; rather they simply applies to both MA organizations and Further, we noted that consistent with attest that they will meet the Part D sponsors related to our the revisions to § 422.650(b)(2) and requirement. Therefore, an explanation application evaluation procedures and § 423.660(b)(2), which are discussed of all the program requirements in the appeals of our determinations regarding elsewhere in this final rule, the application is not necessary for applications. At § 422.502 and applicant would not be permitted to organizations to submit successful Part § 423.503, we specifically proposed to submit additional revised application C or D applications to us. make explicit that we will approve only material to the Hearing Officer for Comment: Several commenters stated those applications that demonstrate that review should the applicant elect to that CMS has been unclear in its they meet all (not substantially all) Part appeal the denial of its application. previous deficiency responses to C and D program requirements. Allowing for such a submission and applicants and that it has been difficult We noted that the application process review of such information as part of the to obtain guidance from CMS. under Part C and D requires an hearing would, in effect, extend the Commenters urged CMS to provide clear applicant to submit for our review a deadline for submitting an approvable rules and be consistent. In light of the combination of attestations that it will application. In this final rule, we adopt inconsistencies with which applications comply with stated program these provisions as proposed. Comment: are reviewed, one commenter requirements, as well as submit A number of commenters expressed recommended using a standard that contracts with organizations the support for all areas of this provision. emphasizes the materiality of the applicant has contracted with to Response: We appreciate the requirements that sponsors must meet. perform key Part C or D functions, commenters support of our proposal. Response: We agree that in order for evidence of the applicant’s risk-bearing Comment: Many commenters urged applicants to have a consistent licenses, and data documenting that the CMS to be flexible and allow for unique understanding of the expectations on applicant can provide its members circumstances. Several commenters which we base our contract approval access to Part C and D services noted that SNPs have only limited and denials, we must ensure the clarity consistent with the programs’ ability to influence the terms and and transparency of the program requirements. We proposed at timelines that State Medicaid agencies requirements and review criteria. § 422.501(c)(1) and (2), § 422.502(a)(2), follow in executing the SNP agreements. Applicants receive up to three § 423.502(c)(1) and (2), and Response: We design our solicitations communications which explain our § 423.503(a)(2) to require that applicants to ensure that all organizations have a application requirements and provide demonstrate that they meet all fair opportunity to demonstrate their clear instructions on how to be a requirements outlined in the MA qualifications for an MA or PDP successful applicant. Organizations that organization and Part D sponsor contract. As noted in the preamble to fail to completely and accurately apply applications. the October 2009 proposed rule, receive a courtesy e-mail explaining the We simplified the application allowing exceptions to requirements to deficiencies and are given an evaluation process under § 422.502(a)(1) address unique circumstances would opportunity to cure. Organizations that and § 423.503(a)(1) by limiting the undermine the need for a uniform are still deficient after the initial evaluation of an entity’s application to application process applied fairly to all opportunity to cure receive a notice of information contained in the applicants. With respect to Medicaid intent to deny and are given another application and any additional agency contracts, we may require that opportunity to cure. All application information that we obtain through organizations submit those documents communications include contact onsite visits. As we noted in the as part of an application to qualify to information for CMS subject matter proposed rule, limiting our review to offer a SNP plan. When we include that specialists. We are always willing to this information ensures that we will requirement in a particular year’s SNP work with applicants to ensure a afford all applicants (numbering in the application, we have determined that complete understanding of program and hundreds each of the last 4 years) a fair organizations can reasonably be contracting requirements. and consistent review of their expected to obtain the executed Comment: One commenter stated that qualifications. Organizations can be agreements in time for us to determine the applicants that have disagreed with assured that we will not consider that it is qualified to operate a SNP CMS’ network adequacy determinations additional sources of information during the coming contract year. We do have been reluctant to seek re-

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evaluation of their network adequacy in analysis) to the materials organizations contract include, but are not limited to, specific counties because of the submit in response to the annual poor performance ratings as displayed possibility that CMS will confirm its solicitations. We would also make clear on the Medicare Options Compare and original finding and deny the entire that we retain our authority to conduct MPDPF Web sites; receipt of requests for application. A denial of one county in site visits to conduct compliance and corrective action plans (CAPs) unrelated one state could result in the denial of an monitoring activities. to an audit (as these types of CAPs entire application. To address this Comment: One commenter noted that generally involve direct beneficiary problem, the commenter recommended it would be beneficial to sponsors if harm); and receipt of one or more other that CMS revise its policy to provide CMS provided a tool that allows types of noncompliance notices from that an applicant for a network-based sponsors to self-determine network CMS (for example, notices of plan or service area expansion (SAE) adequacy. The commenter stated that noncompliance or warning letters). may drop a county or portion of its the CMS network adequacy standards Additionally, consistent with the service area that has been identified in are subject to reviewer discretion and proposed changes to § 422.503(b), the intent to deny notice after receiving stated that this ambiguity is unfair when § 422.508(c), § 423.504(b), and CMS’ final decision based upon the the sponsor must identify, negotiate, § 423.508(e), we indicated that the additional information submitted by the and complete contract terms, sometimes withdrawal of Part C or D operations organization. with multiple entities, within a 10-day from some or all of an organization’s Response: We afford sponsors period. newly contracted service area prior to multiple opportunities during the Response: We have developed the start of a benefit year (through application review process for standardized network criteria and an mutual termination or otherwise) is an applicants to modify their proposed automated review process that we will indication of poor performance. Such a service area. However, when we use, starting with the contract year 2011 situation can arise when, for example, conduct our final review of an application cycle, to review network an organization, after it has signed its application prior to the issuance of a adequacy. Applicants may request Medicare contract for the upcoming notice of intent to deny, we must make exceptions where they do not meet the program year, loses a contract with a the reasonable assumption, for the sake standardized criteria for individual significant number or type of providers, of consistency, that the applicant seeks provider types in individual counties jeopardizing its ability to provide its approval for its entire proposed service under limited, defined circumstances. members adequate access to services. area, not some portion that the applicant We believe these changes will increase Also, an organization may suddenly face will identify at a later date. Therefore, the consistency and transparency of financial difficulties that threaten its we will not allow applicants to modify network reviews. ability to offer the benefit packages their service areas after they have 3. Deny Contract Qualification approved by us throughout the received a final notice of denial of their Applications Based on Past Contract upcoming contract year. In such application from us. Performance (§ 422.750 and § 423.750) instances, we noted that we could Comment: One commenter simply leave the contract in place and recommended that CMS explicitly As described in the existing take enforcement actions against the provide in the regulation for a process provisions at § 422.502(b) and organization. However, under such an to permit applicants to cure deficiencies § 423.503(b), we may deny an approach, we would knowingly be identified by CMS subsequent to the application based on the applicant’s permitting beneficiaries to remain issuance of the notice of intent to deny; failure to comply with the terms of a enrolled with an organization that and that if such an opportunity is not prior contract with CMS even if the cannot effectively deliver the benefit. provided, CMS should base any denial applicant currently meets all of the Instead, we indicated our preference to notice only on issues raised in the application requirements. In the October act in the best interests of the notice of intent to deny and not on 22, 2009 proposed rule, we proposed to beneficiaries by agreeing with the deficiencies that are identified later in modify these provisions at § 422.502(b) organization to terminate its contract the application review process. and § 423.503(b) to clarify that we will and work with the organization to make Response: When we have discovered review past performance across any and certain that beneficiaries receive a deficiency after we have issued a all of the contracts held by the uninterrupted access to Medicare notice of intent to deny, we have not applicant, by specifically revising the services through another MA disapproved that application based on language to refer to ‘‘any current or prior organization, PDP sponsor, or original the failure to correct the new deficiency. contract’’ held by the organization, Medicare. We are adopting these Rather, we approve the application instead of the current language referring proposed changes without further (assuming all corrections have been to a ‘‘previous year’s contract.’’ We also modification in this final rule. made based on deficiencies identified in clarified that the period that will be Comment: Several commenters the Notice of Intent to Deny), but examined for past performance expressed their support for our use of communicate to the applicant that the problems will be limited to those the past performance review authority newly identified deficiency must be identified by us during the 14 months to ensure that underperforming corrected prior to executing a Medicare prior to the date by which organizations sponsors are not permitted to expand contract. If the issue is not so corrected, must submit contract qualification their participation in the Part C and D it immediately becomes the subject of a applications to CMS. Fourteen months programs. CMS contract compliance action. covers the time period from the start of Response: We appreciate the Comment: One commenter requested the previous contract year through the commenters’ support. that we clarify the type of information time that applications are received for Comment: Several commenters gained via the onsite visits and how this the next contract year. requested that CMS more clearly information will be used in evaluation In making these proposed changes, we articulate the methodology it will apply of applications. noted that indicia of performance to past performance reviews conducted Response: We clarify, that we limit deficiencies that might lead us to under this regulatory provision. For our application reviews (with the conclude that an organization has failed example, commenters were interested in exception of the past performance to comply with a current or prior knowing the relative weights CMS will

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be assigning to different types of a gap in our past performance review. process. At this time, we can provide a compliance actions (such as, corrective Similarly, limiting the period to the 14- general discussion of some of the action plan requests, warning letters) month timeframe gives sponsors and principles we intend to apply to the and whether we will afford organizations the opportunity and development of our past performance organizations the opportunity to correct incentive to promptly establish a methodology. We are cognizant of the deficiencies before CMS makes past positive compliance track record so that variety of products offered by Medicare performance determinations. the next CMS past performance review contractors, and when an element of our Response: We expect to make past will find them eligible for additional past performance evaluation is affected performance methodology available Part C or Part D business. by the unique feature of a particular through publication in our manuals. We Comment: Several commenters asked plan type, we will adjust the application believe that the manuals provide us and that CMS indicate whether the of our methodology as appropriate. We sponsors with the best available avenue withdrawal from all or part of a service also want to emphasize that we intend for providing such detailed information area, non-renewal of one or more plans to be conservative in our and making updates to it as we continue (on the Part C or Part D sponsor’s determinations. We expect to use our to gain more experience with initiative), withdrawal of an application authority under this provision to conducting past performance analysis. or bid, or termination of a contract after exclude only those organizations Given that, we note that the information it has been executed would be counted demonstrating a pattern of poor on which we will base our past against an organization for purposes of performance. Finally, we acknowledge performance analysis has already been past performance analysis. that not all types of noncompliance will made available to organizations. For Response: We would not consider a be given equal weight, and our example, at any time an organization sponsor-initiated non-renewal of all or a methodology will assign weights to can review its own record of compliance portion of an MA or PDP sponsor different measures based on factors such correspondence received from us to get contract as an indication of poor as beneficiary impact or program a sense of the degree to which the contract performance. (However, under stability. organization should be concerned about separate regulatory authority sponsors Comment: A number of commenters the likelihood that CMS would deny an that non-renew their contracts may not suggested that CMS provide the results application for a new contract. be permitted to reenter the program for of its past performance analysis prior to We believe that questions regarding a period of 2 years.) We would treat the due dates for the submission of corrective action opportunities are not non-renewed plan benefit packages notices of intent to apply or for the relevant to our process for reviewing similarly, assuming the organization applications for contract qualification. past performance in making application had met the Part C or D requirements for Response: We will explore the determinations. The purpose of the past providing timely notice to us and our feasibility of providing a preliminary performance review is to determine enrollees. We do not consider the analysis in response to sponsors’ whether the sponsor has demonstrated, withdrawal of an application for requests. However, we note that such a over a 14-month period, whether it has qualification as Medicare contractor or report would not be final, and in no case operated its Part C or D contract in a of a bid prior to the publication of the would even a preliminary report be manner that suggests that it is generally annual benchmark calculation as available before December of each year. meeting and capable of meeting program relevant to a performance evaluation. Comment: A number of commenters requirements and that new Medicare We do look unfavorably on requested assurance that the past business would not jeopardize that organizations that withdraw bids after performance review described status. While some organizations take the benchmark has been announced. previously in this final rule and in the corrective action to address any and all Also, we consider the termination of a October 2009 proposed rule would not compliance issues prior to the contract for an upcoming benefit year include information concerning a expiration of the 14-month review after the organization has executed the sponsor’s performance under contracts period, such corrective action would not contract as a failure to meet Part C and other than those governing Medicare change the fact that during that period D program requirements. Accordingly, managed care and prescription drug of time, the organization demonstrated a organizations should expect that these plan operations (such as, Medicaid, QIC pattern of noncompliance that may raise occurrences would be considered contracts). questions about its ability to take on against them when we evaluate their Response: Absent extraordinary new Medicare business. past contract performance. circumstances, we plan to limit our past Comment: Some commenters advised Comment: Several commenters performance review to the operations of that the 14-month review period is too offered suggestions on factors CMS organizations in the performance of long, while others stated that a longer should take into consideration when their Part C and D contracts only. period (for example, 3 years) would developing and applying our past Comment: One commenter objected to provide a more comprehensive view of performance review methodology. CMS’ use of past performance analysis a sponsor’s contract performance. These included accounting for asserting that is equivalent to taking a Response: We believe that the 14 distinctions between national and local second punitive action for a single month look-back provides an adequate organizations, beneficiary impact of instance of noncompliance. amount of time for us to review an MA noncompliance (or lack thereof), unique Response: In this final rule, we are organization’s or Part D sponsor’s characteristics of SNP plans, and clarifying the scope of our existing performance and the choice of 14 whether difficulties in an organization’s authority and we do not believe it is months as the look-back period was not operation of a contract can be attributed equivalent to an additional compliance arbitrary. As we noted previously, and to an entire organization or are limited or enforcement action taken against any in the proposed rule, 14 months covers to operation of only one or more of its of the organization’s existing Medicare the period spanning the start of the contracts. contracts. Our denial of an application previous contract year to the time we Response: As noted previously, we based on an applicant’s past contract receive applications for the following plan to address issues raised by some of performance is a reflection of our belief contract year. To shorten that time the commenters more fully in guidance that an organization demonstrating period to, say, 12 months would leave issued through our manual update significant operational difficulties

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should focus on improving its existing performance standards articulated in of outlier analyses to evaluate operations before expanding into new statutes, regulations, and guidance or compliance is the application of the types of plan offerings or additional when an organization’s or sponsor’s well-accepted principle that we should service areas. Such a determination has performance represents an outlier look to evolving industry standards to no impact, punitive or otherwise, on a relative to the performance of other establish program requirements. sponsor’s current Medicare contract organizations or sponsors. In this final We recognize our obligation, as both rights and obligations. rule, we adopt the provisions as a business partner and a regulatory Comment: One commenter requested proposed. agency, to use the outlier analysis tool that organizations be permitted to attest Comment: Some commenters in a manner that is fair to sponsors and that they will meet all Part C or D supported this provision, specifically is legally supportable. For example, we program requirements as of no earlier the development of consistent want to reassure organizations that we than January 1 of the upcoming contract performance data evaluation processes. understand that effective outlier year, as organizations are focused on Response: We appreciate the analysis is concerned not just with enrollment and readiness activities prior comments. which organizations’ performance to that date. Comment: Many commenters scores are lower than others, but also Response: This comment concerns an recommended that CMS not use outlier with the degree to which some sponsors aspect of the Part C and D application data to make compliance determinations may trail their peers. Therefore, an and contracting processes unrelated to for a variety of reasons. Some outlier analysis does not by definition our exercise of the past performance commenters believed that CMS should and in every case result in a finding of review authority. Thus, it is outside the only use specific, previously articulated non-compliance. Also, we remind scope of our proposal, and we will not criteria to determine non-compliance. organizations that we have adopted over address it here. Other commenters stated that the outlier the last several years, a graduated analysis is arbitrary, inconsistent, and system of compliance notices, and we 4. Use of Data to Evaluate Continued capricious at least in part because it Ability to Act as a Qualified Sponsoring expect that in the large majority of would result in CMS holding sponsors instances, we will make organizations Organization Under Parts C and D to standards that are developed simply (§ 422.504, and § 423.505) aware of their non-compliance with an by measuring sponsors’ performance outlier-based standard through the In the October 22, 2009 proposed rule, relative to each other, not what is lower-level types of notice. These are we clarified our authority to find actually required to comply with Part C the types of notices issued in the earlier organizations or sponsors out of and D program requirements. One stages of CMS’ compliance efforts and compliance with MA and Part D commenter noted that such an approach would afford organizations reasonable requirements. We noted that under the is inconsistent with the operation of a opportunities to take corrective action. authority of Sections 1857(e)(1) and program where Medicare sponsor Finally, we are committed to publishing 1860D–12(b)(3)(D) of the Act, the contracts are not awarded on a regularly outlier-based performance Secretary may add terms to the contracts competitive basis. Still other standards, as they are developed, in with MA and Part D sponsors including commenters recommended that if an guidance materials, including our terms that require the sponsor to outlier analysis is used, it should only program manuals, HPMS memoranda, provide the Secretary ‘‘with such be used as a means by which CMS and our annual call letter, and to update information * * * as the Secretary may identifies plans in need of improvement these standards over time. Further, find necessary and appropriate.’’ not as a determination of non- compliance communications to Additionally, under that authority, CMS compliance. sponsors concerning an area of established § 422.516 and § 423.514, Response: We appreciate these noncompliance where the basis for the which support the submission of Part C comments, but we maintain our belief finding relied on outlier analysis and D Reporting Requirements. We that outlier analysis remains a valid include an explicit description of the clarified that the data acquired through method for identifying non-compliant methodology employed to make such a the reporting requirements are often plan sponsors and a valuable tool in our determination. used for the purpose of monitoring an efforts to monitor hundreds of Comment: Many commenters organization’s or sponsor’s continued contracting organizations in a timely requested that CMS compare like plans compliance with MA and Part D and effective manner. Technically, the with respect to several identifiers, requirements. We also explained that in Part C and D regulations require 100 including: plan types (with particular some instances, we may use an outlier percent compliance with all program consideration given to SNPs), size, analysis to determine a MA requirements. We acknowledge that it market conditions, open vs. closed organization’s or Part D sponsor’s can be impractical to hold sponsors to formularies, and age of enrollees. Some performance relative to industry such an absolute standard. When commenters noted that meaningful standards established by the attempting to establish an acceptable comparisons across sponsors might be performance of all the other level of noncompliance, it makes sense difficult. organizations and sponsors as described for us to compare a sponsor’s Response: Where appropriate, we earlier in the preamble in our discussion performance to that of its peers. Such compare like sponsors and frequently of the development of our policies outlier analysis gives us a sense of the take enrollment (both numbers and concerning the awarding, monitoring, general performance capabilities of a set types of beneficiaries, such as, LIS- and enforcement of Medicare contracts. of sponsors. From such an analysis it is eligible) into consideration. Identifiers As part of the proposed rule, we reasonable, in most instances, for us to that the commenters mentioned are added paragraphs § 422.504(m)(1) and conclude that organizations whose taken into consideration as part of our (2) and § 423.505(n)(1) and (2) to make performance trails that of other similarly data analysis. Our goal is to do explicit our existing authority to find situated sponsors are not making meaningful analysis that can aid us in organizations or sponsors out of reasonable efforts to provide an identifying potential weaknesses. compliance with MA and Part D acceptable level of service to their Comment: Several commenters were requirements when the organization’s or enrollees. As we noted in the discussion concerned with how CMS will conduct sponsor’s performance fails to meet of our proposed rule, inherent in the use outlier analysis and requested that CMS

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define and develop standardized An example of the importance we place the new information supports such a methods for determining outliers. One on the need for clarity and transparency step. We also note that we are commenter recommended that CMS is the fact that we currently make developing requirements concerning work with the industry to establish available our methodologies in the sponsors submitting audited data to methods for outlier analysis. Another technical specifications for the address the concerns about data commenter recommended that the Reporting Requirements and the plan accuracy that the commenters raise. methodology should include different ratings (star ratings). In another Comment: One commenter believed weights assigned to measures based on example, we recently (January 2010) that the annual audits and the outlier the magnitude of beneficiary impact and released an HPMS memo and analyses appear to be duplicative. program integrity. One commenter incorporated into the Part D manual a Response: We use audits, outlier requested that the outlier analysis be comprehensive description of our analysis, and other methods to ensure done at the contract level as opposed to outlier methodology for ensuring compliance with program requirements the plan benefit package (PBP) level. appropriate access to home infusion and to help identify potential Another commenter recommended that pharmacies. In an effort toward compliance problems. Audits and CMS be specific about whether complete transparency, we also outliers analyses are two distinct compliance action would be taken for provided the underlying data and monitoring methods that utilize first-time outliers or only for sponsors necessary information for Part D different sources of information and with a history of being an outlier. sponsors to conduct their own apply different types of analyses to Response: We understand the independent analyses on this topic. evaluate sponsors’ compliance with importance of working with the Comment: Many commenters noted program requirements. Audits represent industry to establish methodologies and that there are reasons other than non- an in-depth review of selected sponsor’s do so where appropriate. For example, compliance that may result in a sponsor documentation related to the operation we have and will continue to share being an outlier. Outlier, by definition, of their Medicare contracts. Outlier drafted or proposed plan rating (star means that there will always be a analysis, by contrast, consists of an ratings) measures and their analyses. sponsor underperforming. agency review of performance data Comments from sponsors are reviewed Response: We acknowledge that (generated by CMS or the sponsor) and considered as we finalize those outlier status does not necessarily mean across all contracting organizations measures. The Part C and D reporting non-compliance. We review the list of which results in the identification of requirements also undergo similar statistical outliers and set thresholds on potential noncompliance and the need public comment periods. a number of factors for the purposes of for further investigation. The issue of assigning different identifying potential compliance 5. Compliance Programs Under Parts C weights to measures is not relevant here problems. This is consistent with our and D (§ 422.503(b)(4)(vi) and as the proposed change concerns the use goal to do meaningful analysis that can § 423.504(b)(4)(vi)) of outlier analysis for particular, not aid in identifying potential weaknesses. aggregated, operational requirements. Most often, a sponsor will receive a In the October 2009 proposed rule, we We incorporate weighting into our request for information, as opposed to a proposed to modify the language at analysis of sponsors’ overall contract compliance letter, to help us better § 422.503(b)(4)(vi) and performance. This analysis is typically understand why that particular sponsor § 423.504(b)(4)(vi) to explicitly provide done at the contract level at least in part was an outlier. These requests clarification as to what constitutes an because we collect data at that level, not frequently result in the sponsor gaining ‘‘effective’’ compliance program. We also the PBP level. a better understanding of our proposed clarifying language for each of As discussed previously, we account requirements and promote program the required elements of an effective for whether a sponsor is a first-time or improvement. compliance program in order to assist repeat outlier when it determines the Comment: There were a few sponsoring organizations with type of compliance notice to issue. comments on the validity of current implementing more effective Depending on the circumstances, analyses performed by CMS. Some compliance programs and to more organizations identified as first-time commenters discussed their observation clearly articulate our expectations. outliers may receive only a notice of that the findings resulting from some of We proposed to add language to the noncompliance, while those that are CMS’ outlier analyses methodology may first element at § 422.503(b)(4)(vi)(A) repeat outliers may receive a CAP penalize some organizations unfairly and § 423.504(b)(4)(vi)(A) to require that request or be subject to an enforcement because—(1) the underlying data on written policies and procedures must action. which the analysis was based was describe a commitment to comply with Comment: Several commenters urged flawed; or (2) analyses based on self- all Federal and State standards, CMS to make the outlier methodology reported data may indicate that one compliance expectations as embodied in available to all sponsors through, for sponsor is reporting data more the standards of conduct, implement the example, the Call Letter or Technical accurately data than its peers. A operations of the compliance program, Specifications. Many of these commenter noted that the compliance provide guidance to others, identify commenters requested an opportunity to letters that result from outlier analysis how to communicate compliance issues review and comment on the come months after the data has been to compliance personnel, describe how methodology. A couple of commenters collected and that there is little compliance issues are investigated and were concerned about CMS’ use of opportunity for an organization to resolved and include a policy of non- outlier analysis and being able to correct its performance. A few intimidation and non-retaliation. predict how other sponsors will perform commenters requested that CMS give The second element requires a to ensure that their own performance is sponsors the opportunity to appeal or sponsoring organization to have a aligned and compliant. explain the outlier status to CMS. compliance officer and committee Response: Where appropriate, we will Response: We are always open to accountable to senior management. We make methodologies available to information and feedback from sponsors proposed to add language at sponsors, as we discussed earlier in our on our analyses and make corrections to § 422.503(b)(4)(vi)(B) and response to comment on this proposal. our compliance determinations where § 423.504(b)(4)(vi)(B) that the

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compliance officer must be employed by these lines of communication be tier, downstream or related entity of the the sponsoring organization, and the confidential and accessible to all sponsoring organization and must be compliance officer and committee must employees and allow for compliance accountable to the governing board of periodically report directly to the issues to be reported anonymously and the sponsoring organization. In governing body and that body must be in good faith as issues are identified. addition, at § 423.504(b)(4)(vi)(C)(3), we knowledgeable about the compliance The fifth element requires a adopt a new regulation for the Part D program and exercise reasonable sponsoring organization to enforce program to specify that first tier, oversight over the implementation and standards through well-publicized downstream, and related entities that effectiveness of the program. disciplinary guidelines. We proposed to have met the fraud, waste, and abuse The third element requires the add language at § 422.503(b)(4)(vi)(E) certification requirements through sponsoring organization to have an and § 423.504(b)(4)(vi)(E) that more enrollment into the fee-for-service effective training and education specifically described that these Medicare program and accreditation as program. We proposed to add language guidelines must be implemented to a durable medical equipment, at § 422.503(b)(4)(vi)(C) and include policies that articulate prosthetics, orthotics, and supplies § 423.504(b)(4)(vi)(C) to specify several expectations for reporting issues and (DMEPOS) supplier are deemed to have key groups and individuals (the chief their resolution, identify noncompliance met the fraud, waste and abuse training executive or other senior administrator, or unethical behavior, and provide for and educational requirements. managers, and governing body timely, consistent and effective We received the following comments members) among the sponsoring enforcement of the standards when on the first element, which requires organization’s employees who are noncompliance or unethical behavior is written policies and procedures: required to have compliance training detected. Comment: Two commenters raised and education. We also proposed to add The sixth element requires a concerns about the resources necessary language that this training must occur at sponsoring organization to have to satisfy our requirements related to a minimum annually and must be made procedures for internal monitoring and written policies and procedures. One a part of the orientation for a new auditing. We proposed to add language commenter stated that sponsoring employee, new first tier, downstream at § 422.503(b)(4)(vi)(F) and organizations are currently spending and related entities, and new § 423.504(b)(4)(vi)(F) to more significant time and resources drafting appointments of a chief executive, specifically describe that an effective and redrafting policies and procedures manager, or governing body member. system for routine monitoring and and are still uncertain if these policies The required compliance training must identification of compliance risks and procedures will cover the items we include training regarding the includes internal monitoring and audits expect to be covered in requisite detail. prevention and detection of fraud, waste and, as appropriate, external audits, in Both commenters suggested that we and abuse. We proposed to add that order to evaluate the sponsoring release our audit worksheets which providers who have met the organization’s compliance with our outline CMS’s expectations for the requirement for fraud, waste and abuse requirements and overall effectiveness contents of policies and procedures, training and education through of the compliance program. We also which would allow sponsoring enrollment into the Medicare program proposed to add language that these organizations to tailor their policies and are deemed to have met that portion of audits should include the sponsoring procedures accordingly. Additionally, the training and education requirement. organization’s first tier entities. one commenter suggested that CMS We noted that, in some instances, a The seventh element requires a should not be dictating the scope or particular pharmacy or other provider sponsoring organization to have components of such policies and may contract with dozens of MA or PDP procedures for ensuring prompt disagreed with our inclusion of more plans, each of which is required by the responses to detected offenses. We ‘‘prescriptive standards’’ into the existing language at proposed to add language at regulatory text and alternatively § 422.503(b)(4)(vi)(C) and § 422.503(b)(4)(vi)(G) and suggested that certain requirements be § 423.504(b)(4)(vi)(C), read literally, to § 423.504(b)(4)(vi)(G) to more issued through subregulatory guidance. provide the required fraud, waste and specifically describe the Response: Our proposals are intended abuse prevention and detection training implementation of a system for to significantly strengthen our oversight to the pharmacy, or other provider, and promptly responding to compliance of compliance programs, and provide its staff. Since we did not intend to issues as they are raised, investigating more specificity and clarity to require duplicative training, we offered potential compliance problems sponsoring organizations with regard to two options in our proposed rule. One identified in the course of self- what we expect to see when we review option was that the sponsoring evaluations and audits, correcting such a compliance program. We believe the organization ‘‘assures’’ or ‘‘obtains an problems promptly and thoroughly to proposals we have made are important assurance’’ that the first tier, reduce the potential for recurrence and changes and are necessary to maintain downstream, and related entity has ensuring ongoing compliance with our consistency and promote appropriate received such training. Another option requirements. focus on these requirements and that was to leave existing language We are adopting all of these proposed going through the rulemaking process is unchanged, but issue interpretive changes into the final rule without the best way to promote these goals. We guidance on this point. We requested further modification with the exception also believe that the proposed changes workable suggestions to assure that our of changes made to to the first element provide important objective is met, while eliminating § 422.502(b)(4)(vi)(B), information as to what we consider a unnecessary duplication. § 423.504(b)(4)(vi)(B) and framework for an effective compliance The fourth element requires a § 423.504(b)(4)(vi)(C), to provide that program. We do not intend to be sponsoring organization to have the compliance officer must be an prescriptive as to the choice of effective lines of communication. We employee of the sponsoring particular processes or procedures, only proposed to add language at organization, parent organization or to provide the minimum amount of § 422.503(b)(4)(vi)(D) and corporate affiliate and clarify that he or information we would expect to see in § 423.504(b)(4)(vi)(D) that requires that she may not be an employee of a first a comprehensive set of written policies,

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procedures and standards of conduct. committee that is accountable to the responsibility be delegated to someone With respect to the comment regarding governing body of the sponsoring other than the compliance officer as that releasing audit materials, we must organization. We have issued extensive would defeat the purpose of the balance the goals of transparency subregulatory guidance on this issue, proposed provision. Therefore, we will regarding our audit program with the both in the 2007 call letter and in not be incorporating the commenter’s goals of conducting an effective Chapter 9 of the Medicare Prescription suggested change into the final rule. evaluation of whether organizations Drug Benefit Manual (‘‘Chapter 9’’). This We also do not believe that the have in fact instituted effective guidance was issued in part in response proposed regulatory language in this compliance programs (and not just to us learning that sponsoring section results in CMS dictating to MA ‘‘paper’’ compliance programs). To the organizations were subcontracting the organizations and Part D sponsors their extent that sponsoring organizations are compliance officer function to their first internal reporting obligations and looking to tailor their policies and tier, downstream and related entities. reporting structures. The proposed procedures for compliance programs to We do not view subcontracting that language does not specify the means or materials released by us, they should be function as an acceptable alternative for manner in which the report should be looking to our regulations, including the a number of reasons, including the communicated to the governing body, changes made by this final rule, and any potential for conflicts of interest that nor does it provide specific subregulatory guidance issued by CMS, would exist by virtue of the compliance requirements as to how often such and not documents related to our audit function residing in a subcontracted reports are made. program, as these may only be a subset entity that is being paid by the entity We received the following comments of CMS’ larger set of requirements. whose compliance the subcontractor is concerning our proposed changes to the We received the following comments charged with monitoring. As a result of third compliance program element, regarding our proposed revisions to the the comments received, we are which—(1) states that sponsoring second element, which addresses the modifying the language in this final rule organizations must establish and designation of a compliance officer and to provide that the compliance officer implement effective training and a compliance committee who report must be an employee of the sponsoring education between the compliance directly to the organization’s chief organization, parent organization or officer and the sponsoring executive or other senior management: corporate affiliate and to provide that organization’s employees, governing Comment: Commenters expressed the compliance officer may not be an board, first tier, downstream and related concern with CMS’ proposal to require employee of a first tier, downstream or entities; (2) specifies that this training that the compliance officer, vested with related entity of the sponsoring and education must occur at a minimum day to day operations of the compliance organization. annually and must be made a part of program, be an employee of the Comment: Proposed sections new employee orientation; and (3) sponsoring organization. Commenters § 422.503(b)(4)(vi)(B)(2) and provides deeming of fraud, waste and recommended that CMS broaden this § 423.504(b)(4)(vi)(B)(2) specify that the abuse educational requirements to first portion of the provision to permit the compliance officer and committee must tier, downstream and related entities compliance officer to be employed by periodically report to the governing who have met the fraud, waste and the sponsoring organization or an body of the sponsoring organization on abuse certification requirements though affiliate in its corporate group. These the activities and status of the Medicare program enrollment: commenters indicated that ‘‘the entity compliance program. One commenter Comment: Some commenters stated who employs the compliance officer is emphatically supported CMS’ proposal that organizations should have the a corporate structure issue that may to strengthen the compliance program flexibility to modify and tailor the have no effect or bearing on the issues by increasing the requirements with training for the governing body so that of accountability and oversight.’’ One respect to interaction with the executive it is not a replication of the training commenter further insisted that in leadership and board members. One needed for front line staff, and instances when related entities are MA commenter recommended that CMS expressed specific concern with CMS organizations and PDP sponsors who revise the language of this provision to requiring training of the governing body hold separate contracts with CMS, state that the compliance officer and annually. Additionally, several having one centralized compliance committee, ‘‘or their delegate’’, report commenters stated that requiring officer is not only effective and efficient, directly to the governing body. Lastly, sponsoring organizations to conduct but it also promotes consistency with one commenter stated that although compliance training at new employee respect to the implementation of the they supported CMS’ goal of ensuring orientations and annually thereafter is compliance program across the sponsoring organizations’ senior administratively and financially contracting entities. Several commenters leadership and governing body are burdensome, and may even result in also stated that having the compliance informed of key developments, the organizations having to conduct such officer at a parent or affiliated group commenter opposed CMS dictating training on a weekly basis. Commenters level would not lessen the internal reporting obligations and made numerous recommendations, accountability of the compliance officer reporting structures. including providing sponsoring with respect to each entity. Response: We disagree with the organizations with flexibility in Response: We agree that having a suggestion to add ‘‘or their delegate’’ to determining the appropriate level and compliance officer being employed at a the language at § 422.503 (b)(4)(vi)(B)(2) timing of training depending on the parent company or corporate affiliate and § 423.504(b)(4)(vi)(B)(2), which audience; modifying the education and may not necessarily lessen the would expand the scope of individuals training requirements to apply to only accountability of the compliance officer who could provide periodic reports to those involved in the administration of to the governing body of the sponsoring the governing body of the sponsoring the Medicare Advantage and Part D organization. Our proposal was organization. The purpose of this lines of business within the intended to provide further clarity on provision is to ensure communication organization; clarifying that the annual how sponsoring organizations can meet between the compliance officer, education and training requirement is the key requirement of having a committee and the governing board. We limited to general compliance training, compliance officer and compliance do not intend that this reporting and does not include the specialized

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training that sponsoring organizations delegated entities conduct such training Benefit Manual (Part D Program to have to implement in accordance with on their own imposes a significant Control Fraud, Waste, and Abuse). Chapter 9; and the suggestion that CMS burden on sponsoring organizations. Chapter 9 can be viewed at: http:// develop a Web-based compliance Response: In response to those www.cms.gov/ training tool or certify an independent commenters who stated that requiring PrescriptionDrugCovContra/Downloads/ industry entity to provide consistent that first tier, downstream and related PDBManual_Chapter9_FWA.pdf. We and efficient compliance training; and entities to receive compliance training is recognize that Chapter 9 was finally, providing additional overly burdensome, we would like to specifically developed for Part D clarification on the required training for reiterate that this is an existing (prescription drug plan) sponsors. In downstream entities. requirement, not a proposed new previous guidance, we have directed Response: We believe that the requirement. We agree that duplicative MA organizations to apply the proposed regulatory language allows training is inefficient and we believe provisions of Chapter 9 to Part C organizations the flexibility to tailor the that commenters have offered valuable (Medicare Advantage) programs as well. content of the training and many aspects suggestions. After reviewing these We are in the process of updating this of how the training is provided. We comments and recommendations, we document to specifically address any have not specified the manner in which have determined that additional particular Part C measures for detecting the training would be provided at new analysis needs to be undertaken and and preventing fraud, waste, and abuse. employee orientations, or to senior additional information sought before Comment: Several commenters leadership or members of the governing providing guidance on how training of expressed support for our proposed body upon their appointment to these first tier, downstream, and related revisions to § 422.503 (b)(4)(vi)(C)(2), positions. Organizations can decide to entities is to be provided and the which clarify that first tier, downstream, provide new employees with a copy of content managed. Additional and related entities who have met the the organization’s compliance policies clarification will be issued in fraud, waste, and abuse certification and procedures and ask new employees subregulatory guidance. requirements through enrollment into to attest that they have been provided Comment: Commenters also suggested the fee-for-service Medicare program are with a copy and have read the material. striking the word ‘‘effective’’ from the deemed to have met the training and We do not believe that such a language of this section which specifies educational requirements for fraud, requirement is overly burdensome or that the sponsoring organization must waste, and abuse under this rule. One difficult for sponsoring organizations to establish, implement and provide commenter disagreed with the proposed implement. ‘‘effective’’ training and education. revision. We also do not believe that it is Alternatively the commenter requested Response: We believe that the appropriate to clarify in regulation text that CMS at least clarify how we would proposed regulatory language eliminates that we are referring to general versus determine if training were ‘‘effective’’ redundant certification made when specific compliance training, as and clarify CMS’ definition of sufficient these entities enroll in the Medicare discussed in Chapter 9. The proposed oversight. program. We also wish to clarify that the language makes no reference to the Response: The use of the term reference to deeming in this regulation training being specialized and we ‘‘effective’’ is existing regulatory is distinct from the MA deeming and believe that the regulatory language language and has already gone through accreditation program described at should be left general as the level of notice and comment rulemaking. § 422.156, § 422.157, and § 422.158. training and education will vary ‘‘Effective’’ is not a new requirement, Comment: A number of commenters depending on the level and therefore, we do not believe it is recommended that CMS extend the responsibilities of the person receiving necessary to remove the word ‘‘effective’’ regulatory change proposed for the Part the training. We believe that the from this regulatory provision. C program at § 422.503(b)(4)(vi)(C) to proposal is sufficiently clear in its Comment: Commenters suggested that the Part D program at description of what is expected of the CMS consider revising the requirement § 423.504(b)(4)(vi)(C). The commenters sponsoring organization in the that fraud, waste, and abuse training noted that Part D first tier, downstream, implementation of its compliance and education occur at least annually and related entities that have enrolled in training and education program and the and be a part of the orientation for a the Medicare program as a supplier of requirements are reasonable. If we new employee, new first tier, Part B covered medications or as a determine in the future that further downstream and related entities, and supplier of durable medical equipment, guidance is necessary, we will issue new appointments to chief executive, prosthetics, orthotics, and supplies subregulatory guidance. manager or governing body member. (DMEPOS) go through the same Lastly, in response to those Commenters believe that CMS should application and certification process as commenters who suggested that CMS require that training only at the time of MA providers. They contend that develop a Web-based compliance initial hire or when there are significant including Part D providers in this training tool, we have determined that changes in the laws and regulations deeming would ensure the requirements additional analysis needs to be related to fraud, waste, and abuse. for Part D sponsors will be identical to undertaken and additional information Response: We disagree and believe those for MA organizations and would sought before providing guidance on that annual training is a necessary reduce unnecessary additional burden. how training of first tier, downstream, component of an effective compliance Response: We agree with the and related entities is to be provided program that addresses the detection, commenters and have adopted a new and the content managed. Additional correction, and prevention of fraud, regulation for the Part D program at clarification will be issued in waste, and abuse in the MA and Part D § 423.504(b)(4)(vi)(C)(3) to specify that subregulatory guidance. programs. The intent of this regulation first tier, downstream, and related Comment: Some commenters stated is to codify the existing CMS entities who have met the fraud, waste, that requiring sponsoring organizations expectation that fraud, waste and abuse and abuse certification requirements to conduct compliance training for all training be provided at a minimum on through enrollment into the Medicare delegated entities (first tier, downstream an annual basis, which is contained in program accreditation as a DMEPOS and/or related) or insuring that all Chapter 9 of the Prescription Drug supplier are deemed to have met the

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training and educational requirements and/or claims submission, and should compliance program with other areas of for fraud, waste, and abuse training. We not require administrative or retail the Federal government, such as the wish to clarify that the reference to clerk/cashier staff to complete the Department of Defense, so that all deeming in this regulation is distinct training. government contractors will have the from the Part D deeming and Response: The requirement for fraud, same compliance program expectations. accreditation program described at waste, and abuse training applies to all Response: We believe that this § 423.165, § 423.168, and § 423.171. MA organization and Part D sponsor comment is outside the scope of this We received the following responses employees (including chief executive or regulation. to our request for comments on whether other senior administrator, managers The seventh element requires a or how to best revise the requirement and governing body members) and first sponsoring organization to have that first tier, downstream, and related tier, downstream and related entities. procedures for ensuring prompt entities receive training in how to We will issue additional clarification in responses to detected offenses. We did prevent and identify fraud, waste, and subregulatory guidance. not receive comments regarding this abuse to address the issue of duplication The fourth element requires a element. of training for providers or entities that sponsoring organization to have 6. Network Adequacy of Coordinated contract with multiple MA effective lines of communication. We Care and Network-Based Private Fee-for- organizations or Part D sponsors: did not receive comments regarding this Service Plans Under Part C (§ 422.112) Comment: Several commenters element. recommended requiring MA We received the following comment In the October 22, 2009 proposed rule organizations and Part D sponsors to concerning the proposed revisions to (74 FR 54644), we requested comments create training materials or approve first the fifth compliance program element on proposed criteria for determining tier, downstream, and related entity- which details a sponsoring whether an MA plan network meets the created materials and require organization’s obligation to ensure its network availability and accessibility attestations that the training was compliance program has well requirement in section 1852(d)(1) of the provided to all appropriate parties. publicized disciplinary standards. Act. As we discussed in the proposed These commenters noted that in order to Comment: The commenter requested rule, we have developed an automated avoid duplicative training, all that CMS provide guidance regarding its system for reviewing network adequacy sponsoring organizations would be expectations as to sponsoring on a continuing basis based on the required to accept attestations from their organization’s enforcement of elements that we have determined first tier, downstream, and related disciplinary standards, and asked for reasonably reflect community patterns entities that they completed training clarification as to whether a policy of health care delivery. As we noted in provided by any other sponsoring identifying the different types of the proposed rule, our operational organization in order to fulfill this disciplinary actions a sponsoring experience has demonstrated that the requirement. Commenters also organization may impose would be concept of community patterns of health suggested that another option to ensure sufficient to meet the requirement. care delivery provides a useful consistent training content and Response: We believe that our benchmark for measuring a proposed minimize duplication is for CMS to proposal is sufficiently detailed to provider network, because it allows for create a standardized training and provide sponsoring organizations with varying geographical and regional require all sponsoring organizations to necessary guidance on how to conditions to be taken into use it for training their first tier, implement an effective compliance consideration in determining what downstream, and related entities. program. constitutes ‘‘reasonable’’ access in a Commenters also recommended that We received the following comment given area. CMS permit first tier, downstream, and regarding the proposed revisions to the In the proposed rule, we described the related entities to create and implement sixth compliance program element elements of community patterns of their own training programs and attest concerning requirements for sponsoring health care delivery that we proposed to to their contracting MA organizations organizations monitoring and include in our evaluations of provider and/or Part D sponsors that they have identification of compliance risks. networks, and stated that our goal was fulfilled the training requirement. Comment A commenter requested to make the standard of community Response: We believe the commenters that CMS specify that its reference to patterns of care more transparent and have offered valuable suggestions. After external audits, especially of first tier consistent across the country. reviewing these comments and entities, does not require sponsoring Specifically, we proposed adding a new recommendations, we have determined organizations to hire an independent, paragraph (a)(10) to § 422.112 to specify that additional analysis needs to be external auditor to perform this function the factors comprising community undertaken and additional information but rather that sponsoring organizations patterns of health care delivery that we sought before providing guidance on may undertake the auditing of these would use as a benchmark in evaluating how training of first tier, downstream, contractors through their internal audit a proposed MA plan health care and related entities is to be provided units. delivery network. Under proposed and the content managed. Additional Response: Our expectation, when § 422.112(a)(10), these factors would clarification will be issued in referring to a sponsoring organization include, but not be limited to— subregulatory guidance. conducting an external audit of itself or • The number and geographical Comment: A few commenters a first tier entity, was that that distribution of eligible health care requested that CMS provide more sponsoring organization would utilize providers available to potentially specificity regarding which entities an auditor who is external of both the contract with an MAO to furnish plan must complete fraud, waste, and abuse sponsoring organization and the first covered services within the proposed training. These commenters believe that tier entity being audited. service area of the MA plans; CMS should limit the training Comment: A commenter • The prevailing market conditions in requirement for first tier, downstream recommended that CMS share its the service area of the MA plan— and related entities to only staff of those preamble language that further defines specifically, the number and entities that are involved in patient care the expectations for an effective distribution of health care providers

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contracting with other health care plans Response: In developing standards for provided considerable subregulatory (both commercial and Medicare) network adequacy we chose the guidance regarding implementation of operating in the service area of the plan; overarching principle of community community patterns of care through this • Whether the service area is patterns of care because it is a robust automated process. An example of this comprised of rural or urban areas or model that allows CMS the necessary subregulatory guidance is the provision some combination of the two; flexibility to develop standards that can of time and distance standards • Whether the MA plan’s proposed be adapted to the significant variations (available on the CMS Web site) by provider network meets Medicare time that exist in health care delivery in the category of health care provider for a and distance standards for member United States. Our proposed regulation number of rural and metropolitan access to health care providers outlined the broad elements that we counties throughout the United States. including specialties; and have found from years of experience to Because we did not propose to • Other factors that we determine to be relevant in evaluating a particular incorporate the technical specifics of be relevant in setting a standard for an community pattern of care. However, our automated system into regulation acceptable health care delivery network we are cognizant of the fact that there text, we believe it is most appropriate to in a particular service area. exist a number of unique local address specific technical suggestions in We proposed providing more detail circumstances related to such factors as the context of implementing and fine- about how we would operationalize geography, market conditions, and tuning the automated network adequacy these requirements through provider availability. Accordingly, this system. subregulatory guidance (for example, final rule codifies an approach to Comment: Several commenters the annual Call Letter). We solicited determining network adequacy that expressed concern about how CMS comment on whether our proposed builds on our experience with would implement time and distance regulatory provisions are sufficiently evaluating health plan provider standards for determining network clear and whether clarification should networks but is also flexible enough to access. One commenter asked that CMS be provided through regulation or adapt to evolving and unique local be mindful of the impact of imposing subregulatory guidance, such as the market conditions. The automated time and distance standards equally annual Call Letter. process we have established to assess among different types of providers. One After considering all the timely network adequacy is likely to be refined commenter stated that the prevailing 30 comments we received on our proposal, as we gain more experience, and minute/30 mile access to services we are adopting § 422.112(a)(10) maintaining flexibility in our regulatory standards need to be fine-tuned without modification in this final rule. requirements for network adequacy specifically for urban, rural, and other Comment: Many commenters supports this goal. We also note that the medically underserved areas. Other expressed concern that the proposed automated system we are using does not comments included recommendations CMS approach to evaluating network specify the providers with which a plan to establish separate and distinct adequacy based on community patterns contracts. Rather, it furnishes a network adequacy standards for Parts A of care would be too limiting, and benchmark so we can determine if a and Part B services, as well as standard would not allow organizations sufficient plan’s provider network is adequate for measuring network adequacy in flexibility to develop networks in rural given the availability of providers in the rural areas for services that are only in areas or areas with unique conditions. area where the plan is being offered and hospitals. Several commenters were concerned the expected enrollment in the plan. In Response: As noted in the October 22, that CMS’ interpretation of what other words, our standards address the 2009 proposed rule, we have constitutes community patterns of care relative size and scope of an acceptable historically used the 30 minute/30 mile would result in an approach that would MA provider network given the access to services as a rough standard not adequately take into account special community patterns of care. However, for evaluating provider networks. plan-specific factors, such as the size of MA plans still have discretion to select However, we agree that this standard is a plan or the quality of its providers. the providers they contract with as long not sufficiently nuanced to stand on its Also, a number of commenters were as that network is adequate to meet the own, and does not fully address our concerned that unique characteristics of health care needs of its enrollees. In needs. Our operational experience has a particular community, such as addition, we will have an exceptions demonstrated that the concept of provider willingness to contract, would process by which plans can highlight community patterns of health care not be captured in the CMS network special circumstances that affect their delivery furnishes a more useful adequacy standards. One commenter ability to meet our access standards. benchmark for measuring a proposed expressed concern that the proposed Comment: Many commenters had provider network because it allows for requirements for network adequacy very detailed, specific questions about varying geographical and regional appear to encourage a fee-for-service our automated system for assessing conditions to be taken into and fragmented care model based on network adequacy, and much of this consideration. geographic access rather than a defined feedback has already been provided to Comment: One commenter asked network of high quality primary care CMS through other mechanisms. For CMS to consider Medicaid provider practices, supported by a limited example, one commenter asked for networks as part of the assessment of network of sub-specialists. One certain adjustments to the ratio of network adequacy for dual eligible commenter was concerned that CMS providers to beneficiaries. Other integrated products. This commenter would only use the prevailing comments questioned how CMS would also suggested comparing contracting community standard of care to evaluate implement various features of network rates across plans serving duals as an network adequacy, citing as an example adequacy and whether they would be additional measure of network a plan with a network that did not meet codified in regulations text. adequacy. In addition, the commenter the prevailing community standard of Response: As noted previously, we suggested that a comparison of the care but was nevertheless adequate or have developed and implemented plan’s provider availability to those even better in terms of the access it automated systems to evaluate the actually open to new Original Medicare actually provides health care services to network adequacy of MA plans. As part enrollees might indicate the value of the enrollees. of that implementation, we have plan to potential enrollees. Another

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commenter asked that CMS include in organization that wishes to be an Comment: One commenter its regulation defining network accrediting organization for the encouraged us to consider adding adequacy the following factors derived Medicare Prescription Drug program additional deemable requirements based from the Medicaid access standards must first apply and be approved by on differences between the Part D under § 438.206: (1) The mode of CMS in accordance with existing program and the Part C program. transportation used by Medicare requirements. Response: We have been granted beneficiaries, particularly those who are Comment: One commenter asked if limited statutory authority regarding dually eligible and those who rely on we will define possible roles and what specific requirements are transportation for the disabled; (2) responsibilities for accrediting deemable. Our proposals reflect our whether the location furnishes physical organizations under the revised Part D current statutory authority. access for enrollees with disabilities; monitoring and oversight audit program. Comment: One commenter requested and (3) delivery of services in a Response: Our proposal did not that since the fraud, waste and abuse culturally competent manner. address the Part D accrediting process program was being removed as a Response: We recognize that special and we do not intend to address this deemable requirement we consider needs plans (SNPs) that specifically process in this final rule. We will allowing ‘‘certification’’ from an external serve the dual eligible population have evaluate whether or not there is a need qualified source to serve in the deeming unique requirements. It is for that to release more detailed information in capacity. reason that in 2011, SNPs that the future through subregulatory Response: We have been granted exclusively serve the dual eligible guidance or other appropriate means. limited statutory authority regarding population will be required to have Comment: One commenter indicated what specific requirements are contracts with State Medicaid agencies that Part D plan sponsors have not been deemable. We proposed modifications where they operate. While given information on accrediting to our regulations to mirror our current transportation is not a Medicare covered organizations that could grant plans statutory authority. To the extent the benefit, it is our expectation that MA deemed status for Part D. The commenter is proposing that CMS plans’ facilities are available and commenter further recommended that consider ways of assessing an accessible to plan enrollees. there be an opportunity to work with us organization’s compliance with fraud, to identify accredited organizations for waste, and abuse requirements that 7. Deemable Program Requirements pharmacy benefit manager operations in suggestion would be outside the scope Under Parts C and D (§ 422.156(b)(7), order to simplify the audit process. of this proposal. § 422.156(f), § 423.165(b), and Response: Our proposal did not 8. Modify the Corrective Action Plan § 423.165(f)) address the Part D accrediting process (CAP) Process as It Relates to In the October 2009 proposed rule, we and we do not intend to address this Procedures for Termination and proposed to clarify what regulatory process in this final rule. However, as of Nonrenewal of a Part C or D Contract by requirements are ‘‘deemable’’ for MA the date of the publication of this CMS (§ 422.506(b)(3), § 422.510(c)(1), organizations that offer prescription regulation, CMS has not approved any § 423.507(b)(3), and § 423.509(c)(1)) drug benefit programs by modifying the accrediting organizations to grant language at § 422.156(b)(7) to refer to the deemed status for Part D sponsors. We In the October 2009 proposed rule, we list of deemable requirements for Part D will evaluate whether or not there is a proposed eliminating the existing sponsors set out at § 423.165(b)(1) need to release more detailed language contained in regulations at through (b)(3). In addition, we proposed information in the future through § 422.506(b)(3), § 422.510(c)(1), modification to § 422.156(f) and subregulatory guidance or other § 423.507(b)(3), and § 423.509(c)(1) that § 423.165(f) to add language clarifying appropriate means. require corrective action plans (CAPs) to that CMS may use its statutory authority Comment: We received a few be submitted for our approval prior to to impose intermediate sanctions and comments indicating that the regulatory us issuing a notice of intent to terminate civil money penalties (CMPs), initiate provisions provided in this section or nonrenew a contract. Instead, we contract terminations, and perform should be further clarified either proposed that the sponsoring evaluations and audits of a sponsoring through rulemaking or subregulatory organization be solely responsible for organization’s records, facilities and guidance. the identification, development, and operations, notwithstanding our Response: We will evaluate whether implementation of its CAP and for deeming provisions. We also proposed or not there is a need to release more demonstrating to us that the underlying to remove language at § 423.165(b)(4) detailed information in the future deficiencies have been corrected within regarding programs to protect against through subregulatory guidance or other the time period afforded under the fraud, waste and abuse from the items appropriate means. notice and opportunity for corrective listed as deemable program Comment: One commenter suggested action. requirements. After considering the that we provide clarification on the We also proposed amending the comments we received in response to criteria we would use to determine existing language at § 422.506(b)(3), these proposals, we are adopting all of whether to perform evaluations, § 422.510(c)(1), § 423.507(b)(3), and these proposals without further conduct audits, or impose sanctions or § 423.509(c)(1) which sets forth the modification into this final rule. civil money penalties relative to a specific timeframes afforded sponsoring Comment: One commenter asked if sponsoring organization’s compliance organizations for the development and CMS will create an avenue for with deemable requirements. implementation of a CAP prior to CMS accrediting organizations who are Response: Our proposal did not issuing a notice of intent to terminate or currently approved under the Medicare intend to modify or affect the manner in nonrenew. Specifically, we proposed to Advantage program to apply for which CMS conducts compliance afford sponsoring organizations with at deeming under the Prescription Drug evaluations, audits or the process for least 30 calendar days to develop and program. imposing intermediate sanctions. These implement a CAP, prior to issuing the Response: Our proposal did not processes are not directly affected by notice of intent to terminate or address the process for becoming an whether the underlying subject of the nonrenew. CMS is adopting the accrediting organization. Any deficiency is a deemable requirement. proposed language into the final rule

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with a few technical changes to best for completing a CAP. A few and if not disapproved by CMS within § 422.506(b)(3)(i) and (ii), commenters expressed that 30 days was a specified period, assume that the CAP § 422.510(c)(1)(i) and (ii), more than enough time to correct is approved from a process perspective. § 423.507(b)(3)(i) and (ii), and deficiencies and that the regulations Response: The commenter has § 423.509(c)(1)(i) & (ii). First, we are need to state more clearly that the misunderstood our proposal. We are deleting the phrase ‘‘that formed the corrective action should be completed proposing to modify the current CAP basis for the determination to non- within the same 30-day period. process to be entirely outcome oriented renew the contract’’ from the proposed Response: Our proposal specifically and we will no longer be requiring revised regulations governing non- stated that the time period afforded sponsoring organizations to submit renewals at § 422.506(b)(3)(i) and sponsoring organizations would be ‘‘at corrective action plans for approval § 423.507(b)(3)(i) and deleting the least’’ 30 days, thereby proposing the (that is, the process for how the plan phrase ‘‘that formed the basis for the minimum amount of time that CMS goes about correcting its deficiencies determination to terminate the contract’’ would afford a sponsoring organization will not be approved or disapproved by from the proposed revised regulations to develop and implement a CAP. We CMS). Rather, the process will be governing terminations at believe our proposal is reasonable and independently developed and § 422.510(c)(1)(i) and § 422.509(c)(1)(i). accounts for those situations where we implemented by the sponsoring The reason for this revision is that, upon determine that longer periods of time organization and our focus will be on further consideration, we have are warranted to demonstrate correction determining whether the deficiencies/ concluded that this language is (for example, when corrections must be problems that created the need for the superfluous and has the potential to made to electronic information CAP have been corrected. cause confusion concerning when CMS systems). Our proposal does not intend Comment: A commenter requested must provide notice and reasonable to limit the development and that CMS not apply the 30-day CAP opportunity to correct deficiencies. implementation of a CAP to 30 days in timeframe to ‘‘routine or ad-hoc audits.’’ Next, we are modifying all cases because we agree that there are Response: The procedures governing § 422.506(b)(3)(i), § 423.507(b)(3)(i), some deficiencies of a complex or the corrective action plan process § 422.510(c)(1)(i), § 423.509(c)(1)(i) to technical nature that may require associated with routine or ad-hoc audits state that CMS will provide the additional time to rectify. are not specified in regulation. To the sponsoring organization a ‘‘reasonable Comment: A few commenters extent, however, that we would initiate opportunity’’ of ‘‘at least 30 calendar requested that CMS clarify how it will a termination or nonrenewal action days’’ to develop and implement a determine if a sponsoring organization against a sponsoring organization based corrective action plan. This has attained compliance (for example, on a routine or ad-hoc audit CAP, we modification made the propose what are CMS’ expectations and what would follow the procedures outlined in provision at § 422.506(b)(3)(ii), supporting documents would we this regulation. § 423.507(b)(3)(ii), § 422.510(c)(1)(ii), require in such situations to Comment: A commenter and § 423.509(c)(1)(i) duplicative and demonstrate compliance). recommended that sponsoring unnecessary, therefore we are deleting Response: Our proposal to change to organizations, which are currently that provision. an outcome based approach is not under a CAP, be allowed to engage the These revisions do not alter the making modifications in the current services of an independent auditor to meaning and purpose of the proposed methodologies for assessing whether an evaluate whether the sponsoring revised regulations and are strictly entity is in (or out of) compliance with organization is in compliance with editorial changes. our requirements. For example, CMS CMS’ requirements. Comment: We received numerous currently conducts validation activities Response: Our proposed language was comments regarding our proposal to based on account management data and not intended to prevent a sponsoring modify the overall approach and information, audit results, beneficiary organization from taking the initiative to timeframe sponsoring organizations are complaints, sponsoring organization use an independent auditor to help afforded for developing and reporting requirements and performance identify and correct underlying implementing a CAP prior to CMS data indicators to determine whether a compliance deficiencies. issuing a notice of intent to terminate or sponsoring organization is in nonrenew. Although almost all compliance with our requirements. We 9. Procedures for Imposing Intermediate commenters were supportive of CMS’ will continue to determine if the Sanctions and Civil Money Penalties proposal to move to an outcome sponsoring organization in is in Under Parts C and D (§ 422.756 and oriented approach for reviewing CAPs, compliance with our statutory, § 423.756) some commenters believe that 30 days regulatory and program requirements by In the October 2009 proposed rule, we is not enough time for sponsoring utilizing these kinds of monitoring and proposed two changes to the regulations organizations to develop and implement oversight measures. The proposed to provide additional tools to assist us a CAP. Commenters provided several language is only clarifying that for non- in making the determination to lift an reasons to support this concern, renewal and termination actions, we intermediate sanction as stated in including the fact that CAPs may will not be requiring the sponsoring § 422.756(d)(3) and § 423.756(d)(3). involve complex and time consuming organization to submit its corrective First, we proposed providing CMS with programming or modification of systems action plans for approval by us, but the discretion to require a sponsoring and that the proposed change could instead the sponsoring organization organization, under an intermediate result in sponsoring organizations must submit proof that identified sanction, to hire an independent auditor pursuing a more cursory or manual deficiencies have been corrected. to provide us with additional remediation rather than a fuller Comment: One commenter suggested information that we will use to remediation. Other commenters that if CMS retains the authority to determine if the deficiencies upon recommended that rather than reject a CAP based on the process used which the sanction is based have specifying a time period, CMS and to fix the deficiency, the sponsoring actually been corrected and are not sponsoring organizations should organization should be allowed to likely to recur. We also proposed an mutually agree on a time period that is submit its CAP to CMS for approval, alternative proposal in which we would

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grant sponsoring organizations the CMS; and that absent standards, CMS the final rule that when a sponsoring discretion to hire an independent could impose this requirement in an organization has been sanctioned CMS auditor to evaluate the sponsoring arbitrary and capricious manner. A may require that the sponsoring organization’s compliance with our commenter opposing both proposals organization hire an independent requirements and would afford the because the commenter did not believe auditor. results of the independent auditor’s it was necessary for CMS to grant the Comment: CMS received a number of review some weight in our sponsor the discretion to hire comments requesting that CMS provide determination of whether the bases for independent auditors, and that by more clarification related to our use of the sanction have been corrected and allowing discretion to hire an the term independent auditor in our are not likely to recur. After considering independent auditor, a sponsoring proposal, including providing a the comments we received in response organization that did not hire the definition, minimum qualifications, and to this proposal, we are adopting the auditor would then be viewed in a whether conflict of interest rules would proposal without modification, which negative light. Finally, one commenter apply. One commenter suggested that provides CMS with the discretion to expressed concern with our alternative CMS provide a list of auditors for require a sponsoring organization, under proposal that when an independent sponsoring organizations to choose an intermediate sanction, to hire an auditor was not required by CMS, but from. Another commenter seemed to be independent auditor. was retained by the sponsoring concerned that an independent auditor Second, we proposed changes to organization at their discretion, CMS is generally used in the context of a § 422.756(d)(3) and § 423.756(d)(3) to would merit only ‘‘some weight’’ in the financial audit and referred to ‘‘Sarbanes provide CMS with the discretion to decisionmaking process to lift the Oxley’’ stating that it has fairly clear require a sponsoring organization, sanction. Specially, the commenter rules with regard to conflicts of interest. subject to a marketing and enrollment recommended that the independent In that respect, commenters requested sanction, to go through a test period auditor’s evaluation should have the that CMS clarify what context it used during which the organization could same standard of weight regardless of the phrase ‘‘independent auditor.’’ market and accept enrollments for a whether the independent auditor was Response: We intend that sponsoring limited time in order for us to determine required or was discretionary. organizations will choose the if the sponsoring organization’s Response: When a sponsoring independent auditor. We will work with deficiencies have been corrected and are organization has been sanctioned, the sanctioned organizations to determine if not likely to recur. Additionally, we organization’s deficiencies have risen to the independent auditor they are proposed to revise these provisions to a serious and significant level. We proposing is appropriate. Some basic provide that following the test period, if believe that we should have the examples, however, of standards that we we determine the deficiencies that flexibility to require the sponsoring will require for independent auditors formed the basis for the sanction have organization to hire an independent are knowledge of the Part C and Part D not been corrected and are likely to auditor for the benefit of both us and the programmatic requirements and recur, the intermediate sanction will sponsoring organization. To ensure that experience evaluating an organization’s remain in effect until such time that we the use of the independent auditor will performance in the areas specific to the are assured the deficiencies have been be beneficial for the sponsoring deficiencies. To the extent that one corrected and are not likely to recur. organization and to us, we intend to commenter was referencing financial The sponsoring organization, in these consider the sponsoring organization’s audits under the Sarbanes Oxley Act of instances, would not have a right to a ability to afford an independent auditor 2002 (Pub. L. 107–204, 116 Stat. 745, hearing to challenge our determination as well as the sponsoring organization’s enacted July 30, 2002), this proposal is to keep the sanction in effect. We are ability to demonstrate through its own not governed by the standards in finalizing this proposal without resources that it has corrected its Sarbanes Oxley. The type of audit modification. deficiencies and they are not likely to contemplated by Sarbanes Oxley is a We also proposed deleting existing recur. To determine whether or not we financial audit and not a program provisions at § 422.756(c) and would require an independent auditor, compliance audit. The audits proposed § 423.756(c) because these provisions we would check to see if the sponsoring here would involve an independent are duplicative of the list of sanctions at organization was on our financial evaluation of whether the sponsoring § 422.750(a) and § 423.750(a) and are list as well as on the financial watch list organization is in compliance with CMS unnecessary. In this final rule, we are of any of the States or commonwealths requirements. We will evaluate whether adopting all of these proposals without in which the sponsoring organization or not there is a need to release more further modification. was licensed. Also, whenever a detailed information in the future Comment: CMS received numerous sponsoring organization is under through subregulatory guidance or other comments regarding the engagement of sanction, we engage in ongoing appropriate means. an independent auditor by a sponsoring discussions with its senior leaders and Comment: Several commenters organization under sanction by CMS, management. If we were considering the requested that CMS provide standards with most commenters supporting the use of an independent auditor, we for when an independent auditor would alternative proposal in which CMS may would discuss this with the sponsoring be needed. Commenters wanted clarity allow the sponsoring organization the organization and solicit their feedback on when an independent auditor would discretion to hire an independent in order to fully comprehend the be required, what types of issues the auditor. Commenters provided various financial makeup and stability of the auditor would be called to review, and rationales for their support of the organization. the parameters under which an auditor alternative proposal, including the As the proposed regulatory language would perform its work. One potential financial and operational reflected, this authority will not be commenter requested that we limit the burden to sponsoring organizations exercised in all circumstances because focus of the audit to the bases for the when required to engage an outside we recognize that an independent sanction. auditor; that sponsoring organizations auditor may not be needed or beneficial Response: During the period of the may already have the internal resources in all circumstances. For these reasons, sanction, we communicate regularly available to provide the information to we are maintaining the requirement in with the sponsoring organization and,

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therefore, we intend to fully discuss However, to the extent these documents Response: We did not propose and do with the sanctioned organization the would be required under existing law to not intend to require the independent basis for concluding an independent be disclosed we fully intend to comply auditor to opine as to whether the auditor is necessary prior to requiring with those requirements. deficiencies are not likely to recur. The the organization to retain the With regard to the commenters who independent auditor will perform an independent auditor. We intend to were concerned about the overall assessment to determine if the utilize the requirement in our proposal effectiveness of using independent sponsoring organization is in when we determine that an independent auditors to assist us in evaluating compliance with our requirements and auditor would be beneficial, such as in compliance, correcting the deficiencies we would use that evaluation, along situations where the deficiencies are is ultimately the responsibility of the with other information provided by the highly technical in nature. Also, if the sanctioned organization. Although, the sponsoring organization, to make our sanctioned organization is having independent auditor may consult with determination as to whether the difficulty demonstrating to us that its the sanctioned organization on the best deficiencies that formed the basis for the deficiencies have been corrected, an way to fix its deficiencies, the main sanction have been corrected and are independent auditor can provide us purpose of the independent auditor is to not likely to recur. The independent with assurances that the deficiencies provide evidence and additional auditors report is evidentiary and not have in fact been corrected through a assurances which would assist us in dispositive as to whether the neutral third party evaluation. We making the determination that those deficiencies have been corrected and are intend to determine what areas the deficiencies have been corrected. We not likely to recur. We make that independent auditor should assess intend that independent auditor results determination. depending on the nature and extent of will be weighed with a host of other Comment: We also received a number the deficiencies. We do not believe it is validation activities conducted by us of comments on the proposal that in possible or appropriate to provide this and will not be the sole source of instances where marketing or information in regulation since each information concerning whether enrollment sanctions have been sanctioned organization may require a deficiencies have been corrected and are imposed, CMS may require a sponsoring different assessment based on its not likely to recur. organization to engage in a marketing or particular deficiencies. With respect to Comment: One commenter stated that enrollment ‘‘test period’’ in order to the comment that the focus of the audit the audit findings of an independent assist CMS in making a determination as should be limited to the bases for the auditor should be subject to attorney- to whether the deficiencies have been sanction, based on our experience, we client privilege and that they would corrected and are not likely to recur. believe the independent auditor would only be subject to release to CMS if the Most commenters wanted more clarity need the flexibility to broaden the sponsoring organization waived the regarding the parameters of the ‘‘test assessment because new or related privilege. period,’’ including any limitation on issues may arise in the period after the Response: We disagree with the enrollment during the test period, the sanction is imposed that need to be commenter that results of the duration, when it would be required evaluated in order to ensure that the independent auditor are protected by and the level of performance required deficiencies have been corrected and are attorney client privilege. The purpose of during the test period. not likely to recur. the independent auditor is to provide a Response: The details concerning Comment: Several commenters were neutral third party evidenced-based implementing a test period will vary concerned with our comparison of the evaluation of whether a sanctioned from organization to organization independent auditor in this requirement organization is in compliance with CMS depending on the nature and extent of to the Corporate Integrity Agreements requirements. Attorney-client privilege the deficiencies that formed the basis for (CIA) used by the HHS Office of is a legal concept which protects the sanction and other factors such as Inspector General (OIG) because communications between an attorney the organization’s size, complexity of information found under the CIA is not and his or her client and keeps certain operations, etc. We intend to work publicly disclosed, and the commenters communications between the parties closely with any sanctioned believe that the results should be confidential. Independent audit findings organization prior to establishing a ‘‘test publicly disclosed. Commenters also are by no means necessarily subject to period’’ and the organization will stated that in the case of nursing homes, the attorney-client privilege and, in this receive specific notice of the standards experience has shown that CIAs have case, the sole purpose of the audit being the organization must meet to not been effective and that nursing performed is to provide information to demonstrate that its deficiencies have homes have not improved as a result of CMS. been corrected during the test period. CIAs. Comment: One commenter stated that Comment: Several commenters Response: When a sponsoring CMS’ determination not to lift the asserted that sanctioned organizations organization is subjected to an sanction after the results of the should be afforded appeal rights if, after intermediate sanction, this information, independent audit should be appealable the marketing and enrollment ‘‘test along with the bases for the sanction, is and such appeal is required by law. period,’’ CMS determines to keep the publicly disclosed through the CMS Response: There is no statutory right sanction in effect. Web site. Additionally, the public to appeal a decision by CMS to keep a Response: Under our proposed subsequently is notified as to whether sanction in effect. Appeal rights are provision, the ‘‘test period’’ is a we have determined that these afforded at the time the sanction is validation activity that will help us to deficiencies have been corrected and are imposed. determine that the deficiencies that not likely to recur. We do not believe Comment: One commenter requested formed the basis for the sanction have that there is any significant value in that we remove the language ‘‘not likely been corrected and are not likely to making the public aware of audit results to recur’’ from the independent auditor recur. For example, when we validate a related to an internal technical requirement. The commenter stated that sponsoring organization’s compliance assessment of the correction of these it was not general practice for an auditor with appeals and grievances deficiencies that may be relied on to to opine as to whether the deficiencies requirements, we may perform an audit make our ultimate determination. were not likely to recur. to test those areas. If the audit

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demonstrates that the sponsoring period proposal was intended to address enumerated bases for termination that organization has not corrected its the specific dilemma faced by CMS and we previously proposed to delete at deficiencies or that they are likely to the sponsoring organization when a § 422.510(a)(6) through (12) and recur, the sanction will remain in effect sanctioned organization cannot market § 423.509(a)(6) through (11). We are, and the sponsoring organization cannot and enroll during the sanction period so therefore, redesignating § 422.510(a)(6)– appeal that determination. Appeal rights as to demonstrate that the deficiencies (12) and § 423.509(a)(6)–(11) as are afforded at the time the sanction is have been addressed. § 422.510(a)(5)–(11) and § 423.509(a)(5)– imposed. Comment: One commenter suggested (10) respectively. Finally, we are adding Comment: Several commenters that CMS specify that any decision not the two new proposed bases, with expressed concern that sponsoring to lift an intermediate sanction at the modified language, to the existing organizations subject to a ‘‘test period’’ end of such ‘‘test period’’ is a separate enumerated list at § 422.510(a)(12) and would be under heightened scrutiny decision from, and shall not § 423.509(a)(11) (failure to comply with and that CMS would have sole automatically result in, an action to regulatory requirements) and discretion to determine the point at terminate a contract. § 422.510(a)(13) and § 423.509(a)(12) which the sponsoring organization has Response: We do not intend to use the (failure to comply with performance corrected the basis for the sanction. One decision not to approve a sponsoring standards). The discussion of these other commenter questioned the value organization’s request to release the revisions is set forth in more detail of a ‘‘test period’’ as well as the sanction, in and of itself, as a basis for below. independent auditor and seemed to reaching a determination to terminate a Comment: A number of commenters equate these validation activities to a contract. Termination determinations expressed specific concerns about our situation where the sponsoring must always meet our specific statutory proposed changes to § 422.510(a) and organization has been issued a and regulatory requirements. § 423.509(a), namely our proposal to corrective action plan (CAP). 10. Termination of Contracts Under remove the enumerated standards for Response: We intend to use a ‘‘test Parts C and D (§ 422.510(a) and termination and proposal to mirror the period’’ as one of a host of validation § 423.509(a)) statutory language. Commenters stated activities and we intend to work closely that the proposed language is too broad with any sanctioned organization prior In the October 2009 proposed rule, we and vague, gives CMS unprecedented to imposing a ‘‘test period’’ to ensure the proposed to delete the enumerated bases discretion and authority and invites sponsoring organization receives for termination contained at arbitrary or inconsistently applied specific notice of the standards it must § 422.510(a)(5) through (12) and determinations by CMS. One meet to demonstrate that its deficiencies § 423.509(a)(5) through (11). We commenter suggested that CMS have been corrected and are not likely proposed to modify language at maintain the existing language. to recur. We fully intend to subject all § 422.510(a) and § 423.509(a) to separate Response: We disagree that the sponsoring organizations placed under a the language into two paragraphs with proposed changes to § 422.510(a)(1) sanction to heightened scrutiny both the first paragraph, (a)(1), listing the through (3) and § 423.509(a)(1) through during the sanction period and for some statutory bases for termination and the (3) provide CMS with unprecedented period afterwards to ensure that the second paragraph, (a)(2), clarifying that authority and discretion. The proposed deficiencies that formed the basis for the a sponsoring organizations (i) failure to language merely mirrors the authority sanction are corrected and are not likely comply with our regulations, (ii) failure provided to CMS through statute. We to recur. The ‘‘test period’’ requirement to meet performance standards; and/or have, however, after considering all of simply provides organizations under (iii) participation in false, fraudulent, or the comments, decided to retain the marketing/enrollment sanctions the abusive activities, may constitute a basis existing provisions from § 422.510(a)(6) same opportunity other organizations for CMS to determine that the through (12) and § 423.509(a)(6) through would have to demonstrate compliance sponsoring organization meets the (11) into the final rule. These examples with our standards for releasing the requirements for contract termination in of substantive bases are now organization from the sanction during accordance with paragraph (a)(1). redesignated as § 422.510(a)(5) through an established enrollment test period. Based on the comments we received (11) and § 423.509(a)(5) through (10) The provision is not applicable to an on the proposed rule, we have decided respectively. organization that has been asked to not to finalize our proposal and as an Comment: A number of commenters implement a CAP and has not had a alternative to slightly modify existing expressed concern with the proposed marketing and enrollment sanction regulations. First, we are finalizing the language at § 422.510(a)(12) and imposed. This provision is limited to proposed modified language in § 423.509(a)(11) (formerly sponsoring organizations subject to provisions § 422.510(a)(1)–(3) and § 422.510(a)(2)(i) and § 423.509(a)(2)(i)) intermediate sanctions. § 422.509(a)(1)–(3) so that the regulatory which provided that CMS may Comment: One commenter requested text mirrors the statutory language. determine that a basis exists to that CMS adopt alternative approaches Second, we are finalizing proposed terminate a sponsoring organization’s for evaluating whether it is appropriate modified language for § 422.510(a)(4) contract if the sponsoring organization to lift a marketing and enrollment and § 423.509(a)(4), which states that fails to comply with any regulatory sanction imposed on a sponsoring CMS may now terminate under this requirement contained in parts 422 or organization when the deficiencies that provision when Medicare, Medicaid, or 423. While one commenter strongly led to the sanction are ones where CMS other State or Federal health care supported the proposed change, many cannot appropriately evaluate the extent programs are affected. Next we are commenters believed that the revision of remediation through a trial finalizing our proposed deletion of removed the ‘‘substantiality’’ or enrollment and marketing period. existing § 422.510(a)(5) and ‘‘materiality’’ tests explicit or inherent in Response: We fully intend to continue § 423.509(a)(5) because we believe that each of the existing requirements, and to explore other ways to effectively the provision is a basis for expedited in effect it would allow CMS to validate whether deficiencies have been termination and therefore terminate on the basis of a single corrected while a sponsoring inappropriately located in this part. We instance in which a particular organization is under sanction. The test have decided to retain the remaining requirement is not met.

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Response: We have considered the § 423.509(a)(2)(iii)) to revise the Since we received no comment on comments and have decided to remove agency’s existing regulatory authority to these sections, these changes are the word ‘‘any’’ from the proposal to allow CMS to terminate a sponsoring adopted without modification in this avoid confusion and have modified the organization when there is credible final rule. regulatory text in the final version of the evidence that shows that the sponsoring 12. Burden of Proof, Standard of Proof, regulation to reflect this change. organization has committed or Standards of Review, and Conduct of Adherence to all our regulatory participated in false, fraudulent or Hearing (§ 422.660, § 423.650, § 422.676, requirements is important and abusive activities affecting the and § 423.658) necessary, but we acknowledge that in Medicare, Medicaid, or other State or making a decision to terminate a Federal health care programs. Two In the October 2009 proposed rule, we contract, we would take into account commenters on this proposed provision, proposed to delete the references to the nature and extent of the failure to one in support and the other opposing ‘‘substantial compliance’’ as a standard meet our regulatory requirements and the provision, stated that CMS should of review at hearing and delete the the materiality of the requirement as not terminate contracts in cases where existing regulations which provide for compared to other requirements. the employees committing the an ‘‘earliest of’’ test from § 422.660 and Comment: A number of commenters fraudulent acts have no involvement § 423.650. We also proposed to also expressed concern about the with the administration of the Medicare explicitly state that the preponderance proposed language at § 422.510(a)(13) lines of business offered by the of the evidence is the standard of proof and § 423.509(a)(12) (formerly sponsoring organization. that we believe applies during the § 422.510(a)(2)(ii) and Response: Our proposal was not appeal of a contract determination or § 423.509(a)(2)(ii)) supporting the use of intended to indicate that we will intermediate sanction. We also outlier analysis to reach a termination terminate a contract in the case of proposed to delete the existing language decision. These commenters opposed employee fraudulent acts unrelated to contained at § 422.660(b) and this proposal and argued that it is Medicare, Medicaid, or other State or § 423.650(b) and replace it with inconsistent with law and unfair to Federal health care programs. language that provides that the equate outlier status to noncompliance. sponsoring organization has the burden 11. Request for Hearing Under Parts C Another commenter stated that it was of proving by a preponderance of the and D (§ 422.662 and § 423.651) improper to make contract termination evidence that our determination was decisions based on a determination that In the October 2009 proposed rule, we inconsistent with the requirements of a sponsoring organization is the lowest proposed to modify the language at the applicable part. Additionally, we performer among a cohort when the § 422.662(a) and § 423.651(a) stating that specified in our proposal that the organization may still be performing the sponsoring organization must file a applicable requirements are § 422.501 adequately. Some commenters stated request for a hearing in accordance with and § 422.502 for the processes and that they needed more clarity on the the requirements specified in the notice standards for applicants for the MA specifics associated with the outlier of the contract determination or program, § 423.502 and § 423.503 for standards and access to the data intermediate sanction. This proposed applicants for the Part D program, underlying these standards. change would ensure that the proper § 422.506 or § 422.510 for MA contract Additionally, commenters asserted that officials within CMS receive the request determinations, § 423.507 or § 423.509 the outlier standards are too vague of a and are able act upon it in a timely for Part D contract determinations, and standard to serve as a basis for contract manner. Current regulations at § 422.752 or § 423.752 for intermediate terminations, particularly when CMS § 422.662(a) and § 423.651(a) governing sanctions. has not disclosed the relevant standards the hearing procedures require We proposed to modify § 422.660(c) or methodology and organizations have sponsoring organizations to file a and § 423.650(c), which specified that not be notified in advance of these request for a hearing on contract the notice of any decision favorable to standards in order to be afforded an determinations with the Hearing Officer a Part C or D applicants appealing a opportunity to improve. Two and to also file it with ‘‘any CMS office.’’ determination that it is not qualified to commenters recommended that CMS As we stated in the preamble to the enter into a contract with us must be allow sponsoring organizations to proposed rule, we believe this issued by July 15th for the contract in appeal CMS findings as a result of procedure is ineffective and inefficient question to be effective on January 1st outlier analysis. because it is likely to result in a request of the following year. We proposed a Response: Outlier analysis is an for hearing not being received by the change from the July 15th deadline to oversight mechanism by which we can appropriate officials within CMS. September 1st. more effectively focus our limited We also proposed a conforming Finally, we proposed to modify resources in determining which change at § 422.662(b) and § 423.651(b) existing regulations at § 422.676(d) and sponsoring organizations to target for which governs the timeframes for filing § 423.658(d) governing the conduct of further compliance analysis and the request for hearing to provide that the hearing to provide that, consistent assessment. We do not intend to use this the request must be filed within 15 with the burden of proof, during the analysis in and of itself as a basis to calendar days after receipt of the notice hearing the sponsoring organization terminate a contract. Therefore, we have (versus the existing language which bears the burden of being the first to decided to remove this outlier language states 15 calendar days from the ‘‘date present its argument to the Hearing from the final rule, to avoid CMS notifies’’ the sponsoring Officer according to any briefing misunderstandings and confusion organization of its determination). This schedule determined by the Hearing among sponsoring organizations proposed change was made to ensure Officer. concerning the use of this data to take consistency with the way deadlines are We are adopting all of the proposed termination actions. described in other regulatory provisions changes as the final rule without further Comment: CMS proposed to modify of parts 422 and 423 governing contract modification. language at § 422.510(a)(4) and determinations or the imposition of Comment: Several commenters § 423.509(a)(4) (formerly intermediate sanctions (including opposed CMS’ removal of the § 422.510(a)(2)(iii) and related appeals processes). ‘‘substantial compliance’’ standard

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asserting that this standard was well appropriate for that party to bear the statutory language concerning our established and well understood as burden of proof. Thus, existing ability to take an expedited termination opposed to the new language that CMS regulations which require that the when we determine that a delay in proposed, which these commenters sponsoring organization bear the burden termination caused by adherence to the stated was vague and unclear. of proof are consistent with the legal required procedures would pose an Response: We disagree that the precedent cited by the commenter. imminent and serious risk to the health ‘‘substantial compliance’’ standard is Comment: One commenter requested of the individuals enrolled with the clear and easy to apply in making a that CMS provide a definition for the sponsoring organization. We are determination. As explained in the ‘‘preponderance of the evidence adopting our proposal to include this preamble to the October 2009 proposed standard.’’ statutory language, and based on the rule, the ‘‘substantial compliance’’ Response: The preponderance of the comments we have decided to retain language has led to confusion among evidence standard is a well established and amend the two existing bases for parties to the hearing, has been difficult and defined legal standard. To make a expedited termination currently located for the Hearing Officer to apply, and showing by the preponderance of the at § 422.510(a)(4) & (a)(5) and does not reflect the nuances of the evidence, one must show that it is more § 423.509(a)(4) &(a)(5). different legal standards provided in the likely than not that the fact that the Comment: We received several Act for making contract determinations claimant seeks to prove is true. comments on our proposals. and imposing intermediate sanctions. Comment: Some commenters opposed Commenters were concerned that our Our proposal, which provided that the changing the notification date from July proposal was overly broad, lacked standard of review is whether CMS’ 15th to September 1st. Some specificity and that there were no determination is inconsistent with the commenters noted that notification by examples of situations where we would regulatory requirements for taking the September 1 of a favorable pursue an expedited termination. underlying action (for example, determination would not leave a Additionally, a few commenters were application denial, non-renewal, sponsor with sufficient time to prepare concerned that a sponsoring termination or intermediation sanction) for the upcoming year given that organization might be subjected to an provides the requisite specificity to be sponsors are permitted to start expedited termination for a single, applied by the hearing officer and the marketing for the upcoming year on isolated incidence of non-compliance parties to these actions. We also believe October 1. One commenter and that sponsoring organizations the proposal properly focuses the recommended moving the application would not be afforded the opportunity hearing officer and all parties to the deadline to March to allow for adequate for a hearing before the termination took hearing on the correct standard, and the preparation of the application and effect. pertinent issue under review at the suggested that adequate preparation Response: After considering all of the hearing. may reduce the number of appeals. comments we received, we have Comment: Several commenters Response: In most cases, we do not decided to retain the two existing expressed concern that the proposed believe a favorable determination issued examples for when CMS may pursue an changes result in the sponsoring by the CMS hearing officer will be expedited termination as well as organizations bearing the burden of rendered as late as September 1st. incorporate the statutory language into proof in appeal proceedings and one However, moving the notification date the final rule. commenter added that CMS’ proposal is of the favorable determination from July The existing regulation references inconsistent with the general rule 15th to September 1st affords applicants § 422.510(a)(5) and § 423.509(a)(5) as articulated by the Supreme Court that that receive a favorable decision the one example of a situation where CMS the party seeking to take action opportunity to be sponsors in the would pursue and expedited ordinarily bears the burden of contract year for which they applied. In termination, but it is also listed as a persuasion and cited to Schaffer v. all instances, this regulatory change basis for termination. In the proposed Weast, 546 U.S. 49 (2005). works to the benefit of sponsors. regulation, we proposed removing this Response: The commenters have We believe that sponsors are given instance as a basis for termination, misunderstood the scope of our adequate time and instruction to thereby removing its associated proposals because we did not propose a complete the application. We believe reference in expedited termination. We change as to which party bears the changing the application due date believed that this language created some burden of proof. Existing regulations would not significantly impact the confusion because it intertwines a basis explicitly state that the sponsoring number of appeals. for termination (that is, failure to make organization bears the burden of proof. services available) with the statutory Also, we believe that the commenter is 13. Expedited Contract Terminations standard for making an expedited mistaken in its reading and Procedures (§ 422.510, § 423.509, termination. Based on the comments we interpretation of the ruling in Shaffer v. § 422.644, § 423.642, § 422.664, and received, however, we see that the Weast. In that case, the Supreme Court § 423.652) Under Parts C and D reference to this basis provided held that the burden of proof in an In the October 2009 proposed rule, we sponsoring organizations with a clear administrative hearing is properly proposed to delete the references to example of the instances under which placed upon the party seeking relief expedited terminations based on false, CMS may decide to take an expedited (‘‘[T]he burdens of pleading and proof fraudulent or abusive activities and termination. In order to resolve this with regard to most facts have been and severe financial difficulties contained in issue, we have decided to add the should be assigned to the plaintiff who the termination procedures at language from § 422.510(a)(5) and generally seeks to change the present § 422.510(b)(2)(i), § 423.509(b)(2)(i), § 423.509(a)(5) to the regulatory state of affairs and who therefore § 422.510(c)(2) and § 423.509(c)(2) and provisions on expedited terminations in naturally should be expected to bear the in the appeal procedures at the final rule. We have decided to risk of failure of proof or persuasion.’’) § 422.644(c)(2), § 423.642(c)(2), finalize our proposal to delete this In our appeal proceedings, the party § 422.664(b)(2) and § 423.652(b)(2). We language as a basis for termination seeking relief is the sponsoring proposed to modify these provisions because we maintain that the organization, thereby making it instead to reflect the more general circumstances in this provision would

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lead CMS to pursue an expedited within 30 calendar days after the hearing. However, based on our termination. ‘‘receipt of the request for the hearing.’’ experience since the promulgation of The second example in the existing This change was made to ensure this rule, we do not now believe a regulation references § 422.510(a)(4) and consistency with the way deadlines are formal discovery process is necessary or § 423.509(a)(4) which concerns described in other regulatory provisions appropriate for these kinds of situations where there is credible of parts 422 and 423 governing contract proceedings. In addition, the existing evidence that a sponsoring organization determinations or the imposition of timeframe in which the hearing committed or participated in false, intermediate sanctions (including normally must take place, 30 calendar fraudulent or abusive activities affecting related appeals processes). We are days after request for a hearing, does not the Medicare, Medicaid, or other State adopting all the proposed changes into easily accommodate a formal discovery or Federal health care programs, the final rule without further process. We also proposed to amend including the submission of false or modification with the exception of the § 422.682 and § 423.661 to require that fraudulent data. Based on the comments timeframes outlined in § 422.670(b) and witness lists and documents be we received, this reference also § 423.655(b) as set forth below. identified and exchanged at least 5 provided sponsoring organizations with Comment: Several commenters calendar days prior to the scheduled a clear example of the circumstances questioned CMS’ proposal to allow hearing. We are adopting § 422.682 and under which CMS may decide to take an sponsoring organizations or CMS to § 423.661 without further modification expedited termination. Therefore, we request an extension for the hearing by into this final rule. have decided to retain the reference to filing a written request no later than 5 Comment: Several commenters § 422.510(a)(4) and § 423.509(a)(4) as a calendar days prior to the scheduled opposed CMS’ removal of the formal basis for expedited termination. hearing. Most commenters believed that discovery process from regulations. Finally, we are moving forward with allowing requests for extensions until 5 Commenters specifically stated that our proposal to incorporate the statutory days prior to the scheduled hearing deleting discovery is a violation of their language in the revised regulations would not allow enough time for due process rights, and would deny governing expedited termination, sponsoring organizations to change sponsors the only opportunity they have thereby permitting CMS to expedite a travel arrangements and commenters to obtain the full breadth of information termination if we determine that a delay proposed different timeframes they they are entitled to for a fair hearing. in termination caused by adherence to thought would be more suitable. One commenter stated that the the required procedures would pose an Response: We agree with the discovery process is the appropriate imminent and serious risk to the health commenters concerns and have decided forum for the sponsoring organization to of the individuals enrolled with the to extend the timeframe for requesting learn of the criteria CMS used in sponsoring organization. We do not an extension to the hearing date from 5 reaching its decision and that agree that our proposal to include the calendar days to 10 calendar days prior sponsoring organizations have a statutory language is overly broad or to the scheduled hearing in our final statutory right under 5 U.S.C. 552 to this vague, and believe that by retaining the rule. information. two existing examples, it provides Comment: One commenter raised Response: We disagree with the sponsoring organizations with some concerns that there may be times when commenters who stated that the removal guidance on the types of issues that an automatic, 15-day extension may not of discovery from regulations is a might lead CMS to pursue an expedited be workable due to previous violation of their due process rights and termination while still allowing us the commitments on the part of the Hearing a violation of their statutory right to flexibility we need to ensure we can act Officer or non-requesting party and obtain information in this manner. Our quickly in situations where adherence suggested CMS add language to the hearings are informal administrative with the standard termination requirement to allow for an alternate, proceedings and as the court held in procedures would pose an imminent mutually agreed upon hearing date if Lopez v. U.S., ‘‘[t]here is no general and serious risk to the health of the Hearing Officer or the non- constitutional right to discovery in Medicare beneficiaries. requesting party is not available on the administrative proceedings’’ Lopez v. U.S., 129 F.Supp.2d 1284 (2000). Also, 14. Time and Place of Hearing Under hearing date that would otherwise result we do not believe that finalizing our Parts C and D (§ 422.670 and § 423.655) from postponement. Response: We believe that the proposal to remove discovery will create In the October 2009 proposed rule, we addition of such language is not unequal or prejudicial treatment that proposed adding new language to necessary because current regulations at will lead to a violation of due process. § 422.670(b) and § 423.655(b) to state § 422.670(b)(1) and (2) and Both CMS and sponsoring organizations that either the sponsoring organization § 423.670(b)(1) and (2) already provide will be equally limited to producing and or CMS may request that a hearing date that the Hearing Officer has the receiving witness lists and documents be postponed by filing a written request authority on his or her own motion, to that must be exchanged at least 5 no later than 5 calendar days prior to change the time and place for the calendar days before the hearing. Also, the scheduled hearing, and that when hearing. we do not believe that full discovery for either the sponsoring organization or sponsoring plans is required to receive CMS requests an extension, the Hearing 15. Discovery Under Parts C and D the necessary information from us for Officer must provide a one-time 15- (§ 422.682 and § 423.661) adequate and proper preparation for the calendar day postponement, and In the October 2009 proposed rule, we hearing. Prior to the hearing, we will additional postponements may be proposed to delete the formal discovery have already provided sponsoring granted at the discretion of the Hearing process contained in § 422.682 and organizations the specific information Officer. We also proposed revising the § 423.661. In the December 5, 2007 relied upon by CMS in reaching the language in § 422.670(a) and Federal Register (72 FR 68700), we determination which they are appealing. § 423.655(a) to provide that the CMS published a final rule with comment In cases of contract terminations or Hearing Officer schedule a hearing to period that finalized our revisions to intermediate sanctions, we will have review a contract determination or the § 422.682 and § 423.661 to provide for a previously provided the specific basis imposition of an intermediate sanction formal discovery process prior to for the determination within the notice

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of intent to terminate or impose 17. Reopening of an Initial Contract applying for new contracts or service intermediate sanctions. Therefore, we Determination or Decision of a Hearing area expansions for a period of 2 years, believe that a witness list and Officer or the Administrator Under Parts absent circumstances warranting special documents are sufficient to meet the C and D (§ 422.696 and § 423.668) consideration. Similarly, in section evidentiary needs of the parties. In the October 22, 2009 proposed rule, § 422.503(b), we added a new paragraph Additionally, any prior decisions of we proposed revising the regulations (b)(7), stating that organizations may be hearing officers are public record, and governing the reopening of an initial qualified to apply for new contracts to therefore, obtainable by sponsoring contract determination or decision of a the extent that they have not terminated organizations. Sponsors have numerous Hearing Officer or the Administrator a contract by mutual consent under statutory rights under 5 U.S.C. 552 under Parts C and D by replacing the which, as a condition of the consent, the which govern the agency’s disclosure of language ‘‘initial determination’’ with MA organization agreed that it was not public information; agency rules, ‘‘contract determination’’ in the section eligible to apply for new contracts or opinions, orders, records, and headings of § 422.696 and § 423.668 and service area expansions for a period of proceedings. The removal of the in the text of § 422.696(a) and 2 years per § 422.508(c). discovery process does not circumvent § 423.668(a). We noted that the term In proposing these changes, we noted the rights provided to the public under ‘‘initial determination’’ is not used that in practice, a voluntary nonrenewal 5 U.S.C. 552. elsewhere in Subpart N (Contract of a contract by a Part D sponsor or MA Comment: One commenter also determinations and appeals). We organization is not dissimilar from an requested that if CMS moves forward received no comment on our proposals organization requesting and being with the proposal to eliminate the and are adopting these changes without granted a mutual termination of their formal discovery process that we revise modification. contract under § 422.503 and § 423.508. our proposal to include a list of the Under § 422.506(a)(4) and specific documents to be shared and to 18. Prohibition of MA and Part D § 423.507(a)(3), if a sponsor voluntarily indicate the action that will result when Applications for 2 Years After a Mutual nonrenews a contract, we cannot enter the required documents are not shared Termination (§ 422.503(b)(6) and into a contract with the organization for prior to the hearing. § 423.504(b)(6)) 2 years unless there are special Response: Appeal proceedings will In the October 22, 2009 proposed rule, circumstances that warrant special vary dependent on what type of we proposed prohibiting an MA consideration, as determined by CMS. determination is being appealed and we organization or Part D sponsor, as a The primary difference between a cannot possibly specify which condition of the consent to a mutual nonrenewal and a mutual termination is documents would be necessary in each termination, from applying for new often timing. For a nonrenewal request and every type of case. Also, if contracts or service area expansions for to take effect at the end of the current documents are not shared prior to the a period of 2 years, absent contract year, it must be received by us hearing, it is within the discretion of the circumstances that warrant special on or before the first Monday in June hearing officer to determine what the consideration as provided under section (the bid deadline), as specified in consequences of that action or inaction 1857(c)(4)(A) of the Act. Specifically, § 423.507(a)(2)(i) and § 422.506(a)(2)(i). for the parties to the hearing. under Part D, we proposed modifying However, once an organization submits § 423.508 by adding paragraph (e), a bid, it can no longer voluntarily 16. Review by the Administrator Under which states that as a condition of the nonrenew its contract for the following Parts C and D (§ 422.692(a) and consent to a mutual termination, CMS year. Rather, the Part D sponsor or MA § 423.666(a)) requires as a provision of the organization must request a mutual In the October 2009 proposed rule, we termination agreement language contract termination. The later in the proposed revisions to the language at prohibiting the Part D sponsor from year the organization requests such a § 422.692(a) and § 423.666(a) to provide applying for new contracts or service mutual termination for the following that the sponsoring organization may area expansions for a period of 2 years, contract year, the more disruptive and request review by the Administrator absent circumstances warranting special difficult the process becomes. In the within 15 calendar days after ‘‘receipt of consideration. Similarly, in October 2009 proposed rule, we noted the hearing decision.’’ In addition, we § 423.504(b), we proposed adding a new that this is particularly true if a request revised the language at § 422.692(c) and paragraph (b)(6) stating that for a mutual contract termination occurs § 423.666(c) governing the notification organizations may be qualified to apply once plan information has become of Administrator determination to state for new contracts to the extent that they publicly available, marketed to that the Administrator must notify both have not terminated a contract by beneficiaries, and beneficiaries have parties of his or her determination mutual consent under which, as a been given the opportunity to enroll. regarding review of the hearing decision condition of the consent, the Part D These late terminations create within 30 calendar days after ‘‘receipt of sponsor agreed that it was not eligible significant disruption for beneficiaries the request for review’’ (versus the to apply for new contracts or service and for us. Similarly, even greater existing language which provides area expansions for a period of 2 years disruption results from mutual within 30 calendar days of ‘‘receiving per § 423.508(e). We also proposed terminations requested to take effect the request for review’’). These changes redesignating the current § 423.504(b)(6) during the course of a contract year. were made to ensure consistency with to § 423.504(b)(7). In light of the disruptions that may the way deadlines are described in other Similar modifications were proposed occur, we proposed that a termination regulatory provisions of parts 422 and for the MA regulations. Specifically, we by mutual consent, which involves a 423 governing contract determinations proposed modifications to § 422.508 by termination by an MA organization or a or the imposition of intermediate adding paragraph (c), which states that Part D sponsor as well as by us, be sanctions (including related appeals as a condition of the consent to a mutual considered a termination of a contract processes). We received no comment on termination, we require as a provision of for purposes of the 2-year ban on this section, and are adopting these the termination agreement language entering into new contracts under changes without modification. prohibiting the MA organization from section 1857(c)(4)(A) of the Act, which

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is incorporated for Part D under section Comment: One commenter stated that by imposing longer-term consequences 1860D–12(b)(3)(B) of the Act. it did not oppose the proposed changes, on sponsors that might otherwise make After considering the comments we but requested that CMS clarify that the annual decisions to exit and re-enter the received in response to these proposals, 2-year moratorium is based on a programs. in this final rule, we are adopting our sponsoring organization terminating all Comment: A commenter asked CMS proposals without modification. of its MA or Part D contracts, not a to clarify that this change applies only Comment: One commenter stated that subset of each line. to mid-year mutual terminations and it is important to inform beneficiaries Response: The regulation as proposed not to a plan electing to non-renew with immediately when—(1) their plan is not would apply to a licensed legal entity ample notice to CMS (such as at the in compliance with CMS requirements; that mutually terminated any of its MA time of bid submission or per non- (2) sanctions have been implemented; or or PDP contracts. A complete exit from renewal guidance). (3) a plan is prohibited from applying either program by an organization is not Response: Consistent with for new contracts or service area required for CMS to invoke the 2-year § 422.506(a)(4) and § 423.507(a)(3), the expansions for a 2-year period. By application prohibition. 2-year ban already applies to sponsors notifying beneficiaries immediately of Comment: One commenter requested electing to nonrenew. The proposed these situations, they will be afforded additional clarity regarding regulatory change is an effort to extend more time to plan. Immediate ‘‘nonrenewal’’ and ‘‘mutual termination.’’ the application of that rule to the notification will increase the likelihood The commenter urged CMS to be analogous situation of a mutual contract that the information will not be lost in especially cautious about any termination, regardless of the effective the extraordinary amount of information presumption by CMS that termination date of that termination. given during the open enrollment may be due to some type of poor Comment: Commenters stated that period. The commenter recommended performance. The commenter stated that while they understood the importance that CMS strengthen compliance in it is possible that after the first week in of the change, they would encourage June a plan will determine that it is not general in order to hold plans CMS to be flexible as there may be feasible to continue with the contract. accountable through CMS monitoring instances where an MAO will conduct The commenter included the example of and oversight. the right level of due diligence on its a State-initiated dramatic midyear Response: Although mutual providers, yet a provider may reduction in payment for Medicaid terminations are often requested when a experience a disruption that causes the services in a dually integrated product. organization to withdraw. The contract is, or will soon be, out of The commenter also stated that the commenters stated that there is compliance with CMS requirements, a references in § 422.508 to § 422.510 significant merit in those instances of an mutual termination can occur even seem to imply some type of failure to MAO acting in the best interest of when there is no current or expected perform. The commenter supported compliance violation. Our proposed providing adequate notice of Medicare beneficiaries and not revision to this portion of the regulation terminations to beneficiaries, but effectuating the new plan or contract. only addresses the period of time during suggested that a 60-day timeframe may Response: Regardless of the degree of which a mutually terminated sponsor be adequate for end-of-year due diligence performed prior to would be precluded from applying for a terminations. The commenter indicated contracting, the sponsor assumes all new or expanded contracts. As a result, that the 2-year prohibition against risks associated with complying with an this comment addressing the issue of applying for new contracts or services MA or PDP contract, including a 2-year beneficiary notice concerning Part C and areas is reasonable given the language ban on new contracting resulting from a D plan performance is outside the scope ‘‘absent circumstances warranting mutual termination. Also, as indicated of the proposed regulatory change. special consideration.’’ The commenter in the proposed rule, CMS will retain Comment: One commenter stated that stated that an example of such a the authority to accept applications it did not support the proposal for a 2- circumstance should include the where special consideration is year ban because market conditions can situation of when a plan is trying to be warranted. create the need for contract terminations responsive to state purchasing Comment: A commenter asked how and service area reductions. The initiatives on behalf of dual eligibles. this provision would be applied if an commenter requested that CMS allow Response: With this proposal, we acquisition or merger is pending. flexibility on market re-entry based on were not addressing whether a sponsor Response: The acquiring sponsor environmental conditions and is a poor performer. Rather, the proposal should assume that it is acquiring all the appropriate negotiations with and was intended to make the consequences Medicare contract assets and liabilities approval by the agency. to a sponsor of a mutual contract of the selling organization, including a Response: Terminations can cause termination the same as that for a non- 2-year ban on new applications. beneficiary confusion and disruption. renewal. Without this change, a plan Comment: A commenter stated that Additionally, if a sponsor responds to might opt for a mutual termination plans should be allowed to terminate market conditions through the rather than the less disruptive non- prior to the start of the benefit year if an nonrenewal process, a 2-year renewal in order to avoid the 2-year ban. adequate network cannot be obtained. application ban would apply. Additionally, the existing 2-year ban on The commenter also stated that if the Accordingly, we believe it is reasonable non-renewing sponsors is not meant to termination occurs after the start of and appropriate to apply the same 2- address those sponsors’ performance, open enrollment, CMS should wait 30 year application ban in situations when although it may help us to identify good days and allow beneficiaries to make a sponsor terminates a plan after the business partners. The 2-year their own elections before assigning nonrenewal deadline. We also note that, application ban, as it has been applied them to an alternate plan. Additionally, the proposed regulation changes to non-renewing organizations and, it was suggested that there should be a preserve our authority to permit affected once this proposed change is adopted by mechanism in place to make sure that organizations to submit applications in CMS, to mutually terminating a plan cannot use termination as a tool less than 2 years when special organizations, is intended to ensure to shift beneficiaries into a higher cost consideration is warranted. continuity in the Part C and D programs plan offered by the terminating sponsor.

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Response: This comment does not by imposing longer-term consequences of standardized technology. We also concern the proposed application of the on sponsors that might otherwise make finalize Part D rules regarding 2-year ban on mutually terminated annual decisions to exit and re-enter the timeframes and responsibility for sponsors. We will not address the programs. making redeterminations. Under Part C, comment as it is outside the scope of the Comment: One commenter asked if we finalize rules to— proposed change. CMS intends to apply this provision to • Authorize us to annually establish Comment: A commenter stated that all types of applications regardless of limits on member cost sharing; there are a variety of circumstances, plan type or geographic location. • Prohibit PPO, PFFS, and MSA plans including but not limited to the loss of Response: In the context of voluntary from using compliance with voluntary an adequate network that may be nonrenewals, our policy has been to prior notification procedures in beyond the control of the plan but force apply this prohibition based on plan determining cost-sharing amounts; it to withdraw a contract. Such type and service area (for example, non- • withdrawal may be in the best interest renewal of a PFFS contract does not Establish new requirements for of the beneficiaries. Therefore, overall prohibit the same organization from organization determinations; and • plan performance should not be judged applying immediately for an MA–HMO Offer two definitional revisions. on this one factor. If a plan can remedy contract for the same service area). We We also finalize Part C and D the issue for the following contract year anticipate applying the same policy to marketing requirements by it should be allowed to re-contract. The mutual terminations. distinguishing marketing materials from commenter suggests that this issue be enrollee communications materials and looked at on a case-by-case basis. B. Changes To Strengthen Beneficiary mandating the use of standardized Response: This provision does not Protections marketing material language and format address whether a sponsor is a poor This section includes provisions to ensure clarity and accuracy among performer. Rather, the provision is aimed at strengthening beneficiary plan documents. We also clarify notice intended to make the consequences of a protections under Parts C and D. Under requirements, and require that mutual contract termination the same as Part D, we address proposals in the area sponsoring organizations disclose those for a nonrenewal. The 2-year ban of eligibility and enrollment policy, information concerning the on nonrenewing sponsors is not meant transition period requirements, organization’s performance and to address those sponsors’ performance; coordination of benefits policy, compliance deficiencies to enable rather, it is intended to ensure retroactive claims adjustment beneficiaries to make informed choices. continuity in the Part C and D programs reimbursements and recoveries, and use This information is detailed in Table 2.

TABLE 2—PROVISIONS TO STRENGTHEN BENEFICIARY PROTECTIONS

Part 422 Part 423 Provision Subpart Section Subpart Section

Broker & Agent Requirements under Parts C N/A ...... N/A ...... N/A ...... N/A. and D. Beneficiary Communications Materials under Subpart V ...... § 422.2260, Subpart V ...... § 423.2260 Parts C and D. § 422.2262. § 423.2262. Required Use of Standardized Model Mate- Subpart V ...... § 422.2262 ...... Subpart V ...... § 423.2262. rials under Parts C and D. Extend the mandatory minimum grace-period Subpart B ...... § 422.74 ...... Subpart B ...... § 423.44. for failure to pay premiums. Maximum allowable out-of-pocket cost Subpart C ...... § 422.100 ...... N/A ...... N/A. amount for Medicare Parts A and B serv- ices. Maximum allowable cost sharing amount for Subpart C ...... § 422.100 ...... Subpart C ...... § 423.104. Medicare Parts A and B services and pre- scription drugs. Prohibition on prior notification by PPO, Subpart A ...... § 422.2 § 422.4, N/A ...... N/A. PFFS, and MSA plans. § 422.105. Requirements for LIS eligibility: expand the N/A ...... N/A ...... Subpart P ...... § 422.773(c)(2). deeming period for LIS-eligible bene- ficiaries to cover at least 13 months. Expand auto-enrollment rules to entire LIS- N/A ...... N/A ...... Subpart B ...... § 423.34. eligible population. Special Enrollment Period (SEP) Policies ..... N/A ...... N/A ...... Subpart B ...... § 423.38. Transition Process ...... N/A ...... N/A ...... Subpart C ...... § 423.120(b)(3). Sponsor responsibility for retroactive claims N/A ...... N/A ...... Subpart J ...... § 423.464. adjustment reimbursements and recov- § 423.466. eries. § 423.800. Time Limits for Coordination of Benefits ...... N/A ...... N/A ...... Subpart J ...... § 423.466. Pharmacy use of Standard Technology (ID N/A ...... N/A ...... Subpart C ...... § 423.120. cards) under Part D. Allow members in stand-alone Part D plans N/A ...... N/A ...... Subpart B ...... § 423.44. to be temporarily out of area for up to 12 months. Prohibit mass SPAP reenrollments during N/A ...... N/A ...... Subpart J ...... § 423.464(e). plan year. Non-Renewal Public Notice 60-day non-re- Subpart K ...... § 422.506 ...... Subpart K ...... § 423.507. newal beneficiary notification requirement.

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TABLE 2—PROVISIONS TO STRENGTHEN BENEFICIARY PROTECTIONS—Continued

Part 422 Part 423 Provision Subpart Section Subpart Section

Notice of Alternative Medicare Plans ...... Subpart K ...... § 422.5(a)(2)(ii) ...... Subpart K ...... § 423.507(2)(ii). Timeframes and Responsibility for making N/A ...... N/A ...... Subpart M ...... § 423.590. Redeterminations under Part D. Requirements for Requesting Organization Subpart M ...... § 422.568 ...... N/A ...... N/A. Determinations. Organization Determinations under Parts C .. Subpart M ...... § 422.566 & § 422.568 N/A ...... N/A. Refine/clarify definitions related to authorized Subpart M ...... § 422.561, § 422.574 N/A ...... N/A. representatives. & § 422.624. Sponsors may be required to disclose to en- Subpart C ...... § 422.111(g) ...... Subpart C ...... § 423.128(f). rollees compliance and performance defi- ciencies. Revise definition of ‘‘service area’’ to exclude Subpart A ...... § 422.2 ...... N/A ...... N/A. facilities in which individuals are incarcer- ated.

1. Broker and Agent Requirements demonstration as well as involved with effective communication, Under Parts C and D recommendations on specific features coordination, and training. The In the preamble to our October 22, that should be included. Some commenter also had concerns about the 2009 proposed rule, we recognized the commenters expressed the concern the role an enrollment broker would play in important role that agents and brokers proposed enrollment broker the disenrollment process. play in assisting beneficiaries with demonstration would prevent plans Response: We thank the commenters accessing and understanding plan from continuing to use plan-employed for this feedback and will consider it as information, making informed choices, agents. Other commenters we continue to improve our tools for and enrolling them in Medicare health recommended that independent agents assisting beneficiaries with their health plans. However, we also stated our and brokers be permitted to make care decisions and as we continue to continuing concern about the inherent referrals and receive a referral fee, with assess the impact of our current rules financial incentives independent agents the enrollment broker merely assisting regarding independent agents/brokers. and brokers have when selling Medicare with actual enrollment. One commenter Comment: A number of commenters products. For this reason, while not suggested that the demonstration provided us with responses to our proposing any specific changes in the initially focus on one State that already request for comments on the idea of October 2009 proposed rule, we uses a third party enrollment assistance limiting the use of agents and brokers to solicited comments suggesting ideas for approach for Medicaid managed care the AEP and OEP, or to selected groups effectively providing Medicare health plan enrollment as a pilot. The same of beneficiaries. The majority of these plan and drug plan information and commenter provided a very detailed commenters expressed concerns that enrollment assistance that ensures plan for how the commenter believed an limiting the use of agents and brokers in beneficiaries select the plan that best enrollment broker demonstration should this way could disadvantage age-ins, meets their needs, including whether work. Under this suggested plan, the dual-eligibles, and those eligible for the additional changes are needed in enrollment broker would receive low-income subsidy. They believe recently established requirements applications, record oral scope of strongly that these limits would relating to plan sponsors’ use of agents appointment confirmations, conduct decrease the service and support that and brokers. We specifically requested third-party enrollment verification calls, beneficiaries depend on to understand comments regarding the tools we and conduct general marketing activities plan benefits and make enrollment currently use (for example, our print providing high-level, standardized decisions. They also indicated that publications and our online resources) general information on plan options. CMS’ current support tools are not to assist beneficiaries with their health The enrollment brokers would refer sufficient to replace the function that care decisions; whether State Health beneficiaries with detailed questions or agents and brokers serve. Insurance Assistance Programs (SHIPs) needing more tailored plan Commenters also indicated that have the capacity to serve significantly presentations to plan-employed agents. limiting the use of agents and brokers to more Medicare beneficiaries; and the The commenter also expressed concerns certain times of the year is not feasible effectiveness of limiting the use of about the enrollment broker given that plans use agents and brokers independent agents and brokers by MA demonstration, suggesting that throughout the year and that current organizations and PDP sponsors to coordination and communication CMS oversight of agents and brokers is certain times of the year, specifically, between the enrollment broker, plans, sufficient. Along these same lines, one the open enrollment period (OEP) and and beneficiaries would be crucial to commenter supported the view set forth annual enrollment period (AEP), or to the success of the demonstration; the in the proposed rule preamble that selected groups of beneficiaries. ability to assure the quality of sufficient time has yet not passed to Comment: Several commenters information provided to beneficiaries fully evaluate the impact of the new provided very specific suggestions for would be important; and enrollment marketing requirements codified by an enrollment broker demonstration. broker training would also be a critical CMS following enactment of the Comments we received on an component of the program. This Medicare Improvements for Patients and enrollment broker demonstration commenter suggested that CMS solicit Providers Act of 2008 (MIPPA). Several included suggestions for guiding additional input from MA plans on commenters suggested that limiting the principles that should govern such a operational and information issues use of agents and brokers to the AEP

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and OEP or to select beneficiary groups • Renewal compensation for all selecting plans based on their health would, in fact, result in increases of the subsequent moves (regardless of plan care needs. As we continue to monitor marketing abuses we are trying to type change). and evaluate our marketing rules and eliminate and would force good agents Commenters also recommended— oversight activities, we will evaluate the out of business, leaving behind agents • Rescinding ‘‘lock-in’’; need for any future notice and comment only interested in short-term gains. • Limiting agent/broker involvement rule making. Several commenters provided in marketing, but not limiting their 2. Beneficiary Communications alternatives to limiting the use of agents involvement to certain periods during Materials Under Parts C and D and brokers to the OEP and AEP or with the year; • (§ 422.2260, § 422.2262, § 423.2260, and selected groups. The suggested Shortening the AEP; and • § 423.2262) alternatives can be grouped into three Eliminating the additional three categories—(1) Recommendations to month OEP for MA plans at the In the October 22, 2009 proposed rule, strengthen current rules, processes, and beginning of the year and applying the in implementing sections 1851(h) and oversight of agents and brokers; (2) enrollment period uniformly to MA 1860D–1(b)(1)(vi) of the Act, we Recommendations to require better plans and PDPs. proposed narrowing the definition of collaboration among stakeholders; and A number of commenters also the term ‘‘marketing materials’’ at (3) Recommendations that may require provided recommendations with respect § 422.2260 and § 423.2260 to exclude a regulatory changes. to our question about whether and how new proposed category of ‘‘current Recommendations for strengthening to expand the role of SHIPs. Almost all enrollee communications materials,’’ current rules, processes, and oversight of these commenters expressed concerns which we proposed defining to include of agents and brokers included— about SHIP funding, capacity, and either situational materials or • Strengthening agent and broker capability. They expressed concern beneficiary specific customized education/training; about— communications. We proposed this • • Inadequate funding; change in order to streamline the review Creating a Medicare license and • industry designation that all agents The fact that SHIPs’ reliance on and approval of beneficiary must have in order to sell Medicare volunteers limits their ability to fully communication notices to current products; standardizing agent replace the role of independent agents members. and brokers; Specifically, we proposed revising compensation by geographic area; • • Creating and requiring the use of a The lack of capacity of existing § 422.2260 and § 423.2260 to exclude ‘‘replacement/suitability’’ form that SHIP networks to service entire States; from the definition of marketing and materials communications targeted to agents would use when moving a • beneficiary to a new plan; The lack of knowledge by SHIP current enrollees that are customized or • Strengthening CMS surveillance volunteers about plans in every local limited to a subset of enrollees or a efforts; market within a State. specific situation, or that involve claims • Stabilizing CMS’ guidance in this Several commenters suggested that by processing or other operational issues. area by limiting the frequency of future limiting plan options and standardizing In the preamble to the proposed rule, we policy changes; and benefits, SHIP counselors would be cited the following examples of the • Tightening our current rules better able to handle questions from types of materials that would be regarding the use of independent agents beneficiaries about plan differences. excluded from our proposed revised and brokers. Other commenters suggested that by definition of ‘‘marketing materials’’: Part Commenters’ recommendations for strengthening SHIP networks, their D explanations of benefits (EOBs); requiring better collaboration with capacity could also be expanded. notifications about claims processing stakeholders included— Response: While we did not propose changes or errors; and other one-time or • Working with plans, advocates, and any changes to our regulations situational, beneficiary specific letters to associations to develop alternatives; governing plans’ use of independent current enrollees. • Creating a list of agents/brokers agents and brokers to sell Medicare In addition, we proposed to revise prohibited from selling Medicare plans plans in our October 22, 2009 proposed § 422.2262 and § 423.2262 to specify that would be shared with all rule, we appreciate the thoughtful ideas that, while the current enrollee stakeholders; and recommendations commenters communications excepted from the • Providing more support to and offered. We recognize the important role definition of marketing materials would coordination with the States; and agents and brokers play in assisting not be subject to the statutory • Periodically publishing best beneficiaries with accessing and requirement that they be submitted to practices. understanding plan information, making CMS for review and approval prior to Additional recommendations that informed choices, and enrolling them in use, we retained the right to review such may require regulatory or statutory Medicare health plans. However, we materials, and their use could be changes included— still have concerns about the inherent disapproved (or disapproved subject to • Requiring plans to share financial incentives independent agents modification) by CMS. information on agent misconduct and and broker have when selling Medicare In this final rule, we adopt these terminations; products. We recently implemented provisions with some modification. For • Creating uniform compensation regulations (§ 422.2274 and § 423.2274) reasons discussed below, we have in rates for MA plans and PDPs; intended to reduce agent and broker this final rule revised paragraph • Requiring agents and brokers to incentives to enroll beneficiaries in § 422.2260(5) (vii) to retain materials register with the National Insurance plans inappropriately. We continue to about membership rules and Producer Registry (NIPR); agree with the commenter that procedures, which we are calling • Precluding agents from selling MA suggested it is still too soon at this time ‘‘membership activities’’ (for example, plans or PDPs or selling to LIS to fully evaluate whether these new materials on rules involving beneficiaries; rules have achieved MIPPA’s goal of nonpayment of premiums, confirmation • Allowing a one-time ‘‘new creating incentives for agents and of enrollment or disenrollment, or non- enrollment payment’’; and brokers to assist beneficiaries with claim specific notification materials) in

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the definition of marketing materials materials excluded from the definition preamble to our proposed rule, in light subject to CMS prior approval. In of marketing materials are not subject to of the comments we received on the addition, we have added a new the Medicare Marketing Guidelines’ scope of the exemption from the paragraph § 422.2260(6) to expressly requirements that plans include certain marketing definition, we no longer exclude from the definition of marketing plan mailing statements on envelopes believe that example was appropriate, materials ad hoc customized or regarding the contents of the materials particularly given the importance of our situational enrollee communications. enclosed within. In addition, these review of EOB templates. Thus, under Comment: A number of commenters commenters requested additional this final rule, we will continue to supported our proposal to modify the guidance regarding how we intend to require submission and approval of EOB definition of the term ‘‘marketing operationalize the process for review templates through the CMS marketing materials’’ to distinguish materials used and approval of situational enrollee review and approval process as part of to market to new potential enrollees communications that would, if the the new definition of marketing from current enrollee communication proposed provisions were finalized as materials, and distinguish this general, materials. However, these commenters proposed, be outside CMS’s current regularly issued notice from documents raised an ambiguity in our proposed marketing review and approval pertaining to the processing of an revision to the definition of marketing processes. individual claim. We intend to provide materials at § 422.2260(5)(vii) and Response: We disagree that it is further guidance on the types of § 423.2260(5)(vii). These commenters necessary, and do not believe it would marketing materials that would be noted that, as written, the revised be appropriate, to attempt to specify in considered ad hoc enrollee paragraph (5)(vii) merely defines the regulations text an exhaustive listing communications materials, as well as ‘‘current enrollee communications of enrollee communications that are not any alternate processes for their review materials’’ without making it clear that considered marketing materials per our and approval, in the Medicare such materials are excluded from the revised definition of the term Marketing Guidelines. revised definition of marketing ‘‘marketing.’’ Our intent is to define Comment: One commenter suggested materials. these exclusions from the definition of that all prospective and current member Response: We agree that, as written, marketing materials narrowly to include materials be submitted to CMS as file the proposed revisions to the definition communications that are either and use materials so that there is a of marketing materials did not make it customized or intended for a subset of centralized and consistent place for sufficiently clear that we were current enrollees and which deal with beneficiary communication to be excluding customized or situational specific situations or cover member- housed within CMS. This commenter current enrollee communications from specific claims processing or other suggested, as an alternative, that the the definition of marketing materials, operational issues. Our intent was not to plan develop internal processes to and that certain materials directed at exclude from the definition of marketing monitor materials for consistency with current members should still be materials communications that are used CMS requirements rather than filing included in the definition. Accordingly, more broadly or that convey information those materials with CMS. We note that as noted above, in response to these about plan benefit structures. As noted MA organizations and PDP sponsors comments, we have revised paragraph previously, in response to earlier already have the responsibility to § 422.2260(5) (vii) to retain materials comments and this comment, we have ensure, from a monitoring and about ‘‘membership activities’’ (such as, revised our proposed definition of compliance perspective, that their materials on rules involving non- current enrollee communications marketing materials are complete, payment of premiums, confirmation of materials in the final rule to add a new accurate, and consistent with marketing enrollment or disenrollment, or non- § 422.2260(6) to better describe our rules. A few commenters suggested that claim specific notification materials) in intent in the proposed rule, and now we require plans to submit a report on the definition of marketing materials. In refer to these materials as ‘‘ad hoc beneficiary communications and audit addition, we have added a new enrollee communications materials.’’ these communications periodically to paragraph § 422.2260(6) to specifically The final definition encompasses ensure that plans are not engaging in exclude from the definition of marketing materials that are targeted to current inappropriate beneficiary marketing ad hoc customized or situational enrollees; are customized or limited to practices, and that we retain oversight enrollee communications from the a subset of enrollees; do not include responsibilities for these materials. definition of marketing materials. information about the plan’s benefit Response: As stated previously, we Comment: Several commenters structure; and apply to a specific have revised the definition of suggested that, in the absence of a clear situation or cover member-specific ‘‘customized current enrollee definition of claims processing or claims processing or other operational communications materials’’ in this final operational issues, we should define the issues. We envision that ad hoc enrollee rule such that it covers a narrow class terms ‘‘situational’’ and ‘‘beneficiary communications materials could of ad hoc, customized beneficiary specific’’ narrowly. Several commenters include the following types of materials; communications materials. We will requested that we specify those • Communications about a shortage provide more information about situations where beneficiary of formulary drugs due to a alternative review and approval communications would be considered manufacturer recall letter. processes for customized current current enrollee communications • Letters to communicate that a enrollee communications materials in materials and be excluded from the beneficiary is receiving a refund or is the Medicare Marketing Guidelines. We proposed revision to the definition of being billed for underpayments. note that we periodically audit marketing materials. These commenters • Letters describing member-specific marketing materials. We will also also suggested that we allow operational claims processing issues. ensure that ad hoc enrollee letters that pertain to enrollment, Although we mentioned the Part D communications materials meet all disenrollment and appeals issues to be EOB in the preamble to the October relevant requirements and are reviewed, excluded from the definition of 2009 proposed rule as an example of a approved, and used appropriately. marketing materials. Some commenters customized current enrollee Comment: One commenter suggested that we specify that any communications material in the recommended that we extend our

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current waivers of marketing review and to use consumer research and testing to members and potentially lead to approval requirements for employer determine the terms and features beneficiary confusion. group waiver plan marketing materials consumers want and the best ways to These commenters also expressed to employer group waiver plan disclose that information to assist concern that without such flexibility enrollment materials. Some other beneficiaries with making informed and space for free form text, plans will commenters requested that our current decisions about their health care be unable to adequately capture the regulations concerning review and options. nuances and unique features of the approval of marketing materials be Several commenters suggested we various plan types. Commenters expanded to apply to third party collaborate with the industry, advocates, specifically indicated that it was entities, as these commenters believe and State agencies to develop imperative for us to allow flexibility third party entities tend to send standardized models, or convene a within standardized models for special inaccurate or incorrect information to workgroup to explore ways of needs plans (SNPs), cost plans, point-of- beneficiaries. improving the wording of model service (POS) plans and employer group Response: These comments address materials. In addition, some of these plans. A few commenters requested the our exercise of employer group waiver commenters suggested, as an alternative, option to waive standardized language authority, and accordingly are outside that we solicit document examples and for SNPs, or to develop separate the scope of this rulemaking, and not suggestions from plans regarding the standardized documents for these plans addressed in this final rule. creation of standardized materials and if we do not provide sufficient establish from these examples best flexibility within standardized models. 3. Required Use of Standardized Model practices for model language, content, A commenter suggested that CMS Materials Under Parts C and D and format. develop documents specifically for low- (§ 422.2262 and § 423.2262) Response: Given the support for our income subsidy (LIS) eligible In order to reduce variability of proposed requirement, we are adopting beneficiaries and that we provide marketing materials and to ensure it as set forth in the proposed rule. We documents translated into non-English documents are more accurate and agree with the commenters’ languages, as well as documents in understandable to beneficiaries, we recommendations that CMS should Braille. proposed, under the authority of research and consumer test Response: We agree that standardized sections 1851(h) and 1860D–1(b)(1)(vi) standardized model marketing materials should be sufficiently tailored of the Act, to move toward greater materials, when practical, as well as to the intended recipients to relay plan standardization of the information engage in dialogue with the industry, information as clearly as possible. provided in plan marketing materials. advocates and State agencies as part of Accordingly, we intend to continue to Specifically, we proposed revising our efforts to standardize more allow plans flexibility to accurately § 422.2262 and § 423.2262 to require marketing model materials. As we did convey specific plan information. As that MAOs and PDP sponsors use when we reissued the standardized with the current ANOC/EOC standardized marketing material annual notice of change/evidence of standardized models, we will permit language and format, without coverage (ANOC/EOC) models for plans to capture the unique features and modification, in every instance in which contract year 2010, we intend to nuances of their various plan types and we provide standardized language and continue to consumer test our marketing plan benefits through variable text, as formatting. We noted that we will materials, as practical, to ensure that appropriate. Our requirement to use provide MAOs and PDP sponsors with they accurately describe plan benefits standardized models when we make standardized marketing materials and assist beneficiaries with making the them available does not change this through the annual Call Letter, Health best health care decisions for their practice; we are simply moving toward Plan Management System (HPMS) particular needs. As part of the process standardizing more marketing memoranda, or other guidance of revising the standardizing ANOC/ documents. documents. We believe this change will EOC models, we also conducted We will consider how best to provide ensure beneficiaries receive more listening sessions with the industry to information to LIS-eligible individuals accurate and comparable information to solicit input on improving standardized as we standardize models. With regard make informed decisions about their documents. We received a great deal of to providing translated materials, our health care options, as well as lead to useful information as a result of those Medicare Marketing Guidelines increased efficiencies and greater sessions, which we believe was critical currently require plans to provide consistency in our marketing material to improving the consumer friendliness translated and alternative format review protocols and processes. In this of those models. In addition, we will documents to beneficiaries. Specifically, final rule, we adopt these provisions as continue to provide opportunities for plans are required to translate materials proposed. For the upcoming 2011 plan external stakeholders to comment on in service areas where at least ten year, we plan to update some of our draft versions of model documents prior percent of the population speaks a non- current standardized documents later to finalizing them. English language as its primary this spring through guidance, but we are Comment: Many commenters language. In addition, plans must make unlikely to standardize new types of requested clarification on whether, in basic enrollee information available to documents. For 2012 and future years, developing standardized model individuals with disabilities (for we will consider and explore marketing materials, we will continue to example, visually impaired standardizing additional forms and allow plans the flexibility to modify beneficiaries) and must ensure that materials. model documents to accurately convey information about their benefits is Comment: Several commenters specific or unique plan information. accessible and appropriate for Medicare strongly supported our proposed rule to Many commenters argued that our beneficiaries who have disabilities. require MAOs and PDP sponsors to use existing models do not adequately To ensure that beneficiaries standardized language and formats in capture the range of variation in plan understand materials translated into a marketing materials in instances where types and benefits and that non-English language, we require that we provide them. Other commenters standardizing additional models could plans translating their marketing supported this proposal but urged CMS impede effective communications with materials into other languages use

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standardized language. For example, standardized documents so that they with respect to an individual’s eventual plans translating materials into Spanish accurately reflect unique plan obligation to pay his or her premiums is or Cantonese should use a standard information. not within the scope of this rulemaking. Spanish or Cantonese language resource Comment: One commenter Comment: Another commenter who (such as, ‘‘Real Academia Espan˜ ola’’ understood and appreciated the need to supported the proposed regulatory [Royal Spanish Academy], the most standardize models but was concerned revision further requested that CMS widely-recognized institution that requiring a standardized format develop a method for beneficiaries to responsible for regulating the Spanish limits options, may expand the length of engage CMS in resolving premium language). current model documents, and could payment disputes, such as whether Comment: Several commenters potentially drive up costs of printed individuals who qualify for the Part D suggested we clearly identify the materials. low income subsidy or are enrolled in documents we intend to standardize, Response: We believe the benefits of a state pharmaceutical assistance while two commenters suggested we increased standardization outweigh the program (SPAP) owe plan premiums, in limit the documents we intend to commenter’s concerns. The move addition to disputes regarding standardize. One commenter wanted toward standardizing more documents individuals who experience problems clarification on what ‘‘when specified by will reduce the variability and errors in with premium withhold from their CMS’’ means. In addition, many marketing materials, and will ensure Social Security benefits. commenters urged us to release that standardized documents provide Response: Although there is no formal standardized documents to plans early more accurate, understandable, and CMS administrative process for dealing in the year to allow plans sufficient time comparable information across plans, with these issues, we do play an to disseminate plan information to thereby helping beneficiaries to make important role in resolving premium beneficiaries. the best possible health care decisions payment disputes through our existing Response: In addition to the ANOC/ for their particular needs. casework procedures. CMS caseworkers EOC, we indicated in the 2009 Call often deal directly with individuals who 4. Involuntary Disenrollment for Failure Letter that we intended to standardize have their premiums withheld from To Pay Plan Premiums Under Parts C the Part D explanation of benefits (EOB), their SSA benefit payment, and we also and D (§ 422.74 and § 423.44) pharmacy directory, provider directory, work with plans to resolve both plan formulary, and transition notice. We proposed to amend the premium issues involving individuals We are currently in the process of regulations at § 422.74(d)(1) and or groups of enrollees, such as the LIS consumer testing and revising some of § 423.44(d)(1) regarding disenrollment population in a plan. We also facilitate these models to include plain language. for nonpayment of premiums to require discussions between plans and SPAPs With regard to the comment about a minimum grace period of 2 months about such payment issues. We will what ‘‘when specified by CMS’’ means, before any involuntary disenrollment continue to look at ways to better as with the ANOC/EOC, CMS will occurs, in order to provide adequate address these issues. specify which documents must be used time for organizations to respond to Comment: One commenter supported without modification through guidance instances in which individuals fail to the change and recommended that the documents such as the annual Call pay their premiums, and for affected 2-month grace period begin the first of Letter or HPMS memoranda. Finally, we enrollees to take steps to remedy the the month for which the enrollee is are committed to releasing final situation and avoid disenrollment. delinquent and not from the point of standardized models as early as possible Furthermore, we proposed to codify notification. in the year in order to permit plans existing subregulatory guidance Response: Current regulations state sufficient time to prepare and regarding the beginning of the grace that the grace period begins the first day disseminate those documents to period for Part D. In this final rule, we of the month for which the premium is beneficiaries for the following contract adopt these provisions as proposed. unpaid. Subregulatory guidance year. Comment: Several commenters (§ 50.3.1 of Chapter 2 of the Medicare Comment: A commenter suggested supported our proposed regulatory Managed Care Manual and § 40.3.1 of that, as an alternative to our proposed revision to increase the length of the Chapter 3 of the Medicare Prescription requirement that plans use standardized minimum grace period and further Drug Benefit Manual) further clarifies documents as specified by CMS, we requested that CMS exempt that the premium is ‘‘unpaid’’ only after should allow for review of requested beneficiaries from having to pay plan the member is notified of, or billed for, changes to standardized language premiums if the organization fails to the actual premium amount due. We similar to our review of hard copy request payment of the premiums in a clarified that the grace period not begin change requests for the Summary of timely manner. Another commenter prior to the member being notified of Benefits. supported this change and further the delinquency was established to Response: We disagree with the recommended that CMS also require ensure that members have the full grace commenter’s suggestion. As stated plans to provide for exceptions in cases period in which to resolve the premium elsewhere in this preamble, we believe of financial hardship or other special payment issue. We agree with the standardization leads to improvements circumstances. commenter that the grace period should in accuracy, comparability, and Response: We appreciate the support begin the first day of the month for understandability, as well as increased for this proposal and are adopting it as which the enrollee is delinquent, but efficiencies and greater consistency in proposed. Although we do not believe only if the organization has previously our marketing material review protocols that it is appropriate to exempt requested payment of the premium and and processes. Permitting hard copy beneficiaries from paying premiums for has provided the member an changes would undermine our efforts to periods of coverage based on late opportunity to pay. Accordingly, in this reduce variability in marketing notification, we strongly encourage final rule, we are revising § 422.74(d)(1) materials. In addition, we believe that plans to work with such individuals to and § 423.33(d)(1) to include the we can address the commenter’s implement payment plans where requirement that the grace period begin concerns by permitting plans to use financial hardship could be involved. on the first day of the month for which variable text fields throughout Also, we note that a change in policy the premium is unpaid or the first day

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of the month following the date on Comment: One commenter requests who utilize higher than average levels of which premium payment is requested, that CMS change the requirement for health care services (that is, in order for whichever is later. issuing disenrollment notices, stating a plan not to be discriminatory in Comment: Several commenters that a timeliness standard of 5 or 7 days violation of section 1852(b)(1) of the representing plans opposed the would be more manageable than the Act). proposed change. One commenter current three business day requirement. In the preamble to our October 22, contended that the change would not Response: The 3-day requirement 2009 proposed rule, we generally result in a reduction in disenrollments referred to by the commenter is not for described the process we have and requested that CMS instead provision of the disenrollment notice; established to comprehensively review maintain the minimum 1-month grace rather, it is the deadline for the proposed cost sharing of each plan period and allow organizations to offer organizations to submit the ensuing benefit package and determine if MA a longer grace period at their discretion. disenrollment transaction to CMS. This plans’ cost sharing designs—both in Another commenter cited the potential timeframe was established to provide terms of aggregate expected out-of- costs that may be incurred by adequate time for data to be transmitted pocket cost-sharing and particular cost- organizations to make systems to CMS to ensure the timely processing sharing amounts for certain health care enhancements and to modify current of any necessary auto-enrollments for services—discriminate against those administrative processes, policies, and those individuals who receive the Part beneficiaries with higher than average procedures. Another commenter feared D low income subsidy. Therefore, we health care needs. We noted in the lengthening the minimum grace period are not adopting this suggestion. preamble to the proposed rule that we from 1 month to 2 months would Comment: One commenter requested have annually established, through potentially expose the organization to that CMS clarify that the grace period subregulatory guidance, a voluntary increased financial liability. applies only to members for whom CMS maximum out-of-pocket limit on Parts A makes payment to the organization. and B services that, if adopted by an MA Response: We believe that providing Response: Our interpretation of this additional time for individuals to pay plan, would allow the plan greater cost comment was that it was intended to sharing flexibility than it would their premiums will assist a great address situations where a plan’s otherwise receive absent the voluntary number of individuals in meeting their enrollment records may not MOOP. We also noted that we have financial obligations and avoid immediately match CMS records, and identified certain health care services disenrollment. As discussed in the thus there is some question as to that beneficiaries with higher than preamble to the October 22, 2009 whether an individual is enrolled in the average health care needs are likely to proposed rule (74 FR 54657), under plan. Given that the plan has need (for example, in-patient hospital, current rules, individuals may have less determined the beneficiary eligible for dialysis, skilled nursing facility (SNF), than a month a resolve payment the plan, has notified the beneficiary of mental health services, Part B drugs and delinquencies. Thus, we believe this the enrollment, has submitted the home health care) and described our proposal will provide a valuable enrollment to CMS and the discrepancy process for conducting outlier analyses beneficiary protection, particularly in in the enrollment record is not caused by which we consider the distribution view of the significant potential gap in by any action of the beneficiary but of cost sharing levels submitted by MA coverage that could result from such a instead is an issue to be resolved organizations to identify levels in the disenrollment, given that in many cases between CMS and the plan, we believe upper end of the range for the purpose an individual may not be able to re- it would be appropriate for the same of reviewing whether cost sharing levels enroll until the following annual grace period policies to apply to such a for submitted benefit designs are election period. It will also help to beneficiary as to a confirmed plan discriminatory. We believe these efforts reduce the number of situations where enrollee. have resulted in reduced discriminatory individuals pay their premiums shortly 5. Maximum Allowable Out-of-Pocket cost sharing and improved the after their disenrollments take effect but transparency of plan design. For the plan has already submitted a Cost Amount for Medicare Parts A and B Services (§ 422.100) example, in contract year 2010, about disenrollment transaction. 39.2 percent of all non-employer MA Many organizations currently offer a In our October 22, 2009 proposed plans representing about 3 million MA grace period in excess of the one month rule, under the authority of sections enrollees adopted the voluntary MOOP minimum that is currently required. As 1852(b)(1)(A), 1856(b)(1), and 1857(e)(1) limit on beneficiary cost sharing. such, the impact of the proposed change of the Act, we proposed to amend In the preamble to the proposed rule, is limited to those organizations that § 422.100(f)(3) by adding a new we stated our intent to use a similar have chosen to implement the minimum paragraph (f)(4) to specify that all local method for establishing a mandatory requirement. For these organizations, MA plans must establish a maximum MOOP amount for Parts A and Part B we believe any administrative costs that out-of-pocket (MOOP) liability amount services for all local MA plans as we may result from changing from a one inclusive of all Medicare Parts A and B used to establish the voluntary MOOP month to a two month grace period are services, the amount of which would be limit for contract year 2010. Therefore, fully justified by the benefits to be set annually by CMS. We also noted the MOOP would be set by CMS at a gained by both the organization and its that, under our proposal to require that certain percentile of fee-for-service members by providing a more a MOOP amount be established for local (FFS) beneficiary out-of-pocket reasonable time frame for all parties to MA plans, the MOOP limit for local spending. We also noted that we set the resolve premium payment issues and preferred provider organization (PPO) voluntary MOOP limit at the 85th avoid disenrollment. With respect to the plans would be inclusive of all in- percentile of FFS spending for contract financial liability issue, we also note network and out-of-network beneficiary year 2010 but could set the limit at a that the proposed change would not cost sharing. As discussed in the different percentile or through a affect an organization’s ability to pursue proposed rule, we believe that requiring modified approach as determined by us collection of past due premium the inclusion of such a limit in plan in future years. We also proposed to payments from current and former design is necessary in order not to continue to furnish information to MA members. discourage enrollment by individuals organizations on our methodology and

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the amounts for acceptable MOOP voluntarily, we were concerned that a MOOP limit may disadvantage smaller amounts on a timely basis through the high cost enrollees would be local plans compared to larger plans, annual Call Letter or Health Plan discouraged from enrolling in MA plans potentially resulting in those smaller Management System (HPMS) that did not include a MOOP limit. We plans being priced out of the MA memoranda. We solicited comments on believe that requiring a mandatory market. One commenter recommended this approach. MOOP limit does not unduly that we use a fixed benchmark for the After considering the comments we disadvantage MA plans relative to MOOP amount, rather than the 85th received on this issue, we are finalizing original Medicare. We note that percentile of expected FFS spending § 422.100(f)(4) largely as proposed but, beneficiaries in original Medicare have cited in the preamble to our proposed as discussed in greater detail below, are the option of selecting between two rule, as the cut-off established for adding a new paragraph (f)(5) to address Medigap policies, K and L, that afford contract year 2010, which they believe concerns raised by commenters about them an annual cap on out-of-pocket would still be too high an amount for applying our proposed MOOP amount expenses (currently at $4,600). In low income enrollees. Another to PPO out-of-network services. addition, enrollees in the original commenter supported a cut-off at a Specifically, we are specifying in Medicare program can select among higher percentile of FFS to ensure that paragraph (f)(5) that the mandatory other Medigap polices that limit their plans do not have to increase their MOOP amount under paragraph (f)(4) cost-sharing liability for Parts A and B premiums or, alternatively, that the would only apply to PPO network services. As noted previously, a MOOP amount be set no lower than services, while a higher catastrophic significant number of MA plans have $7,500 in order not to affect the maximum would apply to both in- and already successfully designed benefit sustainability of the MA program. out-of-network liability. In setting a packages that include MOOP limits and Another commenter supported a higher catastrophic maximum, we will have continued to effectively compete mandatory MOOP amount, but argued take into consideration standard in the marketplace. that plans should be allowed to practices in commercial benefit design We agree, however, that retaining a establish their own MOOP amounts. as well as protecting beneficiaries who voluntary MOOP amount that is lower Response: In establishing the use out-of-network providers. than the mandatory maximum we have mandatory MOOP amount, we will be Comment: Several commenters noted proposed would preserve current cognizant of the balance we must strike that a MOOP amount protects incentives for further reducing enrollee between affording beneficiaries beneficiaries from catastrophic medical out-of pocket liability. Therefore, in reasonable protection from high out-of- costs and supported our proposal. addition to establishing a mandatory pocket expenses and our desire that the Another commenter noted that it was MOOP amount, we also plan to MA program remain viable for health important that all Parts A and B services continue our current policy of offering plans and beneficiaries. We will be included in the MOOP amount. MA plans the option of establishing a carefully assess the impacts of the Another commenter supported our lower voluntary MOOP amount in MOOPs we establish, annually adjusting proposal on the grounds that it will exchange for more flexibility in cost- the limit as necessary based on the bring an element of standardization to sharing thresholds than available for previous year’s experience, as well as the MA program. plans that adopt the higher mandatory other factors as appropriate, to ensure A number of Medicare Advantage MOOP for contract year 2011. Under that this balance is maintained. As organizations (MAOs) expressed this approach, the voluntary MOOP noted previously, we believe the concern that Original Medicare does not amount would be set at an amount approach of establishing a higher, have a MOOP and argued that it would lower than the mandatory MOOP, and mandatory MOOP amount and a lower, therefore not be equitable to require one would therefore not disadvantage those voluntary MOOP amount will allow us for MA plans. These commenters were MA plans that have adopted the to better strike this balance. also concerned that a mandatory MOOP voluntary MOOP in previous contract would increase plans’ costs and result years. We would in effect establish two Comment: A couple of commenters in increased premiums for beneficiaries, sets of Parts A and B service cost- did not believe their systems would particularly if the dollar limit is too low. sharing thresholds under this approach, support tracking of out-of-pocket Some commenters were also concerned one applicable to plans selecting the expenses relative to a mandatory MOOP that a mandatory MOOP amount would higher, mandatory MOOP amount, and limit, and that the imposition of one result in adverse selection, with ‘‘sicker’’ the other applicable to those choosing would therefore introduce a significant Medicare beneficiaries dropping out of the lower, voluntary MOOP. To incent new administrative burden. One Original Medicare and selecting MA plans to adopt the lower MOOP amount, commenter argued that we should plans. One commenter advocated that we would allow plans greater cost furnish additional funding to MA plans we continue our current process of sharing flexibility for Parts A and B due to the costs of implementing a allowing voluntary MOOP limits with a services if they adopt the lower, mandatory MOOP amount. more stringent review for plans that do voluntary MOOP. We plan to articulate Response: We recognize that those not adopt the voluntary MOOP limit. this voluntary MOOP policy through plans that have not already voluntarily Response: As discussed in the subregulatory guidance such as the introduced a MOOP may need to invest proposed rule, we believe that requiring annual Call Letter or a similar resources in ensuring their systems are the inclusion of a MOOP limit is an document. designed to implement this important step to ensure that Comment: Several commenters were requirement. We believe, however, these individuals who utilize higher than concerned that a mandatory MOOP costs need to be weighed against the average levels of health care services are amount should not be set so high as to benefits of ensuring that MA plan not discouraged from enrolling in MA discourage low income individuals from designs without a MOOP limit do not plans that do not have such a limit in joining MA plans. Other commenters discourage enrollment by high cost place. Given that regional PPO plans are recommended that we ensure that the individuals. required by statute to have such a MOOP amount is low enough to benefit Comment: Several commenters liability limit in place, and a substantial low income individuals. One requested clarification regarding the number of local plans have adopted one commenter also expressed concern that applicability of our proposed

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requirement to establish a mandatory of-network cost-sharing than that which eligibility. In those cases, these MOOP amount to MA plans. applies to use of PPO in-network individuals may be required to directly Response: Because a statutory MOOP services. Therefore, we are revising pay the plan cost sharing that otherwise requirement is already in place with § 422.100 by adding a new paragraph (5) would be the obligation of the State. respect to regional PPO plans, we that specifies that, in addition to the Accordingly, we will not exempt SNPs proposed applying the new mandatory MOOP for Medicare Parts A and B from the requirement that they MOOP requirement only to local MA services that all local MA plans will be implement a MOOP amount as plans in our proposed rule. While we subject to—which would apply only to established annually by CMS. now believe regional PPOs should be the use of network providers—all local Comment: Another commenter subject to the same requirements with PPO plans must also establish a total recommended exempting employer respect to a MOOP as local MA plans, catastrophic limit on beneficiary out-of- plans from our MOOP requirements since our proposed rule did not give MA pocket expenditures for both in-network because such a benefit design would be organizations offering regional PPOs an and out-of-network Parts A and B inconsistent with the benefits employer opportunity to comment on such a services consistent with the plans currently offer. proposal, we will need to address this requirements applicable to regional Response: We disagree with this discrepancy in future notice-and- PPOs at § 422.101(d)(3). This total commenter that such a regulatory comment rulemaking. However, we note catastrophic limit will be no greater exception is warranted. The same that regional PPOs will have the option than an annual limit set by CMS. In considerations involving discrimination of implementing any mandatory or addition, we will also offer local PPO against high cost enrollees could also voluntary MOOP amounts we establish plans the option of implementing any apply in the employer plan context, for local MA plans. voluntary MOOP amount CMS particularly if the employer allows more Comment: A number of commenters establishes for local MA plans. than one plan option. In exceptional recommended that we announce the Comment: One commenter requested cases in which CMS agrees that a waiver mandatory MOOP amount, and the clarification regarding whether all of this rule would be in the interest of methodology we use to set it, as early as Medicare Parts A and B services would Medicare beneficiaries served by an possible in the year preceding the be included in the MOOP amount. employer group, CMS could consider contract year in which we will apply Response: As noted in the preamble to waiving the regulations through the that amount (for example, in the our proposed rule, cost-sharing for all employer group waiver authority under Advance Notice of Methodological Parts A and B services would be section 1857(i) of the Act. Employer Changes). Another commenter included in the MOOP amount. Such plans will therefore be subject to the recommended that this information be cost-sharing includes any plan regulatory MOOP requirement finalized provided in our annual Call Letter. deductibles applicable to Parts A and B in § 422.100(f)(4) that applies to all MA Response: As specified in the services, but excludes monthly plan plans. preamble to the proposed rule, we premiums. intend to continue to furnish Comment: A commenter argued that 6. Maximum Allowable Cost Sharing information to MA organizations on our since States pay cost sharing for Amount for Medicare Parts A and B methodology and the amounts for members of dual-eligible special needs Services and Prescription Drugs acceptable out-of-pocket caps on a plans (SNPs), there is no need to apply (§ 422.100, and § 423.104) timely basis through the annual Call a MOOP to these plans. Another In our October 22, 2009 proposed Letter or a similar guidance docunent. commenter contended that dual-eligible rule, we proposed to amend our Comment: Two commenters were SNPs cannot charge their enrollees a regulations on the general requirements concerned that the mandatory MOOP premium as a practical matter, which related to Medicare Advantage (MA) would apply to all in- and out-of- would further disadvantage this plan benefits and qualified prescription drug network PPO services, and contended type if they were required to implement coverage to expressly authorize us to that such an arrangement could lead to our MOOP limit. Another commenter establish cost sharing thresholds for a reduction in the number of PPOs recommended that we provide guidance individual services below which cost offered given the potential increase in on how the MOOP will apply to SNP sharing will be considered non- plan costs that would result. One of enrollees, particularly those in dual- discriminatory. these commenters believed including eligible SNPs. This commenter was For Part C plans, we proposed to cost-sharing applicable to out-of- specifically interested in guidance annually review bid data to determine network plan covered services will regarding what States’ obligation would specific cost sharing levels for Medicare undermine incentives to use preferred be with respect to premiums and cost A and B services below which we providers that are central to the design sharing, as well as the actual out-of- would not consider there to be a of a PPO. pocket liability for a dual-eligible SNP discriminatory effect, and therefore may Response: As stated in the proposed enrollee. Additionally, this commenter be approved in an MA benefit package. rule, we believe that some protection was concerned that dual-eligibles may Specifically, we proposed amending against out-of-pocket liability should experience an unnecessary reduction in § 422.100 by adding a new paragraph apply to enrollee cost-sharing for both supplemental benefits if our final (f)(5) to specify that cost sharing for in- and out-of-network services covered requirement does not clearly distinguish Medicare A and B services may not by PPOs. However, we agree with the what these individuals actually pay as exceed levels annually determined by concerns of the commenter highlighting out-of-pocket costs versus what us to be discriminatory. the effect a single MOOP applying to all Medicaid should pay. Similarly, for Part D plans, we services would have on incentives to Response: We disagree with proposed to annually review bid data to use preferred providers. In addition, for comments recommending that SNPs be determine acceptable cost sharing tiers reasons of beneficiary transparency and exempted from MOOP requirements. for benefit packages offering non- consistency, we believe that local PPOs Dual-eligible individuals entitled to defined standard prescription drug should be subject to the same type of have their cost sharing paid by the State coverage. To this end, we proposed MOOP requirements as regional PPOs, and enrolled in a SNP may experience revising § 423.104(d)(2) by adding a new which have a different MOOP for out- midyear changes in their Medicaid paragraph (iii) to specify that tiered cost

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sharing for non-defined standard benefit number of commenters contended that days, inpatient short stay (10 days), designs may not exceed levels annually individual service category thresholds inpatient mental health (15 days), SNF determined by us to be discriminatory. would limit the availability of unique (42) days, home health (37) days, We also explained in the preamble to benefit designs and, consequently, limit physician mental health visits, renal the proposed rule that we would furnish beneficiary choice. One commenter dialysis (156) visits, Part B drugs, information to MA organizations and argued that we should not limit plans’ chemotherapy, radiation, DME, Part D sponsors on our methodology ability to use cost sharing as a tool to equipment, prosthetics, supplies and and the cost sharing thresholds for the encourage beneficiary choice of cost diabetes tests. following contract year based on the effective and clinically appropriate As discussed elsewhere in this prior year’s bids, and on a timely basis services. Another commenter preamble, in addition to establishing a either through the annual Call Letter or recommended that, rather than adopting mandatory maximum out-of-pocket Health Plan Management System cost-sharing thresholds, we should (MOOP) limit on overall cost-sharing for (HPMS) memoranda. We solicited evaluate other options for identifying Parts A and B services, we also plan to comments on this approach, including and preventing discriminatory benefit continue our current policy of offering the extent to which we provided designs, such as evaluating the MA organizations the option of adopting sufficient clarity on how we would prevalence of utilization control a lower voluntary MOOP with greater determine whether cost-sharing levels mechanisms (for example, prior flexibility in Parts A and B cost sharing are discriminatory. authorization) on services frequently than available for MA plans that meet After considering comments we used by patients with a particular high- only the higher mandatory MOOP. received on this issue, we are adopting cost conditions. Under this approach, the voluntary proposed § 422.100(f)(5) (which, in light Response: We believe establishing MOOP would be set at an amount lower of the new subparagraph (f)(5) discussed individual service cost-sharing than the mandatory MOOP and would above, is recodified as subparagraph thresholds is necessary to ensure that therefore not disadvantage those MA (f)(6)) and § 423.104(d)(2) with minor beneficiaries who utilize higher than plans that have adopted the voluntary revisions made in response to comments average levels of health care services MOOP in previous contract years. In discussed below that are intended to will not be discouraged from enrolling implementing thresholds for clarify that limits will only be in MA plans with cost-sharing in excess discriminatory cost-sharing for established for those Parts A and B of thresholds set by CMS and that our individual services, we plan to establish services specified by CMS. We note that proposal to set specific amounts in two sets of Parts A and B service cost- section 3202 of the Patient Protection advance improves the transparency of, sharing thresholds, one applicable to and Affordable Care Act (PPACA) (Pub. and comparability between, plan plans choosing the higher, mandatory L. 111–148) ‘‘Benefit Protection and choices for beneficiaries. MOOP, and the other applicable to Simplification’’ will apply to MA plans We are therefore finalizing our those choosing the lower, voluntary offered in 2011. Section 3202 of PPACA proposal to allow us to annually set cost MOOP. We plan to articulate the cost- specifies that, unless a specified sharing thresholds for Medicare Parts A sharing thresholds associated with the exception applies, the cost sharing and B services. lower, voluntary MOOP through charged by MA plans for chemotherapy In establishing service category cost- subregulatory guidance such the annual administration services, renal dialysis sharing thresholds, we will be cognizant Call Letter or similar guidance services, and skilled nursing care may of the balance we must strike between document. not exceed the cost sharing for those affording beneficiaries reasonable In establishing cost-sharing services under Parts A and B. Where protection from high out-of-pocket thresholds, we will consider an MA these new limits apply, they will expenses that could discourage organization’s need to use cost-sharing constitute an absolute limit on cost- enrollment and our desire that the MA as a tool for preventing overutilization sharing for the service in question by program remain viable for health plans of services. While we have not been operation of statute, and we will not set and beneficiaries. We will carefully provided evidence that this requirement limits under this final rule. After the assess the impacts of the cost-sharing would increase plans’ administrative publication of this rule, we will issue thresholds we establish, annually costs, we also note that MA clarifying guidance concerning section adjusting the limits and the particular organizations will be able to account for 3202 and other provisions of PPACA Parts A and B services that are subject any increased administrative costs in that impact this regulation. to such limits as necessary based on the their annual bids. Finally, with respect Comment: A number of commenters previous year’s experience and other to the comment about reviewing prior supported our proposed requirement to factors as needed, to ensure that this authorization, we believe that specify that cost sharing for Medicare A balance is maintained. As we have in establishing cost-sharing thresholds is a and B services may not exceed levels previous years, we plan initially to more efficient and effective method for annually determined by us to be establish cost-sharing thresholds for eliminating discriminatory MA plan discriminatory. One of these those Parts A and B services that we designs. commenters supported us in continuing have, through a number of years of Comment: One commenter questioned our current approach to applying a experience with plan benefit reviews, our authority to impose individual discrimination test. identified as particularly likely to have service category thresholds, and urged A number of commenters opposed our a discriminatory impact on sicker us to withdraw our proposal. proposed requirement to establish beneficiaries. Specifically, under our Response: We disagree with this individual Parts A and B service current cost sharing review process commenter. As discussed in the category cost-sharing thresholds, which has developed from our past preamble to the October 22, 2009 suggesting that individual service experience in reviewing benefit proposed rule, our proposal relies upon category thresholds would result in packages we focus our review on 14 the authority in section 1852(b)(1) to higher premiums. Other commenters service categories we have identified a ensure that an MA plan would not believed that cost-sharing limits would particularly likely to have substantially discourage enrollment by present significant additional discriminatory impact on ‘‘sicker’’ certain MA eligible individuals and our administrative costs for plans. A beneficiaries: inpatient catastrophic (90) authority under section 1857(e)(1) of the

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Act, under which we may add beneficiaries, employers could request a stability in the thresholds and the ‘‘necessary and appropriate’’ contract waiver of these limits under the particular services to which those terms; and, with respect to MA plan cost employer waiver authority. thresholds are applied is important, we sharing, the authority in section Comment: Some commenters also believe it is necessary to allow 1856(b)(1) of the Act, under which we recommended that we establish cost ourselves the flexibility to build on may establish MA standards by sharing thresholds for Parts A and B ‘‘lessons learned’’ each year, and to regulation. services as soon as possible prior to the reevaluate both the thresholds and the Comment: Some commenters sought bid submission deadline (for example, Parts A and B service categories to clarification on how we will address in the Call Letter or Advance Notice of which they apply, to account for any cost sharing thresholds with regard to Methodological Changes) and provide statutory changes in Original Medicare dual-eligible special needs plans (SNPs). stakeholders with an opportunity to cost-sharing limits as well as other These commenters specifically asked provide comments regarding the changes to the MA program, and refine whether we would exempt dual-eligible thresholds and the methodology used to our approach accordingly to maintain SNPs from our proposed establishment arrive at those thresholds. Some such a balance. of mandatory Parts A and B service commenters representing non-plan Comment: Some commenters believed thresholds, since States pay dual- stakeholders also requested that we that we were not clear in the proposed eligibles’ cost sharing. These provide this information via means rule regarding whether we would set commenters argued that our proposed other than the HPMS, since only plans cost sharing thresholds for all Parts A requirement could force dual-eligible have access to HPMS and advocates and and B service categories, or only for and chronic care SNPs to charge a other non-plan entities would like to selected categories identified as premium, thus making their plans receive the information we share with potentially discriminatory. These unattractive to dual-eligibles and other plans via HPMS. Another commenter commenters requested further low-income enrollees. recommended that we permit MA clarification on our intended approach. Response: We disagree with organizations to resubmit a bid and Response: As we have done in the commenters recommending that dual or benefit package if the initial bid is context of benefits review in previous chronic care SNPs should be exempted rejected due to a finding by CMS of years, we intend to focus on service from our service category cost-sharing discriminatory cost sharing. categories particularly likely to have a thresholds. As long as a plan has at least Response: As stated in the preamble discriminatory impact on sicker some enrollees subject to all of a plan’s to the proposed rule, we intend to beneficiaries. Initially, we will focus on cost-sharing amount, those enrollees furnish information to MA organizations the service categories we have targeted could still be discouraged from and Part D sponsors on our historically in our benefit review. We enrolling or continuing their enrollment methodology and the cost sharing expect to refine our approach over time in the plan given particularly high cost- thresholds for the following contract in order to achieve the right balance sharing for specific services. Even those year on a timely basis either through the between plan choice and protection SNPs that exclusively serve dual- annual Call Letter or similar guidance from high out-of-pocket costs. We eligible enrollees entitled to have their document. We will consider ways of intend to build on our experience, and cost sharing paid by the Medicaid disseminating this information through potentially make modifications to the program can include some individuals other means to ensure that all list of Parts A and B service categories who lose their Medicaid status midyear stakeholders have an opportunity to to which we would apply cost-sharing and become subject to plan cost sharing comment and note that we generally thresholds. which would no longer be paid by the post draft Call Letters to the CMS Web Comment: A couple of commenters Medicaid program. Plans should not site to ensure broad public availability. recommended that, in setting cost- establish excessive cost-sharing With regard to opportunities to resubmit sharing limits, CMS consider enrollees’ regardless of whether the State is bids and benefit packages, given that we cost-sharing both before and after responsible for beneficiaries’ cost- expect to provide guidance regarding members reach any deductible that may sharing. We are therefore not exempting cost-sharing thresholds prior to bid apply. SNPs from the mandatory MOOP and submission, we do not anticipate the Response: We will consider whether cost sharing limits that apply to other need to allow plans to resubmit bids or to take plan deductibles into account as MA plans. benefit packages if their submissions are part of our methodology to establish Comment: One commenter asked us inconsistent with published guidance. cost-sharing thresholds. to consider exempting employer plans As part of our review of submitted bids Comment: One commenter requested from our cost-sharing threshold and benefit packages, we may contact clarification on how we will establish requirements, arguing that such a plans to give them the option of cost sharing thresholds based on the requirement would complicate their modifying their bids and benefit previous year’s experience. One efforts to offer their current and retired packages if we have made a commenter urged that the thresholds employees parallel coverage. determination that the proposed plan not be adjusted based on current year Response: We disagree with this benefit package or cost sharing contains data. commenter. The nature of employer discriminatory amounts not outlined in Response: As described in the arrangements varies greatly. In some published guidance. preamble to our proposed rule, we cases, an employer may offer more than Comment: One commenter intend to review the prior year’s bid one MA plan option, and one or more recommends that cost-sharing limits, data, as well as actuarial equivalency of those plans may still discourage and the service categories to which they relative to Original Medicare, to identify enrollment by certain beneficiaries apply, remain stable from year-to-year. cost sharing outliers and establish a through their benefit design. Also, in the Response: We intend to implement reasonable threshold. With this case of an employer plan, if a cost-sharing thresholds carefully to information, and other factors we may compelling reason exists for an ensure the right balance of ensuring identify as we gain experience in exemption from the limits in this final against discriminatory effects of high establishing these thresholds, we will rule, and if we determine an exemption cost-sharing and continued viability of annually set cost-sharing thresholds as would be in the best interests of the MA program. While we believe described in this preamble. We do not

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anticipate that these levels will need to sharing tiers for benefit designs that plan type (basic versus enhanced), be changed after bids have been deviate from the standard benefit tiering structure (for example, the submitted. However, as previously package. One commenter indicated that number and type of tiers), and any noted, we will conduct a review of this would bring a level of differences among MA–PDs (including submitted bids and we reserve the right standardization to plans and make it cost plans) and between MA–PDs and to address discriminatory cost sharing easier for them to compare out-of-pocket PDPs. When outliers are identified, we or benefit design we identify in these expenses. conduct negotiation calls with the post bid reviews by asking the plan to Response: We appreciate the relevant plan sponsors to ensure the either modify or withdraw its bid to comments. cost sharing outliers are reduced prior to resolve discriminatory cost sharing. Comment: Several commenters bid approval. We also require cost Comment: One commenter wanted to limit Part D cost sharing to a sharing levels for preferred tiers to be recommended that service category total maximum out-of-pocket amount. lower than cost sharing levels for thresholds be set at fixed dollar Response: We do not believe that a nonpreferred tiers. amounts. regulatory overall liability limit for Part Comment: A commenter expressed Response: We understand that D would be practical or appropriate concern that when coverage of a copayment amounts are more given the current design of Part D nonformulary drug is secured on appeal, transparent and predictable for benefits (such as, the coverage gap). We the cost sharing under the nonpreferred beneficiaries than coinsurance, and will also note that, under the Part D benefit, tier can approximate, or even exceed, attempt to establish thresholds as there is protection afforded to a the negotiated price of the drug. copayment amounts rather than beneficiary once they enter into the Response: The price charged to the coinsurance percentages where catastrophic phase of the benefit where beneficiary cannot exceed the appropriate. Given the fact that original there is nominal cost sharing. negotiated price. The requirements Medicare employs coinsurance Comment: One commenter wanted us related to qualified prescription drug percentages in its cost-sharing, there to establish clear and definitive limits coverage at § 423.104(g)(1) make clear may be cases, in which we may limit the on cost sharing. Another commenter that Part D sponsors are required to coinsurance percentage that can be wanted us to consider the overall charge beneficiaries the lesser of a imposed. affordability of cost sharing that is drug’s negotiated price or applicable Comment: One commenter imposed on non-low-income (LIS) copayment amount. recommended that we not set a cost Medicare beneficiaries. The commenter Comment: Several commenters sharing maximum for routine services, argues that this is particularly important opposed setting cost sharing maximums, such as physician visits and lab when considering a plan design in claiming that this will result in higher services, where there is limited financial which preferred formulary tiers do not premiums for beneficiaries. One liability, or for durable medical include equally safe and effective drugs commenter asserted that CMS’ proposal equipment (DME), where they argue that for the beneficiary’s medical condition. will limit the ability of Part D sponsors any particular cost-sharing maximum Another commenter wanted us to take to design plans that provide choices for would invariably penalize one subset of into account separate rules for cost additional or richer benefits in other enrollees. One commenter contracts with HMOs under section areas important to beneficiaries. For recommended that we establish 1876. Additionally, another commenter example, they argue that establishing thresholds on a per day, per stay, and wanted clarification on how we will maximum Part D brand cost-sharing per benefit period basis for SNF and review plans with more than or fewer levels will impact the ability to offer $0 inpatient services. Another commenter than a three tier benefit design. This copayment for generic drugs; therefore, recommended that any threshold for commenter suggested that all tiers may ultimately inhibiting the greater Part B drugs apply to all Part B covered not exceed levels determined by CMS to affordability and access. A commenter drugs. be discriminatory. contended that our proposal fails to Response: We disagree that physician Response: We appreciate these consider a plan design that is associated visits and lab services should comments. It is important to note that with a robust formulary. The commenter necessarily be exempt from cost-sharing we review both formularies and benefit believes that such a plan should have maximums, though we currently do not designs to ensure that a sponsor’s the flexibility to impose higher member contemplate imposing limits in such prescription drug offering under Part D cost sharing, particularly for cases, and would only do so to the is not discriminatory. We have designed nonpreferred drugs, compared to a extent that we saw cost-sharing imposed our yearly formulary reviews to ensure formulary that meets minimum that had a discriminatory effect. As that all Part D plan formularies include requirements and, coupled with low stated previously, we initially will focus a wide representation of drugs used to premium which may be attractive to on those service categories we have treat the Medicare population. As part those with minimal drug utilization historically identified as particularly of this review, we focus on identifying who seek protection from potential likely to have a discriminatory impact formularies with drug categories that future changes in health status. on sicker beneficiaries and will refine may substantially discourage enrollment Response: In determining a maximum our approach as needed and in line with of certain beneficiaries, for example if cost sharing amount for a tier above our ultimate goal of eliminating the formulary places drugs in which we will view the plan’s benefit discriminatory benefit designs. We nonpreferred tiers without including design as discriminatory, we attempt to welcome the feedback provided by other commonly used therapeutically similar strike a balance between appropriate commenters with regard to DME, SNF drugs in more preferred positions. As coverage under the benefit and the and Part B drug copayments and will part of our yearly review of submitted potential affect on the premium. As part consider these recommendations as we benefit designs, we compare like plans of our benefit design review, and finalize our methodology and to each other for the purpose of ensuring consistent with previous reviews, we thresholds. non-discriminatory cost-sharing. consider all beneficiaries under the Comment: Several commenters Specifically, we perform an analysis of plan, and not just those beneficiaries supported the proposal to review Part D cost sharing at the tier level, to look for expected to have limited utilization. plan bids to determine acceptable cost- outliers. The outlier analysis considers Therefore, any actuarially-equivalent

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cost sharing arrangement is reviewed, this proposal. We also note that we have Response: This comment is outside along with the rest of a plan’s benefit only allowed a higher coinsurance the scope of the proposed rule, which design, to ensure that it does not percentage greater than 25 percent for does not revise our level playing field discriminate against certain Part D specialty tiers under alternative policy between mail and retail drug eligible individuals. This sometimes prescription drug coverage designs with offerings. We refer the commenter to results in a sponsor not being able to decreased or no deductibles. Thus, section 50.2 of Chapter 5 of the support higher member cost sharing overall, consistent with statutory and Medicare Prescription Drug Benefit amount under a robust formulary design regulatory requirements, a basic Manual at http://www.cms.hhs.gov/ for nonpreferred drugs or being able to alternative design must be actuarially PrescriptionDrugCovContra/Downloads/ support zero dollar generics. However, equivalent to the defined standard Chapter5.pdf for our current policy in these cases are usually the exception benefit design. this area. since our review is designed to ensure Comment: One commenter wanted us 7. Prohibition on Prior Notification by the maximum utility of the benefit to study the effects of high out-of-pocket PPO, PFFS and MSA Plans Under Part design for potential enrollees. costs, improve drug pricing disclosure, C (§ 422.2, § 422.4, and § 422.105) Comment: One commenter wanted prohibit plans from changing the price CMS to prohibit the use of both of drugs, notify beneficiaries when a In our October 22, 2009 proposed copayment and coinsurance tiers under drug price is going to increase, ensure rule, we stated that we have become nonstandard Part D benefit designs. that Part D plan sponsors inform increasingly concerned about the use of Response: We disagree with the beneficiaries how to get medications prior notification by PPO and PFFS commenter and believe such a free or at lower prices, and end plans as a condition for lower cost prohibition would unnecessarily limit discriminatory practice cost sharing. sharing. Program experience has demonstrated that such prior plan design. Moreover, we believe that Response: We appreciate the notification provisions are confusing to such a proposal is beyond the scope of commenter’s concerns over price beneficiaries, misleading in terms of this proposed rule, which addresses the fluctuations that may result in changes authority of CMS to establish limits on cost-sharing transparency, and in some in cost sharing under a Part D plan cost sharing for purposes of determining instances, are used inappropriately as a benefit design that includes coinsurance whether or not such cost sharing is form of prior authorization. In the GAO and the effects that these changes may discriminatory. Our proposal did not report titled ‘‘Medicare Advantage: have on beneficiaries enrolled in these address whether nonstandard benefit Characteristics, Financial Risks, and plans. However, several of these designs utilizing coinsurance are Disenrollment Rates of Beneficiaries in comments are outside of the scope of discriminatory. Private Fee-for-Service Plans (GAO–09– Comment: One commenter wanted us the proposed rule, which addresses our 25),’’ the GAO stated that some PFFS to require that at least one drug within ability to establish threshold levels for plans it reviewed ‘‘inappropriately used each therapeutic class be on each tier. cost sharing above which we would the term prior authorization rather than Response: We believe that such a determine such cost sharing to be pre-notification in the informational proposal is beyond the scope of this discriminatory. Moreover, we note that materials they distributed to proposed rule, which only addresses the under section 1860D–11(i) of the Act, beneficiaries, which may have caused authority of CMS to establish limits on commonly known as the ‘‘Non- confusion about beneficiaries’ financial cost sharing for purposes of determining interference provision,’’ we are risks.’’ We have determined that the whether or not such cost sharing is prohibited from interfering in the complexity of cost-sharing designs using discriminatory. We also note that due to negotiations among drug manufacturers, prior notification has made it more the varying number of drugs that may be pharmacies, and sponsors of difficult for both enrollees and available in a therapeutic class, this prescription drug plans (PDPs), and providers to understand the enrollee’s proposal may require many exceptions from requiring a particular formulary or cost sharing obligation in advance of and be impractical to implement. price structure for the reimbursement of receiving services. Therefore, in order to Comment: Several commenters a covered Part D drug. Therefore, we do reduce the complexity of MA plans’ cost expressed concern about our specialty not have the authority to prohibit plans sharing designs and improve tier policy. A few commenters want us from changing the price of drugs. transparency for both enrollees and to eliminate the exemption from tiering Comment: Several commenters providers, we proposed to prohibit PPO exceptions for specialty tiers. Another wanted information on discriminatory plans (for out-of-network services) and commenter asserted that drugs in the cost sharing made available through Call PFFS plans from providing for lower specialty tier are so expensive, an Letter and other public means, and want cost sharing where prior notification argument could be made that specialty such information to be made available rules have been satisfied. Specifically, tier coinsurance above 25 percent is timely so that it can be taken into we proposed to revise § 422.4(a)(1)(v) excessive. Another commenter argues account prior to bidding. and (a)(3) to provide that PPO and PFFS that the use of specialty tiers is a Response: We appreciate the plans will be prohibited from discriminatory practice that targets commenters’ concern that we be as establishing prior notification rules individuals who have medical transparent and timely as possible with under which an enrollee is charged conditions that necessitate use of our guidance in this area. We will strive lower cost sharing when either the expensive medications. to make this information available as enrollee or the provider notifies the plan Response: We appreciate the early as possible for sponsors to begin before a service is furnished. We are commenters’ concern in this area, which constructing their bids for the 2011 adopting § 422.4(a)(1)(v) and (a)(3) is one we will continue to study. Any contract year. without further modification in this revisions to the specialty tier policy will Comment: One commenter stated that final rule. be done in future rulemaking. We note if a plan sponsor offers a plan design In our October 22, 2009 proposed specifically that the commenters’ with zero co-payment amounts for rule, we also proposed to prohibit MSA request for us to eliminate the certain mail order prescription drugs, it plans from establishing prior exemption from tiering exceptions for should be required to offer the same cost notification rules. We believe that prior specialty tiers is outside of the scope of sharing at retail pharmacies. notification rules established by MSA

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plans are also confusing to enrollees of that charge exorbitant cost-sharing (up the enrollee’s cost sharing obligation in those plans and have similar negative to 75 percent) for expensive items such advance of receiving services. effects as those described above for PPO as durable medical equipment when We acknowledge the concerns raised and PFFS plans. Accordingly, we prior notification requirements have not by commenters who opposed our proposed to modify § 422.4(a)(2) such been met. A number of commenters proposals. However, we believe that that MSA plans will also be prohibited opposed our proposals to prohibit PPO most of these concerns can be addressed from establishing prior notification rules plans (for out-of-network services), MSA if the plan takes an active role to under which an enrollee is charged plans, and PFFS plans from establishing educate enrollees and providers about lower cost sharing when either the prior notification rules and prohibit their right to request a written advance enrollee or the provider notifies the plan PPO plans from offering a POS-like coverage determination from the plan, before a service is furnished. We are benefit. Other commenters stated that in accordance with Subpart M of Part also adopting § 422.4(a)(2) without these practices permit plans to alert the 422, before an enrollee receives a further modification in this final rule. enrollee in advance of receiving a service in order to confirm that the Finally, the October 22, 2009 service is medically necessary and will service that it may not be covered; proposed rule discussed similar be covered by the plan. These MA plans reduce enrollees’ cost sharing concerns about beneficiary confusion in should clearly explain the process for obligations when obtaining covered connection with PPO plans that requesting a written advance included a POS-like benefit. As we services from out-of-network providers; determination in member materials and noted in the October 22, 2009 proposed enable plans to better monitor and respond to requests from enrollees and rule and the Medicare Program entitled oversee members’ use of out-of-network providers on a timely basis. Plans may Establishment of the Medicare providers, thus allowing plans to assess also encourage enrollees and providers Advantage Program, published in the and expand their provider networks; to request advance coverage January 28, 2005 Federal Register (70 and identify those plan members who determinations prior to receiving costly FR 4617 through 4619), we had stated may qualify for plan disease services. These MA plans can also use that PPOs could offer a POS-like benefit management and case management requests for advance coverage under which beneficiary cost sharing programs. One commenter indicated determinations as a tool to identify would be less than it would otherwise that MA plan premiums likely would enrollees who may qualify for disease be for non-network provider services, increase if this cost control technique management and case management but still might be greater than it would were eliminated. Commenters opposed programs or who require further care be for in-network provider services, to CMS’ proposals provided several coordination. Plans can use the claims provided an enrollee follows recommendations for addressing our data submitted by non-network preauthorization, pre-certification, or concerns about prior notification rules providers to expand their provider prenotification rules before receiving and POS-like benefits. Commenters’ networks as well as identify those out-of-network services. For the same recommendations included retaining enrollees who would benefit from reasons discussed above, we determined existing policies; enforcing the existing disease management and case that this approach is confusing, and is requirement (for example, requiring management. We do not believe that subject to abuse as a prior authorization greater clarity in enrollee materials) to prohibiting prior notification rules and mechanism for non-network services. address concerns raised in the proposed POS-like benefits will lead to higher MA Therefore, in order to reduce the rule; requiring PPO plans with POS-like plan premiums. We believe that complexity of PPO plans’ cost sharing benefit to better describe the cost- prohibiting PPO plans (for out-of- designs and improve transparency for sharing amounts under each set of network services), MSA plans, and both enrollees and providers, we circumstances that may arise; requiring PFFS plans from creating prior proposed in our October 22, 2009 plans to more clearly describe the notification rules and PPO plans from proposed rule to prohibit PPO plans distinction between prior authorization offering a POS-like benefit will reduce from offering such a POS-like benefit. and prior notification, and expressly the complexity of these plans’ cost- Specifically, we proposed to revise the identify those covered services subject sharing designs and improve definition of POS in § 422.2 and to each process; and encouraging transparency for both enrollees and § 422.105(b), (c), and (f) to indicate that providers’ outreach to plans to confirm providers. Accordingly, we are adopting only HMOs may offer a POS benefit. prior authorization/notification the proposals as set forth in the October The proposed change is consistent with provisions and members’ cost sharing 2009 proposed rule. section 1851(a)(2)(A)(i) of the Act, obligations. We are making a technical correction which states that an HMO may include to the definition of point-of-service a POS option. We are adopting Response: We agree with the (POS) in § 422.2 in this final rule. We § 422.105 without further modification commenters supporting our proposals to are deleting the word ‘‘additional’’ from in this final rule and revising § 422.2 as prohibit PPO plans (for out-of-network the definition since it no longer applies described below. services), MSA plans, and PFFS plans to the definition of a POS benefit option. Comment: Several commenters from establishing prior notification rules supported our proposals to prohibit PPO and prohibit PPO plans from offering a 8. Requirements for LIS Eligibility plans (for out-of-network services), MSA POS-like benefit. As we stated in the Under Part D (§ 423.773) plans, and PFFS plans from establishing October 2009 proposed rule, we believe In the October 22, 2009 rule, we prior notification rules and prohibit that prior notification is confusing to proposed amending the length of the PPO plans from offering a POS-like beneficiaries, misleading in terms of period for which individuals are re- benefit. Some of the commenters disclosure of cost-sharing, and in some deemed eligible for the full low income indicated that these practices are instances, used inappropriately as a subsidy to conform § 423.773(c)(2), with confusing and misleading and penalize form of prior authorization. Also, the guidance we issued in section 40.2.2 of members who are not able to give prior complexity of cost sharing designs using Chapter 13 of the Medicare Prescription notification or who were unaware of the prior notification and POS-like benefits Drug Benefit Manual. As we noted in option. Some commenters also has made it more difficult for both the October 2009 proposed rule, we indicated that they found several plans enrollees and providers to understand review data from State Medicaid

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Agencies and the Social Security experience increases that are enough to believe we have the authority to make Administration (SSA) every year to affect their eligibility. The commenter the additional improvements the determine whether individuals also noted that making eligibility commenter suggested, as appropriate, currently deemed eligible for the permanent would eliminate the need for without further modifying the subsidy should continue to be deemed redeterminations of eligibility, thus regulation. (that is, ‘‘re-deemed’’) eligible for the reducing administrative costs for the 9. Enrollment of Full Subsidy Eligible subsidy. These data, which are sent in program and inconvenience and stress Individuals and Other Subsidy Eligible July and August every year, allow us for beneficiaries. Individuals Under Part D (§ 423.34) sufficient time to update individuals’ Response: We understand the records in our systems, if necessary, and potential benefits to the LIS population We proposed to codify in regulation to make appropriate notifications if an of extending or making permanent their the enrollment procedures that we use individual is losing deemed status for eligibility for the subsidy, and reducing for LIS individuals, which are similar to the subsequent calendar year. the inconvenience and stress to those specified in the regulation for the We also noted that when we review beneficiaries is an ongoing goal of our dual-eligible population. We believe data in July and August, we also administrative processes. Currently, that our regulations would be more identify individuals who are newly approximately 95 percent of LIS-eligible accurate and complete if they eligible for Medicaid, a Medicare beneficiaries are re-deemed for the specifically addressed this population. Savings Program, or SSI, and deem them following year prior to the end of the Therefore, we proposed to include eligible for LIS for the remainder of the current calendar year, and half of those information on how we enroll all LIS- current calendar year. In addition, we who are not initially re-deemed (that is, eligible individuals, including full also re-deem these individuals for the another 2.5 percent) are re-deemed benefit dual-eligible individuals, subsidy for the next calendar year, within next 6 months. In addition to through the following changes: because we do not have sufficient time this, the number of beneficiaries who • In § 423.34(a), we expanded the in the final months of the year to actually receive the annual Loss of general rule to refer to all LIS-eligible conduct a separate re-deeming process Subsidy Letter, also known as the gray individuals, so that the rest of that for them. Moreover, if we waited to re- notice, has been decreasing over the last section applies not only to full benefit deem these beneficiaries after the start 4 years. This suggests that CMS and dual-eligible individuals, but also to all of the next calendar year, they could State efforts to improve the LIS-eligible individuals. • incur greatly increased premium administrative process are working, and In § 423.34(b), we retained the liability and cost sharing amounts at the that individuals who continue to qualify definition of full benefit dual-eligible start of the new calendar year than they for the low income subsidy are being individual, and added a definition for would have otherwise. identified appropriately, while the small ‘‘low-income subsidy eligible To address these issues, we proposed proportion of individuals who may no individual.’’ We have identified the to amend § 423.773(c)(2) to indicate that longer qualify for the subsidy also are need for a technical correction to the the deeming will be, at a minimum, for being identified. We believe that the definition of ‘‘low-income subsidy the following periods: If deemed status approach being adopted here strikes a eligible individual.’’ The proposed is determined between January 1st and balance between making the re-deeming definition could be read to specify that June 30th of a calendar year, the process as efficient as possible while the definition of full-benefit dual individual is deemed subsidy eligible still ensuring that beneficiaries eligible—who are identified as a specific for the remainder of the calendar year. receiving the subsidy are truly LIS- group of LIS eligibles—is that in If deemed status is determined between eligible. For these reasons, we are not § 423.722, which is limited to such July 1st and December 31st of a calendar adopting the suggested modifications. individuals already enrolled in a Part D year, the individual is deemed subsidy Comment: A few commenters plan. However, the enrollment rules in eligible for the remainder of the recommended that we require States to § 423.34(b) applies to full-benefit dual calendar year and the next calendar continue providing Medicaid coverage eligibles not yet enrolled in a Part D year. We have found that this policy to a dual-eligible until the individual’s plan. We made a technical correction to promotes effective administration of the Part D enrollment actually takes effect. the regulation text to specify that the LIS benefit and decreases the Response: Section 1935(d) of the Act definition of full dual eligible administrative burden on CMS, the specifically precludes Federal medical individual is that in § 423.34. Social Security Agency, and State assistance for Medicaid payments for • We amended the paragraph heading Medicaid agencies, as well as on prescription drugs for those Medicaid- of § 423.34(c) to indicate that this subsidy eligible individuals. In this final eligible individuals who are also eligible paragraph describes the process we use rule, we adopt this provision as for Part D, regardless of whether the to reassign LIS-eligible individuals proposed. person is enrolled in a Part D plan. during the annual coordinated election Comment: Several commenters Therefore, no modification to the period. We indicate that the expressed support for our intent to put regulations will be made. reassignment process applies to certain in regulation the minimum time periods Comment: One commenter requested LIS eligible individuals (that is, not just for which beneficiaries are deemed additional regulatory changes to require full-benefit dual-eligible-individuals). eligible for the LIS. improvements to the way we administer • We revised the paragraph heading Response: We appreciate this support the LIS benefit, including improving the of § 423.34(d) from ‘‘Automatic for our intent to outline the minimum Web site, notices to encourage Enrollment Rules’’ to ‘‘Enrollment time periods of LIS eligibility. appropriate actions, and putting in Rules.’’ We made this change to reflect Comment: One commenter urged us place better ‘‘Best Available Evidence’’ the inclusion of full subsidy and other to consider making LIS deemed status policies and procedures to ensure that subsidy eligible groups in the permanent, or granting a 3-year period LIS status discrepancies are corrected. enrollment process, in addition to full of presumptive eligibility. The Response: As noted previously, we benefit dual-eligible individuals. In our commenter noted that while income and continually consider ways to improve guidance, we refer to the process of assets may fluctuate, most low-income the administration of the LIS benefit and enrolling full benefit dual-eligible Medicare beneficiaries are unlikely to beneficiaries’ understanding of it. We individuals as ‘‘automatic enrollment,’’

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and the process for other LIS eligibles as actually enrolled into a plan and receive enrollment. As part of this, the ‘‘facilitated enrollment.’’ (See section that assistance. This timeframe may commenter suggested revising of the 30.1.4 of Chapter 3 of the Medicare have made sense initially, since it was facilitated assignment letter to include Prescription Drug Benefit Manual.) not clear that nondually eligible LIS that portion of premium for which the • We amended § 423.34(e) to indicate recipients would have an ongoing SEP. beneficiary is liable. that the rules regarding declining Now that they have been extended that Response: When we notify plans of enrollment and disenrollment also protection, there is less of a need to wait new facilitated enrollees, we do identify apply to all LIS-eligible individuals. for their selection. Instead, the those beneficiaries who are partial • In § 423.34(f), we clarified that the enrollment should happen quickly to versus full subsidy beneficiaries, both paragraph heading and contents of this ensure access to prescription drugs. on the Transaction Reply Report paragraph are limited to the effective Response: Facilitated enrollment confirming enrollments, as well as on date of enrollment for full benefit dual- constitutes a passive enrollment process the LIS History report. In addition, the eligible individuals. We also amended that requires advance notice of the individuals’ subsidy level is fully § 423.34 (f)(3) to specify that, for opportunity to make an active election explained in the LIS approval letter individuals who are eligible for Part D before the enrollment is effective. We from the Social Security and subsequently become eligible for have been unable to find a way to Administration. However, we appreciate Medicaid on or after January 1, 2006, ensure that individuals who are the suggestion for modifying the the effective date of enrollment would facilitated at the end of the month can facilitated enrollment letter to reference be the first day of the month the receive the required advance notice and a partial subsidy beneficiary’s premium individual becomes eligible for both have an opportunity to make an election liability, and will explore whether this Medicaid and Medicare Part D. on their own before that enrollment is feasible. We believe the latter does • In § 423.34(g), we added a new takes effect (though it is possible to do not necessitate a regulation change since paragraph to specify that the effective so for those at the beginning of the notification details are generally an date for LIS eligibles who are not full month). It is important to keep in mind operational issue, so we will not modify benefit dual-eligibles would be no later that this population consists of the regulation to reference this. than the first day of the second month individuals who have applied for LIS, Comment: A few commenters after we determine that the individual are notified of their approved LIS requested that we require that plans meets the criteria for enrollment into a eligibility, and informed via their LIS notify dual-eligibles in advance of PDP under this section. This change approval notice that they need to elect potential involuntary disenrollments. conforms to section 30.1.4 of Chapter 3 a plan in order to avail themselves of They noted that we conduct a special of the Medicare Prescription Drug the subsidy. Thus, we believe they are auto-enrollment early each month— Benefit Manual. Unlike full benefit likely to follow through on their • To identify full benefit dual- dual-eligible individuals who may have previous actions and choose a plan on eligibles who are disenrolled from their retroactive Part D coverage, these their own, leading to possible confusion previous plan; individuals have only prospective Part if they receive a facilitated enrollment • Who have not chosen a new one; D coverage. notice after they have already made an and In the proposed rule, we also active election. Finally, we note that all • Where there continues to be a risk acknowledged concern expressed by individuals whose facilitated of a coverage gap if the plan submits the some commenters about auto-enrolling enrollment into a PDP has not yet taken disenrollment request to CMS after the beneficiaries on a random basis. For effect may obtain coverage for special auto-enrollment occurs. example, focus groups of seniors suggest immediate drug needs through the Response: Section 423.36(b) of the the possibility that some auto-enrolled Limited Income NET demonstration. regulation and section 40.2 of Chapter 3 beneficiaries may not realize they have We are committed to continue of the Medicare Prescription Drug been enrolled in a drug plan or that they exploring ways of shortening the Manual already require plans to provide have been reassigned to a different drug facilitated enrollment process without advance notice of potential plan. We noted that we are committed infringing on an individual’s ability to disenrollment, so there is no need for a to taking appropriate steps to improve make a choice, or adding to the regulation change to that effect. The this process and welcomed comments possibility of beneficiary confusion. special process we run each month to related to all aspects of these However, it is important to note that capture recently disenrolled individuals procedures. In this final rule, we adopt proposed regulation text that we are already represents a significant advance these provisions as proposed. now finalizing specifies that the in our auto-enrollment procedures. Comment: Several commenters enrollment effective date is ‘‘no later However, we will continue to look at expressed support for expansion of than’’ the first day of the second month’’ ways to modify auto-enrollment to more auto-enrollment and reassignment to all after we determine that they meet the quickly place auto-enrolled individuals with LIS. necessary enrollment criteria. Therefore, beneficiaries in a new plan. Note that Response: We appreciate the support although we are declining to amend the under any circumstances, full benefit for this policy and are adopting the regulation as requested while we dual-eligibles who are disenrolled will proposal without change. continue to address a number of not encounter any coverage gap— Comment: Commenters urged us to operational issues that remain instead their subsequent enrollment will shorten the time period for a plan unresolved, the regulation language be made retroactive to the date of the enrollment so that it would take effect does provide the flexibility to shorten loss of coverage from the preceding as of the date the person becomes the timeframe if warranted and feasible. plan. subsidy eligible. The current time Comment: One commenter noted that Comment: One commenter suggested period can leave an individual who has plans and beneficiaries would benefit adding in § 423.34(f)(3) the phrase applied and qualified for the subsidy from us specifying for both plans and ‘‘unless the individual is not a full with a gap of over 2 months between the beneficiaries any premium liability in benefit dual-eligible as identified in time they express an interest in getting instances when the beneficiary has a 25, § 423.34(g)’’ to the end of the sentence help with drug costs (via the application 50, or 75 percent premium subsidy, in that comprises this subsection. The for the LIS) and the time they are the process of conducting facilitated commenter believes this addition would

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clarify that § 423.34(f)(3) does not apply specific reassignment, we decline to LIS enrollees they may lose to to non-full benefit dual-eligibles who amend the regulation to require it, given reassignment. The commenter suggested have LIS. that § 423.34(c) currently provides CMS such communication be permitted Response: Section 423.34(f), including the discretion to implement such earlier than is currently permitted in the subparagraph (f)(3), is already limited to changes if our ongoing exploration of reassignment process, to ensure affected full benefit dual-eligibles by virtue of such an approach indicates that beneficiaries understand their options. the introductory regulation text before revisions to the current reassignment Response: Plan sponsors are already subparagraph (f)(1). Given this, we see methodology are warranted. permitted to communicate with current no need to further specify that Comment: A few commenters enrollees, subject to Part D marketing § 423.34(f)(3) does not apply to non-full suggested that instead of reassigning LIS guidelines; the reassignment regulations benefit dual-eligibles, so we decline to beneficiaries from plans whose under discussion here do not contain amend the regulation as suggested by premiums are going above the LIS additional constraints on these rules, the commenter. benchmark, we should permit them to and we make every effort to involve Comment: Several commenters stay in the plan and be held harmless. sponsors in the reassignment suggested that we expand the PDPs to They recommended a number of ways communications process as early as which it assigns or reassigns LIS to do so, including giving affected possible. Thus, we believe there is no beneficiaries to include enhanced beneficiaries a grace period of one year need for changes to the regulation to benefit plans. One commenter further to remain in the plan, with no address this issue. clarified that reassignments should additional premium payment; letting Comment: One commenter include enhanced plans whose portion the plan ‘‘absorb’’ any premium recommended that we include LIS of the basic premium falls below the LIS difference between the benchmark and recipients with partial premium subsidy benchmark, as this would be no more the bid amount (up to $2.00 per one as opposed to only full premium costly to the government and would commenter); or waiving the requirement subsidy recipients in the annual give LIS beneficiaries the same options that plans attempt to collect delinquent reassignment process. The commenter as available to other beneficiaries to premiums. noted that while it is true that recipients enroll in enhanced benefit plans. Response: While we have discretion with partial premium subsidy will pay Response: While enhanced benefit to determine which beneficiaries are some premium no matter which plan plans may offer supplemental benefits, subject to reassignment, we believe that they select, the amount they pay is they always create a premium liability section 1860D–13(a)(1)(F) of the Act, lower if they are enrolled in a plan with for the beneficiary, including those who which requires uniform premiums, the premium at or below the are eligible for the 100 percent premium precludes us from adopting these benchmark. subsidy. This is because, by statute, the recommendations (absent a Response: We acknowledge that a LIS does not cover the portion of the demonstration such as the 2006–2008 partial subsidy beneficiary’s premium premium attributable to the enhanced ‘‘de minimis’’ demonstration, where would be somewhat lower in a zero- benefit, even if the total premium is premiums of ‘‘de minimis’’ amounts premium plan versus a plan with a under benchmark, meaning that the were waived). We note that we have premium over the benchmark, but in beneficiary is liable for the enhanced already implemented a demonstration either case, these beneficiaries would portion of the premium. The statute for the 2010 plan year that increased the still have to pay some portion of the clearly limits initial auto enrollments to LIS benchmark, which had the effect of premium. As always, our policies with plans where an individual has zero substantially decreasing the number of respect to reassignment are intended to premium liability, and we have adopted beneficiaries who needed to be strike a fair balance between our dual the same policy approach for purposes reassigned. goals of limiting beneficiary exposure to of reassignments. Therefore, we decline Comment: One commenter suggested premium costs and also avoiding any to modify the regulation as requested. that CMS should allow the plan (rather potential negative impact on an We note that LIS beneficiaries are than CMS) to move the LIS members in individual’s prescription drug coverage always free to elect an enhanced benefit to a zero-dollar premium plan offered by (such as changes to a pharmacy network plan if they wish to access the enhanced the same sponsoring organization. or drug regimen). Since reassignment benefits, but they would incur some Response: As outlined in section cannot eliminate the premium liability premium liability. 30.1.5 of the PDP Eligibility, for such individuals under any Comment: Several commenters urged Enrollment, and Disenrollment circumstances, in this situation, we us to move away from random Guidance, when we reassign a believe that potential for disruption to reassignment of LIS eligible individuals beneficiary, we first attempt to reassign the prescription drug coverage to a system of beneficiary-specific to a PDP offered by the same outweighs the potential financial risks reassignment in which beneficiaries are organization. Only when that is not associated with paying a higher matched with plans that include their possible do we reassign to plans outside premium. Therefore, we do not believe current drugs and preferred pharmacy. of the organization. Our experience has that there is sufficient benefit to They believe this would result in less been that CMS-initiated actions are reassigning these beneficiaries, and we disruption to beneficiaries, and much easier to implement on a timely decline to adopt the commenter’s increased adherence to currently- basis, and to monitor for accuracy and suggested change to our existing prescribed drug regimens, while completion, than are actions that approach. potentially providing the LIS benefit at depend on sponsors to identify and Comment: A few commenters asked the lowest total cost to beneficiaries. submit enrollment transactions for the us to reconsider our decision not to Response: We continue to explore affected population. Therefore, we include beneficiaries who elect their alternatives to random reassignment believe there is little or no benefit to current plan (‘‘choosers’’) in the that would minimize the potential for delegating this responsibility to PDP reassignment process. Our disruptions to continuity of care, and Sponsors, and we decline to make the reconsideration of this issue should appreciate the commenters’ support for requested change. begin with an evaluation of how a beneficiary-specific process. While we Comment: One commenter urged us choosers have been affected by the believe there is merit to beneficiary- to let plans communicate sooner with current process. In particular, the

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Agency should identify the number of more frequently, and provide technical Response: We appreciate the support choosers who— assistance on how to do so. for the Limited Income NET program, • Affirmatively switch plans every Comment: One commenter urged us and will continue to work on improving fall; to ensure that dual beneficiaries receive other areas of the program referenced by • Affirmatively switch plans during clearer information about all the options the commenter. the year; and available to them, including information • Are involuntarily disenrolled due to 10. Special Enrollment Periods Under about Medicare Special Needs Plans Part D (§ 423.380) nonpayment of premium. that can provide their Part D benefits. Response: We share the commenter’s The commenter was especially In the October 22, 2009 rule, we interest in this issue, and recently concerned about the new Limited proposed to expand the SEP described solicited input on whether we should Income NET demonstration, which will in § 423.38(c)(4), which currently reassign choosers who will face a automatically enroll LIS-eligible applies to full benefit dual-eligible premium liability of $10.00 or more in individuals who fail to elect a plan and individuals, to all LIS-eligible the following year (please see page 84 of are in immediate need of drugs in one individuals. This proposed change is the Advance Notice of Methodological Part D plan. This could create obstacles consistent with our authority in section Changes for Calendar Year 2011 for to seamless conversion from a 1860D–1(b)(3)(C) of the Act and will Medicare Advantage (MA) Capitation Medicaid-only managed care plan to a conform our regulations to current Rates, Part C and Part D Payment Medicare Special Needs Plan offered by practice as reflected in CMS guidance in Policies and 2011 Call Letter, issued the same organization. The commenter section 20.3.8, item 7, of chapter 3 of the February 19, 2010). We will continue to encouraged us to establish more Medicare Prescription Drug Benefit assess choosers’ experience in Part D effective procedures to find and Manual. In this final rule, we adopt the plans above the benchmark, including transition new duals into their Medicare provision as proposed. the extent to which they subsequently benefits, especially those who are Comment: Several commenters elect another plan and the extent to becoming Medicare-eligible because expressed support for putting the which they experience problems with they are reaching the end of their 24- continuous Special Enrollment Period premium payments. As noted month disability waiting period. (SEP) for non-full benefit dual-eligible previously, the regulations do provide Response: We appreciate the beneficiaries that is currently in the flexibility to change the existing operational guidance into regulation. process should our reconsideration of commenter’s concern about ensuring dual-eligible beneficiaries receive Response: We appreciate the our approach show it to be warranted. comments that support placing the SEP Comment: Two commenters information about all their options, and the need for ensuring a smooth for non-full benefit dual-eligibles into recommended that we send a notice to the regulation. LIS choosers who have chosen to join or transition for these beneficiaries remain in plans in which they would between Medicaid and Medicare drug 11. Transition Process Under Part D incur a premium liability. The coverage. We have taken several steps to (§ 423.120(b)(3)) commenters suggested notifying them of do so, and believe the Limited Income In the October 22, 2009 proposed rule, their zero-premium options (including NET demonstration is an important step under the authority of section 1860D– an analysis of drug utilization to in further improving that transition. 11(d)(2)(B) of the Act, we proposed to determine most appropriate plan). The With respect to the concerns about the codify in regulation certain plan beneficiary would be permitted to Limited Income NET demonstration, we transition policies at § 423.120(b)(3) respond to the mailing in an efficient note that the Limited Income NET previously established through manner (for example, via postcard, process only involves auto enrollment subregulatory guidance. We specifically telephone call, or online) to indicate his to a single Part D plan for a short, proposed to codify in regulation that a or her choice. retroactive period. For all prospective Part D sponsor must provide for a Response: We continue to assess the periods, the long-standing process of transition for the following— experience of LIS choosers who face random enrollment among all PDPs • New enrollees into PDPs following premium liability, and as noted above, with a premium at or below the LIS the annual coordinated election period; have solicited input on whether we benchmark would continue to apply. • Newly eligible Medicare enrollees should reassign choosers who have a Further, we do not believe the Limited from other coverage; premium liability of $10.00 or greater Income NET demonstration specifically, • Individuals who switch from one for the following year. We remain or auto enrollment generally, creates plan to another after the start of the committed to reaching out to choosers obstacles to seamless conversion. In contract year; and whom we do not reassign to let them both cases, our processes are designed • Current enrollees remaining in the know about their options for zero to ensure that new dual-eligibles have plan who are affected by formulary premium prescription drug plans. access to Medicare drug coverage on the changes from one contract year to the Comment: A few commenters urged first day of their eligibility for it. next. us to require State Medicaid Agencies to However, both those processes are also We also proposed, consistent with our increase the frequency of state designed to ensure that any beneficiary current guidance, that a Part D sponsor’s submission of MMA data exchange files, election will trump a CMS-generated transition process be applicable to which is the primary vehicle for auto enrollment. nonformulary drugs, meaning both— notifying CMS of new dual-eligible Comment: One commenter expressed (1) Part D drugs that are not on a beneficiaries. This would further support for the Limited Income NET sponsor’s formulary; and minimize enrollment delays for new demonstration program, but raised other (2) Part D drugs that are on a dual-eligibles. concerns that the commenter believes sponsor’s formulary but require prior Response: We believe this comment is the demonstration will not address: authorization or step therapy under a outside the scope of this regulation, so enrollment delays, LIS recipients in plan’s utilization management rules. we decline to amend the regulation in non-benchmark plans, and the need for Additionally, consistent with our this manner. However, we continue to accurate, LIS-specific information in current guidance, we proposed to codify encourage states to submit these files plan mailings. the timeframes for the transition process

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and the days’ supply limit for a because the prescribed medication is different drug and request a formulary transition fill of an enrollee’s not on the plan sponsor’s formulary. All exception. medication. Specifically, we proposed of these proposals were addressed by Response: We disagree with these to codify the transition process adding paragraphs (i) to (v) to our commenters that the proposed timeframe to apply during the first 90 general transition policy requirement at timeframe be changed to 3 calendar days of coverage under a new plan. § 423.120(b)(3). We are adopting days, which includes weekends and In addition, noting that our existing paragraphs (i), (ii), and (v) as proposed holidays when standard businesses are guidance directs Part D sponsors to without further modification. As closed. We do not believe that a provide a temporary supply we explained below, we are modifying calendar day timeframe will allow proposed that Part D plan sponsors be proposed paragraph (iii) by clarifying sponsors an acceptable period in which required to ensure that the one-time the existing language to state that the to mail out a transition notice. Rather, temporary supply of nonformulary Part temporary supply of nonformulary Part we believe that the 3 business day D drugs requested during the first 90 D drugs (including Part D drugs that are turnaround time for notice to be sent is days of coverage in an outpatient setting on a sponsor’s formulary but require consistent with current transition policy be for at least 30 days of medication, prior authorization or step therapy and it permits a beneficiary sufficient unless the prescription is written by a under a sponsor’s utilization time to work with his/her prescriber to prescriber for less than 30 days, in management rules) must be for up to 93 change to a therapeutically equivalent which case the Part D sponsor must days in 31 day supply increments, with drug on a plan’s formulary or begin the allow multiple fills to provide up to a refills provided, if needed, unless a exceptions process. total of 30 days of medication. For a lesser amount is actually prescribed by Comment: Several commenters new enrollee in a LTC facility, the the physician, and paragraph (iv) by supported the proposed requirement temporary supply may be for up to 31 clarifying that transition notices must be that sponsors notify the prescriber when days (unless the prescription is written sent to beneficiaries within 3 business a transition fill has been made. One for less than 31 days), consistent with days after adjudication of a temporary commenter stated that the proposal is a the dispensing practices in the LTC fill. positive that allows consistency across industry. In addition, due to the often Comment: A number of commenters the MA population and it provides complex needs of LTC residents that supported our proposal of requiring an protection of certain vulnerable often involve multiple drugs and extended transition supply be given to populations. Many commenters necessitate longer periods in order to enrollees residing in a LTC facilities. requested that we develop a successfully transition to new drug However, commenters requested that standardized transition format for regimens. For these reasons, we CMS provide the same protections to notices and explanations to be provided proposed to require sponsors to honor individuals requiring LTC in to plans. Another commenter requested multiple fills of nonformulary Part D community-based settings as provided our review notices that sponsors drugs, as necessary during the entire to those in institutions. provide to ensure that beneficiaries are length of the 90-day transition period. Response: While we appreciate that not unknowingly being steered to mail Further, we proposed requiring up to a there are community-based enrollees order pharmacies. 31-day transition supply for enrollees in who have nursing facility level of care Response: We appreciate the an LTC facility given that many LTC and may experience access to multiple comments. We note that we have pharmacies and facilities dispense pharmacies, we are not persuaded that developed a model transition notice for medication in 31-day increments. Thus, we should extend the LTC extended plans to send beneficiaries and are a Part D sponsor would be required to transition requirement to such considering for the future whether or provide a LTC resident enrolled in its individuals. We believe that residents of not to make that model standardized. In Part D plan at least a 31 day supply of LTC institutions are more limited in addition, we have prepared model a prescription when presenting in the access to prescribing physicians hired notices for sponsors to ensure that first 90 days of enrollment (unless the by LTC facilities due to a limited beneficiaries are not unknowingly being prescription is written for less) with visitation schedule and more likely to transferred to mail order pharmacies. refills provided, if needed, up to a 93 require extended transition timeframes Model transition notices may be found day supply. in order for the physician to work with at Part D Marketing Model Materials. In addition to proposing to codify the the facility and LTC pharmacies on Comment: Many commenters opposed preceding requirements, we also transitioning residents to formulary the requirement to send the transition clarified our expectations of sponsors products. We believe that community- notice within 3 business days of the with respect to providing transition based enrollees, in contrast, are less temporary fill being dispensed. These notices. Consistent with our guidance limited in their access to prescribing commenters requested changing the that specifies that Part D sponsors send physicians and do not require an proposal to notice being sent within 3 a written notice, via U.S. First Class extended transition period to work with business days after a temporary fill is mail, to each enrollee who receives a their physicians to successfully processed. The commenters argue that transition fill, we proposed to codify the transition to a formulary product. this is consistent with the current guidance that directs sponsors to send Comment: Several commenters language in Section 30.4.10 of Chapter this notice to each affected enrollee disagreed with the proposed timeframe 7 of the Prescription Drug Benefit within 3 business days of the temporary in which to send out the transition Manual, where the phrase ‘‘within 3 fill. In addition to this codification, we notice of 3 business-days and business days of the temporary fill’’ has also proposed requiring plan sponsors recommended 3 calendar days. The been understood by the industry to refer to make reasonable efforts to notify commenters argue that a requirement of to the date the temporary fill is prescribers, via mail, electronic or 3 calendar days is clearer and easier to processed, since it is only when the verbal communication, that the affected enforce, particularly during holiday claim is processed that a plan learns enrollees’ prescription cannot be periods, when holidays delaying U.S. about it and can act on it. refilled, either because of utilization mail combined with the normal delays Response: We agree and note that management requirements such as prior in mail delivery can severely cut into industry practice standards have authorization or step therapy, or the time a beneficiary needs to try a interpreted the language to mean within

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3 business days of a temporary fill being Response: We continue to work with the full amount of a temporary fill or processed. Therefore, we are revising the industry to work on automated from uneven interpretation among plan the language of § 423.120(b)(3)(iv) to methods whereby beneficiaries are sponsors. read ‘‘within 3 business days of notified at point of sale that a drug Comment: Many commenters adjudication of a temporary fill.’’ dispensed is non-formulary. Until such suggested that we articulate in Comment: Some commenters time as these notifications are regulation the extension of transition expressed concerns with our proposal automated, plan sponsors must send fills through the completion of any that Part D plan sponsors make written notice of transition fills through requested exception, even if that process reasonable efforts to notify the the U.S. mail. takes longer than 30 days. Moreover, prescriber of the transition fill, with Comment: One commenter requested commenters suggested that we also some commenters recommending that CMS to define ‘‘other coverage’’ related require a transition fill whenever a we make the prescriber notice to the requirement to provide a member encounters formulary requirement optional so that plans may transition period for ‘‘newly eligible difficulties obtaining current exercise discretion to determine Medicare enrollees from other coverage’’ prescriptions. A few commenters urged whether it is warranted. Another questioning whether this means that us to codify in regulation the commenter stated that for the newly eligible Medicare enrollees who requirement that Part D plans cover an notification to be successful their master do not have ‘‘other coverage’’ should not emergency supply of nonformulary DEA file would need constant updating qualify for a transition period. The drugs outside of the initial 90-day and that the requirement does not take commenter requests that we clarify that transition period. One commenter into account emergency room or urgent ‘‘newly eligible Medicare enrollee’’ suggested that the regulations should be care physicians covered by a blanket would not include anyone who had strengthened to provide that without DEA number from the hospital. Another been eligible for Medicare as a result of evidence of timely written notice to the commenter suggested we should a disabling condition and moves to affected enrollee, the enrollee should be dialogue with the industry to review being eligible for Medicare as a result of entitled to continue to receive the operational challenges to the prescriber reaching the specified age (such as, 65). relevant medication(s). Other Response: We agree and clarify that notification. Yet another commenter commenters requested we codify ‘‘newly eligible Medicare enrollee’’ suggested that we not implement the current guidance encouraging Part D would include anyone who had been requirement unless we provides plan sponsors to incorporate processes in eligible for Medicare as a result of a sponsors with access to databases with their transition plans that allow for disabling condition and moves to being complete and accurate physician transition supplies to be provided to eligible for Medicare as a result of contact information cross-referenced current enrollees with level of care reaching the specified age (such as, 65), changes. with physician identifiers. including enrollees who do not have Response: We note that current policy Response: We disagree with the ‘‘other coverage’’ but who may be paying directs Part D sponsors to provide for a commenters’ request to make the out of pocket for drugs they are transition extension on a case-by-case prescriber notice optional and leave it to currently taking. basis when enrollees have not been the plan’s discretion whether such Comment: One commenter supported successfully transitioned to the notification is warranted. The prescriber the transition proposal but requests that sponsor’s formulary requirements. We notification is a means of further CMS further revise § 423.120(b)(3) to do not believe that it is appropriate to strengthening beneficiary protections standardize the amount of the codify this ‘‘case-by-case’’ directive into when dealing with formulary changes or temporary supplies that PDP sponsors the existing rule. Our guidance already utilization management protocols for are required to provide in the LTC addresses that sponsors need to review necessary medications because the setting. Some PDP sponsors have an enrollee’s request for an extension prescriber is in the best position to interpreted this element of CMS’ and the circumstances requiring such a advise the beneficiary on the benefits or transition policy that temporary request on an individual basis. risks of switching to a different supplies ‘‘may be for up to’’ 31 days to We also disagree with the comments medication. Prescriber notification is an enable them to authorize fills of less that the regulation should be additional step to ensure a beneficiary is than 31 days, even when physicians strengthened to provide that without receiving optimal medication therapy have prescribed a 31-day fill. The evidence of timely written notice, the outcomes with little to no delay in their commenter recommends that we revise enrollee should be entitled to continue drug regimen. As a result of this its proposed regulation to require PDP to receive the relevant medication(s). provision, sponsors and network sponsors to provide transition supplies We believe that this situation would be pharmacies will need to ensure that of at least 31 days unless a lesser more appropriately be handled through they update their databases on a more amount is actually prescribed by the the complaint process given the level of consistent basis. We intend to provide physician. scrunity that would be required to verify additional guidance on what constitutes Response: We agree and are clarifying whether evidence exists that notice was ‘‘reasonable notification efforts’’ in the the existing language to state that the provided to the enrollee by the plan future, but we do not envision providing temporary supply of nonformulary Part sponsor. plans with a comprehensive database of D drugs (including Part D drugs that are We also disagree with the comment physician contact information as this is on a sponsor’s formulary but require requesting that we codify into regulation not information that we keep track of, prior authorization or step therapy at this time our current guidance and therefore it is not feasible for plans under a sponsor’s utilization encouraging transition supplies to be to rely on us to completely and management rules) must be for up to 90 provided to current enrollees with level accurately maintain such a database. days in 31-day supply increments of care changes. As we have not Comment: Several commenters stated unless a lesser amount is actually encountered large number of that notification via U.S. mail occurs prescribed by the physician. We believe complaints, we will continue to after the fact and suggests an alternative this clarification is necessary to protect examine this issue. If we decide to of beneficiary notification at the site of beneficiaries residing in LTC facilities mandate transition in this area, we will service. from unnecessary delays in obtaining do so through future rulemaking.

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Finally, we will consider codifying We also noted in the October 22, 2009 pharmacy claim reversal and rebilling our emergency supply policy for LTC proposed rule that, since our current approaches can adequately address. enrollees in future rulemaking. regulations do not address retroactive In addition, we acknowledged issues Comment: Some commenters urged us adjustments and the complexities regarding proprietary pricing to adopt the GAO recommendation to associated with coordination of benefit information and the chilling effect that make the ANOC sent prior to each open activities that cannot be accomplished disclosure of this information might season more individualized and thus between the Part D sponsor and the have upon the ability of pharmacies to more valuable to plan enrollees. pharmacy through reversal and negotiate with payors. To ensure the Response: We appreciate commenters rebilling, we have issued general confidentiality of pricing information, recommending a more individualized guidance to direct sponsor coordination coordination of benefits on the initial ANOC being sent out prior to each open of benefit activities. As part of our claim is accomplished without reporting season. We believe that this is outside implementation guidance on the complete information on negotiated the scope of this proposal, which is to automated process for the transfer of pricing. The amount then reported in strengthen beneficiary protections TrOOP-related data, we established a the (Nx) transaction to the Part D plan during the transition process. 45-day maximum time limit for the is the amount of the beneficiary sponsor to take adjustment action, make payment after the supplemental 12. Part D Sponsor Responsibility for a refund, and initiate recovery. We payment. As a result, a Part D sponsor Retroactive Claims Adjustment established this time limit after an attempting to determine refund or Reimbursements and Recoveries Under informal survey and discussions with recovery amounts without having the Part D (§ 423.464, § 423.466, and Part D sponsors and their processors. pharmacy reverse and rebill the original § 423.800) We noted in the October 22, 2009 claim can generally only impute the proposed rule (74 FR 54663) that many In the October 22, 2009 proposed rule, amount of any supplemental payment of the post-adjudication adjustments, under the authority of sections 1860D– made by another payer by determining such as those that are due to enrollment 23 and 1860D–24 of the Act, we the difference between the Part D cost- changes, are changes that affect proposed that sponsors make retroactive sharing and the beneficiary amount paid beneficiary cost sharing, premiums and claim adjustments and take other payer after the supplemental payment. The plan benefit phase. Establishing a contributions into account as part of the only alternative is to ask the pharmacy reasonable time limit for all Part D coordination of benefits. In making to reverse and rebill the claim to all adjustment, refund, and recovery payers. However, such a procedure these proposed changes, we noted that activity is in the beneficiaries’ best some beneficiary changes (such as LIS would be generally impractical after the interests because it ensures that industry standard 30-day window status changes or midyear Part D required changes are effectuated on a enrollment changes), LTC pharmacy because many supplemental payers will timely basis, thus correcting retroactive not accept the late claim. billing practices for dual-eligible and prospective beneficiary premium In the absence of legal authority to beneficiaries, and the presence of and cost-sharing amounts. Moreover, it compel supplemental payer cooperation secondary, tertiary, and even quartenary is in the best interest of others who have and to avoid pharmacy underpayment, payers have contributed to a higher than paid a claim on the beneficiary’s behalf imposing a requirement on sponsors to expected volume of retroactive claims because it ensures that these amounts nonetheless calculate a precise adjustments requiring Part D sponsor are resolved timely. reimbursements and recoveries, as well For these reasons, we proposed at reimbursement or recovery liability as a greater than anticipated complexity § 423.464 and § 423.466 to codify our would require the creation of a new of calculating these amounts. While we previous policy guidance by proposing payer-to-payer transaction that would previously anticipated that beneficiaries that sponsors must make retroactive both enable reprocessing and address would be owed reimbursements due to claim adjustments and take other payer pharmacies’ concerns about revealing changes in LIS status, and that plan contributions into account as part of the their proprietary pricing. However, as sponsors would be required to make coordination of benefits. Further, we we noted in the proposed rule (74 FR such reimbursements under proposed adding a new timeliness 54663), it is not clear that both goals can § 423.800(c), we did not believe our standard at § 423.466 to require be achieved. Nor is it clear that even if current regulations addressed the other adjustment and issuance of refunds or this conflict could be resolved, that the entities that may sometimes need to be recovery notices within 45 days of the cost of doing so would be justified by taken into account in reimbursement or sponsor’s receipt of the information the benefits. recovery transactions. Moreover, we necessitating the adjustment. Therefore, while simple adjustments noted that no industry standard As part of making these proposed involving just the Part D sponsor and electronic process exists to explicitly changes, we noted that, to date, most the pharmacy are relatively handle underpayment recoveries or Part D coordination of benefits activity straightforward (and can and should be overpayment reimbursements created by has been performed at point-of-sale or promptly transacted), those involving these adjustments, and that the current soon after, so pharmacy reversal and other payers are not. We solicited Health Insurance Portability and rebilling of claims can be accomplished comments on alternative approaches to Accountability Act (HIPAA) standard within the payers’ timely filing improving post-adjudication for coordination of benefits for windows. For Part D, this window must coordination of benefits necessitated by pharmacy claims only partly supports be a minimum of 90 days, but for other retroactive Medicare enrollment and these activities when the pharmacy (non-Part D) providers of prescription low-income subsidy changes when initiates ‘‘reverse and rebill’’ drug coverage the filing window could multiple payers are involved, as well as transactions. As a result, Part D be as short as 30 days. However, we our assessment that the costs of sponsors sometimes struggle with how acknowledged that with the volatility of achieving precision in such transactions to manage these retroactive adjustments LIS data and Part D enrollments creating may outweigh the benefits. and those sponsors that are refunding a significant volume of retroactive Our specific proposals to modify overpayments or seeking underpayment adjustments, Part D sponsors are facing § 423.464 included the following recovery are each doing it differently. more claims adjustments than current changes:

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• Revising paragraph (a) to clarify alternative approaches are identified, would permit a Part D sponsor to refund that all Part D sponsors must comply we will not require the development of the beneficiary directly without with administrative processes and payer-to-payer coordination of benefit accounting for other payers if the net requirements established by CMS to transactions for retroactive claims claims adjustment is $10 or less and ensure effective coordination between adjustments. Instead, we will work with there is no N transaction reporting Part D plans and other providers of the industry to develop work-around another payer amount paid on the prescription drug coverage for solutions, such as imputing amounts to claim. retroactive claims adjustments, be reimbursed based on best available Response: We disagree with this underpayment reimbursements and information, and will take the suggestion. Although individual claims overpayment recoveries; and commenters’ recommended approaches adjustments may not exceed the • Adding a new paragraph (g)(7) to into consideration during that effort. suggested threshold, cumulative address the sponsors’ responsibility to In the interim, the existing amounts due to other payers (such as account for payments by SPAPs and coordination of benefit requirements SPAPs) could be substantial. other providers of prescription drug require sponsors to coordinate not only Additionally, the other payers would be coverage in reconciling retroactive with beneficiaries, but also with SPAPs, unaware that a claim had been claims adjustments that create other plans or programs providing retroactively adjusted and that a refund overpayments and underpayments, as prescription drug coverage and was issued to the beneficiary. As a well as to account for payments made, beneficiaries and other individuals or result, the other payers would not know and for amounts being held for entities that have made payment on the to seek recovery from the beneficiary. payment, by other individuals or beneficiaries’ behalf. These Therefore, we continue to believe that entities. The new paragraph would also requirements include coordination of sponsors must comply with the specify that Part D sponsors must have benefits at point-of-sale, as well as coordination of benefits requirements systems to track and report adjustment retroactive claims adjustments without regard to the monetary amount transactions and to demonstrate that— necessitated by not only beneficiary of the adjustment. (1) Adjustments involving payments changes, such as retroactive LIS Comment: One commenter asked that by other plans and programs providing eligibility determinations, LIS status we clarify in § 423.464 that pharmacies prescription drug coverage have been changes or mid-year Part D enrollment holding copayments are exempt from made, changes, but also other payer changes, the coordination of benefits (2) Reimbursements for excess cost- beneficiary submission of paper claims, requirements since they do not meet the sharing and premiums for LIS eligible etc. In addition, as discussed elsewhere definition of a plan or program individuals have been processed in in this rule, sponsors must have systems providing prescription drug coverage. accordance with the requirements in to track and report adjustment The commenter noted that this § 423.800(c), and transactions and to process adjustments clarification will ensure that pharmacies (3) Recoveries of erroneous payments and issue refunds or recovery notices recognize they are not a provider of for enrollees have been sought as within 45 days of the sponsor’s receipt prescription drug coverage, and are only specified in § 423.464(f)(4). of information necessitating a entitled to reimbursement if the member Except as otherwise provided below, retroactive claims adjustment. should receive reimbursement and the after considering the comments received As specified in subregulatory pharmacy has attested that it is holding in response to the proposed rule, this guidance in the Medicare Prescription the member’s cost-sharing amounts due final rule adopts the proposed changes Drug Benefit Manual chapters on and has not billed the member. Several to the retroactive claims adjustment Coordination of Benefits and Premium other commenters requested that reimbursement and recovery provisions and Cost-Sharing Subsidies for Low- specific language be added to the in § 423.464 and § 423.466. Income Individuals, Part D sponsors regulations at either § 423.800(c), or Comment: Multiple commenters should also: work with other providers § 423.464(g) and § 423.466(a), to clarify agreed that the costs of achieving of prescription drug coverage to resolve that the requirements, including the 45- precision in retroactive COB payment issues; have a process in place day time period for issuing refunds or transactions outweigh the benefits of to handle payment resolution that is not initiating recoveries due to retroactive creating specialized electronic restricted by implementation of timely adjustments, apply not only when a transactions for calculating payer-to- filing requirements; make retroactive supplemental payer is involved, but also payer claims adjustments. A number of adjustments and promptly refund when a pharmacy is owed for cost- these commenters offered monies owed to the correct party sharing initially withheld by the recommendations to CMS in response to (including, but not limited to, the sponsor for LIS beneficiary claims. our request for alternative approaches to beneficiary); and generally limit Response: We agree that pharmacies improving post-adjudication requests for pharmacy reprocessing to are not providers of prescription drug coordination of benefits, including those situations where the total payment coverage and, therefore, are not covered establishing a process to notify to the pharmacy changes. Coordination under § 423.464(g). However, it was our supplemental payers when an Nx of benefits guidance also includes the intention to apply the 45-day time limit transaction was not generated and the need to transfer TrOOP and gross to all retroactive adjustment regardless Part D sponsor is making a retroactive covered drug cost balances to the new of whether a pharmacy alone, a adjustment to the primary amount paid. plan whenever a beneficiary transfers pharmacy and the beneficiary, or a Response: We appreciate the enrollment between Part D sponsors pharmacy, the beneficiary and another commenters’ concurrence with our during the coverage year. As discussed payer are involved. As a result, we are assessment that the costs to create a elsewhere in this final rule, sponsors finalizing § 423.464(g) as proposed. In specialized transaction for retroactive have a 45-day maximum time limit from response to the concerns raised by the claims adjustments outweigh the receipt of changes in the reported commenters regarding the application of benefits and their recommendations for transfer data to make an adjustment and the 45-day timeframe to pharmacies, in improving post-point-of-sale issue a refund or initiate recovery. this final rule we are also amending adjudication coordination of benefits. Comment: One commenter suggested § 423.800 to add a new paragraph (e) to Until such time as any cost effective that CMS establish an exception that make it clear that the 45-day timeframe

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applies to adjustments involving retroactive enrollment situations, to § 423.466 by adding a new paragraph (b) pharmacies and beneficiaries, including coordinate benefits with other payers as that would establish a 3-year time limit LTC pharmacies holding cost-sharing required by the regulations at on Part D coordination of benefits. Part amounts due. Generally, sponsors will § 423.464(f), as well as to accept claims D sponsors would be required to reimburse the beneficiary for from the beneficiary without imposing coordinate benefits with SPAPs, other adjustments made to retail claims, but time limits. This chapter further states entities providing prescription drug for full benefit dual-eligible individuals, that sponsors, even in those situations coverage, and other (non-network) in the absence of other information when retroactive enrollment is not an payers for a period not to exceed 3 years indicating the cost-sharing has been issue, are liable for claims received after from the date on which the prescription waived, the sponsor will reimburse the the end of the coverage year as defined for the covered Part D drug was filled. LTC pharmacy. in § 423.308 and that, while contract Adding this provision to the regulation Comment: Several commenters argued provisions regarding timely claims filing would clarify timely filing that the 45-day time period for issuing may limit claims from network responsibilities and deadlines for all reimbursement or initiating recovery pharmacies, non-network pharmacies beneficiaries and payers, as well as should be changed to 90 days because and beneficiaries must still have the place a limit on Part D sponsors’ claims of the various research and coordination opportunity to submit claims for payment liabilities and coordination of issues that may need to be resolved with reimbursement without the imposition benefits responsibilities. other stakeholders in the industry. of time limits by the Part D sponsor. As noted in our response to the Response: We disagree with these We also noted the benefits to be comments below, after considering the commenters. We believe a 45-day period derived from this proposed change. In comments received in response to this is more than sufficient to resolve any addition to limiting sponsors’ financial proposal, we continue to believe a 3- coordination of benefits issues and liability, a specified time limit would year time limit on Part D coordination refund overpayments or institute strengthen the ability of SPAPs, other of benefits is reasonable, and in this recovery of underpayments resulting providers of prescription drug coverage final rule, we are adopting the provision from the retroactive claims adjustments. and other payers, including as proposed. As we stated in the proposed rule, we beneficiaries, to obtain payment for Comment: Two commenters considered a 90-day time limit, but covered Part D drugs within that time expressed support for the establishment concluded that this longer timeframe frame. Moreover, we would benefit from of a clear timeframe for coordination of was not in the best interests of a COB time limit because it would benefits, and two others expressed beneficiaries because it would delay the enable us to conduct reopening agreement with the proposed 3-year payment of refunds and notification of efficiently and on a predictable time limit. A number of other the need for payment recovery. schedule. commenters suggested alternative time Moreover, we noted that as part of the In considering whether to establish limits of 2 years, 18 months or 1 year. automated transfer of TrOOP-related time limits on the submission of claims The rationale cited by commenters for a data, we established a 45-day maximum to Part D sponsors by beneficiaries and shorter time period was that it would time limit for sponsors to take other payers of prescription drug more closely align the COB time limit adjustment action, make a refund and coverage for proper coordination of with the regulatory deadline for initiate recovery. We further explained benefits, we noted that the Medicare submission of Part D cost data, thereby that we established this time limit after FFS time limit for filing claims, as reducing the number of payment an informal survey and discussions with specified in § 424.44, is 15 to 27 months reconciliation reopenings and curtailing Part D sponsors and their processors. depending on the date that the item or the costs associated with maintaining For these reasons, we continue to service was furnished and that under open claims databases. believe that a 45-day time limit certain circumstances these time limits Response: We disagree that we should represents a reasonable compromise. may be extended an additional 6 shorten the proposed coordination of Therefore, we are finalizing the months. We also noted that the Deficit benefits time limit. Other payers need requirement as proposed. Reduction Act of 2005 (Pub. L. 109–171) time to seek reimbursement and (DRA) amended section 1902(a)(25) of sponsors need a clear limit in order to 13. Time Limits for Coordination of the Act, to provide for a 3-year time resolve claims for which they are Benefits (§ 423.466) limit for States to seek recovery of responsible. We believe that a 3-year In the October 22, 2009 proposed rule Medicaid claims payments when the limit would permit CMS to address both (74 FR 54664), we proposed to revise State is not the primary payer. Although needs. A timeframe that aligned with § 423.466 by adding a new paragraph (b) this DRA provision does not address the regulatory deadline for submission that would establish a 3-year time limit SPAPs and, therefore, does not impose of PDE data would allow only 6 months on Part D coordination of benefits. In a time limit on the requirement for Part for submission of claims incurred late in making this proposed change, we noted D sponsors to coordinate benefits with the coverage year, a timeframe that we that currently, there is no statutory or SPAPs, it does establish the time limit believe Part D experience to-date has regulatory time limit for Part D sponsor for State Medicaid programs to recover demonstrated would not allow coordination of benefits with SPAPs, from Part D plans. sufficient time for claim identification other providers of prescription drug Having considered these filing limit and subrogation. As we noted in the coverage, or other payers. Current CMS precedents, we proposed to establish a proposed rule, the 3-year limit is also guidance as set forth in the 3-year filing limit for Part D aligned with the DRA timeframe, Coordination of Benefits (COB) chapter coordination of benefits with SPAPs, providing a uniform period for of the Medicare Prescription Drug other entities providing prescription coordination of benefits for all payers, Benefit Manual only directs Part D drug coverage, and all other payers, rather than creating different timeframes sponsors to establish at least a 90-day including beneficiaries or other based on payer type (for example, timely claims filing window and to individuals or (non-network) entities SPAPs or other entities providing make appropriate allowances for COB paying, or holding amounts for prescription drug coverage). This claims on a case-by-case basis. The COB payment, on the beneficiaries’ behalf. alignment will, in our view, ease chapter also directs sponsors, in Specifically, we proposed to revise new administration for all parties.

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Therefore, in the final rule, we adopt 14. Use of Standardized Technology We proposed to codify this guidance the requirement for Part D sponsors to Under Part D (§ 423.120) in regulation because we have been coordinate benefits with SPAPs, other Under the authority of section 1860D– made aware of an increasing number of entities providing prescription drug 4(b)(2)(A) of the Act, we proposed to instances in which network pharmacies coverage, and other (non-network) revise our regulations at § 423.120(c)(3) are not submitting pharmacy claims to payers for a period not to exceed 3 years to require Part D sponsors to Part D Sponsors on behalf of Part D from the date on which the prescription contractually mandate that their enrollees. Generally, we believe it is in for the covered Part D drug was filled. network pharmacies submit claims the best interest of Part D enrollees to By the effective date of this final rule, electronically to the Part D sponsor or have their claims consistently processed the timeframe for coordination will have its intermediary on behalf of the through the Part D sponsor (or its ended for claims for prescriptions filled beneficiary whenever feasible unless the intermediary). Not only does processing any time in 2006, as well as for enrollee expressly requests that a claims through the Part D sponsor ensure access to Part D negotiated prescriptions filled in the early months particular claim not be submitted to the of 2007. For example, a Part D sponsor prices, but it also ensures that proper Part D sponsor or its intermediary. would be responsible for coordinating As we noted in the October 22, 2009 concurrent drug utilization review benefits on a claim for a covered Part D proposed rule (74 FR 54665), the only (including safety checks) is performed. drug filled on March 3, 2008 until way that an enrollee can be assured In addition, online, real-time processing March 3, 2011. access to the negotiated price at the facilitates accurate accounting for It is important to note that this final point of sale is through online enrollees’ true out-of-pocket (TrOOP) rule establishes a time limit for Part D and total drug costs by the Part D adjudication of the prescription drug sponsor liability for coordination of sponsor so that each claim is processed claim. Any other price available to the benefits with other payers and does not in the appropriate phase of the benefit beneficiary at the point of sale cannot be affect the timeframes for Part D sponsors and accurate cost sharing assessed. to pursue Medicare secondary payer deemed to be the negotiated price We also proposed to add a new (MSP) claims and to recover amounts mandated under section 1860D–2(d) of paragraph (c)(2) to § 423.120 to codify paid by the sponsor as primary when an the Act. Therefore, to ensure access to our existing guidance that Part D MSP payer is identified. Such these negotiated prices, billing sponsors utilize standard electronic timeframes are separately identified in information on the NCPDP ‘‘Pharmacy transactions established by 45 CFR 42 CFR part 411. ID Card Standard’’, which is the 162.1102 for processing Part D claims. Comment: One commenter stated the standard for identification cards for the We noted that we would issue guidance application of the DRA’s health claim Part D program, must be used by the on the use of optional or conditional reimbursement rules and standards to pharmacies filling the beneficiaries’ fields in the HIPAA standard prescription drugs is inequitable, prescriptions to submit claims to the transactions through the Call Letter and because Part D claims processing, unlike Part D sponsor (or its intermediary). Prescription Drug Benefit Manual health claims processing, is We noted that CMS guidance set forth instructions. We noted further that we predominantly real-time. As a result, a in the Coordination of Benefits Chapter routinely work with NCPDP and 3-year submission window is not of the Prescription Drug Plan Manual (in industry representatives in arriving at necessary. section 50.4 entitled, ‘‘Processing Claims recommendations for standardized use Response: We disagree. Although no and Tracking TrOOP’’), instructs plan of such fields when necessary to interpretive guidance has been issued sponsors to process all claims online improve administration of the Part D on this provision, the plain reading of real-time. The requirements of accurate benefit. section 1902(a)(25)(J) of the Act TrOOP accumulations, Part D benefit Finally, noting that pharmacies encompasses all Medicaid claims, administration of multiple coverage cannot routinely distinguish Medicare including claims for prescription drugs. intervals, and coordination of benefits Part D claims from other types of As a result, we believe the application with other payers all necessitate online prescription drug coverage when the of this standard for Part D is real-time adjudication of individual same routing information (‘‘RxBIN and appropriate. pharmacy claims. This guidance states RxPCN’’) is used for all lines of business Comment: One commenter further that we expect that Part D plan managed by a single processor, we also recommended that CMS impose time sponsors will establish policies and proposed to add a new paragraph (c)(4) limits for the payment of COB claims procedures appropriately restricting the in § 423.120 to require that sponsors and once filed with the Part D sponsor. use of paper claims to those situations their intermediary processors establish Response: This suggestion is outside in which on-line claims processing is and exclusively utilize unique RxBIN or the scope of the proposed rule. We can not available to the beneficiary at the ‘‘RxBIN/RxPCN combinations’’ to consider whether such a time limit is point of sale in order to promote identify all Medicare Part D member warranted and address the issue as accurate TrOOP accounting, as well as claims, as well as to assign unique appropriate in future rulemaking. to minimize administrative costs to the ‘‘RxID’’ identifiers to individual Part D However, we note that once a COB Part D plans and the Medicare program beneficiaries. We solicited comments on claim has been submitted, we expect and reduce opportunities for fraudulent the operational issues and timelines that Part D sponsors will make good faith duplicative claim reimbursements. We would be involved in making these efforts to promptly coordinate benefits proposed to revise § 423.120(c)(3) to proposed technical changes to claims with the submitter of the claim, whether require Part D sponsors to contractually processing systems. an SPAP, another entity providing mandate that their network pharmacies After reviewing the comments prescription drug coverage, a submit claims electronically to the Part received in response to these proposals, beneficiary or someone acting on his or D sponsor or its intermediary on behalf we are adopting these provisions with her behalf, or another payer. Any payer of the beneficiary whenever feasible some modification. Specifically, we that does not believe a Part D sponsor unless the enrollee expressly requests revised § 423.120(c)(4) to specify that is making good faith efforts to that a particular claim not be submitted effective on January 1, 2012 sponsors coordinate claims on a timely basis to the Part D sponsor or its assign and exclusively use unique Part should report the complaint to CMS. intermediary. D identifiers. Exclusive use of these

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identifiers requires that claims will only effective January 1, 2011. We likewise 1, 2012 and not mid-plan year. One be paid if these specific numbers are agree that contract language alone may commenter stated that we should submitted in the claims transaction. not guarantee pharmacy compliance, accommodate the continued use of Comment: Many commenters but we expect other contract provisions unique identifiers already established concurred with our proposal that Part D will address the procedures the Part D by Part D sponsors, without regard to sponsors mandate that pharmacies sponsor will follow in the event a length or combination of characters. electronically submit all claims to the pharmacy fails to comply with this Other commenters were opposed to the Part D sponsor or intermediary unless requirement. requirement for Part D sponsors to the beneficiary expressly requests Comment: One commenter requested create, and exclusively use, an RxBIN or otherwise. Several commenters offered that CMS clarify that notifying an Rx BIN/PCN combination for Part D recommendations related to beneficiaries or discussing their options enrollees as well as to assign an Rx implementation of this new does not constitute ‘‘solicit[ation]’’ as identifier to a Part D enrollee, because requirement, including that CMS mentioned in the preamble, that our of the costs associated with modify standard beneficiary lower cash price policy is still in place, implementation and potential communications (such as the EOB) to and that any voluntary request to waive disruption for pharmacies and include language that helps the claim submission to the plan survives beneficiaries. One commenter stated beneficiary understand that they should the entire life of the prescription and that CMS should emphasize that the review their EOBs to confirm that all of there would be no need to expect the RxBIN and RxPCN numbers should be their claims are being submitted and, beneficiary to make a request each time assigned and differentiated at the permit either home infusion providers they refill that prescription. sponsor level, and another commenter to attest to the plan, or the plan to Response: We agree with the specifically requested clarification of validate on audit, the beneficiary’s commenter that discussing options per the reference to ‘‘individual’’ Part D claims submission election, since it is se does not constitute solicitation or beneficiaries. impractical for small home infusion steering. However, this must be a bona- Response: We appreciate the general providers to bill electronically. fide discussion of options initiated by support for this provision and agree Response: We appreciate the support the beneficiary; that is, the discussion with the suggestions related to the expressed for the proposed new should not be initiated by the pharmacy timing of implementation, particularly provision and the commenters’ with the intent to encourage the in light of industry wide programming recommendations. However, we believe beneficiary to request his or her claims for HIPPA version D.0 conversion. Thus, the clarifications associated with the not be submitted to Part D in order for the effective date for the requirement for recommendations, since these are the pharmacy to avoid transactions fees. a unique RxBIN or RxBIN/RxPCN related to implementation, are better With regard to our lower cash price combination and a unique Part D Rx addressed in subregulatory guidance. As policy, we have not altered this policy. identifier for each individual Part D we develop our implementation Finally, we intend to confirm in member will be January 1, 2012. We guidance, we expect to consider the subregulatory guidance that any believe this date will provide sufficient clarifications and to continue to seek voluntary request to waive claim time for sponsors to implement input from the industry and NCPDP. submission to the plan survives the necessary systems changes. Currently Comment: One commenter asked how entire life of the prescription and there established unique identifiers may the requirement that pharmacies would be no need to expect the continue to be used. With regard to the electronically submit all claims to Part beneficiary to make a request each time level of assignment of the unique RxBIN D unless the beneficiary expressly the prescription is refilled. or RX BIN/RxPCN combination, the requests otherwise would be enforced if Comment: One commenter appropriate level of assignment is at the members do not show their ID card. encouraged us to ensure that Part D Part D sponsor’s parent organization Response: The requirement applies to sponsors’ contracts with network rather than at the contract. pharmacies and not the beneficiary. pharmacies charge the beneficiary and The assignment and exclusive use of Therefore, we will undertake no the plan sponsor the lesser of the usual these unique Part D Rx identifiers have enforcement action against the and customary price (U&C) or a number of advantages for Part D. The beneficiary if the claim is not submitted contracted rate without regard to special primary advantage is the use of these to the Part D sponsor. However, even if programs offered by the pharmacy. identifiers enables pharmacies to the member does not show his or her ID Response: We believe that this recognize Part D beneficiaries, which is card, pharmacies will be able to identify comment is outside the scope of this possible only with the level of Part D claims based on the unique proposal, which would only require that identification supported by unique RxBIN/PCN identifiers already in the pharmacies submit all claims to Part D identifiers. Distinguishing Part D pharmacy system or in the response to sponsors, unless the beneficiary enrollees from the commercial insured an eligibility query from the TrOOP requests otherwise. When a pharmacy’s permits the pharmacy to comply with Facilitator, and will generally be U&C prices are lower than the plan’s any Part D-specific processing expected to submit claims whenever negotiated price, we agree it is in the requirements, such as the requirement such data are on file. best interests of beneficiaries and to submit claims electronically to the Comment: One commenter urged us taxpayers for the pharmacy to extend Part D sponsor or its intermediary, on to allow 6 months for plan sponsors to those U&C prices to Part D enrollees. behalf of the beneficiary unless the implement the required network However, because we do not directly beneficiary makes an explicit request to pharmacy contract change and noted regulate pharmacies, we have no do otherwise. that sponsor experience suggests that authority to require them to do so. Other advantages to the use of unique contract language alone will not ensure Comment: Several commenters agreed Part D identifiers relate to the pharmacy compliance. with our proposed requirement related coordination of benefits. Currently, the Response: We agree that this to unique payer/processor and enrollee TrOOP Facilitator and other switches provision will require time for Part D identification, with several commenters that relay electronic pharmacy claims sponsors to implement. Therefore, we suggesting that implementation be no are unable to accurately determine will implement the requirement sooner than January 1, 2011 or January whether an initial claim was paid by

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Part D. As a result, the TrOOP rather than a visitor/traveler benefit, 16. Prohibition of Midyear Mass facilitation process receives and given the national pharmacy networks Enrollment Changes by SPAPS Under processes coordination of benefits that are generally involved in providing Part D (§ 423.464(e) claims transactions even when the enrollees with their prescription drugs. Consistent with the authority of initial claims were not paid by Part D. Thus, we continue to believe, as did sections 1860D–23(a)(1) and (b) of the This results in added processing costs most commenters, that this population Act, we proposed to add a requirement for us and added workload for Part D is better served by extending plans’ to § 423.464(e) to prohibit midyear mass sponsors receiving N transactions that flexibility to deliver services on an out- enrollment changes by SPAPs. In cannot be matched to an initial claim of-area basis, rather than by requiring making this proposed change we noted because no Part D payment was made. the establishment and approval of that most SPAPs perform mass Unique Part D Rx identifiers permit Part formal visitor/traveler policies enrollments on a calendar year basis for D claims to be processed independently whenever an enrollee is out of the all its members who have not chosen a and easily segregated for reporting and service area for more than 6 months. Part D plan. However, some SPAPs have other purposes. chosen to perform these enrollments on Comment: One commenter noted that Comment: One commenter wanted us a noncalendar year basis. In these the proposed requirements may have to to further codify that PDP enrollees be modified to conform to the new temporarily absent from the plan service situations, Part D sponsors have found privacy provisions included in the area and residing in a LTC facility be that substantial disenrollment of large Health Information Technology for disenrolled after an absence of 6 numbers of SPAP members from one Economic and Clinical Health (HITECH) months. plan, followed by mass enrollment into another during the calendar year Act that allow an individual to request Response: We disagree with the that a covered entity restrict the significantly affects their financial commenter that an individual residing operations. We also stated our belief disclosure of his or her protected health in a LTC facility while temporarily information. that mass re-enrollment into a new plan absent from the plan service area should midyear disrupts any continuity of care Response: Our proposal would be considered to have a permanent require Part D sponsors to require their the beneficiary has established with his residence outside the plan service area network pharmacies to submit claims other current Part D plan, and and disenrolled on an involuntary basis electronically to the Part D sponsor or introduces transition risks such as drugs due to his or her out-of-area status. its intermediary on behalf of the not being covered by the member’s new beneficiary ‘‘whenever feasible.’’ Federal Current subregulatory guidance (§ 50.2.1 plan, or requiring the member to change regulations implementing the privacy of Chapter 2 of the Medicare Managed his or her pharmacy that are not provisions of the HITECH Act have not Care Manual and § 40.2.1 of Chapter 3 outweighed by any administrative yet been published. Upon publication of of the Medicare Prescription Drug convenience to the SPAP. In this final those regulations, we will review the Benefit Manual) instructs PDP sponsors rule, we adopt these provisions as provisions to determine if modifications to determine whether an enrollee’s out- proposed. of this requirement are necessary. of-area status is temporary or Comment: A few commenters were permanent, such that involuntary concerned that SPAPs may need to 15. Absence from Service Area for More disenrollment would occur prior to the change Part D enrollment midyear for Than 12 Months Under Part D (§ 423.44) expiration of the 6-month period only if their SPAP enrollees because the SPAP We proposed to amend § 423.44 to it is confirmed that the enrollee has determines that its members are not allow a temporary absence from the PDP permanently relocated outside the plan being adequately served by the Part D plan service area for up to 12 months service area. Under our proposed plan (for example, the plan does not before disenrollment would be revision, PDP sponsors would effectuate adequately cover the drugs needed by mandatory, consistent with the time an involuntary disenrollment upon the individual SPAP member), or the frame provided under the MA visitor/ confirmation of an enrollee’s permanent Part D plan fails in its obligation to traveler policy, the nature of the Part D residence outside the plan service area coordinate benefits with the SPAP. One benefit and the strong likelihood that a or expiration of a 12-month period, commenter in particular suggested we PDP enrollee can access the full range whichever occurs first. We believe this change the regulation text to indicate of PDP benefits while temporarily out of addresses the concern raised by the that SPAPs not ‘‘routinely’’ engage in the service area. In this final rule, we commenter with respect to ensuring a midyear plan or non-calendar year plan adopt this provision as proposed. beneficiary’s continued access to the enrollment changes, but allow Comment: Most commenters Medicare prescription drug benefit nonroutine mass re-enrollment when an supported our proposal. One commenter while residing in an out-of-area long SPAP has determined that such opposed the proposed change and term care facility. Accordingly, we are enrollment changes would better serve preferred that we either make no change adopting without change the revision as the needs of its members and has or revise the PDP rules to permit the set forth in the proposed rule. provided CMS with the appropriate offering of a visitor/traveler benefit, prior notification. Comment: One commenter requested similar to the policy applicable to MA Response: We disagree with the that we not extend the period of organizations. commenters that SPAPs should be Response: Although the permissibility permissible temporary out-of-area allowed to mass re-enroll its members of visitor/traveler benefits under the residence for individuals enrolled in during the calendar year, even when it Part D program is not strictly within the MA–PD plans. is nonroutine. There are currently two scope of this proposed rule, we Response: Since our proposed actions the SPAP can take when it finds recognize that these types of policies revision applies only to stand-alone PDP that its members are not being serve an important function in the MA plans, we believe that this clarification adequately served by a Part D plan. program. However, for the Part D is not necessary. The current 6-month First, if an individual SPAP member is program we believe that delivery of the rule for MA plans under not being adequately served by the Part drug benefit is much more easily § 422.74(d)(4)(B)(ii) will remain in D plan (for example, the SPAP accomplished through out-of-area access effect. member’s drugs are not covered or

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pharmacy access is impeded under the and (b)(2)(ii) of the Part D regulations to Comment: Many commenters agreed plan), the SPAP may, using its change the beneficiary notice that the publication of a nonrenewal authorized representative status, re- requirement from at least 60 days back notice in newspapers is no longer an enroll that individual into another Part to at least 90 days. effective means of communication, and D plan. This one-time special We also proposed removing the support removing this requirement for enrollment period for individual SPAP requirement for nonrenewing plans (in nonrenewing plans. members is allowed and further voluntary nonrenewal situations) and Response: CMS appreciates these discussed in our current enrollment for us (in CMS-initiated nonrenewal comments. guidance (Chapter 3 of the Medicare situations) to provide notice of the Comment: Several commenters Prescription Drug Benefit Program nonrenewal to the general public by stressed the importance of CMS issuing Manual). If an SPAP finds that the Part publishing a notice in one or more its model nonrenewal notice in time for D plan is not serving its members newspapers of general circulation. This plans to meet the 90 day requirement. because the Part D sponsor is in change was motivated by the cost of Response: CMS agrees with these violation of Federal statute or newspaper advertisements and the comments and plans to issue the model regulation, the SPAP should contact us declining rate of newspaper circulation, notice during the summer of each year, to report the plan’s violation(s). We will weighed against the very limited benefit as it has in the past, to ensure that plans then take the appropriate action in gained from notice to the general public have enough time to fulfill this accordance with its compliance rules. who is minimally, if at all, affected by requirement. Actions by CMS may include the nonrenewal. Also, nonrenewal Comment: One commenter asked if developing a corrective action plan with information is now easily available to the 90-day period runs from the start of the Part D sponsor, suspending the general public through Internet Web open enrollment. enrollment into the Part D sponsor’s sites maintained by us (for example, Response: The regulation clearly plan, or, if necessary, termination of the http://www.Medicarsuch asov), a indicates that the notice must be sent ‘‘at Part D sponsor’s contract. We believe resource not available to the public least 90 calendar days before the date on that both of these actions will when the newspaper notice requirement which the nonrenewal is effective.’’ adequately address problematic plans was first adopted. We believe that this Comment: One commenter suggested and that an exception for nonroutine information, in conjunction with the that the CMS approved nonrenewal mass midyear enrollments will not be requirement to provide personalized letter which provides information about necessary. nonrenewal information to plan sources for help in comparing Medicare enrollees is sufficient to ensure plans is a good means to provide 17. Nonrenewal Beneficiary Notification adequate notice of the plan’s information in the case of mutual Requirement Under Parts C and D nonrenewal. Therefore, we proposed terminations. (§ 422.506, and § 423.507) deleting § 422.506(a)(2)(iii) and Response: We believe that the topic of In the October 22, 2009 proposed rule, (b)(2)(iii) of the MA regulations and notices for plans that are undergoing a under the authority of sections 1857(a) § 423.507(a)(2)(iii) and (b)(2)(iii) of the mutual termination is outside of the and (c) and 1860D–12(b)(1) and (b)(3)(B) Part D regulations to remove the scope of this proposed regulatory of the Act, we proposed revisions to the requirement that the general public be change. We note, however, that nonrenewal beneficiary notification informed of the impending nonrenewal § 423.508 of the regulation requires that requirements at § 422.506(a)(2)(ii) and through the publication of newspaper when a contract is terminated by mutual (b)(2)(ii) of the MA regulations and notices. consent, the Part D plan sponsor must § 423.507(a)(2)(ii) and (b)(2)(ii) of the Comment: One commenter stated that notify its Medicare enrollees of the Part D regulations to change the in order to improve the member termination ‘‘within timeframes beneficiary notice requirement from at experience and make the requirements specified by CMS.’’ least 60 days to at least 90 days. ‘‘ consistent, the 90 day prior to the 18. Notice of Alternative Medicare Plans We noted that the existing regulations effective date of nonrenewal’’ required notification 60 days prior to Available To Replace Nonrenewing notification deadline should only apply Plans Under Parts C and D the effective date of the nonrenewal for to enrollees whose coverage is being both enrollees and the general public. (§ 422.506(a)(2)(ii) and terminated, and not to enrollees that are § 423.507(a)(2)(ii)) Changing the requirement for the being mapped to another plan (such as personalized beneficiary specific CMS- Consolidated Renewal or Renewal Plan To allow additional operational approved notice to at least 90 days with SAR/Modified ANOC scenarios) flexibility, in the October 22, 2009 provides beneficiaries with an increased because they are not losing coverage. proposed rule, we suggested changing notice period giving beneficiaries more Response: The change to the the requirement for PDP sponsors and time to choose a new Medicare plan nonrenewal regulation only applies to MA organizations to provide written prior to the start of the new benefit year. beneficiaries who are losing coverage for notification of the alternative Medicare We also noted that when we previously the upcoming benefit year. It does not, plans available to replace the changed the required notice period to 60 as the commenter suggests, apply to nonrenewing plan. We proposed days, we did so primarily to provide beneficiaries who are involved in a plan changing the existing requirement to adequate time for the appeals process to consolidation, as their coverage will permit the option of either providing a conclude prior to the start of the next continue without interruption in the written list of alternatives available, or calendar year; however, our recent upcoming benefit year. placing outbound calls to all affected experience has indicated that the vast Comment: Many commenters support enrollees to ensure beneficiaries know number of nonrenewals are voluntarily the change in the notice requirement whom to contact to learn about their elected by the PDP sponsor or MA from 60 to 90 days. Commenters agreed enrollment options. We believe this organization, so there is rarely a need to that beneficiaries should be given more change is advantageous for beneficiaries accommodate the appeals process. For time to choose a new Medicare plan because, depending on where the this reason, we proposed at prior to the start of the new benefit year. beneficiary resides, a listing of available § 422.506(a)(2)(ii) and (b)(2)(ii) of the Response: CMS appreciates these plan options is often very long and may MA regulations and § 423.507(a)(2)(ii) comments. be too overwhelming for the beneficiary

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to use appropriately. We noted that a option to choose to give advance change that allows plan sponsors and much more useful approach would be to information to enrollees about organizations to place outbound calls to provide beneficiaries with contact alternative Medicare plan options in enrollees in plans that they are information and resources for writing or to make outbound calls to all terminating to tell them who to call to identifying the most appropriate option affected enrollees to ensure beneficiaries learn about enrollment options. given their unique, individual know whom to contact to learn about Commenters believed that allowing circumstances. For this reason, we their enrollment options. It was stated telephone calls invites the possibility of proposed revising § 422.506(a)(2)(ii) of that this approach also provides plan marketing abuses. Specifically, the the MA regulations and sponsors with the flexibility to vary the commenters stated that this change § 423.507(a)(2)(ii) of the Part D outreach methods used in order to ‘‘creates a major marketing loophole, regulations, to provide the option of accommodate different segments of their and allows plans to steer enrollees to sending written notices of all available membership on a timely basis. other plans offered by the same alternatives or placing outbound Response: We appreciate the sponsors and organizations, regardless beneficiary calls to ensure beneficiaries commenters support of our proposed of whether those plans are best for know whom to contact to learn about changes. them.’’ The commenters believed that their enrollment options. As discussed Comment: One commenter suggested beneficiaries need to be provided with above, in either case, a personalized, that in the event of a nonrenewing MA all of the information about alternative CMS- approved beneficiary notice plan, CMS should require that the plans, and all other options including regarding the nonrenewal must still be written notification include Original returning to traditional Medicare. They sent to each beneficiary. Medicare and stand-alone PDPs among stated that the information should be After reviewing the comments the alternative options available to the provided by CMS or by a neutral, received in response to these proposals, affected beneficiary. (Under the trained counselor. In addition, they we adopt the proposed changes into this proposed rule change, the MAO would believed once plans have been told that final rule with some modification. only be required to ‘‘provide a CMS- their contracts will not be renewed, Specifically, we revised the regulation approved written description of there is no incentive for the plans to act at § 423.507 to require that both Part C alternative MA plan options available appropriately and according to and Part D organizations inform for obtaining qualified Medicare Medicare marketing guidelines when beneficiaries of all MA and PDP services within the beneficiaries’ interacting with beneficiaries. ’’ available options. We also revised the region. ) Should the information be Commenters suggested that the regulation at § 422.506(a)(2)(ii)(A) to communicated via telephone by the proposed regulation authorizing calls to require that Part C organizations inform MAO, then the person responsible for beneficiaries should be clarified to beneficiaries of all MA, MA–PD, and informing the beneficiary of his or her include strict plan communication enrollment options should similarly be PDP options. restrictions that properly protect Comment: One commenter suggested required to tell the beneficiary about beneficiaries who are especially that instead of providing alternative Original Medicare and stand-alone PDPs vulnerable as a result of plan plan information in the nonrenewal in addition to other relevant plan terminations. Furthermore, CMS should letter, organizations should have the options. make clear that any sponsor that voluntary option of calling beneficiaries. Response: The list of available options markets plans when notifying Additionally, the commenter believed is accompanied by the required beneficiaries of plan terminations will that organizations should provide a personalized beneficiary nonrenewal be considered to be violating Medicare letter that contains language that directs notice that provides information about marketing rules. impacted members to the Medicare Web the beneficiary’s various options site for the most current Medicare plan including, when applicable, Original Response: We do ensure that information available in their service Medicare. We do agree with the beneficiaries are informed of all of their area. commenter’s suggestion to include options by requiring all nonrenewing Response: The requirement to list additional alternative available plans to provide a personalized alternative plans is independent of the Medicare plans; and therefore, have beneficiary notice which is separate requirement to provide a personalized revised the regulation to require that from the plan’s requirement to provide beneficiary notice. The required both Part C and Part D organizations a list of alternative plans or make personalized beneficiary notice already inform beneficiaries of both MA and outbound call to inform beneficiaries of contains information about using the PDP available options. whom to contact to learn about their Medicare Web site to obtain information Comment: Several commenters enrollment options. The required about available plans. We disagree with requested that the notification personalized notice includes the commenter’s recommendation that requirements mandate different information about all of the organizations should not be required to personalized notices with more beneficiaries’ choices and provides provide alternative plan information specialized information for different contact information for CMS and SHIP and that the phone calls to notify populations, particularly dual eligible offices so that beneficiaries can contact beneficiaries be voluntary. Some and SNP beneficiaries. ‘‘neutral’’ parties to obtain additional beneficiaries may not be comfortable Response: We believe this comment is information about enrollment options. with, or do not have access to the outside of the scope of the proposed CMS does not believe that plans should Internet. Therefore, we believe it is in regulatory changes because these be prohibited from contacting the best interest of the beneficiaries to changes did not address the information beneficiaries by phone, especially in be provided with either a written list of required within the personalized light of the fact that plans regularly alternative plans or to receive a phone beneficiary notification. Rather, the speak to beneficiaries by phone as part call informing them of whom to contact proposed changes only discussed the of the normal course of administering to learn about their enrollment options. list of alternative plans that must be Medicare benefits. Furthermore, we Comment: Several commenters provided with the personalized notice. believe that phone calls can provide supported the proposed change that Comment: Multiple commenters beneficial individualized beneficiary provides nonrenewing plans with the raised strenuous objections to the service. Additionally, CMS will issue

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guidance that instructs plans to submit beneficiaries to another plan for the expedited redetermination orally, so all nonrenewal related scripts for CMS following benefit year results in long as a written confirmation of the approval so that plans are providing disparate treatment of beneficiaries. For fully favorable decision is mailed to the appropriate and accurate information example, if one Plan Benefit Package enrollee within three calendar days of about the beneficiary’s plan choices. (PBP) is entirely mapped into another the oral notice. As noted in the Comment: One commenter stated that PBP (so only one PBP continues in the preamble to the proposed rule, the when plans map beneficiaries to an upcoming year), all members in both change is consistent with the alternative plan offered by the sponsor original PBPs receive a standard Annual requirements in § 422.590(d)(3) of the rather than nonrenewing, the Notice of Change (ANOC). However, if MA regulations. beneficiaries are not afforded some counties are mapped into another We also proposed in § 423.590(d)(2) to nonrenewal rights that include a special PBP but others remain (so both PBPs allow Part D plan sponsors to make the election period and the personalized exist in both the current and upcoming initial notice of an adverse expedited beneficiary nonrenewal notice. The years), members in the mapped counties redetermination orally, so long as a commenter believed that the rights of receive a modified ANOC. The written confirmation of the decision is members should be the same, and they commenter stated that from the member mailed to the enrollee within 3 calendar should all default to Original Medicare standpoint, it doesn’t matter which days of the oral notice. In addition, we with the option of enrolling in a PDP. situation they are in, in either case they proposed to revise paragraph (g) by Response: This comment concerns are mapped into a new plan. This adding cross references to paragraphs Part C and D enrollment policy and is disparate treatment of members in § 423.590(d)(1) and (d)(2) in order to outside the scope of the proposed similar situations can lead to confusion apply the written notice requirements in regulatory changes related to beneficiary among members and creates difficulties paragraph (g) to adverse expedited notification included in the proposed for customer service staff attempting to redetermination decisions. As noted in rule. CMS will consider this comment explain the contents of ANOC packets. the preamble to the proposed rule, we when we prepare the annual Response: This comment is outside of believe adding these two notice nonrenewal guidance. the scope of the proposed regulatory requirements to the Part D expedited Comment: Several commenters change. redetermination process is in the proposed allowing plans to provide the Comment: One commenter stated that enrollee’s best interests given the alternative list of plans available via CMS must issue alternative plan expedited status of these requests, and electronic format for beneficiaries who information far enough in advance for is consistent with our subregulatory have chosen to ‘‘opt-in’’ to receiving plans to meet the requirement to guidance and the process for notifying communications by electronic means. include alternative plan information in enrollees of adverse expedited coverage Response: We believe that for the the beneficiary specific letters that are determination decisions in § 423.572(b). purposes of ensuring consistency in the due on October 1. Similarly, we proposed adding application of the notification Response: We have an HPMS module § 423.590(h) to establish the form and requirements, the list of alternative that provides plan option information to content requirements for fully favorable plans should be provided only in hard nonrenewing sponsors. We redetermination decisions, and copy at this time. Also, CMS believes acknowledge that we cannot hold proposed making those notice that beneficiaries’ access to and use of sponsors accountable for meeting the requirements applicable to on-line resources is not yet widespread October 1 deadline unless we provide redeterminations issued under enough to justify the adoption of timely plan option information through paragraph (a)(1). We also proposed to regulations that allow for notification HPMS to the sponsors, and CMS intends reference paragraphs (d)(1) and (d)(2) in exclusively (even on an opt-in basis) to make every effort to ensure that paragraph (h), so that the form and through electronic communication. sponsors receive this information in a notice requirements in paragraph (h) Should Medicare beneficiaries’ Internet timely manner. would also apply to fully favorable use patterns change in the coming years, Comment: One commenter proposed expedited redetermination decisions. As CMS may make appropriate revisions to that if a plan chooses to call we noted in the proposed rule, this policy. beneficiaries instead of sending a list, Comment: One commenter asked the plan should be obligated to incorporating these Part D standard what number of attempts would be document that the beneficiary was redetermination notice requirements required of sponsors that elect the reached and that a message left on an will provide an important beneficiary option to make calls to beneficiaries. answering machine in not sufficient. protection by ensuring continuity of Response: We believe that it is Response: We believe that the issue of care for Medicare beneficiaries who are appropriate to address this question call documentation is better addressed obtaining refills of prescription drugs through the issuance of nonrenewal or through the issuance of nonrenewal under Part D, and doing so does not marketing sub-regulatory guidance guidance which provides more conflict with the related MA provisions. which provides more flexibility for flexibility for changes than the After considering the comments changes than the rulemaking process. rulemaking process. received in response to these proposals, Comment: One commenter asked we adopt these provisions without 19. Timeframes and Responsibility for what to do if the list of alternative plans modification in this final rule. Making Redeterminations Under Part D that is sent in the mail to the beneficiary Comment: We received a number of (§ 423.590) is returned. comments supporting the proposal Response: We believe that the In the October 22, 2009 proposed rule, allowing Part D plan sponsors to make standard practices organizations have we proposed to reconcile a discrepancy the initial notice of a fully favorable presently adopted for handling with respect to notice of completely expedited redetermination orally, so beneficiary mail that is returned should favorable expedited redeterminations by long as a written confirmation of the be applied by the nonrenewing sponsor adding new paragraph (d)(2) to fully favorable decision is mailed to the in such instances. § 423.590. The proposed change would enrollee within three calendar days of Comment: One commenter stated that allow Part D plan sponsors to make the the oral notice. However, one the rules for consolidation that map initial notice of a completely favorable commenter suggested revising the 3

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calendar day requirement to 3 business Comment: Numerous commenters Response: For several years, we have, days. supported the proposal requiring plan without difficulty, allowed enrollees Response: We appreciate the sponsors to include specific information and physicians to orally request comments we received in support of (such as, the conditions of approval) in expedited organization determinations. this provision. With respect to the favorable decision notices. However, Thus, we believe allowing enrollees to comment recommending that we revise one commenter opposed the proposed also request standard organization the calendar day requirement to requirement and suggested instead that determinations orally will not pose any business days, we have consistently we allow plan sponsors to provide the issues regarding tracking such requests. used the calendar-day timeframe for all approval conditions on request. Currently, Chapter 13 of the Medicare Medicare appeals processes, and we do Response: Currently, plan sponsors Managed Care Manual (section 50.2) not believe there is a compelling reason must provide the conditions of approval instructs plans to maintain a process for to depart from that standard for written to enrollees upon request. Thus, the tracking expedited organization notice of favorable decisions. We note commenter’s suggestion would not determinations, and we agree with the that plan sponsors are required to mail address the issue we were trying to commenters’ recommendation to place a (not deliver) the notice within 3 resolve in the proposed rule. As noted similar requirement on plans regarding calendar days. in the preamble to the proposed rule, we oral requests for standard organization Comment: We also received many believe it is important to include the determinations. Accordingly, we are comments favoring our proposal giving conditions of approval in favorable revising § 422.568 as proposed without Part D plan sponsors the option of notices to help ensure continuity of care change. We will also add this making the initial notice of an adverse for Medicare beneficiaries who receive requirement to Chapter 13 of the expedited reconsideration orally and prescription drugs under Part D. Medicare Managed Care Manual to then following up with written Prescription drugs are often provided to ensure compliance. confirmation of the decision. beneficiaries on a recurring basis. 21. Organization Determinations Under Commenters also supported applying Therefore, it is important for an enrollee Part C (§§ 422.566 and 422.568) the written notice requirements in to know the conditions of the approval We proposed to remove the language paragraph (g) to adverse expedited (such as, duration, limitations, and from § 422.566(b)(4) and § 422.568(c) redetermination decisions. However, a coverage rules for refills) before a refill that an enrollee must disagree with the number of commenters expressed is needed, so that, if necessary, the plan’s discontinuation or reduction of a concern about starting the 60-day enrollee can work with his or her service for the plan’s decision to be timeframe for requesting an appeal on prescriber to secure prior approval for considered an organization the date an enrollee receives oral notice additional refills, obtain an exception, determination. Section 1852(g)(1)(A) of of an adverse decision. The commenters or switch to an appropriate alternative the Act requires MA organizations to noted that it may be very difficult for an prescription. have a procedure for making enrollee to keep track of the deadline for 20. Requirements for Requesting determinations regarding whether an filing an appeal if the 60-day timeframe Organization Determinations Under Part enrollee is entitled to receive health begins on the date they receive oral C (§ 422.568) services or payment under the program. notice of a plan’s decision. The In accordance with section 1852(g)(1)(A) commenters suggested starting the 60- We proposed specific language related of the Act, § 422.566 and § 422.568 day timeframe on the date printed on to oral requests for organization establish the requirements related to the written denial notice. determinations, except for payment- organization determinations and Response: We agree and believe the related requests. As we noted in the notices. Existing § 422.566(b)(4) 60-day timeframe for requesting an October 22, 2009 proposed rule, section specifies that an organization appeal of an adverse decision should 1852(g)(3) of the Act allows an enrollee determination includes a decision begin on the date printed on the written to request an expedited organization resulting in ‘‘[d]iscontinuation or denial notice. However, we believe the determination either orally or in reduction of a service if the enrollee appropriate place to make this writing. However, the method for believes that continuation of the clarification is in our subregulatory requesting a standard determination is services is medically necessary’’ guidance. Therefore, we will make this not addressed in either the Act or the (emphasis added). Similarly, under clarification in Chapter 18 of the implementing regulations at § 422.568. § 422.568(c), a plan must give an Prescription Drug Benefit Manual. Both beneficiary advocates and MA enrollee a written notice of the Comment: A commenter requested plans have voiced concern about the determination ‘‘if an enrollee disagrees that CMS develop a model letter for absence of express regulatory authority with the MA organization’s decision to fully favorable redetermination that would allow enrollees to request discontinue or reduce an ongoing course decisions and written redetermination standard organization determinations of treatment’’(emphasis added). We decisions that follow oral notice under both orally and in writing. Therefore, indicated that we no longer believe that § 423.590. we added specific language in § 422.568 it is necessary to require an enrollee’s Response: We agree that it would be to allow oral requests for organization ‘‘belief’’ that the services in question are helpful to provide plan sponsors with determinations, except where the medically necessary in order to consider either model language or standardized request is for payment. these reductions or discontinuations to notices for use in issuing fully favorable Comment: Although one commenter be organization determinations, nor did redetermination decisions and written opposed allowing oral requests because we believe that it is appropriate to redetermination decisions that follow of concerns about proving that a request condition the delivery of a notice on an oral notice, and will explore the was made, we received several enrollee’s ‘‘disagreement’’ with the feasibility of implementing these comments in support of our proposed discontinuation or reduction of an options. Any notice(s) we develop will revision. Many of those who supported ongoing course of treatment. Therefore, be published in Chapter 18 of the our proposal also suggested that we we proposed to change this language by Medicare Prescription Drug Benefit require plans to develop a confirmation removing the phrases ‘‘if the enrollee Manual. and tracking system for oral requests. believes that continuation of the

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services is medically necessary’’ and ‘‘if § 422.626 receive notices with appeal Comment: Several commenters an enrollee disagrees with an MA rights only when services are being supported removing the word organization’s decision.’’ We noted that terminated. However, enrollees do not ‘‘authorized’’ before ‘‘representative’’ in § 422.620 through § 422.626 already automatically receive notices when order to be consistent with the provide enrollees who are receiving care previously authorized ongoing courses definition of the term ‘‘representative’’ in an inpatient hospital, skilled nursing of treatment are reduced in these and less limiting in the application of facility, home health, or comprehensive settings. Consistent with our proposal, the term. However, a perceptive outpatient rehabilitation facility (CORF) we are establishing the policy to require commenter noted that we overlooked setting with the right to receive a notice notice and appeal rights, in all settings, making this revision in two places and expedited review of service for previously authorized ongoing under § 422.566(c). terminations for ongoing courses of courses of treatment that either end or Response: We intended to make this treatment in these settings. Thus, our are reduced prematurely. We note that change throughout all of subpart M, and intention was to ensure that enrollees the phrase ‘‘previously authorized who are receiving previously authorized ongoing course of treatment’’ means a as such, will finalize § 422.566(c) in the ongoing courses of treatment outside the series of services or treatments that have final rule to include these additional settings covered by § 422.620 through been approved in writing (such as revisions. § 422.626 would automatically receive through a plan of care). Accordingly, a Comment: A few commenters notice and appeal rights if such services reduction in the level of care of a requested that we restructure all of were terminated, and enrollees in all previously authorized ongoing course of subpart M of part 422 so that the general settings would automatically receive treatment may include a change in the provisions section (§ 422.562) includes notice and appeal rights if the level of mix or range of services/sessions, a provisions about enrollee rights and MA care or amount of such services was decrease in the intensity of the care, or provider notice responsibilities for reduced. a reduction in the amount of services/ services rendered by skilled nursing Comment: Most commenters sessions provided relative to the original facilities (SNFs), home health agencies, supported our proposed revisions. authorization. (HHAs), and comprehensive outpatient However, a few commenters requested Unlike the provider settings under rehabilitation facilities (CORFs) and further clarification about whether and § 422.620 through § 422.626, when a services provided in the inpatient how this revision altered plan or course of treatment ends in other hospital setting. These commenters also provider notice requirements. One of settings under § 422.568(c), it will not recommended creating new sections to these commenters also requested result in automatic notice and appeal describe provider notice requirements clarification that the changes proposed rights if the enrollee received all of the for all settings and the notice would not create a new requirement for services as planned in the original requirements and appeal rights plans to notify enrollees each time a authorization. In these cases, if an specifically related to Part B services. participating provider discontinues enrollee believes that those services This restructuring, the commenters treatment under § 422.566 and 422.568. should continue, he or she must request suggested, would provide a more This commenter noted that the clauses a new organization determination from thorough overview of beneficiary rights proposed for deletion were originally the health plan. Accordingly, we are under subpart M, and place the notice added as part of the notice and finalizing § 422.566(b)(4) and and appeal language in a more comment process when the § 422.568(c) to include the revisions appropriate place in the regulatory requirements for an enrollee’s noted previously. scheme. expression of dissatisfaction were first 22. Representatives (§ 422.561, adopted. Response: This comment is beyond Response: As we note previously, § 422.566, § 422.574, and § 422.624) the scope of the proposed rule. § 422.620 through § 422.626 We proposed to amend § 422.561 to However, we note that subpart M, like automatically trigger the requirement for clarify that a representative may act on subpart I of part 405 and subpart M of plans and providers to give a notice an enrollee’s behalf with respect to the Part 423, describes the various levels of with appeal rights whenever enrollees grievance process. As we explained in the MA appeals process, including the experience service terminations while the preamble to the October 22, 2009 associated beneficiary rights and they are receiving care in the inpatient proposed rule, for various reasons, provider notice requirements, in the hospital, skilled nursing facility, home enrollees may choose or need to have order in which they occur. We believe health, or CORF settings. Conversely, someone represent them in order to this structuring of the appeals § 422.566 and § 422.568 currently protect their interests. Presently, under provisions makes it easier to follow the require an enrollee to express sections 1852(f) and (g) of the Act, a process. We do not agree with the dissatisfaction about a termination or representative may act on behalf of an suggestion that the current order of the reduction of services in order to receive enrollee or other party when filing a regulatory provisions prevents enrollees notice and appeal rights. Therefore, our grievance. However, unlike the from appealing adverse decisions about goal in no longer requiring an enrollee’s corresponding Part D regulation, Part B (or any other Medicare) services disagreement was to ensure that plans existing § 422.561 does not explicitly and believe that restructuring subpart M would be required to provide notices permit representatives to file grievances as recommended, would not result in whenever they discontinued or reduced on behalf of an enrollee. In order to additional notice or appeal rights for a previously authorized ongoing course rectify this and be consistent with the enrollees. Finally, to make certain that of treatment, regardless of the setting. Part D definition of representative at beneficiaries understand the MA However, as we considered these § 423.560, we proposed to amend the appeals process and their rights under comments, we recognized that some definition of representative under this process, we ensure that beneficiary additional restructuring of the provision § 422.561. Similarly, we proposed to materials and notices, such as the would be needed to ensure a clear and remove the term ‘‘authorized’’ before Evidence of Coverage and Notice of consistent understanding of the policy. ‘‘representative’’ in § 422.574 and Medicare Noncoverage are Enrollees who are receiving care in § 422.624, so that the definition is comprehensive, clear, and easy for settings governed by § 422.620 through consistent throughout subpart M. enrollees to understand.

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23. Disclosure Requirements Under deficiencies such as those that may lead required to be disclosed will have a Parts C and D (§ 422.111(g) and to an intermediate sanction or require positive effect on transparency and § 423.128(f)) immediate correction and where we informed choice. Similarly, we intend to In the October 2009 proposed rule, we believe beneficiaries should be use our normal account management proposed adding new provisions specifically notified. One example of a oversight processes of review and (§ 422.111(g) and § 423.128(f)) to the situation where enrollees should be approval of materials disclosed to existing regulations that govern the notified of performance or compliance beneficiaries to lessen the prospect for information that must be disclosed to deficiencies would be when a beneficiary confusion or concern which enrollees and potential enrollees. sponsoring organization fails to provide could lead to unnecessary grievances Specifically, we proposed to add that beneficiaries with the proper premium and requests for disenrollment. Finally, notices to collect premium amounts in we believe that beneficiaries would be CMS may require a sponsoring arrears. Another example would be if a interested in receiving information organization to disclose to its enrollees sponsoring organization failed to about serious or significant compliance and potential enrollees information provide access to services and we or performance deficiencies which concerning the sponsoring instructed the sponsor to contact potentially could affect them. organization’s performance and contract enrollees regarding this issue and assist Comment: Several commenters compliance deficiencies in a manner them with obtaining needed services or provided suggestions concerning how specified by CMS. While a number of medications. In each of these situations we should make this information commenters opposed this proposal, an we would require a sponsoring available to enrollees. One commenter equal number of commenters supported organization to disclose the deficiency stated that we should require that it. The latter noted that they support the to its enrollees and take affirmative sponsoring organizations make goals of this proposal to provide steps to alleviate any problems for information available upon request or beneficiaries with the information they enrollees, such as providing enrollees on the Medicare Web site and another need to assess the quality of care they with options to fix the issue. commenter requested that we consider are receiving and to make sponsoring The performance ratings routinely alternative means of supplementing organizations accountable for their available to beneficiaries, while equally existing performance information performance deficiencies, which should important for the promotion of available to beneficiaries through the improve compliance with the rules and transparency and informed choice, CMS Web site. requirements of the Medicare program. generally will not include information Response: We do not agree with the We also solicited comments on whether about the type of performance suggestion that sponsoring organizations these disclosure requirements should be deficiencies that will be the subject of should only make such information imposed only in those circumstances these disclosure requirements. Also, we available upon request or on the where a beneficiary would be afforded intend to use the normal account Medicare Web site. We intend to require the opportunity to act on them (for management oversight processes to that enrollees receive this information example, requiring disclosure during review and approve any disclosures from sponsoring organizations in those the particular times of the year when before they are made to beneficiaries to circumstances where we believe beneficiaries would ordinarily be able to ensure that information disclosed is beneficiaries must be affirmatively made make change or elections, except in clear, and unambiguous and to lessen aware of these deficiencies. Providing those situations where the compliance the potential for confusion, alarm or information upon request or merely deficiency is so significant that a other potential negative impacts on posting on a Web site which enrollees beneficiary may be afforded a special beneficiaries. may or may not access does not promote enrollment opportunity). Comment: Several commenters raised the degree of transparency and We are finalizing the proposed concerns that this requirement would be accountability by sponsoring changes to § 422.111(g) and § 423.128(f)) administratively and financially organizations, for their deficiencies, that with a modification to § 422.111(g) burdensome on some sponsoring was contemplated by our proposal. discussed in detail below. organizations either because these Also, not all beneficiaries have access to Comment: A number of commenters disclosures could lead to a significant the Medicare Web site and we believe were concerned that we have not increase in grievances and expenditures beneficiaries may not be aware that they provided enough detail about the responding to beneficiary concerns over can request this information. proposal, including what compliance the disclosures or could unnecessarily Comment: One other commenter and performance deficiencies would alarm beneficiaries and lead to requests suggested that sponsoring organizations rise to a level to trigger the disclosure for disenrollment. These commenters should not be required to disclose requirement, as well as the types, format also were concerned about the utility of deficiencies that occurred in the past and timing of these disclosures. These these kinds of disclosures based on their because those issues may have been commenters were concerned that the experience that Medicare beneficiaries corrected and are not relevant to the proposed regulations allow CMS too rarely request information about current status of the plan. much discretion, could be compliance and performance and have Response: We intend to conduct our inconsistently applied and may lead to demonstrated no interest in information oversight responsibilities in a manner unnecessary confusion and alarm for about sanctions taken by CMS. such that the kinds of compliance and beneficiaries. Also, commenters stated Response: As we stated in our October performance deficiencies contemplated that the existing performance ratings, 22, 2009 proposed rule, the primary by these disclosures come to our through the Medicare Web site, purpose of this requirement is to attention as quickly as possible and are currently provide adequate disclosure to promote transparency and informed similarly disclosed to enrollees in a beneficiaries. choice especially in those situations timely manner. However, it is not Response: As we clarified in the where we believe beneficiaries need or always possible for us to be aware of proposal, our intent is to invoke this should have access to this information. situations contemporaneous with their disclosure authority when we become We intend to exercise our authority occurrence. We intend to take into aware that a sponsoring organization judiciously in those situations where we account whether the deficiencies have has serious compliance or performance believe that the information being been corrected and the utility of making

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such disclosures to beneficiaries in their healthcare. We note that the underlying associated compliance or these instances when making a decision commenter did not provide a further performance deficiency. Therefore we as to whether disclosure will be description or citation to the ‘‘well are not incorporating this commenter’s required. founded legal and policy objectives’’ suggestion. Comment: A number of commenters that they stated had been previously Comment: One commenter expressed expressed concern with the timing of submitted to us. To the extent that the concern that sponsoring organizations these required disclosures and the commenter is referring to a prior do not have the opportunity to related issue of whether beneficiaries proposal related to the mandatory self- challenge or appeal the application of may elect other options once they disclosure of fraud, waste, and abuse this requirement. receive one of these disclosures. Several issues, the disclosures that are the Response: These disclosure commenters requested that disclosure subject of these proposals are entirely provisions merely require sponsoring be imposed only in those circumstances distinguishable and this proposal is organizations to provide beneficiaries where a beneficiary would be afforded completely unrelated to any past with access to information. There is no the opportunity to elect another plan proposals involving the mandatory self- statutory or regulatory right to challenge option, some requested that disclosure disclosure of fraud, waste, and abuse or appeal a CMS requirement to disclose of performance deficiencies be issues. The current provision, for which information to enrollees. However, to immediate so that beneficiaries would there is explicit statutory authority, the extent we take a contract or have more time to plan their health care involves disclosures of compliance and enforcement action (for example, an decisions and several commenters performance deficiencies that we are intermediate sanction or a civil money believe that disclosures throughout the already aware of and has determined penalty) against the sponsoring plan year would decrease the likelihood involve an issue that enrollees should organization for an associated that information would get lost during be notified of expeditiously. However, underlying compliance or performance the annual coordinated election period we are modifying the language in deficiency, the sponsoring organization (AEP) or open enrollment period (OEP). § 422.111(g) to replace the term ‘‘self- would be afforded any appeal rights Response: We agree with the disclosure’’ with ‘‘disclosure’’ to avoid associated with the action taken. commenters who recommended that any confusion. disclosure of these compliance and Comment: One commenter questioned Comment: One commenter was performance deficiencies be made as how CMS intends for sponsoring concerned that sponsoring organizations expeditiously as possible to organizations to disclose to their would not comply with the beneficiaries and therefore we also agree enrollees that they have resolved the requirement. that these disclosures may be required disclosed compliance/performance Response: We have established throughout the plan year. Also, with issues after the required disclosure is mechanisms for ensuring compliance respect to the comments relating to made. and fully intend to enforce these allowing beneficiaries to elect other Response: We recognize that requirements and to take appropriate options, based on the nature and extent sponsoring organizations will want to corrective and enforcement action of the deficiencies that necessitated the correct any underlying compliance or should sponsoring organizations fail to disclosure, we intend to exercise our performance deficiencies that led to comply with this requirement. authority to grant a special election these kinds of disclosures quickly. Our Comment: One commenter period for beneficiaries affected by the proposal was specifically intended to recommended that defined timeframes plan’s compliance or performance utilize transparency to incentivize and be issued in which CMS should respond deficiencies as permitted in § 422.64 promote sponsoring organizations’ to a beneficiary’s inquiry related to the and § 423.38. Our intention is to provide compliance with CMS requirements. As disclosure of a plan’s performance or actionable information to beneficiaries. with the required disclosure notice, we compliance deficiencies. In some cases, the appropriate action intend to use the normal account Response: We have established may be to afford beneficiaries an management oversight processes to mechanisms for ensuring we respond to opportunity to elect another plan review and approve any notices that all beneficiary inquiries and these option. In other cases, it may be sponsoring organizations wish to established mechanisms would apply sufficient to require plans to disclose provide to enrollees concerning a equally to any inquiries received from the deficiency to its enrollees and correction of the underlying compliance beneficiaries concerning these kinds of provide enrollees with options to fix the or performance deficiencies that led to disclosures. issue. the disclosure. Comment: We received one comment Comment: One commenter requested Comment: One commenter suggested that questioned CMS’ authority to that we issue a written warning to that we make public the information on require a sponsoring organization to sponsoring organizations before sending its Web site in a manner that is more disclose to its beneficiaries its the actual notice requiring disclosure. detailed and easier to find. compliance or performance deficiencies. Response: We do not believe issuing Response: Our proposal was not The commenter provided no specifics a written warning to sponsoring intended to solicit comments about the for the assertion and merely stated that organizations prior to requiring information on our Web site and they have expressed to us on numerous disclosure furthers any particular therefore we are not specifically occasions the ‘‘well-founded legal and compliance or oversight objectives and addressing this comment. policy objections’’ to self-disclosure. additionally may not always be feasible, Comment: One commenter requested Response: We currently have both especially if the deficiency has just that we modify the plan ratings for statutory authority pursuant to sections occurred and beneficiaries need to be special needs plans (SNPs) because they 1851(d) and 1860D–1(c) of the Act and notified immediately. We retain the do not accurately measure plan existing regulatory authority under discretion to issue a compliance action performance. § 422.111(f)(8)(v) and § 423.128(c)(1)(vii) (including a written warning), separate Response: Our proposal was not to require sponsoring organizations to and apart from the requirement to have intended to address the methodology for disclose information to its enrollees to sponsoring organization’s disclose plan ratings and therefore we are not help them make informed choices about deficiencies to enrollees, based on the specifically addressing this comment.

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24. Definition of MA Plan Service Area to the definition of MA plan ‘‘service merged with another organization, and (§ 422.2) area’’ without modification. provide that plans that have failed to attract enrollees over a period of time C. Changes To Provide Plan Offerings We proposed to amend the definition without justification may be non- With Meaningful Differences of an MA plan ‘‘service area’’ at § 422.2 renewed. We believe that these to exclude facilities in which This section addresses proposals in revisions will help us accomplish the individuals are incarcerated, consistent our October 22, 2009 proposed rule that balance we wish to strike between with the definition of service area for a were designed to promote plan offerings encouraging robust competition and Part D plan and in light of the fact that with meaningful differences, and ensure providing health plan and PDP choices incarcerated beneficiaries are unlikely plan viability. We discuss below to beneficiaries that do not create to have access to MA plan services, as proposed revisions that would help confusion for beneficiaries because required under § 422.112. We received ensure that plans offered by the same there are meaningful differences in several comments on this provision, all organization in the same area have benefit packages among the plans of which supported our proposal. We meaningful differences from each other, offered. We discuss these provisions in appreciate the support for the changes provide for a transition to the connection with comments we received and are finalizing the proposed revision applicability of such rules when an in response to the proposals outlined in existing organization is acquired by or Table 3.

TABLE 3—PROVISIONS TO ENSURE MEANINGFUL DIFFERENCES IN PLAN OFFERINGS

Part 422 Part 423 Provision Subpart Section Subpart Section

Bid Submissions: Ensuring Significant Dif- Subpart F ...... § 422.254 ...... Subpart F ...... § 423.265 ferences. Bid Review Process ...... Subpart F ...... § 422.256 ...... Subpart F ...... § 423.272 Transition Process in Cases of Acquisi- Subpart F ...... § 422.256 ...... Subpart F ...... § 423.272 tions and Mergers). Non-renewing Low-enrollment Plans ...... Subpart K ...... § 422.506(b)(1)(iv) ...... Subpart K ...... § 423.507(b)(1)(iii)

1. Meaningful Differences in Bid area are submitted only if the plans order to assist them in developing their Submissions and Bid Review (§ 422.254, meet the foregoing test of being plan offerings for the contract year. § 423.265; § 422.256, and § 423.272) substantially different from each other. However, we also believe it is important Under our authority in section After reviewing the comments we are to retain flexibility when considering 1857(e)(1) of the Act, incorporated for finalizing our proposals with the meaningful differences. Therefore, as Part D by section 1860D–12(b)(3)(D) of technical changes to § 422.254(a)(4), specified in our October 2009 proposed the Act, to establish additional contract § 423.265(b)(2), § 422.256(b)(4)(i) and rule, our final regulations at terms that CMS finds ‘‘necessary and § 423.272(b)(3)(i), explained below. § 422.256(b)(4) and § 423.272(b)(3) appropriate’’ and with respect to Part D, Comment: Most commenters continue to include the general our authority under section 1860D– supported our proposal to require substantive standard we will use when 11(d)(2)(B) of the Act to propose meaningful differences in bids but asked assessing plan bids, with the regulations imposing ‘‘reasonable for greater specificity about how the expectation that greater specificity in minimum standards’’ for Part D new rules would apply. Several how this standard will be applied will sponsors, our October 22, 2009 commenters requested that CMS be provided, with an opportunity for proposed rule proposed changes to our identify the specific thresholds and comment on our more detailed criteria, regulations to ensure that plan offerings criteria to be used in determining that through guidance such as our annual by MA organizations and Part D meaningful differences between plans call letter. We do not agree that it is sponsors represent meaningful exist, and several others requested that necessary to provide a separate public differences to beneficiaries with respect CMS annually publish the standards notice of areas with limited plan to benefit packages and plan cost early in the year preceding the contract choices, as the number of choices structures. Specifically, we proposed to year to which the thresholds and criteria available in an area is already provided revise § 422.256(b)(4)(i) and apply. A few commenters requested that to beneficiaries in that area in the § 423.272(b)(3)(i) to specify that we criteria for meaningful differences be Medicare & You Handbook, and on the published annually and be subject to would only approve a bid submitted by Medicare Web site. an MA organization or Part D sponsor if public comment. One commenter its plan benefit package or plan cost requested that CMS include public Comment: One commenter opposed structures were substantially different notice of areas with limited plans. the proposed changes and from those of other plans offered by the Response: We agree with the recommended that CMS reevaluate its organization or sponsor in the area with commenters that it is important to policy on differences that are respect to key plan characteristics such provide more information and greater meaningful to beneficiaries, which the as premiums, cost-sharing, formulary specificity concerning standards that we commenter believed was based purely structure, or benefits offered. We also will use in assessing meaningful on actuarial policies. The commenter proposed to make related changes to differences, and agree that MA argued that CMS’ policy could be § 422.254(a)(5) and § 423.265(b)(3)(i) to organizations and Part D sponsors considered discriminatory because require that MA organizations and Part should have this information early in geography would be a factor in whether D sponsors must ensure that multiple the year preceding the contract year to multiple plans had to be different from bids submitted for plans in the same which the standards would apply in each other.

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Response: We believe our proposed only if they are determined to provide the same organization, we would not policies would require differences in adequate access consistent with those consider five SNPs offered by the same criteria that beneficiaries, not actuaries, requirements. As explained in 30.2.7 of organization to be meaningfully would find meaningful, while still Chapter 6 of the Medicare Prescription different simply because the plans providing MA organizations and Part D Drug Manual (see http:// offered are SNPs. As is also the case in sponsors with flexibility in offering www.cms.hhs.gov/ our provision to non-renew low different plan options. We disagree with PrescriptionDrugCovContra/ enrollment plans, we believe that SNPs the commenter who believes that 12_PartDManuals.asp#TopOfPage), we may warrant special attention when considering the geographical region of a review submitted drug lists to ensure assessing meaningful differences plan could be considered that they are consistent with best because of such factors as the enrollee discriminatory, since the beneficiary practice formularies currently in population served and differences in confusion issue we are addressing in widespread use today. Our goal is to benefits (Medicare and Medicaid in the this rule only applies when duplicative ensure that all Part D formularies are case of dual-eligible SNPs). However, plans are offered by the same sufficiently broad in scope so as to we do not believe that such plans organization in the same area. Moreover, contain the drugs most commonly used should receive exemptions from either we believe that greater scrutiny of to treat the conditions faced by the requirements concerning low differences between an organization’s Medicare beneficiaries. Nothing in our enrollment or meaningfully different plan offerings in an area where more proposed regulations would permit a plans simply because they are SNPs. plans are offered is justified in that the sponsor to offer anything less than the Half of all Medicare beneficiaries have higher the total number of plans offered current standard for the basic Part D over 40 MA plan choices (this figure in an area, the greater is the potential for benefit. does not include special needs plans or beneficiaries to be confused and Comment: A commenter asked if five employer group health plans which overwhelmed. SNP plans offered by the same MA have additional criteria for enrollment), Comment: Several commenters had organization would be considered and many states offer 50 or more stand specific questions, concerns, or meaningfully different, even if the alone Part D plans, a number that can suggestions about how to best assess formulary offered by each resulted in double when one includes Medicare meaningful differences. Several similar out-of-pocket costs, simply Advantage plans with a Part D benefit. commenters wrote that CMS should not because the plans offered were SNPs. Several studies suggest that the MA and place so much focus on Part D Another commenter cautioned that Part D program offerings are so formularies as a means of determining coverage in the gap may be little numerous that they can be confusing. In meaningful differences. In connection different than no coverage in the gap if a report by Marsha Gold of Mathematica with this issue, several commenters such coverage consists solely of generic Policy Research, Inc., for example, Gold believed that focus on the plan drugs. The commenter suggested that a writes of the MA program that ‘‘Existing formulary could lead to sponsors plan’s initial coverage limit is a better research suggests that simplification offering at least one plan with a ‘‘bare indicator of meaningful differences may have advantages for beneficiaries,’’ bones’’ formulary. Such ‘‘baseline’’ or between plans. A commenter noted that and that one such advantage is ‘‘benchmark’’ plans could harm LIS that his studies indicate that enhanced preventing competitors from taking enrollees, as such enrollees would likely Part D benefits are increasingly advantage of the system ‘‘through be disproportionately enrolled in such meaningless, and that genuine coverage product design.’’ 1 Gold continues by plans and are least able to navigate in the gap is the primary indicator identifying the sheer array of plan types barriers such as utilization management between enhanced and standard plans, with their different characteristics, such restrictions. Concerning other specific given that cost-sharing and premiums as access to services or cost structures, issues, a commenter wrote that MA–PD are often no different between enhanced as confusing to beneficiaries to the point plans offered by the same organization and basic prescription drug coverage. that they may not choose the plan that should be assessed for meaningful According to this commenter, his is best for them in terms of costs or differences based on the health care studies show that gap coverage is also benefits. In his study, ‘‘How Much benefits offered by each plan and not often not meaningfully different because Choice is too Much? The Case of the the Part D benefits of each, as such coverage is: (1) Almost always Medicare Prescription Drug Benefit, T. standardization of the Part D benefit is accomplished through generic drugs; (2) Rice argues, based on Part D beneficiary generally helpful for beneficiaries. many generic drugs are not normally studies that he and others in the field Response: With respect to focusing on covered by plans claiming to offer such have conducted, that ‘‘The results show plan formularies as a criterion for coverage; and (3) copayment amounts in that decision quality [of seniors’ ability assessing meaningful differences in Part the gap are higher than copayments to choose plans with the lowest annual D plans, we note that while we believe before reaching the initial coverage total cost] deteriorated as the number of differences in formularies to be a limit. The commenter suggested that a plans increases.’’ 2 In another study of fundamental area for assessing plan plan should be required to cover all Part D plan offerings, published in a differences, this was not the only formulary drugs in the gap if the plan 2009 paper by Jason T. Abaluck and element of Part D plan offerings we wants to offer gap coverage and, if this Jonathan Gruber, the authors determine proposed to assess. Indeed, we proposed is not feasible, plans offering gap that ‘‘elders place much more weight on to look at premiums and cost-sharing, as coverage for generics should be required plan premiums than they do on the well. With respect to the concerns that to offer the same coverage in the gap for expected out of pocket costs that they focusing on the formulary could lead to generics that they offer in the initial will incur under the plan’’ and that ‘‘bare bones’’ plans in which LIS coverage period. Another commenter beneficiaries could be wrote that its experience was that 1 Gold, Marsha. Strategies for Simplifying the disproportionately enrolled, the Part D utilization of generic drugs is one of the Medicare Advantage Market. Publication prepared program requirements clearly specify best ways that a member can delay onset for the Kaiser Family Foundation. July, 2009. 2 Rice, T. Reducing the Number of Drug Plans for the minimum requirements for basic of the coverage gap. Seniors: A Proposal and Analysis of three Case prescription drug coverage, and plans’ Response: With respect to the Studies. Presentation at Academy Health Annual formularies are reviewed and approved comment on multiple SNPs offered by Research Meeting: Washington, DC. June 9, 2008.

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‘‘they substantially under-value variance or by which organization the plan is services (that is, through a network, as reducing aspects of alternative plans,’’ offered. While it is important to ensure in an HMO or in a non-network context confirming that the array of Part D plan that plan options are meaningfully such as a PPO) and overall plan costs. offerings can often lead to inconsistent different, we also believe MAOs should The addition of individual choices among seniors with respect to have the flexibility to craft distinct plan supplemental benefits may not trigger determining costs, and plan features options for beneficiaries. the annual thresholds we have used to most beneficial to them.3 Comment: One commenter implied establish significant differences in We agree with the commenter who that CMS was not aware that plan overall plan costs among an MA wrote that coverage in the gap may not benefit designs with low or no organization’s plan offerings in a service always be meaningfully different if such premiums and higher cost-sharing may area. That said, our recent experience in coverage consists solely of a subset of be attractive to some beneficiaries, and reviewing plan benefit packages formulary generic drugs but we disagree plans with no deductibles and higher suggests that the addition of some that an enhanced alternative plan premium attractive to others and, as a supplemental benefits can result in should be required to cover all result, both structures should remain a significant differences in out-of-pocket formulary drugs in the gap if the plan viable choice in the marketplace. A costs. Therefore, it is possible that an wishes to claim to offer gap coverage. commenter urged CMS to look at an individual supplemental benefit or Rather, we believe that a meaningful organization or sponsor’s plans group of supplemental benefits could difference with respect to an enhanced ‘‘holistically’’ when assessing result in plans being meaningfully plan must be represented by a meaningful differences. Another different from one another. With respect significant increase in benefits over commenter cautioned that while to the comments concerning our basic coverage. Similarly, if two establishing meaningful differences example that PPOs and HMOs with a enhanced plans are offered by the same among plans offered by an MAO or POS option could be considered similar sponsor in a service area, a meaningful sponsor is important, CMS must watch if offered by the same MAO even though difference among those two plan for complexities in plans’ cost-sharing they technically are different plan types, offerings must be represented by a structures, as these various structures we cited this example to illustrate that significant difference in benefits offered. make it far more difficult for even though these are different plan Comment: One commenter beneficiaries to evaluate differences types it is possible that such plans, if recommended that we permit an MA between or among benefit packages. offered by the same MAO, could be organization to offer three plans of each Response: Contrary to the considered similar under some plan type in a service area, while commenter’s suggestion, we are well circumstances. For example, if access to another wrote that CMS should not aware that some beneficiaries prefer care in-network, and coverage of arbitrarily limit the number of plans plan benefit designs with low or no services out-of-network is essentially offered by an MA organization in a premiums and higher cost-sharing while the same in both plans, and there are no service area. others may prefer high deductible/high other significant differences between the Response: Although permitting an premium plans, and we have no two in benefits or costs, there would not MA organization to offer three plans of intention of prohibiting these as ‘‘a be ‘‘meaningful’’ differences between the each plan type may be reasonable in viable choice’’ for beneficiaries. To the two plans. some circumstances, we do not agree contrary, our requirement that plans with the commenter that this should have meaningful differences from one Comment: A commenter cautioned necessarily be the case. To the extent another is designed to promote such that CMS should be aware that an MA that the three plans have meaningful differences in plan design. CMS’ organization offering several dual SNP differences from each other that avoid concern is with MAOs and Part D plans might have several similar benefit beneficiary confusion, we believe that sponsors that offer several plans in the packages for Medicare benefits, but the three plans of the same type (for same service area that have few same plans could have quite different example, coordinated care plan) would distinctions, not with plans with benefit Medicaid benefits. Another commenter be permissible. Because the number of or cost structures which are clearly supported our intention, as expressed in plans of the same type that would be quite different. the proposed rule, to permit multiple permitted under this rule would depend Comment: A commenter requested plan filings by the same MA on the plan design, and on ensuring that that we consider premiums, the organization in certain circumstances beneficiaries are not confused, we provision of health and wellness and wrote that CMS should formally disagree with the commenter that we are programs, and dental or vision coverage recognize the ‘‘Medicaid agency’s imposing an ‘‘arbitrary’’ limit on plan in our assessment of meaningful purchasing strategy’’ ’ in any assessment offerings. differences between MA plans. Another of meaningful differences among dual Comment: A commenter suggested commenter took exception to our eligible SNP plans. that CMS require all health care plans example in the proposed rule that an Response: We do not consider to have at least one basic, standardized HMO with a point of service (POS) differences in Medicaid benefits among plan that would be transparent and option and local PPO can sometimes be dual eligible SNPs offered by the same understandable to beneficiaries no similar, that is, may not be meaningfully MA organization as significant matter where or by which organization different, and wrote that local PPOs are, differences for purpose of our review, the plan was offered. in fact, different by virtue of offering since we are reviewing differences in Response: We do not agree with the out-of-network coverage. Another MA plan offerings, not Medicaid commenter that all MAOs offer at least commenter agreed that HMOs with a benefits. We would consider Medicare one standardized plan no matter where POS option are largely indistinguishable premiums (as part of a plan’s cost from local PPO plans. structure) as part of its review of bids. 3 Abaluck, Jason T, and Jonathan Gruber. Choice Response: The focus of our review for In short, as an earlier commenter urged, Inconsistencies among the Elderly: Evidence from meaningful differences is primarily on CMS intends to look ‘‘holistically’’ at an Plan Choice in the Medicare Part D Program. NBER Working Paper Series. Working paper 14759. cost differentials between plans for Parts organization or plan sponsor’s offering February, 2009. http://www.nber.org/papers/ A and B services, the presence of a Part in a service area when determining w14759. D benefit, the ways beneficiaries access whether or not an organization’s or

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sponsor’s offerings are meaningfully MA organization’s or Part D sponsor’s plans and PDPs, that PDP sponsors different. bids are meaningfully different should affected by mergers or acquisitions Comment: A commenter wrote that be connected with ‘‘or’’ instead of the would be afforded a 3-year transition CMS should ensure that CMS’ policies coordinating conjunction ‘‘and.’’ As a period. After reviewing the comments do not inadvertently remove meaningful result, we are revising our regulations at received in response to this proposal, choices in areas where choices may be § 422.254(a)(4), § 422.256(b)(4)(i), we are finalizing the proposed comparatively limited (Barrow County, § 423.265(b)(2), and § 423.272(b)(3) to provisions without modification. Alaska v. Dade County, Florida, for state that an [MA or Part D] Comment: Several commenters agreed example). Another commenter wrote organization’s bids must reflect with our proposal to require that CMS should consider limiting an differences in ‘‘benefit packages or plan organizations and sponsors acquiring or organization’s or sponsor’s plan costs.’’ We also are making conforming merging with existing entities to offer offerings in a geographic area similar to changes to § 422.256(b)(4)(ii) and plans with meaningful differences the Federal Employee Health Benefits § 423.272(b)(3)(ii) which concern within two years of the merger or Program or plans offered by some other acquisitions and mergers, as these acquisition. One of the commenters employers. sections use similar language. However, wrote that 2 years was ‘‘more than Response: We do not intend to we disagree with the commenter who adequate’’ for affected organizations and prevent plan choice in rural areas urged that the preamble language sponsors to offer meaningfully different through implementation of the referencing ‘‘plan characteristics such as plans. Another wrote that while 2 years requirement for meaningfully different premiums or cost-sharing’’ (MA was sufficient, CMS should consider plans. The intent of the provisions is to program) or ‘‘premiums, cost-sharing, notifying beneficiaries 1 year in advance ensure genuine choices for beneficiaries formulary structure,’’ (Part D program) of a plan’s non-renewal so that they as well as transparency in plan offerings should be reflected in the regulations have clear notice of any changes. so that beneficiaries can make informed text. Although these are certainly Several commenters disagreed with decisions about their health care plan elements that may result in the proposal to permit 2 years for choices. For this reason, we do not agree meaningfully different plans, we believe transition, recommending, instead, that with the commenter who suggests that the current language captures these CMS maintain the current 3-year we limit an organization/sponsor’s plan elements while providing the necessary requirement articulated in the 2008 Call offerings in a geographical area to an flexibility to view plans ‘‘holistically.’’ Letter. A few commenters believed that arbitrary number of plans, since this In addition, the commenter correctly the language in the proposed rule could could actually limit additional points out that in order to make the Part be interpreted to permit as little as one meaningful choices. C and D regulations consistent, bidding cycle/bidding year between an Comment: Two commenters cited § 422.256(b)(4)(i), which concerns MA acquisition or merger and the offering of discrepancies in the preamble and bid reviews, should cross reference meaningfully different plans. One regulations text for Parts C and D § 422.254(b)(4), which concerns commenter said that a 2-year transition concerning bid submissions submission of MA bids. period would be disruptive to (§ 422.254(a)(4) and § 423.265(b)(2)) and With the exception of the revisions beneficiaries and would not permit asked that we ensure the final noted previously, we are finalizing the plans to develop adequate benefit regulations text reflects the language of provisions as proposed. packages. This commenter requested the preamble by specifying that that CMS permit a 3-year transition 2. Transition Period in Cases of Mergers meaningful differences include period. Another commenter contended and Acquisitions (§ 422.256, § 423.272) differences in ‘‘cost-sharing or benefits that organizations/sponsors need 3 years offered, (MA regulations)’’ and In connection with our proposal to after a merger or acquisition in order to ‘‘premiums, cost-sharing, formulary ensure that plan offerings represent adapt their benefit packages to comply structure, or benefits offered’’ (Part D meaningful differences, we proposed to with the meaningful differences rule, regulations) instead of the proposed add § 422.256(b)(4)(i) and and to implement a robust regulations text for these sections, § 423.272(b)(3)(ii) to provide MA communications plan for implementing which was more general ‘‘benefit organizations and Part D sponsors required changes. packages and plan costs’’ (MA involved in mergers or acquisitions a 2- Another commenter argued that CMS regulations), ‘‘beneficiary out-of-pocket year transition period from the merger should not state that the transition costs, and formulary structures’’ (Part D or acquisition to ensure that plans period will be ‘‘as determined by CMS,’’ regulations). In addition the offered by the MA organization or Part but rather specify how the transition commenters asked that the list of D sponsor are significantly different period will be measured. The same meaningfully different elements cited in from each other. After a transition commenter wrote that if CMS does the bid submission and review sections period of 2 years, we would only finalize the proposed requirement, we be connected with the coordinating approve a bid submitted by an MA should not apply it to any acquisition conjunction ‘‘or’’ instead of ‘‘and.’’ One organization or Part D sponsor, or a prior to issuance of the rule, as the of the commenters recommended that parent organization to that entity, if the organization would have already taken the bid review sections for both the Part benefits or plan cost structure action based on transition-related C and D regulations at § 422.256(b)(4)(i) represented by that bid were guidance in the 2008 and 2009 call and § 423.272(b)(3)(i) cross reference the substantially different from any other letters. criteria for meaningful differences in the bid submitted by the same MA Response: As stated in the preamble bid submission sections for both organization or Part D sponsor (or to the proposed rule, based on our programs (§ 422.254(a)(4) and parent organization of that entity). We experience, we believe that our § 423.265(b)(2)). requested comments regarding the proposed timeline for transitions Response: We agree with the adequacy of our proposed transition provides ample time for organizations comments suggesting that the period length of 2 years in both the MA and sponsors to ensure that benefit regulations text for the bid submission and Part D contexts, particularly since packages are sufficiently different and to and review sections specifying the we had previously, as articulated in the notify enrollees of any changes. Because criteria we will use in assessing if an 2008 Call Letter for Medicare health the transition period actually applies for

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the two contract years following the case could be made that low enrollment recognize that we must be flexible in year of the acquisition or merger, that is, is justified, and the absence of such a assessing minimum enrollment to if a merger takes place in 2010, the plan would significantly limit ensure that plans with legitimate MAO or sponsor would have until 2013 beneficiary health care options in a reasons for low enrollments, such as to offer meaningfully different plans, we service area, consistent with effective lack of other health care plan options, believe this period is disruptive neither and efficient administration of the Part specialized plan offering (such as, a to plans nor to beneficiaries, and thus C or Part D benefit, we would not non- chronic care SNP), or recent disagree with the commenter who renew that plan. Similarly, we also establishment of the plan, may continue asserted that a 3-year transition was stated that the threshold for low to operate and that beneficiaries who needed to allow MA organizations and enrollment could fluctuate, although we might not otherwise have access to Part D plan sponsors to adapt their noted that we used a threshold of 100 health care options offered by a low- benefit structures and communicate to enrollees for purposes of reducing the enrollment plan will continue to have beneficiaries about the changes being number of low enrollment plans for such access. Because we intend to made. contract year 2010. Therefore, we did provide for public input annually on We clarify that only organizations or not propose to revise our regulations to our implementation guidance and will sponsors that merge or are acquired after specify a specific threshold. We consider the suggestions for specific the effective date of this final rule will solicited comments on this approach threshold amounts submitted by the be subject to the requirement at and whether we had provided sufficient commenters in that context, we do not § 422.256(b)(4)(ii) and § 423.272(b)(3)(ii) clarity on how we would determine believe the suggested ‘‘workgroup’’ to be that their offerings are meaningfully whether a low-enrollment plan would necessary. With respect to the question different after a 2-year transition period. be non-renewed. of what constitutes ‘‘a small number of In the case of plans offered by Comment: Several commenters enrollees’’ over a period of time, the organizations or sponsors that merge or supported the proposal to non-renew process described above may also be acquire other plans prior to the effective low enrollment plans, but used to determine the number of date of this regulation, the previously recommended that the threshold and enrollees that would trigger application articulated 3-year transition period guidelines we would use to apply this of this regulation, as well as the period would apply. requirement (including such factors as of time for which the small number the number of plans in a market, plan 3. Non-Renewing Low-Enrollment Plans would have to be sustained. enrollment, and the number of years of Comment: Another commenter (§ 422.506(b)(1)(iv), § 423.507(b)(1)(iii)) operation with low enrollment recommended that CMS make clear that As part of our process to streamline numbers) be clear and transparent, and the length of time a plan has had low and simplify the plan selection process that they be made available publicly enrollment will be a primary factor in for beneficiaries, and ensure that early in the year preceding the contract determining whether a plan is non- beneficiaries are only offered plans with year to which they will apply. One renewed, and that we should modify long-term viability, we proposed in commenter wrote that CMS should our regulations language to explicitly § 422.506(b)(1)(iv) and convene a working group prior to provide for ‘‘waivers’’ of the proposed § 423.507(b)(1)(iii) to include, as a enacting our proposed policy to non- requirement at § 422.506(b)(1)(iv) specific ground for non-renewal of a renew low enrollment plans. Another (§ 423.507(b)(1)(iii) for Part D plans) contract, a finding that a Part C or Part commenter wrote that CMS should when special circumstances such as the D plan has failed to attract a significant consider low enrollment to be in the 250 type of beneficiaries served, geographic number of enrollees over a sustained to 500 enrollee range rather than 100 location, and absence of the plan would period of time. We justified this enrollees (the number used in our significantly limit beneficiary health requirement on the grounds that, as a efforts to reduce low-enrollment plans care options in a service area. general matter, continuing such a low for contract year 2010, as detailed in the Response: The length of time in enrollment plan was not consistent with preamble to our proposed rule). Another which a plan has had low enrollment is effective and efficient administration of recommended a low enrollment only one of the factors that we will the Medicare program for purposes of threshold of 1000 enrollees because it consider in determining whether it is section 1857(c)(2)(B) of the Act believes that plans serving fewer than consistent with effective and efficient (incorporated for Part D under section 1000 people in a service area would be administration of the Part C or Part D 1860D–12(b)(3)(B) of the Act), which unable to offer negotiated savings, benefit. We will also consider the type provides authority to terminate a quality managed care, or popular plan of benefits being offered under the plan contract under such circumstances. In features. A commenter asked CMS to and the nature of the enrollment in the the preamble to the proposed rule, we clarify what is meant by ‘‘a small plan. As stated above, we recognize that acknowledged that there may be number of enrollees over a period of we must be flexible in applying any instances in which low enrollment over time.’’ minimum enrollment requirement to a sustained period of time is a function Response: We agree that guidelines ensure that plans with legitimate of the type of beneficiaries served, concerning minimum enrollment reasons for low enrollments, such as geographic location, or other thresholds and criteria should be lack of other health care plan options, circumstances, and that we would published annually and as early as specialized plan offering or recent consider continuing to renew a low possible in the year preceding the establishment of the plan, may continue enrollment plan in such situations contract year to which they will apply. to operate. This flexibility will ensure including, but not limited to, chronic While we disagree that we should that beneficiaries who might not care SNPs offering health care services specify thresholds in regulations, we otherwise have access to health care especially tailored to this category of intend to provide opportunities for the options offered by a low-enrollment beneficiaries and not available public to review and comment on our plan will continue to have such access. elsewhere or employer group health proposed thresholds and criteria for Because we intend to apply this plans offering benefits augmenting those assessing low enrollment for the requirement in a flexible manner that of an MA plan to employees of a small following contract year (for example, considers the particular circumstances business. We further stated that, if a through our annual call letter). We of each low enrollment plan, we do not

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believe it is necessary to modify the exception wrote that ‘‘status as a SNP plan(s) discussed, not just the proposed regulations at should be prima facie evidence that low organization’s Web site as is now often § 422.506(b)(1)(iv) and enrollment is justified.’’ A few of these the case. § 423.507(b)(1)(iii) to provide explicitly commenters specifically requested that Response: We are not making the for ‘‘waivers’’ of this requirement. such exceptions be codified in the final suggested change at this time as we Comment: A commenter regulations text. One commenter believe that MOC already includes recommended that non-renewed plans requested an exception be made for be permitted to passively enroll affected employer group plans. One commenter sufficient information to contact plans. enrollees into another plan offered by requested an exception for MA-only Comment: Another commenter the MA organization or Part D sponsor. plans, stating that enrollees who get requested that the tool clearly indicate Response: With respect to the their prescription drugs through some what is meant by an ‘‘enhanced plan,’’ recommendation to provide for passive means other an MA–PD should still even if this is just a general description enrollment of beneficiaries in a non- have the option of remaining in an MA- in the tool of the typical features of an renewed plan into another plan offered only plan, and another commenter enhanced plan. by that organization, we believe this is requested that ‘‘national’’ plans be Response: We do not believe that appropriate only in limited exempted from these requirements. circumstances when a compelling case Response: While we will consider revisions are necessary as information can be made that such passive exceptions on a case-by-case basis to on enhanced plans is currently available enrollment is in beneficiaries’ best any low-enrollment thresholds we in the glossary and at http:// interests. In making such establish, we do not believe it is www.medicare.gov/medicarereform/ determinations, we take into necessary to exempt any specific plan howtoread.asp. consideration criteria such as benefits, type a priority. As we stated in the Comment: A commenter requested cost sharing, the provider network, and preamble to the proposed rule, there that CMS add back the search function premiums to ensure a comparable plan may be reasons for exceptions based on in MPDPF notifying the user of the offering. In all other cases, we believe it plan type, geography, or special health number of drugs covered by a particular is most appropriate to leave enrollment conditions of enrollees served that plan. The same commenter requested decisions to beneficiaries, who will warrant a waiver of the requirements. that information be included about have an opportunity during the annual However, a specific plan type, for when a plan last updated its drug coordinated election period to select example, a SNP or employer group plan, pricing information and that the tool another MA plan or Part D plan offered will not automatically be exempt from by the MA organization or Part D the minimum enrollment standard for includes information about coverage of sponsor offering the plan being renewal due to plan type alone. While drugs traditionally covered under Part terminated. If a plan is terminated or sustained low enrollment may well be B, for example, infused and injectable nonrenewed, the affected organization justified in the case of certain SNPs drugs for MA–PD plans. or sponsor must follow all beneficiary serving individuals with a relatively Response: Currently the drugs an and CMS advance notification rare condition, a SNP serving an individual beneficiary takes may be requirements as specified in §§ 422.506, individual with a more common disease entered and displayed to determine 422.508, 422.510, and 422.512 (MA such as diabetes, or serving dual coverage, but the MPDPF does not program regulations), §§ 423.507, eligibles, should be able to attract permit display a list of all the drugs a 423.508, 423.509, and 423.510 (Part D enrollees. Similarly, we do not believe plan covers as this would take a very program regulations) and related there is justification for exempting MA- long time for the tool to display. CMS guidance for both programs. In addition, only plans or ‘‘national’’ plans from the reviews drug pricing on a regular basis passive enrollment initiated by an requirements unless there are other and the data is updated monthly to organization or sponsor in the absence reasons to exempt them (for example, reflect any changes. We believe the of CMS approval is not among the lack of other health care plan options, compare function best permits users to transactions permitted by us in our the specialized nature of the plan, or the tailor their searches for the specific annual renewal/non-renewal guidance. recent establishment of the plan). Because of these requirements and drugs in the specific forms that they policies, an MA organization or Part D 4. Medicare Options Compare and need. sponsor wishing to enroll members from Medicare Prescription Drug Plan Finder Comment: Another commenter wrote the terminating or non-renewing plan In the proposed rule we asked for that the MOC is relatively thorough but into another of their plans could not do comments on ways to improve the web inconsistent in that some plans in the this without prior CMS review and tools, Medicare Options Compare tool do not include information about consent. If we were to determine that (MOC), and the Medicare Prescription health care costs and that saved such a transaction was in beneficiaries’ Drug Plan Finder (MDPF). We searches often yield different results best interests, we would, as is our summarize and respond to these when retrieved later. The commenter practice, facilitate and closely monitor comments below. recommended that the tool be refined to the process. We note as well that Comment: One commenter requested allow the user to move easily back and beneficiaries in terminated or non- that CMS add a function to limit the forth between information for MA and renewed plans have guaranteed issue information that can be seen in the MOC Part D plans, that the conditions Medigap rights, access to information so that users of the tool can focus on required for enrollment in a chronic about other available health care information they need most. care SNP be specified, and that the options, and other information that will Response: The 2011 contract year function concerning costs for tiers of assist them in finding plans most suited update will include functions that drugs is ‘‘incredibly unfriendly and to their needs. expand and collapse which will help confusing.’’ Comment: Several commenters users of the MOC better focus on supported our proposal but asked that specific information. Response: We are considering how we make exceptions for SNPs. One Comment: Another commenter asked best to streamline and make the use of commenter requesting the SNP that the MOC contain direct links to the these comparative functions easier.

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D. Changes To Improve Payment Rules and Processes This section addresses three payment issues under Part C. These provisions are outlined in Table 4.

TABLE 4—IMPROVING PAYMENT RULES AND PROCESSES

Part 417/422 Part 417/422 Part 423 Part 423 Provision Subpart Section Subpart Section

Risk Adjustment Data Validation ...... Subpart F ...... § 422.2 N/A N/A. Dispute and Appeals Process ...... Subpart G ...... § 422.311 ...... Payments to Medicare Advantage Organizations-Actuarial Valuation Subpart F ...... § 422.254 N/A N/A. Determination of Acceptable Administrative Costs by HMO/CMP Subpart O ...... § 417.564 N/A N/A. Cost Contract and Health Care Prepayment Plans (HCPPs). Calculation of the Minimum Percentage Increase under Part C ...... Subpart G ...... § 422.306 N/A N/A.

1. Definitions Related to Risk currently specify a process for appealing a three-pronged RADV dispute and Adjustment Data Validation Appeals overpayments resulting from RADV appeal procedure that MA organizations (§ 422.2) and Addition of Medicare audits, the appeals process we proposed could employ to reduce their RADV Advantage Organization Risk was based on our authority to establish payment error rate, including— Adjustment Data Validation—Dispute MA program standards by regulation at • Physician/practitioner and Appeal Procedures (§ 422.311) section 1856(b)(1) of the Act. attestation(s); • In the October 22, 2009 proposed rule, Specifically, we proposed adding a new Documentation dispute; and • we proposed regulations establishing an § 422.311 to part 422, subpart G, to RADV payment error calculation appeals process to be used by MA specify RADV dispute and appeal rights appeal. organizations to appeal the error for MA organizations. We proposed We noted that analysis of data calculation resulting from Risk regulatory provisions allowing MA originating from medical records Adjustment Data Validation (RADV) organizations that undergo RADV submitted by MA organizations that audits. As explained in the preamble of audit(s) to—(1) submit physician and have undergone RADV audit indicates that proposed rule, under RADV audits other practitioner signed attestations that a substantial percentage of medical and medical records are reviewed to relating to physician and other record-related payment error determine whether they support outpatient medical records that had a determinations are due to missing diagnosis codes (known as Hierarchical missing signature, or credentials that signatures or credentials on medical Condition Codes, or HCCs) submitted to resulted in a payment error finding; (2) records. Medicare program rules dictate us under the MA risk adjustment dispute certain other types of medical the necessity of physician signatures on methodology. Under this methodology, record review-related findings through medical records, and MA risk certain diagnosis codes are considered the use of a documentation dispute adjustment requirements dictate that to signify higher costs for the enrollee, process; and (3) appeal our RADV risk adjustment diagnosis data be and therefore, we pay a higher amount payment error calculation. By availing accepted only for health services that to the MA organization for an enrollee themselves of these RADV dispute and were provided by certain physician to reflect these higher costs. If, in fact, appeal processes, we noted that MA specialties. Therefore, RADV audit a diagnosis code was not justified by the organizations would be able to reduce procedures require that, in addition to enrollee’s medical condition, the higher their RADV payment error and thereby, finding diagnosis information that payment amount associated with that reduce their overall estimated MA would support the HCCs submitted by diagnosis code would have been an payment error. Therefore, we proposed the MA organization for risk adjustment overpayment. Under the RADV audit the following provisions under part 422: purposes, physician signatures, and process we plan to recover the • To revise § 422.2 to add definitions appropriate credentials must be present overpayments identified during the of six terms that pertain to RADV on medical records. Medical records RADV audit. The appeals process we activities, and thus to our proposals for with missing signatures or credentials proposed in the October 22, 2009 implementing a RADV dispute and are scored as errors under RADV audit proposed rule was intended to provide appeal processes. procedures. We estimated that if given a mechanism for MA organizations to • A new § 422.311 describing the opportunity to do so, many appeal the error calculation associated procedures that we would implement to physicians and other practitioners that with the overpayments identified under afford MA organizations facing a provided the diagnosis information on RADV audits. We invited and received potential overpayment determination RADV-reviewed medical records would a large number of comments from health resulting from RADV audits the in fact attest that they documented the plans, managed care industry trade opportunity to have certain potential information in these medical records, associations, and other interested RADV payment errors addressed in even though signatures and credentials parties regarding not only the proposed advance of RADV-audit-related payment were missing from those records. appeals process, but on the RADV audit error determinations, and to have other Moreover, the presence of a signature or process and underlying MA payment types of confirmed payment errors credential attestation to accompany policy producing the overpayment overturned. At § 422.311(a) and (b), we these medical records would in our findings and our definitions proposed at summarized the RADV audit opinion, provide justification for § 422.2. Since neither the statute nor procedures. Beginning with preventing both contract-level and existing MA program regulations § 422.311(c), we proposed implementing national-level RADV payment errors

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that would otherwise originate from submit attestations before or after of RADV payment errors that would be medical record signature, or credential- submission of their RADV medical eligible for documentation dispute, related discrepancies. records. describe the documentation dispute Therefore, in proposed • Attestations would need to process that we would undertake, along § 422.311(c)(1), we proposed to originate from the physician/ with the process that we would implement a process that would allow practitioner whose medical record undertake to notify MA organizations of MA organizations to voluntarily submit accompanies and corresponds to the the results of documentation dispute CMS attestations (that is, attestations attestation. We would not accept reviews. As described at proposed developed and pre-populated by CMS). attestations or medical records from any § 422.311(c)(2)(v), our documentation These attestations would be signed by party other than the MA organization. dispute review determination would be physicians/practitioners who would • Organizations would not be final and binding upon both parties and attest responsibility for providing and permitted to submit attestations during would not otherwise be eligible for documenting the health services in the the documentation dispute or RADV further administrative appeal. physician and outpatient medical reconsideration processes described at Proposed § 422.311(c)(3) would record(s) that were submitted for RADV § 422.311(c)(2) and § 422.311(c)(3). establish an appeals process under audit. We specified at proposed At proposed § 422.311(c)(1)(iv), we which RADV payment error calculations § 422.311(c)(1)(ii) and (iii) that MA described the process that we would would be subject to appeal. Unlike our organizations would be eligible to use undertake to review attestations and proposed attestation process described attestations to address signature or notify appellant MA organizations of the at § 422.311(c)(1), and proposed credential-related discrepancies only results of these attestation reviews. Our documentation dispute process describe from physician or outpatient medical attestation review determinations would at § 422.311(c)(2), which would afford records; attestations would not be be final and binding upon both parties MA organizations the opportunity to allowed to address signature or and would not be eligible for further dispute aspects of our medical record credential-related discrepancies found appeal. review process, the proposed RADV on inpatient medical records. The We further proposed affording MA payment error calculation appeal proposed use of an attestation would organizations the option of disputing process was specifically designed to not in any way supplant the medical other nonsignature or credential-types afford MA organizations the opportunity record, nor would it permit attesting of RADV-related medical record to appeal our contract-level RADV physicians/practitioners to alter the diagnosis coding discrepancies via a payment error calculation. Under the existing medical record. Attestations proposed documentation dispute proposed RADV payment error would not be acceptable to address any process that we described in new calculation appeal process, we proposed issues outside of the RADV-audit paragraph § 422.311(c)(2). Under our establishing a three-level appeal process process. proposal, in order to be eligible for whereby MA organizations may— At proposed § 422.311(c)(1)(C)(iv), we documentation dispute, MA • Seek reconsideration; indicated that we would prospectively organizations would need to submit • Appeal the reconsideration decision notify MA organizations that if the ‘‘one their ‘‘one best’’ medical record in to an independent CMS Hearing Officer; best’’ medical record used to validate an accordance with RADV medical record and audited HCC were missing a physician/ submission deadlines established by us • Appeal the decision of the practitioner signature or credential, the during the RADV medical record independent CMS Hearing Officer to the MA organization would be permitted to request process. CMS Administrator. submit a CMS–RADV attestation along At proposed § 422.311(c)(2)(a), we Given the complexity of RADV audits with the medical record, to fulfill the specified the types of RADV-related in general, and the calculation of RADV- requirement that medical records errors that would be eligible for the related error rates in particular, we contain physician/practitioner proposed documentation dispute stated our belief that it was prudent to signatures and credentials. process. The documentation dispute afford appellant MA organizations We described the proposed process process would apply only to the errors multiple-layers of RADV-related that we would jointly undertake to that arise out of operational processing payment error appeal. review attestations submitted for our of medical records selected for RADV At proposed § 422.311(c)(3)(ii), we review at proposed § 422.311(c)(1)(iv) audits and submitted to us by also specified that MA organizations and (v), noting the following: established deadlines. In this context, would not, under the proposed RADV • Only CMS-generated attestations errors that arise from operational payment error calculation appeal that meet certain requirements processing mean errors that arise from process, be permitted to appeal medical described at § 422.311(c)(1) and (d) the collection and processing of medical record review errors, nor would MA would be eligible for consideration. records for a RADV audit. organizations be permitted to seek Failure to meet these requirements At § 422.311(c)(2)(ii), we proposed formal appeal of physician or would result in us not reviewing or limitations that we would impose upon practitioner signature or credential- accepting submitted attestations. the documentation dispute process; related review errors. We believed that • CMS attestations that have been namely that MA organizations would medical record review-related issues altered or amended (for example, not be permitted to dispute any medical would be addressed as a result of the striking out prepopulated words and record coding discrepancies, nor would rigorous medical record review process, replacing them with hand-written MA organizations be permitted to and the attestation and documentation replacement words) without instruction submit altogether new medical records dispute processes described earlier in or written concurrence from us would in place of previously submitted the proposed regulation. In accordance not be accepted. medical records. Payment errors that with our proposed regulation at • Attestations would need to resulted from missing medical records § 422.311(c)(3)(i), the RADV payment accompany the medical record at the would not be eligible for documentation error calculation appeals process would same time that the medical record was dispute. At proposed § 422.311(c)(2)(iii) only apply to errors identified in the submitted to us for RADV audit. MA and (iv), we indicated that we would RADV payment error calculation. MA organizations would not be permitted to prospectively notify MA organizations organizations would not be permitted to

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utilize the payment error calculation organizations would be prohibited from decision of the CMS official or appeal process as a method for submitting medical record-related contractor to sustain our initial RADV submitting any medical records for evidence such as new or previously payment error calculation, the consideration in the calculation of the submitted medical records or physician reconsideration official similarly would payment error. In order to be eligible for or practitioner attestations and from notify the appellant MA organization of RADV payment error calculation appeal, appealing any issues pertaining to the its determination. In either instance, the MA organizations would need to adhere methodology applied in any part of the decision of the reconsideration official to established RADV audit RADV audit. At proposed would be final and binding, unless a requirements, including the submission § 422.311(c)(3)(iv), we further specified request for hearing was filed by CMS or of medical records in the manner and by that the MA organization would bear the the appellant MA organization. the deadlines specified by CMS. burden of proof to demonstrate that our At proposed § 422.311(c)(4), we Furthermore, we noted that MA RADV payment error calculation was clarified that if CMS or an MA organizations would not be permitted to clearly incorrect. organization were dissatisfied with the appeal our RADV payment error We described our proposal regarding decision of the CMS reconsideration calculation methodology. Our the conduct of a RADV payment error official described at § 422.311(c)(3), justification for excluding calculation reconsideration, the CMS or the MA organization would be methodological appeals was two-fold. decision of the reconsideration official permitted to request a second-level First, we said the methodology that we and the effect of the CMS RADV payment error calculation appeal, planned to employ to calculate RADV reconsideration decision official at which is a hearing on the RADV payment errors was methodologically proposed § 422.311(c)(3)(e) and (f). payment error calculation sound and academically defensible. We At proposed § 422.311(c)(3)(v) and determination. CMS or MA organization stated that we intended to ensure that (vi), we described the first level of choosing to pursue a hearing would be all MA organizations understand the RADV payment error calculation appeal, required to file a request for hearing RADV payment error calculation the request for reconsideration of our within 30 calendar days of the date the methodology by providing annual RADV payment error calculation. Under MA organization received the written notice to all MA organizations of the this process a CMS official or our RADV payment error calculation methodology that will be employed for contractor not otherwise involved in reconsideration decision, as described at calculating Part C payment errors. MA error-rate calculation activity would proposed § 422.311(c)(3)(vi). organizations that object to CMS’ RADV review our RADV payment error We noted that CMS or MA payment error calculation methodology calculation and any written evidence organizations requesting a hearing would be given an opportunity to submitted by the MA organization that would need to do so in writing, provide comment to us under ours pertains to CMS’ RADV payment error including a copy of the CMS annual notice of RADV audit calculation, recalculate the payment reconsideration official’s decision to methodology. Second, in addition to error utilizing our RADV payment error either uphold or overturn the initial providing an annual notice of RADV calculation methodology (as specified in RADV payment error calculation, and audit methodology, we stated that we our standard operating procedures), and specify the findings or issues in that would provide an expanded explanation render a determination whether the reconsideration decision that they of methodology as part of each RDV RADV payment error calculation was disagreed with and why they disagreed audit report that we send to MA accurate. This CMS official or CMS with them. The hearing would be organizations that undergo RADV audit. contractor not otherwise involved in conducted by the CMS Office of Included in this expanded explanation RADV error-rate calculation activity Hearings and presided over by a CMS of methodology would be RADV would recalculate and arrive at an Hearing Officer who neither receives payment error calculation factors independent RADV payment error. testimony nor accepts any new evidence unique to each audited MA organization Whether the official or contractor agreed that was not presented with the request that would enable the MA organization with our payment error calculation, or for reconsideration of the RADV to independently calculate its own overturned the calculation and payment error calculation. The hearing RADV payment error. established a new RADV payment error, would be held on the record, unless the At proposed § 422.311(c)(3)(iii) and this party’s RADV payment error parties requested, subject to the Hearing (v), we specified that MA organizations calculation determination would be Officer’s discretion, a live or telephonic would be notified of their RADV issued to a CMS reconsideration official. hearing. The Hearing Officer would also payment error calculation appeal rights The CMS reconsideration official would be permitted to schedule a live or at the time we issue a RADV audit review their analysis and make a telephonic hearing upon their own report to that organization. MA determination whether to accept or motion. The CMS Hearing Officer would organizations would have 30 calendar reject the findings of the CMS official or be limited to a review of the record that days from the date of this notice to CMS contractor that recalculated the was used for the initial RADV payment submit a written request for RADV payment error. In instances when error calculation and the reconsidered reconsideration of its RADV payment the CMS official or contractor RADV payment error calculation. error calculation. A request for recommended overturning CMS’ RADV Additionally, we noted that the reconsideration would need to specify payment error calculation and the Hearing Officer would have full power the issues with which the MA reviewing CMS reconsideration official to make rules and establish procedures, organization disagrees, the reasons for agreed with the newly calculated RADV consistent with the law, regulations, and the disagreements and explain why the payment error, we would issue a CMS rulings. These powers would organization believes the issues are reconsideration decision which include the authority to take appropriate eligible for reconsideration. The request informed the appealing MA action in response to failure of an for reconsideration would need to organization in writing of its organization to comply with such include additional documentary reconsideration decision, in effect, procedures. evidence that the MA organization notifying the MA organization of its new At proposed § 422.311(c)(4)(iv), we considers material to the RADV payment error. If the also indicated that the CMS Hearing reconsideration, though MA reconsideration official upheld the Officer would review and decide

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whether the reconsideration official’s While many comments that we set forth in our proposed regulations, decision was correct and to notify CMS received relate to the underlying RADV such as our ‘‘one best medical record’’ and the MA organization in writing of audit process and risk adjustment and other documentation requirements, his/her decision, explaining the basis methodology and may not directly established a substantive legal standard for the decision, which would be final address the RADV appeals process governing the payment to MA and binding, unless the decision was specifically, we are responding to these organizations, and therefore, they had to reversed or modified by the CMS comments, because they appear to be be included in the annual notice of Administrator in accordance with relevant to the RADV appeals process changes to payment methods required § 422.311(c)(5). that we had proposed in our Notice of under section 1853(b)(2) of the Act, We explained that the third level of Proposed Rulemaking. Certain which requires that MA organizations RADV payment error calculation appeal comments were outside the scope of our be afforded an opportunity to comment that MA organizations can request proposed rule and we have not included on changes in the methodology for would be discretionary review by the responses to those comments. determining MA payments. CMS Administrator. We described this Comment: A comment alleged that it Response: We disagree. The proposed process at § 422.311(c)(5). At was premature for CMS to propose rules requirement in section 1853(b)(2) of the this level of appeal, CMS or the MA related to the RADV appeals process Act to provide an advance notice of organization would be permitted to because the commenter stated that the methodological changes to MA appeal the decision of the CMS Hearing Administrative Procedure Act (APA) organizations of proposed changes to Officer by requesting that the CMS required that the underlying RADV the methodology and assumptions used Administrator review the CMS Hearing audit process giving rise to the to compute annual MA capitation rates Officer’s determination. Parties overpayments that would be appealed pertains to the methodology for requesting CMS Administrator review under our proposed regulations be determining the proper amount of would have to request the review within subjected to notice and comment payment. All substantive changes to the 30 calendar days of receipt of the CMS rulemaking. risk adjustment methodology at issue in Hearing Officer’s determination. If the Response: We disagree and believe the RADV audit process have been Administrator agreed to review the case, that the RADV audit process does not described in the annual advance notice. the Administrator would review the establish any substantive rules within The RADV audit process and appeals Hearing Officer’s decision as well as any the meaning of the APA or section 1871 procedures proposed in the October 22, other information included in the record of the Act, but rather is a means for of the Hearing Officer’s decision and ensuring that payments made to MA 2009 proposed rule do not make any would determine whether to uphold, organizations comply with substantive substantive changes in the methodology reverse, or modify the CMS Hearing rules governing MA payments that are for determining MA payment amounts. Officer’s decision. The Administrator’s set forth in the statute, and in Rather, they are designed to ensure that determination would be final and regulations that have been subjected to this payment methodology has been binding. notice and comment procedures. applied correctly, and the MA We also noted that, based on our Regulations specifying that payment organization has received the amount to experience with appeals of MA and amounts are subject to audit (for which it was entitled under this Medicare Part D program contract example, § 422.504(d)(1)(i) have been methodology. The risk adjustment determinations, we have determined subjected to notice and comment methodology provides that a specific that it would be necessary for us to procedures, and provide ample notice of amount be paid if an enrollee has a establish a ‘‘compliance date’’ to use as the fact that we have the right (and, particular condition. The RADV audits a reference point in issuing a ruling indeed, the duty) to ensure that MA and appeals process are designed to regarding RADV audit findings. payment amounts are accurate. See also, ensure that the enrollee in fact has that Therefore, we proposed at § 422.310(e), which states that MA condition, and that the MA organization § 422.311(b)(2), to require that the organizations and their providers and is thus entitled to the amount that has compliance date for meeting Federal practitioners will be required to submit been paid for that condition. The fact regulations requiring MA organizations a sample of medical records for the that audits might determine that an MA to submit medical records for the validation of risk adjustment data, as organization was not, in fact, paid validation of risk adjustment data required by CMS, and that there may be correctly, is not a change in (§ 422.310(e)) also be the due date when penalties for submission of inaccurate methodology or assumptions related to MA organizations (or their contractor(s)) data. how the payment amount is to be selected for RADV audit would need to Indeed, we would point out that determined and therefore is not subject submit medical records to us. We stated throughout the Medicare program, and to the advance notice requirements we would inform an MA organization in government programs generally, audit under section 1853(b)(2) of the Act. writing regarding selection for RADV policies and procedures intended to Nonetheless, in our October 22, 2009 audit, including the due date for ensure or verify payment accuracy assist proposed rule, we proposed to provide submission of medical records. in the enforcement of rules, and are not notice of RADV audit methodology to We invited and received a large themselves substantive rules subject to the public, as well as a summary of number of comments from health plans, APA notice and comment procedures. RADV methodology issues for each managed care industry trade Therefore, to the extent we are audited MA organization at the time we associations, and other interested providing a RADV appeals process, we issue our audit finding pursuant to an parties regarding not only the proposed are providing an opportunity that does actual RADV audit. We offered to appeals process described in proposed not currently exist for MA organizations provide details of our RADV audit § 422.311—but also the RADV audit to appeal audit findings that they would methodology in an attempt to provide process and underlying Medicare otherwise not have been permitted to additional transparency related to the Advantage payment policy. These question. process. We anticipate providing comments have resulted in changes to Comment: Some commenters stated additional notice of RADV audit our above-described proposals as that CMS did not follow proper methodology to the public by discussed below. procedures and stated that procedures publishing the methodology in some

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type of Medicare program document— should be addressed, and as such, we do In addition, the RADV methodology most likely in a Medicare manual later so as follows. that we employ in the process of this year (2010). Comment: Many commenters reporting a component of the national Comment: A commenter stated that recommended that CMS independently Part C payment error is similar to the CMS was not complying with test and validate its RADV methodology methodological approach that we requirements in section 1871(a)(2) of the before CMS implements it. The employ in conducting contract-specific Act, which states that ‘‘No rule, commenters indicated that CMS failed RADV audits and error calculations. requirement, or other statement of to provide any record of submitting its This methodology has been reviewed policy (other than a national coverage methodologies to an academic review and approved by officials at the HHS. determination) that establishes or and that if CMS has done so, we should This notwithstanding, in considering changes a substantive legal standard have included such studies with the the commenters’ questions, where governing the scope of benefits, the proposed rule so that interested parties necessary, we will incorporate payment for services, * * * shall take could review and comment on any of additional independent third party effect unless it is promulgated by the these academic studies. The review for purposes of validating RADV Secretary by regulation* * *’’ commenters recommended that CMS error-calculation methodology. As Response: As discussed previously, provide a process that permits thorough indicated in our proposed rule and cited the RADV audit process, and the review and comment by plans of RADV elsewhere in the preamble to this final appeals procedures addressed in this audit methodology issues before rule, we intend to publish its RADV rulemaking, do not ‘‘establish’’ or undertaking further RADV audits. methodology in some type of public ‘‘change’’ any ‘‘substantive legal standard Several commenters further document–most likely, a Medicare governing * * * payment.’’ To the recommended that all methodological Manual, so that the public can review contrary, they are designed to ensure issues pertaining to RADV audits be and provide comment as it deems that the substantive legal standards for appealable. necessary. Finally, to ensure that audited organizations understand how payment set forth in the statute and Response: Previously in this preamble their RADV error rate was calculated, as regulations are correctly applied. The we indicate that the process of indicated in our proposed rule, we substantive rules governing the amount independently reviewing medical further intend to describe our RADV of payment to which the MA records to validate risk adjustment data methodology in each audited organization is entitled are unchanged submitted by MA organizations for as governed by statute and organization’s RADV audit report. payment purposes has been established Given these efforts to ensure that the implementing regulations. and operational for more than 10 years. RADV process is transparent to audited Comment: A commenter urged that Over the course of this timeframe, we MA organizations and the public, and CMS suspend RADV audits until such have been advised on the RADV process that the methodology used under that time as CMS subjects the rules to notice by statisticians, senior analysts, expert process is reasonable, consistent, and and comment rulemaking. medical record coders, physicians, accurate, we do not believe any further Response: As discussed previously, managed care professionals, and other action is required. we do not believe subjecting the RADV health care providers. From a medical Comment: Several commenters argued audit process to rulemaking is required record coding perspective, we have that CMS should include Medicare plan or appropriate, there would be no basis secured expert direction from Peer enrollees for whom no diagnosis code for suspending the audit process. Review Organizations (PROs) (in the was submitted under the risk Comment: One commenter noted that past) and Quality Improvement adjustment methodology as part of its when the risk adjustment system was Organizations (QIOs) (currently) by RADV error testing samples. These initially established, the Secretary was incorporating them into the RADV team. commenters also recommended that required to submit a report to Congress From an analytic design and CMS include ‘‘under-coding’’ findings in in accordance with section 1853(a)(3)(A) implementation perspective, we have in the audit error estimates in order to of the Act that documented the the past and continue to employ senior more accurately account for members’ proposed method of risk adjustment of level expert analysts from different health status. MA payment rates, and that included an academic fields as independent Response: Our RADV audit policy evaluation of the method by an outside, contributors to the RADV operations does account for both underpayments independent actuary of the actuarial team to review and validate the and overpayments. The RADV process soundness of the proposal. The accuracy of the findings across the addresses under-coding through the commenter believed that such an RADV process, including peer review of application of rules for crediting a evaluation was required in the case of statistical sampling and payment error sampled enrollee with additional HCCs the RADV audit process. calculation methodologies. The that are identified incidentally, during Response: We disagree that RADV independent expert analysis and review medical record review. We emphasize audits impact the risk adjustment is similar to that conducted in an that these ‘‘additional’’ diagnoses were system in any manner. As indicated academic setting in that the not originally submitted for payment for earlier, RADV audits are solely to verify participating parties are credentialed in enrollees selected in the sample, and yet that the risk adjustment methodology is a specific field of study, such as we provide audited organizations credit being correctly applied. statistics, and possess substantial years through our RADV medical record We also received a large number of of expertise conducting similar review process. comments from MA organizations, processes and analyses. The However, we have not and do not managed care trade associations and a independent methodology review expect to sample enrollees for whom no law firm regarding RADV processes also involve the use of HCCs were submitted. This is because methodological-related issues. While internal controls, and tests for the RADV is an audit process that is some comments were not relevant to the consistency and accuracy. RADV intended to validate the HCCs that were rules that CMS proposed regarding the procedures are subject to the evaluation submitted by MA organizations in order RADV appeals process, there were a requirements of the CMS Annual to determine whether the additional number of comments that we believe Financial Audit. payment amounts associated with these

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diagnosis codes were properly made. not have considered in developing bids medical record review coders have the Under our separate Risk Adjustment for affected prior years. Commenters qualifications and experience necessary Data Submission Process, the data suggested that CMS’ sampling to code RADV-related medical records. submission period for any given methodology undercuts the mandate in Commenters specifically questioned payment year is lengthy and extends section 1854(b)(6)(B)(iv) of the Act that whether RADV coders were equipped to beyond the actual payment year, MA organizations’ rates reflect the code accurately in situations in which providing a substantial amount of time revenue needs of the organization. The clinical training may be required in for organizations to submit and/or commenters assert that MA order to recognize all extractable ICD–9 correct enrollee HCC risk adjustment organizations did not develop bid codes. They inquired into the data for any given payment year—to submissions for calendar years 2006 certification and coding experience reflect of enrollee health status. This is through 2009 with an expectation that qualifications for the RADV coders. sufficient time for plans to submit data CMS would implement contract-wide Response: The coders that CMS uses on all their enrollees, including those payment adjustments based on provider to review RADV medical records are with no HCCs. The RADV audit process documentation issues outside of the MA fully qualified to code RADV-related is not intended to serve as a de facto organizations’ control. As a result, if medical records. All coders are mechanism for extending the HCC data payments effectively are reduced professionally certified for example, submission deadlines under which MA retroactively as the result of RADV Certified Professional Coder (CPC), organizations operate. audits, the bid submissions (and Certified Coding Specialist (CCS), We received a number of comments resulting payments) arguably would not Registered Health Information from MA organizations and a law firm adequately reflect Plans’ risks, and MA Administrator, (RHIA) and Registered regarding the financial impact of RADV organizations may be forced to dip into Health Information Technician (RHIT), audits. While these comments did not their reserves to repay dollars that were and must have prior experience coding pertain directly to our proposed RADV not anticipated to be at risk. medical records. Coders have access to appeals procedures, some comments Response: We disagree. If plan bids physician consultation as needed. nevertheless indirectly impact the are developed based on faulty data, such Coders also have access to our RADV appeals rules. Therefore, we as inappropriate claim costs or risk Independent Coding Consultant—a respond to several of these comments score data, there is a greater likelihood coding expert with more than 10 years here. of error in the bid projection. There are of professional coding experience, Comment: Several commenters many factors that influence the accuracy which we require to be RHIA, coding suggested that CMS’s proposed of bid projection, and data quality is just certified and to have at least 5 years of methodology to calculate and apply one such factor. There is no legal experience in RADV-specific coding. error rates and payment adjustments authority to change a bid amount after Comment: Several commenters across contract years after payments it has been accepted regardless if objected to what they contend is a were made undermines the actuarially- additional information suggests that the burden that RADV audits impose upon based risk assumptions inherent in bid is too high or too low. the physicians and physician practices Plans’ bid submissions. In general, it is our belief that health who must produce medical records Response: Regarding the assertion that plans are confusing actuarial necessary to conduct audits. These RADV audits undermine the Part C equivalence in payment amount— commenters recommended that CMS bidding process, beginning with the which demographic adjustments, risk take into account the potential impacts introduction of the HCC risk adjustment adjustment methodology, and coding of more aggressive program integrity model for CY 2004, we have published intensity adjustment are all designed to efforts on the medical practices that clear guidelines to be followed by MA achieve— with differences in the way provide care to MA plan enrollees. organizations in the collection and costs are documented. Because MA Outside of the proposed rule, we have support of diagnosis codes underlying organizations are paid on a capitation also received letters arguing that the risk scores for plan enrollees. In their basis, costs are not covered for a specific burden associated with RADV audits is preparation of a MA bid, certifying service provided. Rather, they are based not limited to the CMS’ audits but also actuaries are expected to ensure that the on the actuarial value of such costs. The extends to internal audit activity underlying data are reasonable and risk adjustment methodology uses undertaken by Medicare health plans appropriate for the circumstance, diagnosis codes as a proxy for higher that mimics the RADV audits that we including the base year risk scores. If costs associated with a particular undertake for Medicare payment the ultimate risk scores for a plan’s diagnosis. Because, under original validation. These commenters raised population are lower than initially Medicare, costs of specific services concerns that Medicare health plans forecast by the certifying actuary, then received are reimbursed, the diagnoses were misrepresenting their internal the plan is likely to experience lower leading to such costs being incurred audit activity as official CMS RADV than expected margin. Conversely, if the have a different relevance under original audits. ultimate risk scores for a plan’s Medicare than they do under the Response: Section 422.310(e) requires population are higher than initially Medicare Part C payment system. The that providers who voluntarily enter forecast by the certifying actuary, then risk adjustment methodology and RADV into contracts with MA organizations the plan is likely to experience greater audit process that we employ to ensure submit data to CMS contractors/IVCs for than expected margin. These results accuracy under Medicare Part C actually RADV audits. In an effort to minimize illustrate the nature of health plan further actuarial equivalence, rather the burden associated with this activity, capitation and the risk borne by MA than conflicting with it. The differences we have developed best practices that organizations. between MA and original Medicare are we encourage health plans to employ in Comment: Commenters stated that the simply attributable to differences in their efforts to gather medical records establishment of an audit methodology how payment is made. It is these from providers and hospitals. To the that involves retrospective contract- differences that necessitate the actuarial extent MA organizations employ these level payment adjustments creates the equivalence standard in the first place. practices, it is our belief that the impact potential for unpredictable retroactive Comment: Several commenters of RADV audits on providers can be liability that MA organizations could questioned whether CMS’s RADV minimized.

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We also understand the increasing best medical record policy to the Moreover, we believe that the one best need for providers to be able to exclusion of other sources of medical record policy and the distinguish when they are being asked information that might confirm an HCC, operational process associated with it for medical records in association with the RADV appeals process should allow are far less restrictive than Medicare an MA plan’s own audit or in for HCC medical record review findings FFS. MA organizations are not limited accordance with an official Medicare to be appealed. to the specified date(s) of service they program RADV audit which is subject to Response: To address these comments reported to us with regard to selecting legislative requirements. Therefore, we as described in § 422.311(c)(2) of this a medical record as supporting issue letters on our letterhead that MA final rule, we have revised the process documentation for a specific HCC. We organizations must use when requesting so that MA organizations may appeal continue to believe that the one best medical records from providers when medical record review determinations medical record policy is appropriate for the request is specifically related to an in accordance with the procedures the Medicare Part C risk adjusted official CMS RADV audit. Providers specified in § 422.311(c)(2). payment system which is distinct from may rely upon these letters as an Comment: A number of commenters a FFS payment system where payment indicator that a given medical record argued that the one best medical record is determined on a claim-by-claim basis. request is for CMS’ RADV, and policy is flawed in that it provides an Under Part C, we only require that plans providers may request this authorizing insufficient basis for confirming an HCC send one HCC for payment for an entire letter before responding to requests by for members with chronic diseases year; it therefore logically follows that the MA plan. when a collection of several records, we would only require one medical We received a large number of perhaps from various providers, record to validate this HCC. comments from MA organizations, considered in the aggregate might better Comment: Some commenters stated managed care trade associations and a verify a patient’s condition. that the one best medical record rule ‘‘ law firm regarding the one best medical Response: We disagree. In the case of was inconsistent with the mandate that ’’ record policy that CMS proposed to a chronic disease such as congestive MA payment adjustments be actuarially apply to the RADV program. By way of heart failure, all that is required is equivalent to the FFS sector. ‘‘ Response: It is our belief that health explanation, the one best medical medical record documentation from one ’’ plans are confusing actuarial record policy specifies that for any one visit to a physician or a hospital, over sampled beneficiary—with any one equivalence in payment amount— the course of the data collection year, to HCC—the MA organization is allowed which demographic adjustments, risk validate the audited HCC. to select and submit supporting medical adjustment methodology, and coding Comment: We received several record documentation of a face-to-face intensity adjustment are all designed to comments comparing the RADV audit encounter for a physician or outpatient achieve—with differences in the way and appeals process to varying program visit (one date of service) or an inpatient costs are documented. Because MA stay (range of dates from admit to attributes of the Medicare FFS program. organizations are paid on a capitation discharge). The face-to-face encounter For example, some commenters argued basis, costs are not covered for a specific would have needed to occur at some that CMS’ one best medical record rule service provided. Rather, they are based point during the data collection year conflicts with Medicare FFS standards on the actuarial value of such costs. The (from January 1st to December 31st). since there is no one best medical risk adjustment methodology uses Comment: Commenters contended record rule applied to Medicare diagnosis codes as a proxy for higher that the one best medical record policy payment error-rate testing for FFS costs associated with a particular forces plans to omit relevant data that providers. diagnosis. Because, under original could be supported through Response: Payment error-testing Medicare, costs of specific services documentation that CMS does not under original Medicare is different received are reimbursed, the diagnosis permit—such as prescription drug data than payment error testing under leading to such costs being incurred has and lab results. Medicare Part C. Under original a different relevance under original Response: The RADV risk adjustment Medicare, much of what comprises the Medicare than they do under the model is based upon FFS claims data error testing regimen is aimed at Medicare Part C payment system. The from specific risk adjustment provider validating that a particular level of risk adjustment methodology and RADV types, and not alternative data sources, service was provided and therefore audit process that we employs to ensure such as, prescription drug data or lab justifies a given level of Medicare accuracy under Medicare Part C we results. Therefore, the RADV audit payment. Under RADV, the payment believe furthers actuarial equivalence, process is based upon supporting error testing focuses on validating HCCs rather than conflicts with it. The medical record documentation from by examining medical records to differences between MA and original provider data sources that are used to determine whether they contain Medicare are simply attributable to calibrate the model. As for the one best supporting diagnostic codes. This error differences in how payment is made. It medical record policy, while MA testing is aimed at validating that a is these differences that necessitate the organizations that voluntarily submit particular Medicare beneficiary indeed actuarial equivalence standard in the HCCs for Medicare payment are has the medical condition for which the first place. prospectively paid based on these MA organization has been paid for, and Comment: A commenter noted that in unaudited and unvalidated HCCs not whether a particular level of service Medicare Part A and B appeal contexts, submissions, we, upon the (for example, level 1 office visit vs. level supplemental information and recommendation of MA organizations, 2 office visits) was provided. Moreover, testimony are considered, and given agreed to allow any one medical record there is no evidence to support the such weight as the fact finder from across an entire data collection notion that the Congress, in establishing determines is appropriate. period to validate an HCC incorporated the Part C payment process, ever Response: Under our proposed into the payment to the MA intended the Part C payment process to appeals procedures that affords MA organization. mimic payment processes under organizations the ability to appeal the Comment: Some commenters contend Original Medicare. Indeed, they are Part C error calculation specifiedat that if CMS is going to rely on the one fundamentally different. § 422.311(c)(3), the CMS Hearing Officer

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has the discretion to conduct the We do not require MA organizations medical conditions not fully supported hearing in alternative ways beyond to submit HCCs for beneficiaries; MA in the medical record submitted to CMS. conducting the hearing on the record. organizations choose whether or not to The commenters further argued that For example, the Hearing Officer can do so. For risk adjustment diagnoses CMS should permit attestations to be choose to conduct the hearing by way of that are submitted, it is the used to validate not only the physician teleconference or in person. The CMS responsibility of the MA organization to signature and credentials that are Hearing Officer also has the discretion obtain appropriate documentation. If missing from a medical record, but also to request supplemental information or MA organizations are not confident in for patient name, identifier, date of to accept testimony, as he or she deems the information they obtain from their service, and other documentation necessary. Also, under the medical providers, they may wish to initiate inadequacies that can result in a RADV record review appeal processes that we education efforts, or include provisions medical record coding error. specify at § 422.311(c)(2), we afford MA in their contracts that ensure providers Response: Taken in the aggregate, organizations the ability to submit appropriately document diagnoses and commenters’ recommendations supplemental information—the provide medical record documentation regarding an expanded use of attestation reviewed by the IVC— to to the plan upon request. attestations in the RADV audit process validate the same HCC that the Initial In regards to supplemental reflect a misunderstanding of what Validation Contractor (IVC) initially information, we have determined, and attestations are intended to accomplish. determined to be in error. MA plans have been informed multiple Many of the comments submitted Comment: Several commenters, times, that the appropriate format for suggest that we adopt a policy that in focusing on the relationship between obtaining risk adjustment information is effect, allows attestations to stand in the MA organizations and their providers, a medical record. For validation place of the medical records that are noted that errors in documentation are purposes, plans are asked to submit the required to validate the HCCs that have ultimately attributable to providers, not one best medical record documenting resulted in higher payments already MA organizations. These commenters the HCC. We carefully determined the made to MA organizations. For example, argued that, due to the nature of the MA one best medical record policy, after permitting physicians to use attestations program, while CMS makes a capitated consultation and input from the to ‘‘correct’ medical record coding- payment to organizations that have industry supporting this policy. We do related deficiencies determined relationships with providers, these not believe that supplemental pursuant to medical record review; or information would be sufficient, or add providers may not have an incentive to allowing attestations to be an acceptable value to a record that does not support document the HCCs which affect vehicle for the submission of new HCCs an HCC for which the plan had been payment to the MA organization. The that were not otherwise already paid. submitted to CMS for payment. commenters also stated that contract- Comment: Many commenters from the level payment adjustments penalize MA MA industry recommended that before We believe that we must validate the organizations, while it is providers who CMS audit MA organizations under HCCs that result in additional payment are responsible for maintaining RADV, the agency first account for any through the existence of clear, adequate records. A commenter also error rates inherent in Medicare FFS unambiguous diagnostic information in suggested that we accept ‘‘other data’’ to data that affect MA error rates. These a beneficiary’s medical record. A supplement, or substitute, a medical commenters stated that through the medical record provides the written record. proposed RADV audit appeal process, support for the diagnosis that was made Response: Section 422.504(i)(1) CMS is imposing a set of rules regarding and must meet certain well recognized clarifies for MA organizations that they physician recordkeeping that were not documentation requirements. Consistent are ultimately responsible for the risk anticipated in the ICD–9CM coding with the Medicare FFS program, adjustment information submitted to guidelines, is not consistent with medical record documentation, rather CMS. This section of the regulations standard practices and is not enforced than other alternative documentation, states, ‘‘Notwithstanding any on original Medicare claims. The result, such as attestations, is required to relationship(s) that the MA organization they allege, is de facto MA payment validate information provided to us for may have with first tier, downstream, adjustments based on recordkeeping the purpose of making provider and related entities, the MA discrepancies without an adjustment to payments. The existence of an organization maintains ultimate original FFS Medicare risk scores for the accompanying attestation simply responsibility for adhering to and same recordkeeping discrepancies. provides a mechanism for the physician otherwise fully complying with all Response: We recognize that there to validate that the medical record that terms and conditions of its contract with may be potential merit in further is missing a signature or credential is in CMS.’’ MA organizations are further refining the error rate calculation. We fact his or her patient’s medical record. directed in § 422.504(i)(2) that all their are currently studying this issue. That is, attestations are intended to ‘‘first tier, downstream, and related Comment: A number of commenters complement medical records, not stand entities are required to agree that HHS, stated that the CMS-defined attestation in the place of them. the Comptroller General, or their process was overly narrow and should We continue to believe that the designees have the right to audit, be expanded to provide for more Medicare program is best served by evaluate, and inspect * * * medical widespread use of attestations in the limiting the applicability of attestations records.’’ Therefore, while we RADV audit process. Commenters to instances in which the original acknowledge the comments, we contended that attestations should be diagnosing physician submits a signed maintain that it is the responsibility of expanded to provide MA organizations and dated attestation to validate that the MA organizations to ensure that they with a greater ability to correct medical medical record in question is theirs. We submit accurate risk adjustment record coding-related errors or see no justifiable reason for CMS to information, and that the providers with deficiencies in submitted medical expand the applicability of attestations whom they contract are aware that we records. Commenters requested that beyond this intended purpose and have authority to audit medical records CMS permit MA organizations to submit therefore, we are not accepting these to verify this information. attestations that attest to the presence of comments.

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Comment: Several commenters organizations be allowed to submit a Response: We do not agree. We objected to CMS’ prohibition on using letter from a provider group or other proposed that the submission timeframe attestations for inpatient medical- responsible party, along with an for attestations line-up with the record-related RADV coding errors, and attestation in instances where the deadline for submitting medical records noted that CMS did not provide diagnosing physician is no longer able in order to simplify the medical record sufficient explanation why CMS would to sign and date an attestation—for and attestation submission process for not permit them. The commenters example, in instances in which the plans. Under the proposed process the recommended that CMS permit diagnosing physician has died, moved medical record and associated attestations to be submitted with respect or is no longer working for the medical attestation are submitted together. We to inpatient records. practice. strongly believe that 3 months is Response: We do not believe that Response: As stated previously in our sufficient time for MA organizations to permitting attestations for inpatient response to earlier commenters’ obtain and submit to us the medical medical records is justifiable. The recommendations that we expand the records and attestations necessary to decision to permit attestations for RADV applicability of attestations, we do not validate audited HCCs. To provide was in response to industry concerns agree that attestations are acceptable additional time beyond the 12 weeks about the lack of signatures in medical vehicles for submitting new risk afforded to MA organizations to submit records that are generated out of adjustment data and enrollee HCCs for the requested medical records would physician-office settings and not payment to CMS. The data submission split-up and unnecessarily complicate hospital settings. Upon preliminary period for any given payment year the medical record and attestation evaluation of RADV findings, our data opens 12 to 18 months before the start submission process. Since the corroborates industry concerns in that it of payment year, and closes 3 months attestation is intended to in effect— clearly shows that the majority of after the actual payment year ends, make the medical record ‘‘whole’’ by RADV-identified payment errors providing in total, at least 27 months for way of the signature and/or credential associated with lack of provider MA organizations to submit or correct attestation—we believe it is signatures were derived from medical enrollee HCC data for any given unreasonable to set up a submission records submitted and reviewed under payment year. This provides ample time system that separates the attestation the guidelines for physician/outpatients for MA organizations to voluntarily from the submission of the medical settings. Indeed, the data further submit HCCs to CMS for Medicare record. Therefore, we are not accepting corroborates that payment errors related payment. this recommendation and instead are to the lack of signature in inpatient Furthermore, a fundamental tenet of finalizing the requirement that medical records is minuscule. RADV is validating the existence of attestations be submitted to us by the Note that, with respect to the ongoing diagnoses information in a medical medical record submission deadline. use of attestations within the RADV Comment: Several commenters record. Consistent with Medicare FFS, audit context, we reserve the right to recommended that CMS permit health medical record documentation rather continue to evaluate payment error plan officials to amend the CMS than other documentation, such as related to physician/practitioner attestation form through hand-written attestations, is required to validate signatures, and the impact that annotations or to submit MA information provided to us for the attestations have upon these types of organization or provider-developed (that errors. We further reserve the right to purpose of making Medicare payments. is, attestation forms that were not amend the regulations in the future Therefore, we see no justifiable reason generated by CMS) attestation forms to regarding the use of attestations should to abandon this principle by allowing CMS. A more limited number of experience under the program justify the submission of unsubstantiated HCCs commenters recommended that CMS this change. via attestations, and therefore, reject the allow physicians not involved in the Comment: Several commenters commenters’ recommendations. diagnostic face-to-face encounter to recommended that CMS implement an Under our RADV audit policy, to the attest to medical records in instances administrative appeals process for extent we discover acceptable diagnoses where the diagnosing physician is either reviewing attestation determinations codes contained in the one best medical dead or no longer at the medical made by CMS. record that plans submit for purposes of practice or facility from which the Response: We understand the HCC validation that were not earlier medical record originated. These commenters’ concerns, but do not submitted to CMS for payment via the commenters reasoned that in believe this additional appeals process Risk Adjustment Payment System extenuating circumstances such as the is necessary. As noted in section (RAPS) system (what are known as death of a provider or a provider having § 422.311(c), in light of the changes we ‘‘additional HCCs’’) —we credit these relocated, another provider within the are making in this final rule to the diagnoses codes to the submitting MA medical practice could be permitted to proposed RADV appeal procedures that organization. Our reason for giving sign the attestation on behalf of the permit MA organizations to appeal health plans credit for these additional treating provider. Under this scenario, medical record review determinations diagnoses is precisely because they the signing provider would annotate the made at the RADV IVC review-level, existed in beneficiaries’ medical CMS attestation form explaining the MA organizations will be permitted to record(s)—and not in other types of situation—for example, ‘‘Due to the appeal medical record review-related documentation that would not be expiration of Dr. Smith on June 1, 20xx, determinations whose outcome was acceptable in any Medicare venue for I am signing this attestation on his determined by the existence or absence justifying Medicare payment. behalf.’’ of an attestation. Comment: Several commenters stated Response: We believe opening the Comment: Some commenters that the 12-week timeframe for door to allowing modifications to a CMS recommended that CMS allow submitting attestations was payment-related document raises attestations to be used as acceptable unreasonably short. These commenters serious program integrity-related vehicles for introducing new HCCs to recommended that CMS afford plans concerns and could result in fraud to the Medicare Part C payment process. additional time to gather and submit the Medicare program. The extent to Several commenters suggested that MA attestations. which one provider can reliably and

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validly attest to a medical record determinations that arise from the In order to be eligible for RADV prepared by another provider is collection and processing of medical medical record review appeal, MA questionable. We consulted with other records by CMS’ RADV IVC) will now organizations must adhere to Medicare program components within be permitted to do so via the medical established RADV audit and RADV CMS that are or will be utilizing record appeals process described in this appeals requirements, including the attestations or similar-like documents final rule at § 422.311(c). submission of medical records and (for example, certificates of medical We received many comments from documents in the manner and by the necessity, attestations used in MA organizations and a managed care deadlines specified by CMS. Failure to conjunction with Comprehensive Error industry trade association regarding the do so will render the MA organization Rate Testing (CERT)) that have some proposed RADV appeals process at ineligible for RADV medical record bearing on Medicare payment and § 422.311(c)(3). review appeal. At § 422.311(c)(2)(i)(1) of confirmed that there are very limited Comment: Many commenters stated this final rule, we specify that in order circumstances under which we permit that the proposed RADV appeals to be eligible for medical record review external modification to any payment- process was too narrow, and failed to determination appeal, MA organizations related documents. Given these program allow for all relevant evidence to be must adhere to established RADV audit integrity-related concerns, we are considered as part of the appeal process. procedures and RADV appeals rejecting these recommendations. Of particular interest to many requirements. Failure to follow our rules We received a large number of commenters was the fact that MA regarding the RADV medical record comments regarding our proposed organizations were prohibited from review audit procedures and RADV RADV documentation dispute appealing the substance of medical appeals requirements may render the procedures. record coding determinations, as MA organization’s request for appeal Comment: A commenter noted that described in our proposed regulation at invalid. the proposed definition of § 422.411(c)(3). With regard to the At § 422.311(c)(2)(i)(2) of this final ‘‘Documentation Dispute Process’’ in RADV appeals process, these rule, we provide that the medical record § 422.2 indicates that MA organizations commenters specifically recommended review determination appeal process can ‘‘dispute medical record that CMS: applies only to error determinations discrepancies that pertain to incorrect • Expand the scope of issues that may from review of the one best medical ICD–9–CM coding * * *’’ and appeared be raised in the appeals process to record submitted by the MA to conflict with language in proposed include, at minimum, challenges to organization and audited by the RADV § 422.311(c)(2)(ii)(A) stating that medical record coding decisions and IVC. medical record coding discrepancies are challenges to methodology—audit MA organizations must submit the ineligible for the documentation dispute methodology, sampling methodology, original, IVC-audited medical record process. Another commenter contended and error-calculation methodology. and any attestation reviewed by the IVC that the term ‘‘operational processing’’ as • Permit MA organizations to appeal to CMS for consideration under the described in the regulation, was vague HCC findings from the medical record appeals process. MA organizations’ and needed to be further defined. One review process. request for appeal may include the commenter recommended that CMS • Permit MA organizations to submit attestation reviewed by the IVC in allow MA organizations 60 days to coding corrections along with the accordance with § 422.311(c)(1) but may request documentation dispute instead additional medical records necessary to not include any additional documentary of the proposed 30 days. Several validate audited HCCs that CMS evidence. commenters recommended that MA determines are in error. At § 422.311(c)(2)(ii), we specify that organizations be permitted to appeal • Incorporate diagnoses identified in MA organizations may not appeal errors documentation dispute review medical records, but not previously that resulted because MA organizations determinations. submitted nor assigned to a member (so failed to adhere to established RADV Many other commenters asserted that called ‘‘additional’’) in its RADV-related audit procedures and RADV appeals the proposed documentation dispute payment adjustment calculations. requirements. This includes failure by process was too limited in scope, and Response: At proposed the MA organization to meet the effectively amounted to nothing more § 422.311(c)(3)(ii) we specified that MA medical record submission deadline than a mechanism for rectifying clerical organizations would not be permitted to established by CMS. We also specify errors that provided no meaningful way appeal medical record review because that any other documentation submitted to contest the accuracy of the auditors’ medical record review-related issues to us beyond the one best medical interpretation of the medical records would be resolved as a result of the record and attestation submitted to and submitted, or to supplement the record medical record review process and the audited by the IVC will not be reviewed being audited. attestation and documentation dispute by us under the medical record review Response: As noted in § 422.311(c) of processes described earlier in the determination appeal process. MA this final rule, in light of the changes to proposed regulation. However, based on organizations’ written requests for the proposed RADV appeal procedures the public comments we received, we medical record review determination that we are making in this final rule that have reconsidered this proposed appeal must specify the audited HCC(s) permit MA organizations to appeal restriction, and are for purposes of this that we identified as being in error and medical record review determinations final rule, changing our policy to now eligible for medical record review made at the RADV IVC review-level, we allow MA organizations to appeal determination appeal, and that the MA are withdrawing the proposed medical record review that occurs at the organization wishes to appeal. A request documentation dispute procedures IVC level. for medical record review determination described in the proposed rule. By way Therefore, under a new final appeal must specify the issues with of this final rule, MA organizations that § 422.311(c)(2), we are implementing a which the MA organization disagrees wish to dispute RADV medical record process that would allow MA and the reasons for the request for review determinations that arise out of organizations to appeal medical record appeal. operational processing of medical review that occurs at the IVC level of We describe the manner and timing of records selected for RADV audit (that is, medical record review. a request for medical record appeal at

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§ 422.311(c)(2)(iii). We will issue each appeal will be final and binding upon organizations voluntarily submitted to audited MA organization an IVC-level the MA organization unless the MA CMS for Medicare payment. Moreover, RADV audit report that provides details organization requests review by the a policy that supports submitting on the results of the medical record CMS Administrator. At corroborating evidence to accompany an review findings. This RADV audit report § 422.311(c)(2)(vi), we indicate that the already-submitted medical record will clearly specify the HCC MA organization has 30 calendar days violates CMS’ one best medical record determinations that are eligible for to request a review of the CMS Hearing policy. Therefore we are not accepting appeal. MA organizations will have 30 Officer’s determinations and that the the commenters’ suggestion. calendar days from the date of the CMS Administrator has discretionary Comment: Several commenters issuance of the RADV audit report to authority whether to review the recommended that CMS afford MA submit a written request for medical determination of the Hearing Officer. organizations 60 days, rather than 30 record review determination appeal. A After receiving a request for review, the days, to submit a written request for request for RADV medical record review Administrator has the discretion to elect reconsideration of its RADV payment appeal must specify the HCCs that we to review the Hearing Officer’s decision error calculation to provide sufficient have identified as being eligible for or to decline to review the hearing time to prepare for the request. medical record review appeal and that decision. If the Administrator elects to Response: We do not agree. We the MA organization wishes to appeal. review the hearing decision, the continue to believe that 30 calendar The request for appeal must also Administrator must review the CMS days is sufficient time for any MA include the IVC-audited one best Hearing Officer’s decision and organization considering appealing its medical record and may include an determine, based upon this decision, the RADV payment error calculation to attestation form in accordance with the hearing record, and any written prepare and submit such a request. We rules at § 422.311(c)(1), but may not arguments submitted by the MA are therefore, rejecting this include additional documentary organization or CMS, whether the recommendation. evidence. Please note that MA determination should be upheld, Comment: Several commenters organizations are not obligated to appeal reversed, or modified. The objected to the fact that all RADV- HCCs that we have identified as being Administrator notifies both parties of related appeals tasks are conducted by eligible for medical record review his or her determination regarding either CMS employees or agents determination appeal. review of the hearing decision within 30 employed by CMS. The commenters At § 422.311(c)(2)(iv), we describe the calendar days of receiving the request suggest that to ensure impartiality and process that we will undertake to for review. If the Administrator declines an independent review of plan appeals, conduct the medical record review to review the hearing decision or the the appeals process should allow for appeal. We designate a Hearing Officer Administrator does not make a independent reviewers outside of CMS. to conduct the medical record review determination regarding review within Plans should be allowed to choose and determination appeal. The Hearing 30 calendar days, the decision of the pay for a third party review of the error- Officer need not be an ALJ. We also CMS Hearing Officer is final. It is rate calculation under reconsideration— describe procedures for disqualifying a important to note that notwithstanding rather than use the CMS contractor. Hearing Officer in the event either party our implementing procedures that Response: As described in our objects to the designation of a Hearing permit MA organizations to appeal HCC proposed rule at § 422.311(c)(3)(v) and Officer. We provide written notice of the determinations at the IVC level of (vi), the CMS officials and/or time and place of the hearing at least 30 medical record review that we have contractors that will adjudicate calendar days before the schedule date. identified as being eligible for medical individual appeal cases will be fully The hearing is conducted by a CMS record review appeal and that the MA independent of the initial RADV error Hearing Officer who neither receives organization wishes to appeal, the determinations. One important attribute testimony nor accepts any new evidence ability of MA organizations to appeal in constructing an independent appeal that was not presented to the IVC. The these IVC-level medical record review structure for the RADV program is CMS Hearing Officer is limited to the determinations does not otherwise alter ensuring that the review officials or review of the record that was before the MA organizations’ ability to appeal contractors called upon to perform these IVC. RADV payment error calculations tasks have the necessary expertise to The CMS Hearing Officer reviews the described at § 422.311(c)(3). However, serve in the capacity of an independent IVC-audited one best medical record MA organizations cannot appeal RADV appeal official. It would be altogether and any attestation submitted by MA payment error calculations until all unreasonable for us to assume that plans organizations to determine whether it RADV medical record review-related would select appeal officials that meet supports overturning medical record appeals are finalized. our standards, not would we be able to determination errors listed in the MA Comment: Several commenters validate this process in a timely manner. organization’s IVC RADV audit report. suggested that CMS afford MA We cannot be put in the position of As soon as practical after the hearing, organizations a reasonable amount of having to review the qualifications of the Hearing Officer issues a decision time after the medical record plan-selected appeal officials and still which provides written notice of the submission deadline to submit be able to effectively administer the Hearing Officer’s review of the appeal of additional documentation that appeals process in a timely manner. As medical record review determination(s) corroborates an already-submitted such, we are rejecting the suggestion to the MA organization and to CMS. medical record. that plans be allowed to choose and pay Pursuant to the Hearing Officer’s Response: We do not agree that the for their own independent review decision, we recalculate the MA amount of time provided to MA officials. organization’s RADV payment error and organizations to submit medical records Comment: A commenter stated that issue a new RADV audit report to the under existing RADV audit policy is the CMS’ RADV appeal rules should appellant MA organization. unreasonable. We provide MA provide for a meaningful way to appeal As described at § 422.311(c)(2)(v), the organizations 3 months to obtain and payment determinations. decision of the CMS Hearing Officer submit to CMS the medical records Response: We believe that the regarding RADV medical record review necessary to validate the HCCs that MA commenter means that our ability to

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adjust payments once RADV audit At proposed § 422.311(c)(3)(v) and Without a specific date as a reference results are finalized should likewise be (vi), we specified that a CMS official or point for evaluating compliance, MA subject to appeal. We agree and for this contractor not otherwise involved in organizations could choose to assert that reason, as explained in the proposed error-rate calculation activity would while they were unable to meet RADV regulation, we are providing multiple review the written request for audit requirements on the date we avenues for MA organizations to appeal reconsideration, the RADV payment specified as the due date for medical the RADV findings, including the ability error calculation and any written record submission, they were later able to appeal mistakes in the contract evidence submitted by the MA to do so. Under this scenario, specific payment error estimate as organization that pertains to CMS’ organizations would be free to assert the determined by our payment error RADV payment error calculation. We right to submit medical records in place estimate calculation methodology. are finalizing that proposal in this rule. of, or in addition to, records that were These opportunities to appeal provide Comment: A commenter believed that or were not, as the case may be, ample recourse to MA organizations to the level of detail proposed for the submitted to us by the RADV audit due have RADV findings fairly readdressed. RADV appeals process was too specific. date. The medical record review process As part of this process, at § 422.311(c)(3) This commenter indicated that because could continue ad-infinitum, preventing (vi)(B) and (D), we specified that we MA organizations’ and CMS’ experience us from closing out RADV audits and would hire an independent RADV with data validation is relatively new, collecting any identified overpayments. payment error appeals contractor to CMS should avoid putting a high level The notion of considering additional replicate and validate the payment of detail into the regulation and should evidence and testimony after the determinations that result in our error- instead, maintain the flexibility compliance date has passed negates the calculation. Therefore, MA necessary to do what makes sense in the intended purpose of establishing a organizations that seek to appeal their context of the data validation. compliance date in the first place, and error rate calculation can rest assured Response: We do not agree that our is therefore rejected. that the payment determinations that experience with data validation is result in our error calculation are relatively new, since we have been 2. Payments to Medicare Advantage reviewed by an independent contractor. performing RADV audits for over 10 Organizations—Actuarial Valuation Comment: Several commenters noted years. The expertise and experience (§ 422.254) that, although the proposed rule brought to the development of this provides for the review of the RADV function in that timeframe has enabled We proposed amendments to calculation by a neutral third party, the us to present a balanced level of detail § 422.254 to expressly require an proposed rule did not specify the with regard to the proposed regulation. actuarial certification for Part C bids. As criteria that the independent third party While we certainly appreciate the we noted in the preamble to the will utilize in determining whether the commenters’ concerns regarding the proposed rule, operationally we require error rate calculations are correct. These level of specificity proposed—and now an actuarial certification to accompany commenters recommend that CMS be finalized—in the regulation, we contend every bid, for both Parts C and D. A required to accept the third-party’s that this level of detail is necessary in qualified actuary who is a Member of findings or that CMS otherwise ensure order for the public to fully understand the American Academy of Actuaries that the decision on the findings is not how the RADV appeals process will (MAAA) must complete the made by an official who has a role in the operate. We concur with the certification. The objective of obtaining RADV payment error calculation that is recommendation that we remain flexible an actuarial certification is to place under review. as we take further steps to implement greater responsibility on the actuary’s Response: The independent third these rules. professional judgment and to hold him/ party will utilize the same error- Comment: One commenter stated that her accountable for the reasonableness calculation criteria that will be the compliance date proposed by CMS of the assumptions and projections. This employed by us in calculating its initial is unduly restrictive. This commenter requirement is already set forth in the error calculation. This methodology will recommended that CMS consider Part D regulations at § 423.265(c)(3). We be known to audited MA organizations. additional evidence and testimony after noted that our change in the Part C In the preamble to our proposed rule the compliance date has passed. regulation text will bring the Part C and as stated previously in this Response: We disagree. Based on our regulation at § 422.254(b)(5) in line with preamble, we state that we intended to experience with appeals of MA and current operational requirements and ensure that all MA organizations Medicare Part D program contract Part D. We are adopting § 422.254(b)(5) understand the RADV payment error determinations, it is absolutely essential as proposed into this final rule. calculation methodology by providing for us to establish a compliance date to Comment: We received three notice to all MA organizations of the use as a reference point in issuing a comments supporting the addition of methodology that will be employed for ruling regarding RADV audit findings. this operational requirement to calculating Part C payment errors. We In proposed § 422.311(b)(2), we regulatory text. We also received one anticipate publishing the RADV error specified that the compliance date be comment asking us if this requirement calculation methodology in some type the date that MA organizations are would apply to 2011 Part C bids. of CMS document—most likely some required to submit medical records for type of Medicare manual—and annually the validation of risk adjustment data Response: The 2011 Part C bids are providing notice of any changes that (§ 422.310(e)). By way of this final rule, due on June 7, 2010, the first Monday will be made to this manual. In addition we are extending the compliance date to of June. Regardless of whether this to providing an annual notice of RADV include the date that MA organizations regulation is final by that date, we will audit methodology, we indicated we that choose to appeal IVC medical expect MA organizations to submit Part would provide an expanded explanation record review in accordance with C bids in accordance with current of methodology as part of each RADV § 422.311(c)(2) must submit medical operational guidance, which guidance is audit report that we send to MA records for review by the date we consistent with the regulatory language organizations that undergo RADV audit. determine for the appeal process. we are finalizing in this rule.

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3. Determination of Acceptable codifies what they understood to be therefore, we are not providing the Administrative Costs by HMO/CMP CMS’ existing policy regarding the specific guidance that was requested by Cost Contractors and Health Care exclusion of these costs. these commenters at this time. We Prepayment Plans (HCPPs) (§ 417.564) Response: We agree with the intend to provide further sub-regulatory commenters supporting our proposal to We proposed revising the regulations guidance to HCPPs and HMO/CMP cost exclude the costs described in governing payments to health care contractors on issues that would § 417.564(c) when reimbursable prepayment plans (HCPPs) authorized generally impact all HCPPs and cost administrative costs are computed by under section 1833(a)(1)(A) of the Act contractors. We will also provide HCPPs and HMO/CMP cost contractors. and cost HMOs/CMPs authorized under assistance to individual HCPPs and cost Accordingly, we are adopting contractors on a case-by-case basis. section 1876 of the Act to clarify how § 417.564(c) without further we believe the reasonable cost modification in this final rule. 4. Calculation of the Minimum principles in section 1861(v) should Comment: Two commenters agreed Percentage Increase Under Part C apply to HCPPs and HMOs/CMPs by with our proposals to clarify how (§ 422.306) specifying the methodologies that must HCPPs and HMO/CMP cost contractors In the October 22, 2009, proposed be used in determining the different must determine reasonable rule, we proposed to revise § 422.306 to allowable administrative costs for both administrative costs, and the eliminate the 2 percent minimum such entities. requirement that this information be update for all rate calculations other Specifically, we proposed revising available to CMS upon request. than ESRD. As we noted in the § 417.564(b)(2) to clarify how HCPP and However, these commenters wanted preamble to the proposed rule, section cost contractors authorized under CMS to consider the following 5301 of the DRA added section 1853(k) section 1876 of the Act must determine recommendations with respect to the of the Act to create a single rate book for ‘‘reasonable’’ administrative costs. At proposed requirements—(1) providing calculating MA payments and § 417.564(b)(2)(iii), we proposed that guidance that would further clarify applicable adjustments. Section 5301 of personnel costs claimed for CMS’ expectations about how cost DRA also modified the methodology for administrative costs in both HCPP and contractors will document this updating the MA payment rates by cost contracts authorized under section information, including examples of how adding section 1853(k)(1)(B) of the Act. 1876 of the Act must be linked to the time should be tracked and how to Beginning in 2007, the statute requires, specific administrative function evaluate the match between skill level for purposes of calculating the performed by persons, at a specific rate and tasks performed; (2) ensuring that minimum percentage increase rate, that of pay, for a specified period of time. the documentation requirements will be the previous year’s benchmarks be We also clarified in the proposed rule reasonable and structured in a manner updated annually using only the that this level of information must be that is not unduly burdensome to cost national per capita MA growth available to us upon request or in the contractors; (3) providing cost percentage for the year—as described in course of a review. Additionally, we contractors an opportunity to comment section 1853(c)(6) of the Act. Prior to proposed revising § 417.564 by adding a on this guidance before it is finalized to 2007 the minimum percentage increase new paragraph (c) that specifies that, in ensure that operational issues can be rate was the greater of 102 percent of the order for costs to be considered fully considered; and (4) applying the MA capitation rate for the preceding ‘‘reasonable costs’’ within the meaning requirements to cost years following the year, or the MA capitation rate for the of section 1861(v) of the Act, which year in which the regulation is effective. preceding year increased by the national expressly excludes ‘‘incurred cost found One of the commenters also per capita MA growth percentage for the to be unnecessary in the efficient recommended that CMS consider year. delivery of needed health services,’’ the modifying this proposal to clarify the We noted that since the statute, as following costs must be excluded when meaning of the term ‘‘task,’’ and limit the revised by the DRA, no longer provides computing reimbursable administrative tracking of time for the performance of for the 2 percent minimum update, we costs: separate tasks performed by a single can no longer apply it to the MA rates. • Donations. individual to circumstances when it is The 2 percent minimum update still • Fines and penalties. necessary to achieve the objectives of applies to the end stage renal disease • Political and lobbying activities. the rule (for example, when the tasks, MA update because the statute at • Charity and courtesy allowances. consistent with CMS rules and policy, section 1853(a)(1)(H) of the Act provides • Spousal education. have different apportionment statistics). that ESRD rates are to be calculated in • Entertainment. The commenter also suggested that CMS a manner consistent with the way those • Return on equity. clarify in the final rule that when rates were calculated ‘‘under the In the proposed rule we specifically personnel perform some administrative provisions of [section 1853 of the Act] asked for comments on our clarification functions that are included in the as in effect before the date of enactment of reimbursable administrative costs. As administrative and general specified of the MMA.’’ The pre-2003 version of indicated below, after considering the cost areas while performing some section 1853 of the Act included the 2 comments we received, we are adopting administrative functions that are viewed percent minimum update. Therefore, we our proposed § 417.564(b)(2)(iii) and as plan administration, only the time proposed to revise § 422.306 to § 417.564(c) without further spent on the administrative and general eliminate the 2 percent minimum modification in this final rule. functions should be tracked and update for all rate calculations other Comment: We received two comments documented. than ESRD. We are adopting that supported the list of costs that we Response: We believe that it is § 422.306(a) as proposed into this final proposed must be excluded by HCPPs important for HCPPs and HMO/CMP rule. and HMO/CMP cost contractors when cost contractors to have the flexibility to Comment: A few commenters computing reimbursable administrative establish their own methodology for supported CMS’s proposed requirement. costs. The commenters agreed that these determining reasonable administrative A commenter believed CMS’ costs should not be included in cost costs in order to meet the requirement interpretation of section 1853(k) of the reports and that the new provision described in § 417.564(b)(2)(iii); Act was incorrect and suggested that

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CMS retain the 2 percent minimum growth percentage; or the amount E. Changes To Improve Data Collection update requirement and recalculate (and calculated under section 1853(c)(1)(D) for Oversight and Quality Assessment pay) any retroactive payment from prior of the Act, which is 100 percent of fee- This section discusses and finalizes years (where the 2 percent minimum for-service costs. Further, in section four proposals in our October 22, 2009 update would have caused payments to 1853(k)(1)(B)(i) of the Act, we are also proposed rule intended to improve Part be higher than they would have been in required to ignore any adjustment under C and D data collection and use for its absence). The commenter contended section 1853(c)(6)(C) of the Act for any oversight and quality assessment. The that section 1853(k)(1)(B) of the Act year before 2004 when calculating the first proposal would address quality only removes the minimum percentage national per capita MA growth improvement programs and data on increase for years prior to 2004. percentage. This adjustment, called the quality and outcomes measures under Response: We disagree with the ‘‘adjustment for over or under projection Part C. As part of this proposal, we commenter. Section 1853(k)(1)(B) of the of national per capita MA growth proposed to address data collected by Act is clear in saying that it applies to percentage,’’ also did not include such Quality Improvement Organizations for years subsequent to 2007, in other an adjustment for years before 2004 MA quality improvement and words, to payment years beginning with when the minimum percentage increase performance assessment purposes. calendar year 2008. Section was calculated per section The second and third proposals 1853(k)(1)(B)(i) of the Act applies to all 1853(c)(1)(C)(v) of the Act for years would address payment for beneficiary payment years other than years in between 2004 and 2006. Finally, the surveys and independent yearly audits which rebasing is done in accordance calculation of MA payment increases of Part C and Part D measures (collected with section 1853(c)(1)(D)(ii) of the Act. based on the national per capita MA pursuant to our reporting requirements) In rebasing years, the calculation of MA growth percentage beginning with to determine their reliability, validity, payment rates is determined by section payment year 2007 were never less than completeness, and comparability in 1853(k)(1)(B)(ii) of the Act where the 2 percent. However we note that even if accordance with specifications amount payable is the greater of: Either it were, there would be no additional developed by us. The last proposal the amount calculated under section payment due MA organizations on this would amend our rules on the 1853(k)(1)(B)(i) of the Act, the MA basis because the 2 percent minimum collection and use of prescription drug payment amount for the previous year increase was eliminated beginning with event data for nonpayment-related increased by the national per capita MA 2007. purposes.

TABLE 5—IMPROVE DATA COLLECTION FOR OVERSIGHT AND QUALITY ASSESSMENT

Part 422 Part 423 Provision Part 480 Subpart Section Subpart Section

Requirements for Quality Improvement Subpart D ...... § 422.152 N/A ...... N/A § 480.140 Programs under Part C. § 422.153 Require that Sponsors pay for the Con- Subpart D ...... § 422.152(b)(5) Subpart D ...... § 423.156 N/A sumer Assessment Health Plan Sur- vey (CAHPS). Require validation of reporting require- Subpart D ...... § 422.516 Subpart D ...... § 423.514 N/A ments. § 423.514 Allow collection of all PDE data ele- N/A ...... N/A Subpart D...... § 423.505 N/A ments to be collected for non-payment purposes.

1. Requirements for Quality of care provided to enrollees in each data’’ that were collected as of Improvement Programs Under Part C MA plan offered by the MA November 1, 2003. (§ 422.152, § 422.153, and § 480.140) organization. Section 1852(e)(3)(A) of a. Quality Improvement Programs In our October 22, 2009 proposed the Act requires that, as part of this rule, under the authority in sections quality improvement program, MA In our October 22, 2009 proposed 1851(d)(4)(D), 1852(e)(1) and organizations collect, analyze, and rule, we noted that under our current 1852(e)(3)(A) of the Act, we proposed report data that permits the regulations at § 422.152(c) and several new requirements related to measurement of health outcomes and § 422.152(d), MA organizations have quality improvement programs and data other indices of quality as part of their flexibility to develop criteria for chronic on quality and outcomes measures quality improvement program for their care improvement programs (CCIPs) and under Part C. coordinated care plans. To the extent initiate any quality improvement Section 1851(d)(4)(D) of the Act that local PPO, regional PPO, PFFS, and projects that focus on clinical and non- requires us to make available to MA MSA plans have a network of contracted clinical areas based on the needs of their eligible individuals information providers, these plan types must meet enrolled population. However, based on comparing MA plan options, including the same quality improvement our experience with MA organizations information on plan quality and requirements as other coordinated care employing inconsistent methods in performance indicators to the extent this plans. Section 1852(e)(3)(B)(i) of the Act developing criteria for their CCIPs and information is available. Separately, generally limits the collection of data on quality improvement projects, we section 1852(e)(1) of the Act requires quality, outcomes, and beneficiary expressed concerns in the proposed rule that each MA organization have an satisfaction under section 1852(e)(3)(A) that giving MA organizations complete ongoing quality improvement program to facilitate consumer choice and discretion to establish their own CCIPs for the purpose of improving the quality program administration to ‘‘the types of and quality improvement projects does

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not allow beneficiaries to effectively areas, identified by CMS. Some of these survey data, there is a need for CCIP or compare plans and organizations to commenters wanted CMS to consider quality improvement projects manage and report projects. More additional recommendations with development due to performance and/or importantly, we expressed concerns that respect to our proposed requirements, clinical outcomes. We have offered MA these projects are not addressing quality including: (1) Providing an opportunity organizations identified through this improvement areas that we believe best for public comments as CMS develops targeted methodology assistance during reflects beneficiary needs. For example, priority areas for MA organizations and our initial communication regarding the some projects may be designed to on the process that CMS will use to need for CCIP or quality improvement improve processes only, without linking identify specific areas for quality project development. Technical the processes to clinical outcomes. We improvement with respect to particular assistance for the development of CCIPs are interested in MA organizations MA organizations; and (2) establishing a and quality improvement projects is focusing on individual as well as fixed time period after CMS establishes also available to all MA organizations population-specific health risk needs, its CCIP goals during which CMS could on an as needed basis. such as MA organizations’ use of not establish new CCIP goals. Using the HPMS, the Medicare internal data sources to identify clinical Response: As we develop our Managed Care Manual, and other means outcomes that not only fail to meet requirements, we will offer of communication that we determine to national averages, but also may opportunities for the industry and other be appropriate, we will annually inform jeopardize the overall health and quality interested parties to offer MA organizations individually and/or of life of the beneficiary. recommendations. While our goal is to generally of the process by which CCIPs As a result of our concerns, we keep any such requirements stable, we and quality improvement projects must proposed to revise § 422.152(a)(1) and note that it may be important for us to be conducted, which tools to use to § 422.152(a)(2) to require that MA modify our requirements in keeping report activities, and the time frame for organizations conduct CCIPs in patient with our goal of ensuring that CCIPs and submitting data and reports. We will populations, and conduct their required quality improvement projects address also use these communication methods quality improvement projects, in areas those quality improvement areas we to identify the patient populations and identified by CMS based on our review believe reflect beneficiary needs. areas we have determined would benefit of data collected from MA Comment: Many commenters opposed most from CCIPs and quality organizations. Specifically, we proposed our proposals to require that MA improvement projects. However, as to determine what areas would most organizations conduct CCIPs in patient noted previously, this does not preclude benefit from quality improvement, and populations, and quality improvement MA organizations from developing to provide guidance on specific quality projects in areas, identified by CMS. CCIPs and quality improvement projects improvement projects for MA Some of the concerns commenters that they independently determine to be organizations to implement, either raised were: (1) CMS’ requirements may needed for their population. based on those organizations’ specific not be aligned with MA organizations’ Comment: Many commenters quality improvement needs, or quality identified priorities for benefiting their suggested alternatives for CMS to improvement needs for MA plans enrollees; (2) systemic inequities would consider to its proposed requirements generally. We also proposed suggesting develop among competing MA plans for CCIPs and quality improvement methods and processes by which to that would undermine the competitive projects. These recommendations manage a quality improvement project structure of the MA program; and (3) generally fell into three groups—(1) as appropriate. organizations would lose the flexibility CMS should not adopt the proposed We proposed in the preamble to our to pursue projects of special clinical and policies and should allow MA October 22, 2009 proposed rule to operational value to their enrollees. organizations to develop their own annually inform MA organizations Response: We agree that CCIPs and CCIPs and quality improvement individually and/or generally which quality improvement projects should be projects; (2) CMS should provide patient populations and areas we have based on the needs of the plan’s general guidance to MA plans on CCIPs determined would benefit most from a enrolled population, and in line with and quality improvement projects and CCIP and quality improvement project, the organizations’ identified priorities develop a process for approving a plan’s respectively. We would convey for benefiting their enrollees. We will CCIPs and quality improvement projects generally applicable information via the continue to provide MA organizations prior to the plan implementing them; Medicare Managed Care Manual and the generally with the flexibility to identify and (3) CMS should consult industry Health Plan Management System topics for the development of CCIPs and before making changes to CCIP and (HPMS), and convey information that is quality improvement projects based on quality improvement project plan specific directly to the the particular needs of their members. requirements. organizations offering the MA plans in However, we are finalizing the revisions Some commenters specifically question. We are adopting to § 422.152(a)(1) and § 422.152(a)(2) to recommended that CMS impose CCIP or § 422.152(a)(1) and § 422.152(a)(2) require that, under certain quality improvement project obligations without further modification in this circumstances, some MA organizations on all MA organizations operating final rule and are clarifying, in our conduct CCIPs in patient populations within a given geographic area rather responses to comments below, that MA and quality improvement projects in than on an MA plan-specific basis and organizations will continue to have the areas identified by CMS based on our that CMS provide a list of programs and flexibility to develop criteria for CCIPs review of data collected from MA projects for MA plans to choose from and quality improvement projects based organizations and the populations and allow plans to select the programs, on the needs of their enrolled served by the plans. projects, and populations to which they population. To date, we have communicated with should apply in order to maximize the Comment: We received many MA organizations about specific benefit to beneficiaries. One commenter comments that supported our proposals operational areas and member suggested that, to address CMS’ concern to require that MA organizations populations for which we believe, based that some plans focus on process, rather conduct CCIPs in patient populations, on data collected through HEDIS, audit than outcomes, CMS focus on those and quality improvement projects in findings, member complaints, and other plans, and work with them to identify

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more appropriate programs and projects. required of C–SNPs to fulfill this health outcomes and quality measures Another commenter believed that CMS requirement, and allowing dual-eligible that we currently collect as part of these could provide more generalized SNPs (D–SNPs) to implement specific processes. guidance on the types of measures that projects for the dual-eligible population. We also noted that we believed the are acceptable (for example, the Several commenters were concerned collection of these data to be consistent commenter suggested that CMS consider that the CCIP and quality improvement with our authority under section requiring that CCIPs and quality project models that CMS develops may 1852(e)(3)(A) of the Act, and that we do improvement projects link processes to not be appropriate for special needs not believe that the limitation described clinical outcomes). Several commenters plans (SNPs) and that some SNPs will under section 1852(e)(3)(B) of the Act suggested that CMS consult with experts face significant challenges meeting State limits this proposed additional data in the industry to before imposing as well as MA requirements in the event collection because the data collected specific CCIP and quality improvement that CMS requirements for specific would be of the same ‘‘type’’ of data that project requirements on MA plans. One quality improvement topics that differ we currently collect as part of the commenter recommended that CMS from State requirements. HEDIS®, HOS, and CAHPS® processes. hold MA organizations accountable for Response: As discussed previously, In the preamble to the proposed rule, we choosing a CCIP based on their own MA organizations will continue to have noted post-surgical infections or patient population and data, and prior approve the flexibility to choose CCIP and falls as examples of additional areas on quality improvement project topics and quality improvement project topics that which we planned to collect data. methodologies based on specific quality meet the needs of their population and Therefore, we proposed to modify improvement needs identified by MA operational processes. When MA § 422.152(b)(3) and § 422.152(e)(2) to organizations. This commenter further organizations are required to conduct require MA plans to collect, analyze, indicated that a prior approval process CCIPs in patient populations and and report quality performance data would allow CMS to assist MA quality improvement projects in areas identified by CMS that are of the same organizations in focusing on quality that we identify which are appropriate type of data that plans are currently improvement areas that reflect for SNPs, SNPs will follow the same required to collect and report to CMS. beneficiary needs and include sound quality improvement project and CCIP We also proposed that, consistent with methodologies that address clinical as processes identified for other types of the Paperwork Reduction Act (PRA), we well as process outcomes. MA plans. We will not expect SNPs to would provide the public at least two Response: As discussed previously, employ quality improvement project or opportunities for public comment before MA organizations will continue to have CCIP programs that are not appropriate imposing additional quality-related the flexibility to choose CCIP and for their population. We note that CMS collection and reporting requirements. quality improvement project topics that may use data collected from SNPs to We are finalizing our proposal to meet the needs of their population and determine if there are population- require MA plans to collect, analyze, operational processes, and we will offer specific topics that require targeted and report quality performance data opportunities for the industry to offer monitoring in the future. identified by CMS as described in the recommendations for fine-tuning our Comment: A few commenters were proposed rule and adopting CCIP and quality improvement project concerned about the challenges MA § 422.152(b)(3) and § 422.152(e)(2) requirements. We will take into organizations would face in allocating without further modification in this consideration the specific additional resources to meet the final rule. recommendations offered by proposed requirements as well as the Comment: A number of commenters commenters as we develop future potential for increased administrative supported CMS’ proposal to require MA guidance related to CCIPs and quality costs. plans to collect, analyze, and report improvement projects. Response: With respect to quality performance data identified by Comment: Several commenters were commenters’ concerns about the CMS that are of the same type of data concerned that the proposed additional cost of implementing these that plans are currently required to requirements could impinge on the requirements, we do not believe that collect and report to CMS. Commenters efforts of MA organizations to satisfy MA organizations will experience also supported CMS’ proposal to accreditation standards for National significant additional financial burdens provide the public at least two Committee for Quality Assurance as a result of these requirements. opportunities for public comment before (NCQA) or other accrediting bodies. imposing additional quality-related b. New Quality Measures Response: MA organizations that collection and reporting requirements, participate in the quality improvement In our October 22, 2009 proposed consistent with the PRA. deeming program will be subject to the rule, we stated that as we strengthen our Response: We agree with the standards of their accreditation oversight of quality improvement commenters supporting our proposal to organization. We will continue to programs implemented by MA require MA plans to collect, analyze, ensure that standards applied by organizations, we believe it is necessary and report quality performance data of deeming organizations are at least as to collect additional data on quality and the same type of data that plans are stringent as those applied by us. outcomes measures in order to better currently required to collect and report, Comment: Several commenters were track plan performance. We currently that we identify. Accordingly, we have concerned about special needs plans collect from MA organizations data on finalized our proposed § 422.152(b)(3) (SNPs) meeting the proposed quality, outcomes, and beneficiary and § 422.152(e)(2) in this final rule. requirements. Commenters satisfaction under the Healthcare Comment: A few commenters did not recommended allowing MA Effectiveness Data and Information Set support our proposal to require MA organizations to customize overall (HEDIS®), the Health Outcome Survey plans to collect data on additional quality improvement programs for their (HOS), and the Consumer Assessment quality performance measures. specialized populations in chronic care Health Providers Survey (CAHPS). We Commenters were concerned about the special needs plans (C–SNPs), deeming stated in the proposed rule that we administrative burden and costs all the individual model of care and anticipated additional collection and associated with additional data quality improvement initiatives reporting of the same types of data on collection and recommended that CMS

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use existing quality measures rather the industry in the development of the c. Use of Quality Improvement than require new measures. One new measures for which additional Organization Review Information commenter questioned whether collection of quality performance data In our October 2009 proposed rule, additional quality measures beyond the will be required. we asserted that data collected by Response: We will identify measures HEDIS, HOS, and CAHPS would be Quality Improvement Organizations and standards using internal CMS useful since these measures are (QIOs) to accomplish their mission methods as well as nationally accepted industry standards. One represent an important data resource for recognized methodologies. These commenter questioned CMS’ efforts to CMS in our efforts to improve quality ‘‘ ’’ measures and standards will be based use quality measures to score plans, under the MA program. QIOs collect on the information that is currently indicating that plans with lower survey, administrative, and medical collected, as well as any additional data enrollment and more direct control over records data in order to monitor and patient care, for example a closed model we find to be necessary to collect for assess provider performance. These data HMO, could achieve better measures this purpose. We have begun a year-long are frequently required by scope of work through more intensive interventions. project to research and analyze Response: As the MA program has population specific health outcomes contracts administered by CMS to assess evolved, attracting an increased number and plan operations data. As an whether or not QIOs are meeting of beneficiaries that present with important part of this project, industry performance goals. We discussed several proposed uses specialized health concerns, it has leaders, researchers, and individuals of the data collected by the QIOs. For become increasingly important for us to with expert knowledge of the Medicare focus on developing measures that meet population will be involved in the example, certain QIO data could be used the MA population’s needs. We believe discussions as we identify appropriate to develop a standardized core set of that collection of additional data on quality measures and standards for the clinical and non-clinical quality and quality outcomes measures is necessary MA program. We plan to use this performance measures that could be to better track plan performance in this information to further develop and applied to all MA plans in order to area. As noted previously, we disagree analyze the effectiveness of the current allow beneficiaries to make better with commenters that MA plans will and future measures associated with comparisons across all MA plan types experience significant additional health outcomes, operational and make an informed decision when financial burden as a result of these procedures and processes, and member selecting a plan. These measures could requirements. experience. As indicated in the also be used to rate plans according to Comment: Commenters provided proposed rule, we will provide the their performance. suggestions on how to identify the public at least two opportunities for We also outlined our plan to develop measures for which additional public comment through the PRA minimum performance levels and collection of quality performance data process before imposing additional requirements that address clinical and will be required. Several commenters quality-related collection and reporting nonclinical areas from the data collected recommended that we use existing requirements. by QIOs, as part of our efforts to provide nationally endorsed, clearly specified Comment: One commenter meaningful information to beneficiaries measures for any new reporting encouraged us to explore ways to when selecting an MA plan. In addition requirements we place on MA release timely, plan-specific data to to tracking plan performance, these data organizations, and that the measures be third parties to allow them to could also be used to monitor plan those of national standard setting experiment with different ways to compliance with MA contract organizations. One commenter indicated analyze claims data, and underlying requirements and support compliance that it would like to work with CMS to plan performance data, to assist or enforcement actions against plans see if any of the new measures should consumers with the identification, that are poor performers on certain be incorporated into HEDIS. Two selection, and use of their MA plans or quality and performance measures. commenters requested that the new PDPs based on plan performance or These data would also be appropriate quality measures be measurable through quality attributes. for use in a competitive value-based administrative data instead of chart Response: We do not collect claims purchasing program based on quality of reviews. One commenter supported the data from MA and Part D plans. care. examples we provided of new quality However, we do collect Part D Finally, we explained our intent to reporting requirements we indicated in prescription drug event (PDE) data, use one particular type of information our proposed rule, specifically, post- which is based on claims data submitted already collected by QIOs, that is, surgical infections or patient falls and by pharmacies to Part D sponsors. These quality review study (QRS) information recommended that the reporting be data are available for research purposes, (defined in 42 CFR 480.101(b)) and expanded to all health care acquired consistent with § 423.505. We are retool the data elements to make them conditions (the Medicare ‘‘never working to provide additional public specific to beneficiaries enrolled in MA events’’) and all infections. Another use files based on PDE data in the plans. A QRS is ‘‘an assessment, commenter indicated that additional future. More information on PDE data conducted by or for a QIO, of a patient broad based measures, such as for research purposes may be found at care problem for the purpose of readmission rates, also could provide http://www.resdac.umn.edu/ improving patient care through peer critical insights on performance. Available_CMS_Data.asp. For the analysis, intervention, resolution of the Additionally, one commenter suggested quality and performance data for Part C problem and follow-up.’’ By QRS that CMS consult with the Medicare and Part D plans, we release a database information, we mean all Payment Advisory Commission, which with all of the contract-level individual documentation related to the QRS recently finalized recommendations measures that make up the Part C and process. We proposed to obtain from the related to quality in the MA program Part D plan ratings. These data are QIO only the data that relate to MA plan and the measures that could be adopted available on the CMS Web site at beneficiaries, providers, practitioners, to compare MA plans to one another as http://www.cms.hhs.gov/ and services and to then aggregate the well as to Original Medicare. Some PrescriptionDrugCovGenIn/ data applicable to each MA plan based commenters suggested that CMS involve 06_PerformanceData.asp. on beneficiary enrollment.

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Accordingly, we proposed adding a deemed by NCQA would also be data to enable beneficiaries to compare new § 422.153 to indicate that we would required to send additional information health coverage options and select obtain and use quality review study to their QIO to comply with the among them, measure performance information that is generated, collected, proposed regulation. One commenter under the plan, and ensure compliance or acquired by QIOs under 42 CFR part indicated that the use of QIO review with plan requirements under Part 422, 480. We stated our intent to use these information would be administratively and other purposes related specifically data for the following functions: burdensome and duplicative of current to MA plans as specified by CMS. • Enabling beneficiaries to compare reporting measures such as HEDIS. Commenters agreed that CMS should health coverage options and select Response: We share the concerns not plan to disclose any beneficiary among them, measuring performance raised by commenters about the identifiable information. under the plan. inconsistency and timeliness of the data Some of these commenters asked CMS • Ensuring compliance with plan collected by QIOs. These concerns relate to consider additional recommendations requirements under Part 422. to QIO review of beneficiary quality of with respect to our proposals. Some of • Other purposes related specifically care concerns, medical necessity the recommendations were that CMS to MA plans, as specified by CMS. reviews, appeals, and other case should ensure that an adequate sample We also clarified that we did not plan reviews. of QIO data for dual eligibles is to disclose any beneficiary identifiable After reviewing these comments, we reviewed; allow plans to review the information. have discovered that the data that will information the QIO intends to submit In addition, we proposed amending be needed to meet the functions to CMS in order to give plans the § 480.140 to add a new paragraph (g), described in § 422.153 is not collected opportunity to correct errors; ensure authorizing our use of quality review from QIO case reviews. Instead, appropriate procedures are available for study information solely for the hospitals report this information to us as plans that may dispute the data that purposes specified in § 422.153. As part of the Reporting Hospital Quality CMS intends to make available to described below, we are modifying Data for Annual Payment Update beneficiaries before those data are § 422.153 and § 480.140(g) in this final (RHQDAPU) program, which is released; provide ample notice to plans rule. authorized under section of the specific data that CMS intends to Comment: A number of commenters 1886(b)(3)(B)(viii) of the Act. Much of collect to allow for programming and were concerned about the use of data this data is self-reported by hospitals on testing of data collection tools prior to collected from QIOs to measure plan a quarterly basis, and some is validated submission to CMS; and make Original performance and recommended that for accuracy. Further, the data does not Medicare data available to beneficiaries, CMS reconsider its proposal. One possess any of the timeliness and where available, along with MA plan commenter recommended that CMS reliability issues cited by the data. discuss current MA experience with commenters. Hospitals self-report One commenter indicated that CMS QIO studies and the potential future patient-level quality measure data for should develop a methodology to uses of QRS information with plans. patients covered by MA plans, Original stratify the data so that MA Some of the concerns cited by Medicare, and other payors to CMS for organizations would be grouped by local commenters are that— the RHQDAPU program. or regional MA organizations, and • There may be inconsistencies In response to the comments we defined by statewide or selected among QIOs on their assessments and received, we are narrowing the scope of geographic areas such as number of findings, which may disadvantage some our proposed § 480.140(g) to provide counties within a State, benefit design, plans. Individual QIOs may offer that QIOs must disclose to us QRS and plan type. This commenter also consistent and reliable data sources, but information collected as part of the indicated that data provided to aggregating data from multiple State- RHQDAPU program following hospital beneficiaries would be misleading if specific entities may dilute the review of the data (with identifiers of CMS compared all MA organizations in consistency and reliability that would MA plan beneficiaries, hospitals, a State without classifying these be required to accomplish CMS’ practitioners, and services) when we organizations by type and service area. proposed uses; request this information for the sole Response: As we refine our work plan • Some MA organizations have purpose of conducting activities related for using the data collected under experienced delays in the receipt of QIO to MA organizations as described in section 1886(b)(3)(B)(viii) of the Act study findings; therefore, the § 422.153. We believe that restricting (RHQDAPU data) for the functions organizations do not have timely notice our access to include only RHQDAPU described in § 422.153, we will consider of any deficiencies and are not able to hospital quality data that we may use these commenters’ recommendations to use the findings in their quality for the functions described in § 422.153 ensure we achieve our goals of improvement activities. The delay in will address the concerns about the providing meaningful information to dissemination of findings may not be timeliness and reliability of this data. beneficiaries, developing minimum sufficiently timely for CMS’ intended We are also modifying § 422.153 to performance levels and requirements purpose; indicate that we will acquire RHQDAPU that address clinical and non-clinical • Depending on the QIO, there is data from QIOs and may use it for the areas from the data collected by QIOs, often a substantial lag in the availability limited functions described in and ensuring plan compliance with MA of QIO data. Current MA performance § 422.153. As proposed, we do not plan contract requirements. assessment should not be assessed to disclose any beneficiary identifiable Comment: Commenters recommended based on data that are 2 or 3 years old; information. We also do not plan to that CMS ensure that the measures it and disclose any provider or practitioner develops are based on nationally • There may be additional burden identifiable information. endorsed measures, are collected in a placed on deemed plans that do not Comment: Many comments supported uniform fashion, and have large enough submit to the QIOs so that the data our proposal to obtain and use QRS sample sizes to support public reporting could be all inclusive from the QIOs. information that is generated, collected, as well as any value based purchasing Commenters recommended that CMS or acquired by QIOs. Commenters also decisions. One commenter clarify whether plans that are already supported CMS’s proposal to use these recommended that CMS specify that

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plans will have multiple opportunities administration of the CAHPS survey to of data for the CAHPS survey, asserting to comment on any performance their members. Under our proposal, Part that this information is necessary in measures proposed for the MA program. C & D contractors and section 1876 cost order to appropriately account for the Response: We will identify measures contractors would select a vendor from costs in their annual bid submissions. and standards using internal CMS a CMS list of approved vendors to Response: We respectfully disagree. methods as well as nationally conduct the survey on their behalf. We Both the estimated CAHPS costs and recognized methodologies. The process also noted that this change would burden were addressed in the proposed for developing measures based on data provide the sponsoring organizations rule. As stated therein, the estimated collected by the QIOs is not subject to with the flexibility of adding their own mean annual cost per contract is the PRA review process since it does not questions to the Medicare CAHPS approximately $5,000 for MA represent a new data collection survey. organizations, cost contracts, and Part D requirement for MA plans. We also noted that the first survey sponsors with more than 600 enrollees using the new model of data collection for the CAHPS annual survey. (74 FR 2. CAHPS Survey Administration Under would be conducted in early 2011. 54711). Data collection is to be Parts C and D (§ 417.472, § 422.152, and Contracts that were in effect on or before performed by a contractor hired by the § 423.156) January 1, 2010, would use the number MAO or Part D sponsor. In the October 22, 2009 proposed rule, of enrollees in a plan as of July 1, 2010 Comment: A few commenters noted under the authority of sections to determine whether they are required that proposed § 422.472(i) would 1857(e)(1), 1860D–12, and 1876(i)(3)(D) to conduct the 2011 CAHPS survey. In require section 1876 cost contractors to of the Act to impose additional contract late 2010, all MA and Part D contracts contract with approved CAHPS survey requirements that the Secretary finds that are subject to the CAHPS survey vendors to conduct the Medicare ‘‘necessary and appropriate,’’ we requirement in 2011 would need to CAHPS satisfaction survey for ‘‘MA plan proposed to revise the regulations to select an approved Medicare CAHPS enrollees.’’ However, they assert that require that MA organizations, Part D survey vendor to administer the survey. cost plans do not have MA plan sponsors, and section 1876 cost Finally, we noted that, in addition to enrollees. Moreover, cost plans are not contractors would pay for the data approving a list of survey vendors to ‘‘coordinated care plans,’’ which is a collection costs of the annual CAHPS conduct the survey on behalf of all MA term that describes certain MA plans. survey beginning in 2011. As we noted and Part D contracts, we would select The commenters recommend that CMS in the preamble to the proposed rule, in the sample of enrollees to be surveyed delete the references to coordinated care the 2010 Call Letter to Part C and D for each contract, approve survey plans and other MA references. sponsoring organizations, we informed vendors, provide oversight of survey Response: We appreciate the all MA and Part D contracts with at least vendor activities, analyze the CAHPS commenters’ suggestions and are 600 enrollees as of July 1 of the prior data for plan ratings, and produce revising § 417.472 and § 422.172 as calendar year that they would be individual-level reports for quality follows: ‘‘All coordinated care contracts expected to pay for the data collection improvement use by MA and Part D (including local and regional PPOs, costs of the CAHPS survey starting with contracts. Vendors will be trained by contracts with exclusively SNP benefit the administration of the 2011 annual CMS to collect and submit data within packages, private fee-for-service CAHPS survey. The proposed rule set specified timeframes. contracts, and MSA contracts), and all forth this requirement in regulations at After reviewing the comments cost contracts under section 1876 of the § 422.152 for Part C, § 417.472 for received in response to this proposal, Act, with 600 or more enrollees in July section 1876 cost contracts, and we are adopting the proposed CAHPS of the prior year must contract with § 423.156 for Part D. data collection requirements as final. approved Medicare Consumer The proposed rule would require only However, we are revising § 417.472 and Assessment of Healthcare Providers and MA organizations, Part D sponsors, and § 422.152 to clarify the distinction Systems (CAHPS) survey vendors to section 1876 cost contractors with 600 between cost contracts under section conduct the Medicare CAHPS or more enrollees to pay for the data 1876 and coordinated care plans. satisfaction survey of Medicare plan collection costs of the CAHPS survey. Specifically, the revised wording is: ‘‘All enrollees in accordance with For reasons of statistical precision, a coordinated care contracts (including specifications and submit the survey target minimum of 300 or more local and regional PPOs, contracts with data to CMS.’’ completed Medicare CAHPS Surveys exclusively SNP benefit packages, Comment: Several commenters must be received for each contract. In private fee-for-service contracts, and expressed approval and support for order to obtain 300 or more completed MSA contracts), and all cost contracts CAHPS, applauding CMS’s efforts to surveys, we determined that plans under section 1876 of the Act, with 600 provide enrollees with consumer-tested, would need to have 600 or more or more enrollees in July of the prior standardized information about plan enrollees because some enrollees will year must contract with approved choices. The commenters also support not be eligible to receive the survey, Medicare Consumer Assessment of changes that will increase data such as institutionalized enrollees, and Healthcare Providers and Systems collection, provide beneficiaries with not all enrollees selected to be surveyed (CAHPS) survey vendors to conduct the additional information with which to will respond to the survey. Medicare CAHPS satisfaction survey of make plan comparisons, and overall In making this proposal, we noted Medicare plan enrollees in accordance improve quality of plans. that we conduct other Medicare quality with specifications and submit the Response: We appreciate these surveys, such as the Hospital CAHPS survey data to CMS.’’ commenters’ support of our quality and the Medicare Health Outcomes Comment: CMS received comments efforts. Survey (HOS) for which the MAOs are concerning the proposed requirements responsible for the cost of the data for Part C and D contracts regarding the 3. Validation of Part C and Part D collection, and that this model for data CAHPS survey. A few commenters Reporting Requirements (§ 422.516 and collection is standard industry practice. noted that CMS did not provide any § 423.514) For example, Federal Employees Health estimate of, or other information related In the October 22, 2009 proposed rule, Benefit (FEHB) plans pay for the to, the costs associated with collection under the authority of sections 1857(e)

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and 1860D–12 of the Act, we proposed integrity of the CMS data collection, and D Reporting Requirement Technical to amend § 422.516 and § 423.514 to plan reporting, and plan validation Specifications documents, which will state that each Part C and Part D sponsor processes so that needed data for be updated and posted to our Web site. be subject to an independent yearly monitoring and public reporting are The data validation standards will also audit of Part C and Part D measures timely, reliable, valid, and comparable be updated and provided for comment (collected pursuant to our reporting among organizations. Specifically, the as part of a PRA package in 2010. We requirements) to determine their following changes became effective note that these changes do not affect our reliability, validity, completeness, and January 1, 2010: proposal to require an annual comparability in accordance with • independent audit of Part C and Part D specifications developed by us. Part C Reporting Requirements measures. Rather, because these changes Additionally, in the preamble we ++ Reporting of the Agent reduce the amount of data that must be noted that our rationale for making this Compensation and Agent Training and submitted by plan sponsors, they will proposed change, which was also Testing measures will be suspended. make the data validation audits announced in the 2010 Call Letter to ++ The frequency of reporting of two somewhat less time-consuming. Part C and D sponsoring organizations, Part C measures will be reduced. After considering the comments was that only an independent data — Only annual reporting for Plan received in response to the proposed validation audit conducted by an Oversight of Agents will be required; the rule, in this final rule, we adopt the external entity under contract to the quarterly reporting will be suspended. requirements as proposed. MAO or PDP sponsoring organization — Only annual reporting for Comment: Several commenters argued would ensure that the results of the Employer Group Plan Sponsors will be that plans need information regarding audit are in accordance with CMS required; the semiannual reporting will the data validation requirement in a specifications, that data used to develop be suspended. timelier manner to allow for plan performance measures are credible ++ Validation of PFFS Provider consideration during preparation of the to other stakeholders, and that Payment Dispute Resolution and PFFS 2011 bids. They also noted that CMS information used to respond to Plan Enrollment verification calls will should provide plans with sufficient Congressional and public inquiries are not be required. information and time to modify their reliable. We noted that we were working operations to incorporate any new • Part D Reporting Requirements with a contractor to develop data requirements prior to the data validation validation specifications to ensure that ++ Reporting of five sections will be mandates taking effect. the goals of reliability, validity, suspended: Vaccines, Generic Drug Response: With this final rule, we completeness, and comparability are Utilization, Transition, Drug Benefit believe that we are providing plans with met at the conclusion of the data Analyses, and Agent Training and information in sufficient time to allow validation audit. We intend that these Testing. for consideration in their 2011 bids. A specifications will focus on how ++ The frequency of reporting of six regulatory impact analysis for this organizations and sponsors compile Part D sections will be reduced as proposed requirement was included in numerators and denominators, take into follows: the October 22, 2009 proposed rule. The account appropriate data exclusions, — Only annual reporting for proposed rule also contained the and verify the sponsor’s calculations, Employer/Union-sponsored Group information collection requirements. computer code, and algorithms. In Health Plan Sponsors, Fraud, Waste and Plans should be able to use the burden addition, the specifications will be used Abuse Compliance Programs, Long and cost estimate information to to inform CMS as to how the MAOs, Term Care (LTC) Utilization, and develop an estimate of any increase in cost plans, and Part D sponsors collect, Medication Therapy Management resources and costs associated with the store, and report data. We expect that Program (MTMP) will be required; the implementation of these provisions. these specifications will be utilized by semi-annual reporting will be Additionally, two HPMS memoranda the auditors hired by MAOs and Part D suspended. were released this fall: Part C and Part sponsors to conduct the data validation — Only annual reporting for Plan D reporting requirements and data audits, the results of which will be Oversight of Agents and P & T validation dated November 23, 2009 and forwarded to us. We indicated that we Committees/Provision of Part D Implementation changes in the expected to make these specifications Functions will be required; the quarterly Medicare Part C and Part D Reporting available on our Web site for public reporting will be suspended. Requirements and Data Validation dated comment early in 2010. We solicited ++ Validation of eight sections will December 23, 2009. These memoranda comment on this approach. not be required: Enrollment, Access to contain detailed, updated information Subsequent to publication of the Extended Days. on changes in implementation of the proposed rule, in an HPMS — Supply, Prompt Payment by Part D data validation requirement. The first memorandum dated December 23, 2009, Sponsors, Pharmacy Support of memorandum clarified the timing of we noted that after careful review of the Electronic Prescribing, P&T implementation (that is, the data reporting requirements and CMS’ Committees/Provision of Part D validation needs to occur in the spring continued data needs, the amount of Functions, Pharmaceutical Rebates, of 2011 for reported 2010 data), while data required to be reported to CMS for Discounts and Other Price Concessions, the second memorandum reduced the CY 2010 and contract years contract Licensure & Solvency, and Fraud, Waste overall data validation and reporting beyond was to be reduced. We noted and Abuse Compliance Programs. requirements for Part C and Part D that the reason for the reduction in We are also excluding PACE measures. reporting was that some of the data organizations from CY 2010 Part D Comment: While one commenter could be derived from other means (that Reporting Requirements, which is supported the implementation of the is, through analyses of prescription drug consistent with Part C Reporting data validation audit requirements for event data already collected by CMS). Requirements. 2011, others recommended we delay We believe these adjustments reduce the These changes will be incorporated in codifying the data validation audit overall burden on sponsoring the final CY 2010 Part D Reporting requirement. They argued that codifying organizations while maintaining the Requirements document and the Part C the requirement before the process has

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been evaluated and finalized is Comment: Several plans expressed each Part C and D measure. We believe premature and will take away CMS’ concern that the cost of implementing that the standards and procedures under flexibility to refine the requirements as the data validation audit will be high or development for the data validation it gains experience with the process. excessive. effort provide sufficient flexibility to The commenters were also concerned Response: We do not agree that the accommodate different types of that the validation mechanisms are very costs of implementing the data available reportable data. preliminary and should be vetted validation audit will be excessive. In the Comment: One commenter states that through the subregulatory process. They October 22, 2009 proposed rule (74 FR any final rule on data validation noted that the validation approach 54711), we estimated that the costs of requirements should take into stipulated in the proposed regulation these independent audits would be consideration the plan’s state regulatory places the full cost burden of the audit approximately $5,200 per plan. Because requirements and the plan’s processes on the health plan. One commenter the costs on a per plan basis are not required to comply with state mandates, specifically recommended that the excessive, they will likely be reflected laws, and regulations and consider proposed new paragraphs (g) be revised in only minimally higher bid prices deeming in areas of overlap. by striking Each Part C [Part D] sponsor across the board. Response: We appreciate that plans must and inserting instead, CMS may Comment: Two commenters stated may also have state reporting require each Part C [Part D] sponsor to that plans should have the option of requirements with respect to licensure * * * and strike independent audit and using their own internal auditing staff. and solvency. We believe, however, that insert audit. Response: We disagree that plans deeming with respect to issues subject Response: We disagree with the should have the option of using their to state reporting requirements is recommendation to delay codifying the own internal auditing staff in lieu of an outside the scope of this proposal, data validation audit. We have begun independent, external auditor. The data which is to require an independent data evaluating the data validation audit validation needs to be credible to validation audit of information reported process and will have completed a pilot stakeholders, including Congress and to CMS. evaluation by May 2010, that is, the American public. We believe that Comment: One commenter questioned approximately 10 months before the only an external independently whether CMS needed to define implementation of the data validation conducted audit can establish this performance benchmarks so plans can audits. Therefore, we believe we will credibility. manage and monitor data before they have sufficient time to perform any Comment: One commenter requested are submitted to CMS. needed refinements of the requirements clarification as to whether CMS intends Response: We will be defining the well before actual implementation of the to issue a list of certified contractors data validation standards prior to the data validation process. We strongly from which an organization may select data validation audit. Performance believe that it is important to have the a vendor. This commenter also benchmarks relevant to these standards data validation audit process in place by recommended that the validation and will be made available prior to the data 2011 since there is a need to monitor the testing of a plan’s compliance with validation audit. Part C and D programs effectively and Fraud, Waste, and Abuse (FWA) Comment: One commenter offered to to respond to questions from Congress, programs regulations include the use of review the measures on behalf of CMS oversight agencies, and the public with a certified fraud investigator. and explore ways for including them in data that are timely, reliable, valid, and Response: At this time, we do not the HEDIS measurement set and audit allow for comparisons among plans. expect to issue a list of certified program. We also disagree that the data contractors from which an organization Response: Although we appreciate the validation audit requirements should be may select a vendor to conduct data commenter’s interest in this issue, we provided only in subregulatory validation audits. Instead, we will be are not committing to the inclusion of guidance. We proposed to implement issuing standards for selected vendors. the new Part C and D measures as part these requirements through notice-and- A draft of these standards was issued for of the HEDIS measurement set and audit comment rulemaking in order to ensure informal comments last fall and a program at this time. that, if they were adopted, they would revised version will be issued with the be enforceable with the full force and PRA package associated with the data 4. Collection of Additional Part D effect of law. Detailed procedures for validation specifications that will be Claims Elements for Nonpayment- meeting the regulatory requirements available for public comment. We also Related Purposes (§ 423.505) will be provided through sub-regulatory note that the commenter’s second In the October 22, 2009 proposed rule, guidance and will also undergo the PRA recommendation is likely in reference to we proposed to use the authority under process. As a result, we believe we will a CMS program audit. Because this section 1860D–12(b)(3)(D) of the Act to retain sufficient flexibility to make proposal relates to a data validation collect all additional elements added to necessary changes before the audit, we do not believe that plans the prescription drug event (PDE) record requirements are implemented as well should be required to use a certified beyond the original 37 elements as to update the procedures in the future fraud investigator. currently collected under section as necessary. We further believe that it Comment: One commenter stated that 1860D–12(b)(3)(D) of the Act. As a is necessary to conduct the data flexible criteria should be considered in result, we would be able to use these validation audit on all plans so that the data validation audit’s report data elements for nonpayment-related there is assurance that all the data are specifications, that is, CMS should purposes. reliable, valid, and can be used to consider using flexible criteria in As we explained in the preamble to compare health plan performance. If we developing the specifications for the the proposed rule, section 1860D– find through the data validation audit data validation report. 12(b)(3)(D) of the Act, which process that some plans are not Response: We agree that the criteria incorporates section 1857(e) of the Act, reporting accurate data, then it will be used in developing the specifications for provides the Secretary with authority to possible to take this factor into account the data validation report should include in Part D sponsor contracts any when reporting plan performance and in accommodate different types of terms or conditions the Secretary deems comparing performance among plans. reportable data that a plan collects for necessary and appropriate, including

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requiring the organization to provide the of the addition of new elements to the responding to external research Secretary with such information as the PDE record without undertaking requests. Thus, the beneficiary ID, plan Secretary may find necessary and rulemaking for each additional element ID, prescriber ID, and pharmacy ID are appropriate. We noted that under this added in the future. We believe that the encrypted prior to release to external authority, in the May 28, 2008 Federal May 28, 2008 Part D Claims Data final entities. However, in the case of Register (73 FR 30664), we published a rule (73 FR 30664) resolved any beneficiary ID, prescriber ID, and final rule that allowed the Secretary to statutory ambiguity surrounding our pharmacy ID, this information may be collect Part D ‘‘claims’’ data from the broad authority to collect PDE data provided in an unencrypted format prescription drug event (PDE) record under section 1860D–12(b)(3)(D) of the when needed to link to another data set. and use the information gathered for Act. Accordingly, we may use this same In contrast, under the current rule, there non-payment purposes. However, this authority to collect additional elements is no exception to the requirement that rule limited what data (hereinafter that have been added to the PDE record plan identifiers be encrypted for all referred to as PDE elements) we may since 2007. Once data have been external research requests. Under the collect and use for nonpayment collected under section 1860D– current regulation, grantees of HHS purposes to the original 37 elements 12(b)(3)(D) of the Act, we may use these agencies are treated as external entities reported on the PDE record. The rule data for nonpayment-related purposes and may not access plan identifiers. also described circumstances under and may release PDE data consistent However, contractors acting on behalf of which we may disclose the data to other with our minimum necessary policy and HHS are not considered to be external government and external entities, and our data sharing procedures. entities and may receive unencrypted the limitations associated with any such We also noted in the preamble to the plan identifiers when necessary for a release. proposed rule that we believe the ability particular project. In the October 2009 proposed rule, we to analyze new claims-related elements Because some HHS agencies also noted that in 2008 the number of added to the PDE record will increase accomplish their mission through PDE elements collected was expanded both specific and general knowledge of grants, rather than contracts, and hence from the original 37 elements to 39 Medicare beneficiaries’ healthcare and cannot rely on the access that is elements. The additional PDE elements the operation of the Part D program and provided to HHS contractors and the are ‘‘Rebate Amount Applied to the would aid our ability to conduct fact that research performed by HHS Point-of-Sale Price’’ and ‘‘Vaccine program oversight, support operational grantees will advance the interests of Administration Fee.’’ The ‘‘Rebate tasks, and provide more information for Medicare beneficiaries, who may also be Amount applied to the Point-of-Sale use in internal and external healthcare served by other HHS programs, we Price’’ is generally the standard amount research studies. Moreover, as a result of proposed to revise § 423.505(m)(iii)(C) of a rebate that the plan sponsor has the proposal, we would not be required to permit CMS disclosure to HHS elected to apply to the negotiated price to undertake a separate rulemaking and grantees of unencrypted plan identifiers as a reduction in the drug price made public comment process each time new when certain conditions are met. The available to the beneficiary at the point elements are added to the PDE record, conditions we proposed to be met of sale. The ‘‘Vaccine Administration but rather would automatically begin include— Fee’’ is the amount charged for the collecting for nonpayment purposes • The plan identifier is essential to administration of a vaccine separate elements added to the PDE record using the study and there is no other source from the actual vaccine. our authority under section 1860D– of CMS data that would substitute for In the 2010 Call Letter to Part C and 12(b)(3)(D) of the Act and § 423.505(f)(3) plan identifiers in order to carry out the D sponsoring organizations, we noted of the regulations. However, because we study; that we were planning to make did not propose any change to our data • The study is key to the mission of mandatory the collection of a new (40th) sharing procedures or our minimum the sponsoring agency; element to the PDE record, referred to as data necessary policy, we will continue • The study provides a benefit to the the ‘‘Prescription Origin Code.’’ (at to— Medicare program; and http://www.cms.hhs.gov/ • Ensure that beneficiary, prescriber, • The requestor attests that any PrescriptionDrugCovContra/Downloads/ or pharmacy identifiers are not released public findings or publications will not CallLetter.pdf). The prescription origin unless absolutely necessary for a project identify plans or plan sponsors. code is designed to capture the (for example, to link to another In evaluating requestors’ proposals to frequency with which providers use e- database); determine whether these conditions are prescribing. • Encrypt Part D plan identifiers and met, we propose the following Under our proposal, we would be able aggregate cost data elements (ingredient evaluation standards: to utilize these data for non-payment cost, dispensing fee, and sales tax) when • Plan identifier, we will evaluate the related purposes. Similarly, we would sharing PDE data with external requestor’s rationale to determine be able to release these elements to requesters; and whether an encrypted plan identifier governmental and external entities, • Subject each request to our data would be sufficient for the study design under the authority of section 1106 of sharing procedures which includes or if the real identifier is necessary for the Act, using the same process that we ensuring that requestors have the the study. now use to release the original 37 appropriate experience and are working • Agency mission, we will review the elements, namely our minimum for, or on behalf of, a reputable requestor’s agency’s rationale for the necessary data policy, our data sharing institution and that, when appropriate, study and how the study would help the procedures, and the encryption of make their project results public. agency achieve its mission. certain identifiers and aggregation of External requests concerning beneficiary • Medicare program benefit, we will cost data to protect beneficiary identifiable data would continue to be review the requestor’s rationale for the confidentiality and commercially reviewed by the CMS Privacy Board, importance of study findings to the sensitive data of Part D sponsors. and would require the requestor to sign Medicare program. Our proposal would allow us to a data use agreement. • Public reporting, we require an collect and use for non-payment-related We also noted our current policy of attestation from the requestor that the purposes any data obtained as a result protecting various Part D elements when requestor will not identify specific plans

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or plan sponsors in any public Congressional support agencies (in necessary policy,’’ additional reporting. accordance with their obligations to restrictions to protect beneficiary In the proposed rule, we indicated support Congress as set out in their confidentiality and commercially that we believed that these conditions authorizing statutes) for the purposes of sensitive data of Part D sponsors, and would mitigate the risk of unauthorized conducting Congressional oversight, our data sharing procedures (which use or disclosure of commercially monitoring, making recommendations, ensure the agency’s compliance with the sensitive plan information. We also and analysis of the program under this Health Insurance Portability and solicited comments on whether it would title.’’ While section 181 of MIPPA did Accountability Act of 1996 (HIPAA), the be appropriate to extend the proposal to not directly address the issues of Privacy Act of 1974, and other permit grantees of other Federal statutory ambiguity associated with Part applicable laws), we limit the use and agencies to have access to plan D claims data collected by CMS, it can disclosure of Part D claims data to identifiers when this access may be be read as an implicit Congressional ensure that the data are only used or necessary for a particular research ratification of the arguments presented disclosed as permitted or required by project and that project otherwise meets by CMS, in the Part D claims rule, as the applicable law, and not inappropriately the conditions described above. After legislation only overrides one provision disclosed in a manner which could considering the comments received in of that rule. Specifically, under section undermine the competitive nature of the response to our proposals, we are 181 of MIPPA the Secretary must make Part D program. finalizing the proposed changes to data collected under section 1860D– Comment: We received a number of § 423.505(f) and (m) without 12(b)(3)(D) available to Congressional varied comments on the sharing of PDE modification. support agencies, without regard to data. Several commenters provided Comment: Some commenters CMS’ minimum data necessary recommendations related to the sharing questioned CMS’ authority to share PDE standard. Accordingly, for reasons of Part D PDE information for non- data for non-payment purposes given detailed in our May 29, 2008 final rule, payment purposes, suggesting that the limiting language in section 1860D– CMS— we believe the restrictions of section • 15 of Act. One commenter alleges the 1860D–15 of the Act do not apply to Use only non-identifiable approach outlined in the proposed rule PDE data collected under the authority information for any public analysis, would result in a potential violation of of 1860D–12(b)(3)(D) of the Act. As a arguing that research can be done the Trade Secrets Act. Another result, these data may be used for without an actual plan ID; • Exclude data elements that could commenter mentioned that section purposes other than payment. 1927(b)(3)(D) of the Act protects pricing, because of geographic information, and/ rebates and other financial information In response to concerns about or other aggregated information from disclosure except to very specific releasing proprietary data to external indirectly identify plan sponsors; and recipients (such as CBO or the entities, we note that this rule pertains • Share information (especially plan Comptroller), which does not extend to to additional elements added to IDs, or PHI) only with written approval HHS grantees. One commenter does not prescription drug event data and does from the sponsor and publish guidance want the release of rebate data, not extend to plan bid or reconciliation well before adding another element to estimated or otherwise, stating that payment data provided outside of the the PDE format. rebates at point of sale reflect PDE. Because PDE data are collected Another commenter stated that proprietary business information. under section 1860D–12(b)(3)(D), rather despite the restrictions in sharing plan Response: We respectfully disagree than section 1860D–2(d)(2), they are not IDs, certain plans could easily be with the commenters’ assertions. In the subject to the limitations on disclosure identified. A few other commenters May 28, 2008 Federal Register (73 FR under section 1927(b)(3)(d). In addition, stated that CMS has no specific 30664), we published a final rule as we explained in the May 28, 2008 restrictions in the regulation protecting regarding the collection and use of Part final rule (73 FR 30680), because price information. D claims data. This regulation resolved § 423.505(m) was issued under the Response: We believe these comments the statutory ambiguity between authority of section 1106 of the Act, any are outside of the scope of the proposed sections 1860D–12(b)(3)(D) and 1860D– release of potentially proprietary data rule, which was issued not to reopen 15 of the Act, noting that section pursuant to this provision would be also our May 28, 2008 final rule on Part D 1860D–12(b)(3)(D) of the Act (and its be authorized by law under the Trade claims data but rather to address the use incorporation of section 1857(e)(1)) of Secrets Act. Furthermore, we also note and disclosure of additional PDE data the Act) provide broad authority to the that rebates applied at point of sale are elements beyond the original 37 Secretary to require Part D sponsors to not the same as aggregate rebates elements that were the subject of the provide the Secretary with ‘‘such estimated by plans as part of their bid May 28, 2008 final rule. To the extent information as the Secretary may find or actual rebates received from the comments are applicable, we necessary and appropriate’’ and that manufactures that are submitted outside disagree with the recommendations on when information is collected through a of the claim for payment reconciliation using only aggregate data and obtaining statutory authority independent of purposes. Rather, they most often reflect written plan approval prior to use of the section 1860D–15 of the Act, the a standard amount that the PDE data. Our rationale is the same as restrictions of section 1860D–15 of the manufacturer is providing to a the one we expressed in response to a Act would not apply. Following the particular sponsor for a specific drug similar comment to the May 28, 2008 issuance of this Part D claims data final that is then passed through to final rule on Part D claims data: if PDE rule, Congress enacted the Medicare consumers as part of the plans’ price at data are collected only under the Improvements for Patients and point of sale, the net amount of which authority of section 1860D–15 of the Act Providers Act of 2008 (MIPPA). Section is available to beneficiaries as an CMS, HHS and external entities can 181 of MIPPA added clause (ii) to estimate on the drug plan finder tool. never use the data for evaluations, section 1860D–12(b)(3)(D) to provide We also remind commenters that we analyses, and research important to that any Part D data collected under the place certain limitations on PDE data public health, and vital to program authority of section 1860D–12(b)(3)(D) when released outside of CMS. Through oversight. In the Part D claims data final ‘‘shall be made available to the application of our ‘‘minimum data rule we provided a detailed description

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of the potential purposes for which Center, at http://www.resdac.umn.edu/, are currently collected is at the these data might be used, including as opposed to FOIA. However, as noted Secretary’s discretion and will be evaluating the effectiveness of the in our May 28, 2008 final rule on Part diligently reviewed and accorded the prescription drug benefit and its impact D claims data, if a FOIA request is proper protection consistent with the on health outcomes, performing received for PDE data used for non- principle outlined in the May 28, 2008 Congressionally mandated or other payment purposes, we will follow our final rule. Plan sponsors will be notified demonstration and pilot projects and ordinary FOIA procedures and not of any changes to the collection of PDE studies, reporting to Congress and the release under FOIA data the agency data through the CMS Call Letter to Part public regarding expenditures and other determines are trade secrets, or D plan sponsors, or via HPMS statistics involving the Medicare commercial or financial information memoranda. Therefore, we do not prescription drug benefit, studying and protected by FOIA Exemption 4 (5 believe it is necessary to undertake a reporting on the Medicare program as a U.S.C. 552(b)(4). separate rulemaking to authorize CMS, whole, and creating a research resource Comment: Commenters opposing the to use section 1860D–12 of the Act to for the evaluation of utilization and rule pointed out that it does not place collect each new element that we may outcomes associated with the use of any perimeters on the type of additional add to the PDE record in the future. prescription drugs. Balancing these data CMS may classify as claims data, Comment: Some commenters opposed important objectives with the potential and thereby make available for sharing the Plan identification element sensitivity of PDE data, we implemented disclosure. The commenters expressed from the PDE record in an unencrypted a rule that ensures that, subject to many concern that nothing in the proposed form with HHS grantees expressing safeguards put in place to guard against regulation would require confidentiality concern about the data security and the inappropriate use and disclosure of of rebate and pricing information if it need to protect sensitive data, and commercially sensitive and beneficiary were collected under section 1860D–12 arguing that encrypted data should identifiable information, Part D PDE of the Act. satisfy most research needs. Other data are available for research purposes One commenter also questioned CMS’ commenters supported the PDE data under similar data sharing processes to conclusion that we could use section sharing provisions in the proposed rule, those used for sharing Parts A and B 1860D–12(b)(3)(D) of the Act to collect with some supporting a proposed option claims data. While we agree with the new elements to the PDE record without in the preamble of the proposed rule commenter that in some situations, even undertaking rulemaking for each that would also permit grantees of non- if we provide samples of PDE data with additional element added in the future. HHS Federal agencies access to plan masked plan identifiers, public Response: We reiterate that our identifiers. One commenter supporting information may be added to the PDE authority to collect PDE elements for the rule asked that we go further and record to identify the particular plan, non-payment purposes has already been with proper restrictions allow access to we believe that our data sharing decided with the clarification of our plan identifiers to all legitimate procedures mitigate against any authority under 1860D–12(b)(3)(D) of researchers. inappropriate use or disclosure. Under the Act, as set forth in Medicare Part D Response: After the Part D Data rule these procedures, we require each Claims Data rule published on May 28, was published in May 2008, we limited researcher to sign a Data Use Agreement 2008. Because that final rule was the use of actual plan identifiers, but (DUA) that spells out the multiple expressly limited to the 37 original after gaining experience in releasing restrictions on the use of the data and elements of the PDE claim, it was Part D data it soon became apparent that the penalties for any failure to comply necessary for us to undertake further there was a compelling need for other with the terms of the agreement. In rulemaking in order to collect new HHS (such as FDA and NIH) agencies to addition, we require research using elements that have been added to the use plan identifiers in their linking, beneficiary identifiable data to be PDE record. Rather than proposing to oversight and research (for example, conducted by an experienced entity at a collect only the 3 new elements that influence of brand name recognition, reputable organization, with an have been added to the PDE record and benefit design on consumer choice) appropriate research design, and with since 2007, we concluded that it was under certain conditions. These assurances to protect beneficiary appropriate to propose to collect all agencies cannot possibly conduct all of confidentiality. Research is to be made elements that are currently part of the their own research. Accordingly, they available to the public and identifiable PDE record or that may be added to the engage grantees to perform approved data is not released for commercial PDE record in the future. As we stated studies. These studies often assist CMS purposes. Further we will only release in the preamble to the October 22, 2009 in better understanding and improving beneficiary identifiable data for research proposed rule, we believe that the the Medicare program. Furthermore, purposes if the CMS privacy board ability to analyze new claims-related HHS is able to affect more oversight of approves the data release and then, will elements added to the PDE record its own grantees through the threat of only release the minimum data would increase both specific and future withdrawal of funding—a great necessary for the study. We believe general knowledge of Medicare disincentive for researchers—should these procedures allow us to safely beneficiaries’ healthcare and the any terms of the data use agreements be balance the need to support legitimate operation of the Part D program and broken (as opposed to a study research while at the same time would aid in our ability to conduct independently funded by a University). guarding against the misuse or program oversight, support operational Therefore, with this final rule we are inappropriate disclosure of data that is tasks, and provide more information for permitting access to plan identifiers sensitive in nature. use in internal and external healthcare HHS grantees for nonpayment purposes Comment: A commenter asked to research studies. These rationales apply when the following conditions are what extent are PDE data uses and not only to the collection of the 3 new present: disclosures subject to requests under the PDE elements that have been added • The plan identifier is essential to Freedom of Information Act (FOIA). since 2007, but also to the collection of the study and there is no other source Response: Requests for Part D PDE any new elements that may be added in of CMS data that would substitute for data should be directed through our the future. Furthermore, the addition of plan identifiers in order to carry out the contractor, the Research Data Assistance more PDE elements beyond those that study;

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• The study is key to the mission of Response: We note that the vaccine that time on March 23, 2010 section the sponsoring agency; administration fee and the rebate at 3307 of the PPACA was enacted. • The study provides a benefit to the point-of-sale were added to the original Rather than specifying statutory Medicare program; and 37 elements for CY 2008, and that in the criteria for identifying protected classes • The requestor attests that any 2010 Call Letter we notified sponsors of drugs, as did section 1860D– public findings or publications will not that a 40th element, Prescription Origin 4(b)(3)(G)(i) of the Act at the time of the identify plans or plan sponsors. Code, collected on an optional basis in proposed rule, section 1860D–4(b)(3)(G) While we believe that similar benefits 2009, would be part of the mandatory of the Act now provides that the may accrue to grantees of non-HHS reporting requirements beginning Secretary shall establish criteria for entities and to many external January 1, 2010. determining ‘‘classes of clinical researchers conducting studies of Comment: A commenter asked about concern’’ and until such time as the beneficiary plan choices, we believe that downstream entities, noting that the Secretary establishes such criteria, the additional time is needed to evaluate rule does not specify who may have following six classes of drugs shall be this issue. Therefore, for now, we will access to this sensitive data. protected: anticonvulsants, limit the exception to the prohibition antidepressants, antineoplastics, against releasing unencrypted plan Response: We share the commenter’s antipsychotics, antiretrovirals, and identifier elements to external entities concerns over the re-release of data to immunosuppressants for the treatment in § 423.505(m)(1)(C) to HHS grantees at entities not included on the DUA. of transplant rejection. As there are this time. Under our current data sharing many provisions in the PPACA affecting Comment: One commenter asked for procedures, researchers or other Medicare Part D beneficiaries, we clarification on whether or not CMS external entities wishing to re-release believe it is important to take some time intended to allow unencrypted data to Part D data must notify us and receive to thoughtfully consider how best to be transmitted to requesters of data. The express permission for any subsequent establish appropriate criteria. As such, commenter had concerns with regard to release, with appropriate modifications and in accordance with 1860D– potential risk of violation of the security made to any DUAs. 4(b)(3)(G) of the Act, we are protecting rules under HIPAA. F. Changes To Implement New Policy the six statutorily-specified drug classes Response: We ensure that any data and categories of drugs of ‘‘clinical transmission is done only after This section addresses two policies concern’’ and will turn in the future to undergoing an approval process that under Parts C and D respectively. Under consider the criteria the Secretary requires requesters to detail their Part D, we proposed new regulatory would issue under the statute. security procedures during requirements pertaining to the required Under Part C, we proposed to revise transmission, storage of and access to inclusion of protected drug categories our rules to allow beneficiaries who Part D data. and classes on Part D formularies. While elect MSAs as a type of health insurance Comment: Another commenter our proposals initially were intended to plan to pay only a pro-rated deductible wanted clarification as to whether the implement provisions in section 1860D– if their MSA deposit is pro-rated fields discussed in the proposal had 4(b)(3)(G) as in effect at the time of our because they enroll after January 1. already been added to the PDE layout. October 22, 2009 proposed rule, since These revisions are detailed in Table 6.

TABLE 6—REVISIONS TO IMPLEMENT NEW POLICY

Part 422 Part 423 Provision Subpart Section Subpart Section

Provide Criteria and a Process for identifying Protected Classes of N/A ...... N/A Subpart C..... § 423.120(b)(2)(v) Drugs. Pro-rating the Plan Deductible for Part C MSA Enrollments Occurring Subpart C ..... § 422.103 N/A ...... N/A During an Initial Coverage Election Period.

1. Protected Classes of Concern Under protected classes and undertake to formularies, or to otherwise limit access Part D (§ 423.120(b)(2)(v)) identify classes of drugs that met two to (including utilization management In the October 22, 2009 proposed rule, criteria specified statutory criteria: restrictions or prior authorization), • based on comments that we received on Restricted access to the drugs in the certain Part D drugs in the protected an earlier January 16, 2009 interim final category or class would have major or categories and classes. Section 176 of rule with comment period (IFC) (74 FR life threatening clinical consequences MIPPA required that such exceptions be 2881), we proposed criteria and for individuals who have a disease or subject to a public notice and comment procedures for identifying ‘‘protected disorder treated by drugs in such process. classes’’ of drugs, within which all category or class. In the October 22, 2009 proposed rule, covered Part D drugs must be included • There is a significant need for such we proposed interpreting several of the in Part D formularies. While we had individuals to have access to multiple statutory terms used in the criteria set previously identified six such classes drugs within a category or class due to forth in section 176 of MIPPA to better under our authority in section 1860D– unique chemical actions and define the scope of the protections 11(e)(2)(D) of the Act to ensure that pharmacological effects of the drugs afforded under that section. To that end, formularies were not discriminatory, within a category or class. we proposed to add several new section 176 of MIPPA added a new Under section 176 of MIPPA, the definitions at § 423.100, including: section 1860D–4(b)(3)(G)(i) to the Act Secretary was provided discretion to ‘‘restricted access,’’ ‘‘major or life- which required the Secretary, effective establish exceptions permitting Part D threatening clinical consequences,’’ plan year 2010, to address the issue of sponsors to exclude from their ‘‘significant need for access to multiple

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drugs,’’ ‘‘a short period of time,’’ and drugs in the categories and classes class or category does not extend to the ‘‘multiple drugs.’’ Further, we proposed identified by the Secretary as classes inclusion of all brand-name drugs and that the MIPPA protections did not and categories of ‘‘clinical concern.’’ It generic versions of a covered drug in apply to non-Part D drugs and their requires the Secretary to establish question. They argue that this exception exclusion from the formulary criteria to determine, as appropriate, is inconsistent with other CMS requirements would not be based on the categories and classes of drugs of formulary requirements, namely our exceptions authority under section ‘‘clinical concern.’’ It provides for an midyear formulary change policy for 1860D–4(b)(3)(G)(iii) of the Act. exceptions authority similar to the one which they argue that CMS makes it We also proposed to add a new included in section 176 of MIPPA. clear that a brand-name drug and its paragraph to § 423.120(b)(2) to identify Section 3307 of PPACA further requires generic counterpart are different ‘‘drugs’’ exceptions to the inclusion of all drugs that until the Secretary establishes for the purpose of submitting formulary meeting the criteria set forth in section criteria to determine classes of ‘‘clinical changes. In addition, one commenter 176 of MIPPA and our implementing concern,’’ the following categories and expressed concerns about different regulations. Under proposed classes of drugs shall be identified and exceptions in therapeutic equivalent § 423.120(b)(2)(vi), exceptions would protected as classes of ‘‘clinical products, stating that some may not include the following: concern’’: anticonvulsants, provide the same benefit in the • Drug products that are determined antidepressants, antineoplastics, physician’s judgment. to be therapeutic equivalents under the antipsychotics, antiretrovirals, and Response: We disagree with the FDA’s Orange Book. immunosuppressants for the treatment commenters’ arguments. It is important • Edits that limit the quantity of of transplant rejection. to distinguish our formulary change drugs due to safety. Given that PPACA was recently policy from the definition of a ‘‘drug’’ for • Other drugs that we may specify enacted and there are many provisions the purpose of explaining therapeutic through a process that is based upon affecting Medicare Part D beneficiaries, equivalence. For the protection of scientific evidence and medical we need time to thoughtfully consider beneficiaries who may experience cost standards of practice (and, in the case of how best to establish criteria to identify sharing changes, we require that when antiretroviral medications, is consistent classes and categories of drugs of a new generic equivalent is released into with the Department of Health and ‘‘clinical concern.’’ Accordingly, the market and a plan sponsor proposes Human Services Guidelines for the Use consistent with the PPACA, at this time to add the new generic to its formulary of Antiretroviral Agents in HIV–1– we are requiring that PDP sponsors and remove the brand-name drug, we Infected Adults and Adolescents) and include all covered part D drugs in the approve the change and notice be sent which permits public notice and following categories and classes: to affected beneficiaries to make them comment. We welcomed comment on anticonvulsants, antidepressants, aware that a generic equivalent is these proposed definitions and antineoplastics, antipsychotics, available and that there may be a change clarifications. antiretrovirals, and in their cost-sharing if they continue to Finally, we noted in the preamble to immunosuppressants for the treatment take the brand-name. the October 22, 2009 proposed rule that of transplant rejection. This requirement For the purpose of formulary we continue to believe that the best way will be in effect for plan year 2011 and submission to us, our regulations to determine which drug classes and until such time as we undertake specify at § 423.120(b)(2)(i) that two categories should be identified as a additional notice-and-comment therapeutically equivalent drugs cannot protected class and category is through rulemaking to establish the criteria for be used to satisfy our requirement that a data-driven process, which includes identifying classes and categories of there be at least two drugs per category an analysis of prescription drug event drugs of ‘‘clinical concern.’’ Continuing and class on formulary. Contrary to the data, a review of widely used treatment to protect the current six classes of commenters’ assertions, we believe this guidelines, validation of the results by ‘‘clinical concern’’ will ensure that existing formulary requirement is a expert committee of clinicians, and beneficiaries will continue to have consistent with our proposal in that acceptance by the Secretary. access to the medications they need and both standards acknowledge that We also offered two approaches for will not experience a disruption in care. therapeutically equivalent products are consideration, and solicited comment We note that PPACA requires that the same drug. Further, as stated in our on which option the public believed sponsors cover ‘‘all’’ Part D drugs rather January 28, 2005 Part D final rule (70 FR would allow us to make timely than ‘‘all or substantially all’’ as required 4260), inclusion of ‘‘all covered Part D determinations in a transparent manner. under section 30.2.5 of the Prescription drugs’’ within a class or category of Those options were— Drug Manual. clinical concern does not extend to • Option 1: Announce protected Consistent with this approach, we inclusion of all brand-name drugs and classes through subregulatory guidance have decided to adopt, in regulatory generic versions of the covered drug in (for example, the Call Letter) that text, neither the criteria we proposed in question. The Orange Book, published provides a notice and comment process the October rule which were specified by the FDA, is a widely accepted but does not entail formal Federal by MIPPA for identifying classes and standard for determining therapeutically Register notice and comment categories of drugs of ‘‘clinical concern,’’ equivalent drugs within the same class/ rulemaking; and nor the definitions used to interpret the category (see http://www.accessdata. • Option 2: Announce the protected MIPPA criteria. However, we are fda.gov/scripts/cder/ob/default.cfm). classes through formal notice and retaining the exceptions process in the Therefore, we disagree that our policy comment rulemaking. regulatory text, as new Section 1860D– stating that inclusion of ‘‘all covered Since issuance of the October 22, 4(b)(3)(G) of the Act retains the Part D drugs’’ on formulary from a 2009 proposed rule, the PPACA was exceptions process established under protected class or category does not enacted. Accordingly, new section MIPPA. extend to the inclusion of all brand- 1860D–4(b)(3)(G) of the Act replaces Comment: Several commenters name drugs and generic versions of a section 176 of MIPPA. Section 1860D– expressed opposition to our exception covered drug in question is somehow 4(b)(3)(G) of the Act requires a PDP that inclusion of ‘‘all covered Part D inconsistent with other formulary sponsor to include ‘‘all’’ covered part D drugs’’ on formulary from a protected policies.

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Finally, with regard to the one evaluating safety-based exceptions, CMS exception to the inclusion of all drugs comment that some therapeutically should not rely only on information and biologicals in a protected category equivalent drugs may not provide the contained in the package insert, but or class only when warranted by same benefit in the physician’s should also consider clinical trial data scientific evidence and medical judgment, we note that a beneficiary, and accepted standards of care. standards of practice, and only after a working with his or her physician, may Response: We have been clear on notice and comment period. pursue an exception if they believe that what is meant by a safety edit. As Response: We will undertake future a drug considered to be a therapeutic indicated in section 30.2.2.1of Chapter 6 rulemaking to identify additional equivalent is not providing the same of the Medicare Prescription Drug exceptions, as necessary. Further, where benefit as the brand drug originally Manual (see http://www.cms.hhs.gov/ appropriate, we will provide the citation prescribed. PrescriptionDrugCovContra/downloads/ for the supporting scientific evidence Comment: Several commenters R2PDBv2.pdf), safety edits refer to and medical standards of practice to oppose the application of any utilization point-of-sale (POS) edits implemented support our findings. We note that an management edit applications for to satisfy concurrent drug utilization example of scientific evidence may protected class drugs. Other review (DUR) requirements set forth in include information contained in the commenters contended that our § 423.153(c)(2). Examples include FDA drug approval records or may proposal undermines the benefits of screening for therapeutic duplication, include evidence referenced in widely- formulary and utilization management age or gender-related contraindications, used treatment guidelines, such as those processes. A few commenters in over-utilization, under-utilization, drug- approved by the Agency for Healthcare particular oppose our exception for drug interactions, incorrect drug dosage Research and Quality (AHRQ). drugs ‘‘with very limited applicability to or duration of drug therapy, drug-allergy 2. Pro-rating the Plan Deductible for Part the Medicare Part D population and contraindications, and clinical abuse/ C MSA Enrollments Occurring During non-Part D drugs’’ to be included on misuse. For the protection of an Initial Coverage Election Period formulary under the regulatory beneficiaries, we continue to believe (§ 422.103) protected classes provision, arguing that that the protected classes provision if a drug fits the criteria, it should be must not interfere with this POS DUR to In the October 22, 2009 proposed rule, protected. help ensure that adverse events do not we proposed to revise the regulations to Response: We disagree with these occur. We believe that such edits must provide for the pro-rating of the plan commenters. Consistent with the be consistent with FDA labeling to deductible under an MA MSA plan in definition of a Part D drug under ensure that they are based on scientific the case of enrollments occurring during § 423.100, we do not require inclusion evidence and medical standards of an initial coverage election period at a on formularies those drugs that are paid practice. To the extent that an time other than the beginning of the for under Part B (for example, ‘‘incident individual’s clinical needs require a year. As we noted in the preamble to the to’’ drugs supplied and administered by quantity greater than permitted under proposed rule, section 1851(a)(2)(B) of physicians during patient visit and paid the FDA labeling, we believe that the the Act provides that Medicare for under Part B), and drugs whose exceptions process is the appropriate Advantage Medical Savings Account regulatory status under the definition of vehicle for resolution of such cases. (MSA) plans are a type of MA plan that a Part D drug is unknown. To do so Finally, in response to the comment that a MA-eligible Medicare beneficiary can when they are not payable under Part D permitting the use of safety edits would elect to receive his or her Medicare Part would lead to beneficiary confusion. create a significant opening for plans to A and B benefits. An MSA plan Therefore, we are maintaining this establish restrictive policies, we combines both a tax advantaged Medical policy in this final rule. disagree. Rather, our guidance is clear Savings Account (MSA) and a high- Comment: A few commenters that edits need to conform to FDA deductible health insurance policy. expressed concern over CMS’s proposal labeling. To the extent that a plan Under this MA plan option, Medicare permitting the use of utilization sponsor would establish safety edits that pays the MA organization offering the management processes that limit the were more restrictive than FDA labeling MA plan the premium amount charged quantity of drugs under protected contrary to our guidance, we would by the organization for a high- classes due to safety. One commenter likely uncover such edits through deductible insurance policy and the argues that this policy would create a complaints or through a review of remainder of the MA payment amount significant opening for plans to expand exceptions and appeals data and would is deposited in the enrollee’s MSA. If an ‘‘restrictive policies’’ and that CMS instruct the plan to revise its processes individual enrolls in such a plan should be clear on what we mean by immediately. midyear, under section 1853(e) of the safety edit. The commenter asserted that Comment: A commenter requested Act, a pro-rated share corresponding to it is important for CMS to further define that CMS clarify what is meant by the number of months remaining in the what a valid safety edit is and to ‘‘scientific evidence’’ and specify how calendar year is placed into the specifically link it to prevention of the use of such evidence would be individual’s savings account. However, imminent harm to the health of the validated with respect to CMS’ as provided under § 422.103(d) beneficiary. Another commenter proposed language that we may identify beneficiaries newly eligible for asserted that the safety of any course of other exceptions ‘‘through a process that Medicare who enroll in MSAs midyear drug therapy is a clinical concern and is based upon scientific evidence and pursuant to an initial coverage election it is critical for utilization controls not medical standards of practice (and, in period (ICEP) are currently required to to interfere with appropriate clinical the case of antiretroviral medications, is pay the full ‘‘high deductible’’ for the decisionmaking. This commenter notes consistent with the Department of calendar year. For example, an enrollee that the imposition of safety-based Health and Human Services Guidelines whose 65th birthday is in May and who quantity limitations—even where well- for the Use of Antiretroviral Agents in chooses to enroll May 1 will be given 8/ intentioned—may harmfully interfere HIV–1–Infected Adults and 12ths of the deposit that has been with patient needs if his or her clinical Adolescents) and which permits public approved for the plan for the year, but context is not fully taken into account. notice and comment).’’ Another this enrollee is required to pay the full The commenter suggested that in commenter urged CMS to establish any deductible approved for the plan for the

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entire calendar year. An enrollee whose enrollment letter that would inform months in which the individual is 65th birthday is later in the year could them of both their pro-rated deposit enrolled is not limited to a late enroll, for example, on September 1 and amount and their pro-rated deductible. enrollment under an ICEP. We thus would receive a pro-rated deposit As the result of our review and believe that the symmetry supported by representing only 4/12ths of the year; consideration of commenter support for the commenter should apply in all cases however, this enrollee would also be our proposal, we are modifying of midyear enrollment in an MSA plan. required to pay the full calendar year § 422.103(d) in this final rule to provide For example, a beneficiary who receives deductible. for a pro-rated deductible in the case of a special election period for relocating, The deductible under an MSA plan is any beneficiary enrolling in an MSA and enrolls in a MSA plan after January governed by section 1859(b)(3)(B) of the plan after January 1, not just an 1, should be required to pay only a pro- Act, which specifies the maximum enrollment pursuant to an ICEP. rated deductible. Therefore, we are amount of what the statute refers to as Comment: A commenter supported as modifying § 422.103(d) in this final rule the ‘‘annual deductible’’ under an MSA ‘‘positive’’ our proposal to ‘‘revise the to allow all beneficiaries who enroll in plan. In the October 22, 2009 proposed regulations to specify that beneficiaries a MSA plan midyear to pay a pro-rated rule, we proposed to infer from the who enroll in a Part C MSA during the deductible. statute’s use of the term ‘‘annual’’ that year’’ be required to ‘‘pay only a pro- the deductible amount at issue was rated deductible consistent with a pro- G. Changes to Clarify Various Program intended to apply to a full 12-month rated deposit.’’ Participation Requirements period, and thus to specify in a Response: While the commenter’s proposed revised § 422.103(d) that an point in support of the policy rationale This section addresses proposals from individual who enrolls in an MSA plan for our proposed revision to the October 22, 2009 proposed rule that under an ICEP other than at the § 422.103(d) was made in the context of would either clarify existing regulations beginning of the calendar year would our proposal to pro-rate deductibles for or implement new requirements only be subject to that portion of the beneficiaries who enroll after January 1 consistent with existing policy ‘‘annual’’ deductible corresponding to under an ICEP, the commenter’s point guidance, to assist MA organizations the number of months in which the in support of symmetry between a pro- with and PDP sponsors in attaining the individual is enrolled. Interested rated deposit and a pro-rated deductible goals envisioned by the Congress when beneficiaries would be able to inquire would apply to any situation in which the legislation implementing the with organizations sponsoring MSA a beneficiary enrolls in an MSA plan Medicare Advantage and Prescription plans about their options prior to after January 1. It is noteworthy that the Drug Benefit programs was first passed. enrollment, and, upon enrollment, language in section 1853(e) of the Act These clarifications are detailed in would receive a confirmation of limiting the Medicare payments to Table 7.

TABLE 7—CLARIFICATIONS OF VARIOUS SPONSOR PROGRAM PARTICIPATION REQUIREMENTS

Part 422 Part 423 Provision Subpart Section Subpart Section

Clarify what we mean by Subpart C ...... § 422.100(d) ...... Subpart C ...... § 423.104. uniform benefits. Ensure security of pro- Subpart K ...... § 422.504 ...... Subpart K ...... § 423.505. tected health information and other personally identifiable information. Require plans to report Subpart C ...... § 422.108 ...... Subpart C ...... § 423.464. other payer information to support coordination of benefits (COB). Visitor/Traveler Benefit Subpart B ...... § 422.74 ...... N/A ...... N/A. under Part C for the Pur- pose of Extending En- rollment up to 12 Months. Codify authority to estab- N/A ...... N/A ...... Subpart D ...... § 423.153(d). lish (MTM) Program re- quirements. Clarify Pharmacy & Thera- N/A ...... N/A ...... Subpart C ...... § 423.120. peutics (P&T) Committee requirements. Generic equivalent disclo- N/A ...... N/A ...... Subpart C ...... § 423.132. sure. Application of access N/A ...... N/A ...... Subpart C ...... § 423.120. standards at application level. Standard Timeframe for N/A ...... N/A ...... Subpart M ...... § 423.568. coverage determinations. Clarify Novation require- N/A ...... N/A ...... Subpart L ...... § 423.551. ments.

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TABLE 7—CLARIFICATIONS OF VARIOUS SPONSOR PROGRAM PARTICIPATION REQUIREMENTS—Continued

Part 422 Part 423 Provision Subpart Section Subpart Section

Cost Contract Program re- Subpart O ...... § 417.428 ...... N/A ...... N/A. visions: Appeals and § 417.492 ...... Marketing Requirements. § 417.494 ...... § 417.500 ...... § 417.640 ......

1. Uniform Benefits Under Parts C and outlines our expectations of Part D and assessing plan compliance with D (§ 422.100(d) and § 423.104(b)) sponsors when administering the Part D personal health information-related In the October 22, 2009 proposed rule, benefit during a natural disaster or requirements. we proposed to revise § 423.104(b) to public health emergency. Response: We appreciate the suggestion and will consider this as we mirror the language at § 422.100 to 2. Ensuring the Security of Protected develop any additional guidance on specify that Part D sponsors apply Health Information (PHI) and Other PHI-related requirements. uniform premiums and cost-sharing. As Personally Identifiable Information Comment: A commenter questioned we noted in the proposed rule, section (§ 422.504 and § 423.505) 1852(d)(1)(A) of the Act requires a MA CMS’ authority to request backup tapes organization offering a plan to select the In our October 2009 proposed rule (74 and computer-generated information providers from whom the benefits under FR 54690), we specified that we held by pharmacies as part of CMS’ the plan are provided so long as the interpret the Secretary’s right to audit or review of privacy/security of PHI organization makes such benefits inspect the facilities of MAOs and Part requirements. The commenter writes available and accessible to each D sponsors to monitor compliance with that tapes and computer data can individual electing the plan within the MA and Part D program regulations as contain information beyond that plan’s service area with reasonable including the evaluation of compliance normally submitted by plans and which promptness and in a manner which with our requirements for maintaining is often unrelated to a pharmacy’s Part assures continuity in the provision of the privacy and security of protected D contract. If CMS is, in fact, asking for benefits. Section 1860D–2(a) of the Act health information (PHI) and other information outside of that provided as defines qualified prescription drug personally identifiable information of part of the pharmacies’ contracts with coverage to mean access to standard or Medicare enrollees. In order to clarify Part D plans or claims data that actuarially equivalent prescription drug our policy that beneficiaries’ PHI and pharmacies routinely submit, the coverage and access to negotiated prices other personally identifiable commenter requests that CMS clarify its (in accordance with section 1860D–2(d) information must remain secure, we authority for doing this. of the Act). We codified these sections proposed to revise § 422.504 and Response: Although we have the of the statute in our regulations at § 423.505 to make this interpretation authority to review information § 422.100(d) and § 423.104(b) prior to explicit. In a related change, we generated in connection with the the proposed rule, but believed that proposed to clarify that we interpret the downstream or related entity’s contract § 423.104(b) should be further clarified term ‘‘facilities’’ to include an MAO’s or with an MAO or Part D sponsor, in regards to the PDP sponsor’s Part D sponsor’s computer or other including information related to imposition of uniform premiums and electronic systems. We proposed to compliance with privacy and security cost sharing. In this final rule, we adopt implement these proposed changes at requirements, it has never been our this provision as proposed with a minor § 422.504(e)(1)(ii) and § 423.505(e)(1)(ii). intent to review documents or revision. We also proposed conforming changes information unrelated to a pharmacy’s Comment: One commenter is to the contract requirements related to or other downstream or related entity’s concerned about how the uniform downstream entities at § 422.504(i)(2)(i) Part C or Part D contract. requirement would be applied in and § 423.505(i)(2)(i), respectively. We 3. Requirement for Sponsoring unusual circumstances that may not be noted in the preamble to the proposed Organizations Under Parts C and D to in the enrollee’s best interests. For rule that we may review systems and Report Other Payer Information to the example, the commenter asked what computer information generated by Coordination of Benefits Contractor would happen if an enrollee has already downstream and related entities for (§ 422.108, § 423.462, and § 423.464) paid the applicable cost sharing amount compliance with privacy and security once, but by no fault of the beneficiary, requirements. Such information In the October 22, 2009 proposed rule, the drug is either no longer usable, or includes, but is not limited to, backup under the authority of sections available because of a natural disaster. tapes, print outs of screen shots, CDs, 1852(a)(4) and 1860D–2(a)(4) of the Act, Waivers should be considered in these and similar information, whether in the we proposed to require the reporting of special circumstances. possession of a downstream or related other coverage information in § 422.108 Response: The circumstance the entity or obtained from such entities by for MA organizations and § 423.462 and commenter refers to is more the MAO or Part D sponsor. We are § 423.464 for PDP sponsors. Our appropriately addressed by our adopting the revisions to § 422.504 and rationale for proposing these changes emergency access policy and not by a § 423.505 as specified in the proposed was the importance of the other payer revision to, or waiver of, the uniform rule. information for Medicare Seconday benefit requirement. Our emergency Comment: Several commenters Payer (MSP) procedures and for access policy is currently provided in supported the proposed provisions with prescription drug program coordination Chapter 5 of the Medicare Prescription one commenter suggesting that CMS of benefits. We proposed to limit Drug Benefit Program Manual and draw upon its expertise in evaluating required reporting to that information

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which is reported to the sponsor as MSP procedures and for Part D sponsor the preamble discussion to the final rule being inconsistent with existing COB (see 42 U.S.C. 1395y(b)(7) and (8)). that we will only require reporting on information on the COB file. Most insurers will need to report their information that is inconsistent with As we noted in the October 22, 2009 own coverage already. It is only when that in the COB data file. proposed rule, MA organizations are an MA organization becomes aware of Response: In this final rule, we are responsible for identifying payers that coverage that is primary to Medicare reiterating that the portion of the are primary to Part C of Medicare, offered by another insurer that it will preamble discussion in the proposed determining the amounts payable by need to report under this rule. rule related to the requirement to report those payers, and for coordinating the Accordingly, given the importance of only MSP and COB information that is benefits the plan offers with the benefits the other payer information to MA inconsistent with existing information of such payers. Additionally, MA organization and PDP MSP procedures on the COB data file. We have also organizations must take into account and for prescription drug program repeated the preamble discussion of Part C costs that could have been coordination of benefits, we proposed to what we mean by ‘‘credible’’ new recovered or avoided due to MSP when include in regulatory text the information and confirmed that we only determining costs in the base period for requirement that MA organizations and expect MAOs and PDPs to report such purposes of their MA plan bids. MA Part D sponsors, upon being notified of ‘‘credible’’ new information to the organizations must account for Part C credible new information regarding COBC. We have not modified the MSP amounts in one of three ways. MA other payers, or changes to existing regulatory language since we believe it organizations must— other payer information, report this is unnecessary to do so. However, we • Recover from liable third parties; information to the CMS COB Contractor have added § 423.464(h), which we • Avoid Part C costs by directing (COBC) in accordance with the inadvertently omitted from the providers to bill liable third parties processes and timeframes established by proposed rule. Operational guidance, in directly; or us. The proposed changes would change the form of our implementing • Account for Part C costs that could the requirement on MA organizations, instructions, will be consistent with have been recovered or avoided, but that but would not change current MSP and preamble language in both the proposed were actually not recovered or avoided, coordination of benefits policy for the rule and this final rule. by not including them in Part C base prescription drug program. Comment: One commenter pointed period costs. We noted that by ‘‘credible’’ we mean out the apparent discrepancy between MA organizations and PDPs are information that is consistent with the 30-day timeframe for reporting required to follow the same rules conventions for how group health credible MSP/COB information to the regarding— insurance coverage is identified, for COBC we mentioned in the preamble of • Their responsibilities under the instance, information that includes the the October 2009 proposed rule, and the MSP statutory and regulatory name and address of the insurance 45-day timeframe for correcting provisions; company and the policy identification discrepancies in MSP status (with an • Collection of payment from number. We also proposed to extend the additional 10 days to submit insurers, group health plans and large reporting requirements to MA corrections) discussed in Chapter 5 of group health plans, the enrollee, or organizations as they relate to other the MSP Manual. The commenter other entities for covered Part D drugs; primary payers. We noted that original requested that CMS retain the existing and Medicare, MA organizations, or Part D 45-day timeframe, with an additional 10 • The interaction of MSP rules with sponsors should never be reported to days for submission to the COBC. State laws. CMS as a ‘‘primary’’ payer. In the Response: As noted in the preamble of A Part D sponsor must also coordinate absence of another (that is, non- the proposed rule, section 50.2 of the with SPAPs, as well as other drug plans, Medicare) primary payer, original Coordination of Benefits chapter of the including Medicaid programs, group Medicare, an MA organization, or a Part Medicare Prescription Drug Benefits health plans, FEHBP, military coverage, D plan are always primary. This is not Manual (CMS Publication # 100–18, and other plans or programs providing to say that if an enrollee has primary Chapter 14, last updated in September prescription drug coverage. To support individual or employer group coverage 2008) provides for reporting within 30 the required benefit coordination, with the same insurer or organization days of receipt and can be accessed on section 1860D–2(b)(4)(D)(ii) of the Act through which they also have MA or the Internet at: http://www.cms.hhs.gov/ permits Part D sponsors to request Part D coverage, such primary coverage prescriptiondrugcovcontra/ information on third party insurance should not be reported. In fact, such 12_PartDManuals.asp. from beneficiaries. In addition, we coverage must be reported. However, We will consider this comment as we noted that the growing number of CMS reporting original Medicare, an MA or develop operational guidance related to data sharing agreements with other Part D plan themselves as primary the reporting of MSP information payers has improved the volume and serves no purpose and merely causes related to Part C by MAOs. However, we quality of other payer information confusion. note that the timeframe for reporting available to MA organizations and After reviewing the comments MSP status in section 10.1 of Chapter 5 prescription drug sponsors on the COB received in response to the proposed of the MSP manual is actually the lesser data file provided by CMS. New rule, we are adopting § 422.108(b)(3) of 10 calendar days from completion of mandatory insurer reporting of MSP and § 423.462(b) as proposed. the evaluation or 45 calendar days from group health plan coverage, liability Comment: A commenter supported receipt. insurance, no-fault insurance, and CMS’ proposed Part C reporting Comment: A commenter asked if the workers’ compensation, required by requirement. Another commenter requirements in § 422.108 and § 423.462 section 111 of the Medicare, Medicaid, requested that we revise the new apply to only MA plans, or if these and State Children’s Health Insurance regulatory language to reference the fact requirements also apply to Group Program (SCHIP) Extension Act of 2007 that we will only require MAOs and Health Plans. (P.L. 110–173) (MMSEA), further PDPs to report ‘‘credible’’ new Response: The regulations at expands the other payer information information and that CMS either revise § 422.108 apply to MA organizations, available for MA organization and PDP the regulatory language or mention in while the regulations at § 423.462 apply

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to both MA organizations offering Part benefit option under an MA plan if that mandatory and optional supplemental D benefits as MA–PDs and free standing plan furnishes all plan covered services, benefits) at in-network cost sharing in PDPs. Information on the rules related that is, Medicare Parts A and B services the areas where the V/T benefit is to Group Health Plan reporting of and all mandatory and optional offered. We note that it is optional for insurance coverage required by section supplemental benefits at in-network MA organizations to offer a V/T benefit 111 of MMSEA can be found on the cost-sharing levels consistent with and that a V/T benefit gives MA following Internet Web site: http:// Medicare access and availability organizations the flexibility to retain www.cms.hhs.gov/mandatoryinsrep/. requirements at § 422.112. Under this their members when they are outside Comment: A commenter noted an proposed clarification, MAOs that offer the service area for extended periods of inconsistency between the preamble a V/T benefit under an MA plan would time when they might otherwise be and the regulation language. The be required to make the option available required to disenroll them for residing commenter stated that CMS seems to to all plan enrollees. We proposed that outside the service areas for more than have failed to include regulation the V/T benefit must be available to all 6 months. We do not agree that language at § 423.464 requiring Part D plan enrollees who are temporarily in supplemental benefits should be sponsors to report new or changed the areas where the V/T benefit is excluded from a V/T benefit. Since MA supplemental prescription drug offered for the 6 to 12 months the organizations will receive full capitation coverage information. member may remain in the area and stay payments for enrollees that reside Response: In the preamble of the enrolled in the MA plan. We are outside the plan’s service areas for more proposed rule, we indicated our adopting our proposed revision to than 6 months, we believe that requiring intention to revise § 423.464 to include § 422.74(d) (4) (iii) without further the plan to cover all plan-covered a new requirement for Part D sponsors modification in this final rule. benefits will allow the enrollees to to report new or changed other Comment: A few commenters continue to realize the complete benefit prescription drug coverage information supported our proposed revisions to the package for which they enrolled in the to the CMS COB Contractor. However, V/T benefit requirements. They plan. An MA organization that is not due to an oversight, the regulatory indicated that currently there is able to form a network of direct language for this requirement was not confusion surrounding the V/T benefit, contracted providers to furnish included in the proposed rule. However, and many beneficiaries have found the supplemental benefits may, with CMS the preamble discussion of this benefit does not provide them with approval, allow its enrollees to obtain proposed requirement put interested access to Medicare-covered services these services from non-contracted parties on notice that we were they expected to have when outside providers in the areas in which it offers considering imposing a new their plan’s network. the V/T benefit. We are therefore requirement on Part D sponsors to One commenter supported providing retaining our proposed changes to report new or changed prescription drug Medicare-covered services under the § 422.74(d)(4)(iii) in this final rule. coverage information to the CMS COB V/T benefit, but opposed our proposed contractor. Furthermore, we continue to requirement to also include optional 5. Medication Therapy Management believe that this reporting requirement supplemental benefits. The commenter Program Requirements (§ 423.153) is necessary to support the effective believed that this change would require coordination of prescription drug organizations to adjust plan premiums In the October 22, 2009 proposed rule, benefits. Accordingly, we are including and could ultimately impact an we proposed to codify our policy this new requirement at § 423.464(h) in organization’s decision to offer optional guidance regarding medication therapy this final rule. supplemental benefits if a plan is not management programs (MTMPs) in the able to develop and meet network Part D regulations at § 423.153. As we 4. Visitor/Traveler Benefit Under Part C access requirements in the areas in noted in the preamble to the proposed for the Purpose of Extending Enrollment which it intended to offer the V/T rule, based on the experience garnered Up to 12 Months (§ 422.74) benefit. from the first few years of the Part D In the October 2009 proposed rule, we Another commenter objected to the program, and as we await further proposed to revise our requirements for fact that the proposed revisions are less development of MTMP outcomes MA visitor/traveler benefits under Part flexible than the existing rules measures that can serve the Part D C. Section 422.74(d)(iii) currently governing V/T benefits and opposed the program, we have determined that it is provides that an MA plan can offer a proposed requirement to provide necessary to have more specific Part D ‘‘visitor’’ or ‘‘traveler’’ (V/T) type program supplemental benefits under the V/T MTMP requirements for enrollment which would allow its enrollees to benefit. The commenter indicated that it methods, targeting procedures, and remain enrolled in the MA plan while may be more feasible for MA MTM services. The 2010 Call Letter out of the plan’s service area for up to organizations to enter into arrangements included policy guidance regarding the 12 months. Although we stated in the with providers in other areas of the implementation of MTMPs that preamble of the final rule in which country to provide access to Medicare- reflected common practices among Part § 422.74(d)(iii) was promulgated covered benefits than supplemental D MTMPs that were derived from (August 22, 2003 (68 FR 50848)) that the benefits. The commenter recommended extensive review of MTMP applications, visitor or traveler program must cover that CMS defer incorporating the plan-reported data, exploratory research the ‘‘the full range of services available proposed changes into the MA on MTM, informational interviews with to other members,’’ we did not specify regulations and instead issue draft sub- Part D sponsors, and other relevant in regulation text what we intended by regulatory guidance for public literature and data. In the proposed rule, ‘‘full range of services.’’ comment. we indicated that codifying this MTM In order to clarify an MA Response: We agree with the guidance in the Part D regulations organization’s obligation to cover commenters supporting our proposal to would promote greater consistency services out of the service area, we require MA organizations that offer a V/ across the Part D program, and allow for proposed to amend § 422.74(d)(4)(iii) to T benefit under an MA plan to furnish better evaluation and comparison of specify that an MA organization may all plan-covered services (Medicare MTMPs when outcomes measures offer an extended enrollment V/T Parts A and B services and all become available.

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Specifically, in accordance with require reporting of MTM payment data medicines for all chronic therapies. sections 1860D–4(c)(1)(C) and 1860D– to ensure payment adequacy. The non- MTMPs should also be required to 4(c)(2) of the Act, we proposed to add interference provision at section 1860D– initiate interventions to address the following regulatory requirements 11(i) of the Act explicitly provides that underutilization on at least a quarterly regarding MTMPs— the Secretary may not interfere with the basis. • Section 423.153(d)(1)(v) to require negotiations between pharmacies and Response: We appreciate these Part D sponsors to enroll beneficiaries in PDP sponsors, which would include comments, but not all beneficiaries can their MTMPs using only an opt-out payment negotiations between the Part access the MTM services face-to-face or method of enrollment. The opt-out D sponsors and pharmacies for MTM at the provider’s location. Furthermore, method of enrollment is currently the services. we believe permitting alternative preferred method of enrollment among Comment: One commenter interactive methods (for example, by Part D sponsors, used by approximately encouraged CMS to require Part D telephone or Web cam) will allow the 85 percent of current MTMPs, and has sponsors to disclose to CMS their sponsors to try innovative techniques increased enrollment of targeted criteria for determining whether a that may better serve the beneficiary, beneficiaries into MTMPs; comprehensive medical review (CMR) especially when the beneficiary resides • Section 423.153(d)(1)(vi) to require will be performed face-to-face or by in a remote location or cannot travel to Part D sponsors to target beneficiaries phone. the provider’s location. We emphasize, for enrollment in the MTMP at least Response: We appreciate this however, that when using alternative quarterly during each plan year. comment, but believe that as long as the interactive methods, the CMR Currently, more than 95 percent of Part CMR is interactive and person-to- interaction must remain a real-time D sponsors target beneficiaries for person, plans continue to have the interaction. enrollment in their MTMPs on a daily, discretion to determine whether it can We do not require the quarterly weekly, monthly, or quarterly basis; and be achieved through a phone or other assessment to be interactive because we • Section 423.153(d)(1)(vii) to require alternative real-time method. We will believe lower touch interventions, Part D sponsors to offer a minimum monitor MTM program outcomes and coupled with the annual comprehensive level of MTM services for each performance to ensure best practices are medication review will allow the beneficiary enrolled in the MTMP that adopted. In the event we receive data patient to be adequately served. includes interventions for both revealing weaknesses in this approach However, we encourage plans, to follow beneficiaries and prescribers; annual to CMR, we may consider revising the up with a person-to-person interaction if comprehensive medication reviews; and CMR minimum requirements in future the quarterly review reveals that the quarterly targeted medication reviews. rulemaking. patient is facing medication related In addition, we proposed to revise Comment: One commenter suggests problems. § 423.153(d) to clarify which that when enrollees are provided with a Comment: One commenter indicated beneficiaries should be targeted for written summary of the interactive that CMS should clarify what it means MTMP services. consultation, such summary be by interactive, person-to-person In this final rule, based on the public provided promptly to all prescribers consultation. For some hearing impaired comments we received in response to involved in an enrollee’s care. or technically savvy beneficiaries the the proposed rule, we adopt these Response: We agree with the Internet is a valuable communication provisions with some modification, as commenter and believe such written tool. CMS should allow the use of explained below. Specifically, at summaries should be provided emerging technologies to conduct the § 423.153(d)(2)(iii), we adopt a specific promptly to the provider. However, we CMR. dollar threshold of $3,000 in incurred believe the timeframe for the release of Response: As indicated in an earlier annual costs for covered Part D drugs, such summaries to providers is better response, we agree that the use of instead of, as proposed, relying on the addressed in the agreements between alternative interactive methods be used Initial Coverage Limit (ICL) as the the MTM providers and the plans. The by Part D sponsors, as long as the CMR threshold at which plans must target written summaries from the CMR will is conducted in real-time. beneficiaries for MTM services. The vary in complexity, depending upon an Comment: One commenter $3,000 cost threshold will be indexed individual’s diagnoses and medication recommends sponsors have the using the annual percentage increase in usage; therefore, the time needed for flexibility to determine if an MTMP average per capita aggregate preparation of such summaries will intervention should be for member, expenditures for Part D drugs, which is vary. prescriber or both. Another commenter found in § 423.104(d)(5)(iv). We note Comment: A few commenters indicated that additional clarification is that these provisions are consistent with indicated that the outcomes of MTMPs needed about any and all prescriber the changes made in PPACA. would be enhanced by requiring at least interventions to ensure that MTM Comment: One commenter is one initial face-to-face consultation with services are coordinated with and do concerned that the proposed rule does a pharmacist to review the patient’s not adversely impact on, or interfere not ensure adequate payment to drug regimen and by offering another with, the relationship between the pharmacies for MTM services. The face-to-face consultation at least enrollee and his/her prescriber. commenter believes plan sponsors may quarterly. Another commenter indicated Response: Section 423.153(d)(1)(vii), shift costs associated with MTMPs to that the quarterly reviews should be would require Part D sponsors to offer providers (specifically pharmacies) done person-to-person as this interventions to the enrolled beneficiary through lowered payments. The interaction permits evaluation of cues and his/her prescriber. As indicated in commenter urges CMS to require that may otherwise be missed if the preamble to the proposed rule, this quarterly reporting of payment to performed through lower touch does not mean that all interventions pharmacies for MTM services and interventions. Furthermore, periodic re- must be targeted to both the beneficiary should ensure that pharmacies are paid evaluations must be conducted and and prescriber. Instead, sponsors must adequately for furnishing these services. MTMPs should initiate programs to determine, based upon the specific Response: We disagree with the detect proactively, on a monthly-basis, nature of the intervention, whether it commenter’s recommendation that CMS under-utilization of prescribed should be targeted to the beneficiary,

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the prescriber, or both, in order to Response: We appreciate the criteria for targeting beneficiaries for promote coordinated care. commenters’ interest in this issue. We MTMPs are not yet clear. Comment: One commenter indicated will continue to utilize valid Response: We disagree with these that it is important that CMS clarify how performance measures such as the commenters regarding placing the the MTM requirements will be applied, measures developed by the PQA. In requirements in regulation. This if at all, in the long-term care setting. addition, we will evaluate MTM rulemaking process has afforded both Furthermore, this commenter asked how outcome data that we receive under the Part D plans and the public the Part D sponsors will coordinate their Part D reporting requirements to ensure opportunity to comment on the MTMP efforts with the consultant pharmacists that Medicare beneficiaries are receiving requirements prior to any changes being who conduct monthly drug regimen effective and appropriate MTM services. made to the existing requirements. reviews for all residents in Medicare/ We will also continue to evaluate Furthermore, because the MTMP Medicaid certified facilities. MTMPs to ensure consistent guidelines requirements are being incorporated in Response: The same MTM program are applied, and issue best practices our regulations, in the event a Part D requirements apply to long-term care when necessary. We note that an MTM sponsor fails to meet its MTMP services residents as apply in the outpatient contract was awarded through 2010 to requirements, our ability to enforce setting, except that Part D sponsors are assist CMS in monitoring and evaluating those requirements has been enhanced. not required to offer an interactive CMR sponsor’s MTM programs. Accordingly, we believe that including to targeted beneficiaries in an LTC Comment: Two commenters indicated these MTMP requirements in our setting. The Part D sponsor will still be that MTM services should be included regulations will help to ensure that required to do the quarterly medication as part of access standards for retail targeted beneficiaries receive reviews and offer interventions targeted pharmacies. Another commenter appropriate MTM services. to the individual’s prescribers. Part D requested that CMS ensure that Comment: One commenter sponsors are not required to coordinate pharmacists working in community recommends that CMS develop their MTM services with the monthly pharmacy practice settings (network standardized billing and documentation drug regimen reviews of the facilities’ pharmacies), and pharmacists data sets to eliminate the need for consultant pharmacists at this time. unaffiliated with network pharmacies, pharmacists to utilize specific platforms Comment: We received several have the opportunity to contract with to obtain payment from different plans. comments regarding performance Part D plans to provide MTM services. A standardized data set should include a measure of a patient’s clinical measures for pharmacists. Commenters Response: These comments are outcomes as well as the rates at which made the following recommendations: outside the scope of this rulemaking and • the patient’s providers accept the CMS should continue to use therefore we will not be addressing validated performance-based measures pharmacist’s recommendations. them in this rule. Response: We agree that the adoption for pharmacy providers, such as the Comment: A few commenters Pharmacy Quality Alliance (PQA) of standardized documentation for recommend that CMS consider MTM could be helpful in measuring the measures. These measures will give requiring, or signaling a preference for, further definition to MTMPs, outcome of MTM. However, we believe pharmacists to provide MTM services. any such standard documentation or distinguish among different pharmacy Another commenter requested providers and the types of MTMPs billing be developed via an industry clarification regarding the standard-setting group, and not by CMS. provided and appropriately compensate characteristics of an ‘‘other qualified pharmacists that are able to improve Comment: Several comments were provider’’ in the regulation and at a received regarding the MTM targeting quality of care. minimum, a requirement that the • CMS should consider additional criteria. Specifically, commenters provider have demonstrated expertise in performance measures, in conjunction suggested that CMS— medication use management. • with participating pharmacists, and the Decrease the maximum number of Response: At present, 99 percent of performance measures should be made medications that a plan could require the MTMPs are utilizing the services of available publicly, on a yearly basis. for a targeted beneficiary to be eligible pharmacists. While CMS believes The commenter suggested that CMS for MTM services; currently that pharmacists will continue to be the adopt only performance measures number is eight. One commenter main provider of MTM services, the established by national voluntary recommended decreasing the number to statute at 1860D–4(c)(2) of the Act consensus building. six, to prevent patients taking • CMS should continue to allow as permits plans the flexibility to use other combination drug products from being much flexibility as possible until qualified providers to perform the unintentionally excluded from the evidence can demonstrate what aspects MTM. At this time, CMS does not program because a single medication of an MTMP bring desired results. believe it is necessary to issue has replaced two separate drug • CMS should expand upon existing regulations to govern the qualifications products; data collection and reporting for providers of MTM services, but may • Allow Medicare beneficiaries who requirements. At a minimum, reported consider rulemaking in the future, if do not qualify for MTM services to data should include— further data reporting and experience receive MTM services through a referral ++ Number of adverse drug events reveal that additional refinement of the or prior authorization process initiated avoided, categorized by reason; policy is needed. by their prescriber or pharmacist. Some ++ Data on adherence and Comment: Several commenters patients with only one chronic disease persistence by enrollees to their recommend that CMS not set specific or less than 8 medications may still prescribed drug therapies; program requirements in regulatory have medication use issues that would ++ Information on the form, language, but continue to use the benefit from participation in their plan’s frequency, and types of interventions; subregulatory mechanism offered by the MTM program; and, and annual industry call letter. They believe • Require MTM services upon ++ Data on the per capita there is insufficient experience to discharge from the hospital or anytime administrative and drug costs under include MTM policies in regulation, and a beneficiary undergoes a transition of each program. the implications of the more detailed care. In both situations beneficiaries

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would benefit from receiving MTM Response: We do not agree with this Response: To the extent that the services because MTM has the potential approach. Pursuant to section 1860D– commenter appears to be stating that it to reduce costly hospital readmissions 4(c)(2)(A)(ii)(III) of the Act, targeted is improper to consider cost due to medication misuse or non- beneficiaries are defined as Part D considerations in targeting beneficiaries adherence. eligible individuals who ‘‘are identified for the MTM program, we disagree. As Response: The regulation governing as likely to incur annual costs for discussed above, section 1860D– the number of prescriptions an covered Part D drugs that exceed a 2(c)(2)(A)(ii)(III) of the Act expressly individual must take before he or she is specified level by the Secretary.’’ instructs CMS to consider costs for Part targeted for MTM services sets both a Accordingly, the statute does not afford D drugs when targeting beneficiaries for ceiling and a floor on the number of CMS the flexibility to permit plans to MTM. However, following further prescriptions that may be required. target individuals for MTM services consideration of this issue, reliance on Therefore, a plan sponsor has the based upon their expected aggregate the ICL, which is specifically tied to the discretion to determine whether to health care spending. Furthermore, cost structure of the Part D benefit to target beneficiaries taking anywhere given the complexity of this suggested target beneficiaries for MTM may be from two to eight medications. Our data alternative, we believe the collection problematic. There have been further indicate that 85 percent of the plans and review of health care spending data legislative proposals to restructure the reviewed targeted beneficiaries in a prior to determining whether an Part D benefit, including revising the range of two to eight medications. individual will be targeted for MTM ICL, that may have unintended As for targeting certain other services would only delay access to consequences for basing the MTM beneficiaries for MTMP services, our MTM services. targeting criteria on the ICL. regulations provide that sponsors must Comment: One commenter indicated Accordingly, we believe the provide a minimum level of MTM that a Part D sponsor’s use of an opt-out establishment of a specific dollar services to targeted beneficiaries. To the only enrollment process for placing threshold is more appropriate and are extent a Part D plan wants to offer beneficiaries in its MTM programs must reverting back to the $3000 limit, which additional MTM services, or provide be carried out thoughtfully and we previously established in the 2010 MTM services to individuals who do carefully. CMS should require MTM call letter. Consistent with statutory not meet the targeting criteria, including program policies that promote patient requirement that drug costs be those individuals who have undergone collaboration with their physicians, considered in targeting beneficiaries for a transition in their level of care, they provide adequate enrollment MTM, we will apply an index that is may do so. However, additional notification and include clear equal to the annual percentage increase administrative reimbursement will not instructions on opt-out. CMS should in average per capita aggregate be available for the provision of these also undertake an outreach initiative to expenditures for Part D drugs. additional services. physicians. Specifically, we will adjust the $3000 Comment: We received some Response: We appreciate the threshold by the index used to increase comments regarding MTM targeting commenter’s concerns regarding the the ICL, as originally proposed, which is frequency. One commenter indicated application of the opt-out method to currently found at § 423.104(d)(5)(iv). that CMS should consider increasing the enroll beneficiaries into MTMPs. The decision to apply a $3000 minimum requirements regarding the However, we believe the opt-out threshold is based upon program frequency with which plans conduct approach is critical for the health and experience and our analysis of PDE outreach to eligible beneficiaries for well-being of the Medicare population. data. We originally established the enrollment in MTM programs, and The elderly and disabled populations initial $4000 cost threshold at the specifically recommended that are most at risk of polypharmacy inception of the Part D program. At that beneficiaries be targeted for enrollment consequences. Therefore, an opt-out time, it was estimated that at least monthly. enrollment policy that requires no approximately 25 percent of the Part D Response: The requirement of further action by the enrollee helps to eligible population would meet the quarterly targeting that was included in ensure that vulnerable individuals will three criteria and be targeted for MTM the proposed rule, and that is being be enrolled in MTMPs, which we services. After two years of experience adopted into this final rule, is a floor believe will reduce adverse drug and analysis of plan reported data, we that Part D sponsors may build upon. reactions and ensure safe prescription found that only 10.0 percent of Sponsors may adopt more frequent drug practices, before their health is at beneficiaries enrolled in a Part D plan targeting than the minimum quarterly risk. In addition, CMS has found that with an approved MTMP were eligible outreach threshold required under the the opt-out enrollment method is the for MTMP in 2006 (13.1 percent were regulation. We will also continue to preferred method among Part D eligible for MTMP in 2007). In 2008, we monitor and evaluate MTM programs to sponsors to increase the number of conducted an analysis using PDE data determine if there is any significant beneficiaries participating in MTMPs. In from contract years 2006 and 2007 difference in MTM outcomes when 2008, fewer than 15 percent of MTMPs obtained from the Integrated Data beneficiaries are targeted more utilized an opt-in method. We will Repository (IDR) system. The total gross frequently and will consider making continue to monitor Part D plans to drug cost and number of beneficiaries further changes to our requirements if ensure they engage in best practices that incurred annual drug costs (below) warranted. when applying the opt-out enrollment or (greater or equal) to the $4000 cost Comment: One commenter believed a method to their plan members. threshold was determined. The average better method for targeting beneficiaries Comment: One commenter was number of PDE fills and average cost per would be to examine an individual’s concerned that the use of the initial beneficiary was also calculated. Further historical and expected aggregate health coverage limit (ICL) as a targeting analysis examined cost breakouts in care spending using a cost threshold for benchmark for Part D MTM may elevate $500 increments to determine the eligibility that is based on total cost considerations over clinical distribution of beneficiaries, as well as projected Medicare spending, rather considerations in targeting beneficiaries the number of fills, and gross drug cost than just Part D spending. for the Part D MTM program. for beneficiaries with annual drug costs

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within these breakouts. It was protocols, and quantity limit restrictions indication (an indication only determined that close to 25 percent of applied to each covered Part D drug. supported in the statutory compendia) Part D enrolled beneficiaries with drug In this final rule, we adopt these before providing access to a drug utilization (beneficiaries with at least provisions as proposed. supported by an FDA approved one PDE during the study period) Comment: One commenter is indication (on-label indication) unless during 2006 and 2007 had annual gross concerned that utilization management the off-label indication is supported by drug costs of at least $3000. Therefore, (UM) requirements have become widely used treatment guidelines or CMS lowered the cost threshold to barriers to timely access, especially for clinical literature that we consider to $3000 in the 2010 Call letter. Based the low-income population for whom represent best practices. Generally, we upon our analysis of the most recent the exceptions, reconsideration, and require such authoritative guidelines to data, it appears that this threshold will appeals processes are difficult to be endorsed or recognized by Federal continue to ensure that approximately navigate. While UM tools may be used government entities or medical specialty 25 percent of these beneficiaries appropriately by a Part D plan, they may organizations. utilizing the Part D benefit receive MTM also result in impeding appropriate and Comment: One commenter indicated services. Accordingly, we are adopting timely access to prescribed medications that they agree, theoretically, that the the $3000 cost threshold in this final and in themselves, can be P&T committee should not have to rule. discriminatory in beneficiary selection approve administrative PA criteria, such of the Part D plans to the extent that as Part B versus Part D coverage, but 6. Formulary Requirements— beneficiaries are even aware of the their experience has been that plans Development and Revision by a restrictions. utilize administrative criteria as excuses Pharmacy and Therapeutics Committee Response: It is our intention that the not to cover drugs. Therefore, they (§ 423.120) changes adopted specifying the believe P&T committees should review In the October 22, 2009 proposed rule, responsibilities of the P&T committee in the administrative criteria to make sure we offered further clarifications this final regulation will address this they are being applied properly. surrounding our formulary requirements commenter’s concern regarding Another commenter indicated that CMS associated with pharmacy & potentially discriminatory practices that allow plan sponsors to implement non- therapeutics (P&T) committees. As we may affect beneficiary protections. We clinical UM criteria without the input explained in the preamble to the believe P&T committees are in the best and prior approval of their P&T proposed rule, section 1860D–4(b)(3)(A) position to ascertain whether certain committees. of the Act requires Part D sponsors to UM tools, when applied to covered Part Response: Consistent with the use a P&T committee to develop and D drugs, will inappropriately impede operational guidance in Chapters 6 and review the formulary if the Part D access to these drugs, since the 7 of the Medicare Prescription Drug sponsor uses a formulary. In developing committee’s membership includes Benefit Program Manual, we continue to and reviewing the formulary, section independent practicing pharmacists and require Part D sponsors to submit 1860D–4(b)(3)(B) of the Act requires the physicians with the clinical knowledge utilization management requirements, P&T committee to base clinical necessary to provide an unbiased review such as prior authorization, step therapy decisions on the strength of scientific of the impact of UM tools on the Part and quantity limits not based upon the evidence and standards of practice, D sponsor’s formulary. FDA’s maximum daily dose limits, as including accessing peer-reviewed Comment: One commenter indicates part of their Health Plan Management medical literature, such as randomized that it supports CMS’ improvement of System (HPMS) formulary submission. clinical trials, pharmacoeconomic the rigor of evidence supporting We believe these UM tools should be studies, outcomes research data, and on decisions of P&T committees, but reviewed by Part D sponsor P&T such other information as the committee encourages CMS to strengthen its committees for the reasons stated above. determines to be appropriate. The P&T evidence requirements even further. However, we continue to believe that committee must also consider whether This commenter is concerned that the the administrative criteria a plan uses the inclusion of a particular Part D drug widely used treatment guidelines or should not be subject to the P&T in a formulary or formulary tier has any clinical literature standard may not be committee review because they do not therapeutic advantages in terms of specific enough and recommends that require clinical information or safety and efficacy. CMS amend § 423.120 to provide that a justification. Moreover, we believe that Based upon our experience with the Part D sponsor may require that when a beneficiary is subject to an formulary development process since beneficiaries try drugs supported solely administrative UM tool (that is, one that the beginning of the Part D program, we by off-label indications only if the is not a coverage determination) that the have come to recognize that the sponsor demonstrates that there are beneficiary believes unfairly denies application of prior authorization (PA) generally accepted, widely used and access to his/her prescription drugs, criteria, step therapy, and quantity evidence-based treatment guidelines or such cases can be addressed through the limits are as important to the clinical substantial and credible clinical plan’s grievance process. In accordance soundness of a formulary as the drugs literature that recommend patients use with § 423.564, Part D sponsors must that are included. Access to Part D drugs an off-label indication. provide meaningful procedures for may be influenced as much by the Response: The policy regarding a plan timely hearing and resolving enrollee application of PA criteria, step therapy member’s use of drugs for off-label grievances. Chapter 18 of the Medicare requirements, or quantity limit indications is out of the scope of this Prescription Drug Benefit Manual restrictions as it can be by exclusion of final rule. However, we have recently defines a grievance as any complaint or a Part D drug from a Part D formulary. adopted in our guidance (see the 2010 dispute other than one that involves a Therefore, in accordance with section Call Letter released on March 30, 2009) coverage determination or a low-income 1860D–4(b)(3)(A) and (b)(3)(B) of the that as part of our assessment of a subsidy or late enrollment penalty Act, we proposed adding new paragraph formulary’s appropriateness, Part D determination, expressing § 423.120(b)(1)(ix) to require P&T sponsors will not be permitted to dissatisfaction with any aspect of the committees to review and approve all require an enrollee to try and fail drugs operations, activities, or behavior of a clinical PA criteria, step therapy supported only by an off-label Part D sponsor, regardless of whether

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remedial action is requested. Because Comment: One commenter indicated the authority to waive this requirement another avenue exists for redress of a that plans inform beneficiaries of for certain entities in certain cases as beneficiary’s concern about utilization management criteria prior to specified in § 423.132(c). administrative criteria such as ‘‘B versus selecting their plans. When we issued the January 28, 2005 D’’ determination, we decline to adopt Response: As provided in § 423.128(c) (70 FR 4273) Part D final rule, we the commenter’s suggestion. (2), a Part D plan, upon the request of specified that for enrollees in long-term Comment: One commenter questioned a Part D eligible individual, must care pharmacy settings, the timing the value of committing the resources of provide the procedures the Part D plan portion of the disclosure requirement a P&T committee to review and approve uses to control utilization of services (that is, the requirement that the quantity limits. and expenditures. CMS guidelines for enrollee be informed at time of Response: We believe there is value to marketing materials spell out that as purchase) may be waived. Accordingly, P&T committees reviewing quantity part of a plan’s formulary, Part D plans sponsors were required to disclose the limits since the imposition of quantity must indicate any applicable utilization differential (if any) in pricing for long- limits can affect clinical outcomes. As management tools (such as, prior term care network pharmacies by we previously stated in the preamble to authorization, step therapy, and requiring that this information be the proposed rule, quantity limits are as quantity limit restrictions) for the drug. provided in the explanation of benefits important to the clinical soundness of a Also, formulary and utilization (EOB). However, over time, we have plan’s formulary as the drugs that are management criteria must be heard from sponsors, as well as included on the formulary. The P&T appropriately displayed on the plan’s pharmaceutical benefit managers on committee, as a body of clinicians, Web site. behalf of sponsors, that providing this should review the quantity limits to Comment: One commenter requested information in the EOB is unworkable ensure restrictions do not affect a plan that CMS require that P&T committee from a plan operational standpoint. member’s access to covered Part D drugs decisions be in writing, including the We also came to realize that the that could lead to health or life- rationale behind formulary and generic equivalent information provided threatening outcomes, especially when utilization management policies, and on the EOB is of no value to the long- quantity limits are not based upon the that the committee’s decisions be made term care beneficiary. Unlike the FDA’s maximum daily dose limits. public. enrollee standing at the retail pharmacy Comment: One commenter indicated Response: As stated in response to the counter at time of service, enrollees in that CMS provide Part D sponsors with previous comment, utilization criteria long-term care institutions have limited minimum standards for P&T are made available to the public prior to opportunities to effect a switch to a committees’ clinical review and make enrollment, and to enrollees of the plan. lower-priced generic substitute before those standards publicly available to Additionally, § 423.120(b)(1)(viii) dispensing. further strengthen the clinical requires the Part D sponsor’s P&T For the aforementioned reasons, we appropriateness of formularies. committee decisions regarding proposed revising § 423.132(c) by Response: We disagree with the formulary development or revision, as adding long-term care network commenter’s suggestion that we dictate well as utilization management pharmacies to the list of entities for minimum standards for P&T activities, be documented in writing. which from the public disclosure committees’ clinical review. Section However, the Part D sponsors may requirement is waived, and revise 1860D–4(b)(3)(B) of the Act requires the consider decision by their P&T § 423.132(d) to remove the requirement P&T committee base clinical decisions Committees to be proprietary and for that long-term care network pharmacies on the strength of scientific evidence this reason, we decline to require plans provide the pricing differential and standards of practice, including to make them public. information in enrollees’ EOBs. In this accessing peer-reviewed medical 7. Generic Equivalent Disclosure Under final rule, we adopt these provisions as literature, such as randomized clinical Part D (§ 423.132) proposed. trials, pharmacoeconomic studies, Comment: A number of commenters outcomes research data, and on such In the October 22, 2009 proposed rule, supported this change. One commenter other information as the P&T committee we proposed revisions to part D wanted to go even further and eliminate determines to be appropriate. Since the requirements related to the disclosure to this requirement for all areas of statute specifically directs P&T Part D enrollees who are residents of pharmacy practice because it imposes committees to make these clinical long term care institutions of any an unreasonable administrative burden. decisions, we believe it does not have differential in pricing of drugs Response: We disagree that the authority, or the capability, to dispensed compared to generic elimination of this requirement should establish clinical review criteria for the equivalents. As we explained in the be extended to all areas of pharmacy P&T committees. preamble to the proposed rule, section practice. Providing this information to Comment: One commenter urged 1860D–4(k)(1) of the Act requires a Part the beneficiary at the time of purchase CMS to continue to engage in robust D sponsor to have each of their network enables the beneficiary to choose the formulary review to ensure that a plan pharmacies inform enrollees of any lowest priced product available at the formulary appropriately reflects the difference between the price of the pharmacy. The pharmacy can avoid the clinical needs of Medicare beneficiaries. drug(s) they are purchasing via the plan administrative burden by dispensing the Response: We appreciate the and the price of the lowest priced lowest priced product. comment, but changes to CMS’ therapeutically equivalent generic Comment: Only one commenter did formulary review are outside the scope product available to the pharmacy. not support this change and thought of this final rule. We are not making any Section 1860D–4(k)(2)(A) of the Act that providing this information in the further changes to our current formulary requires that this information be EOB would help identify fraud, waste, review process at this time because we provided at the time of purchase except and abuse and enable the beneficiary to believe we already conduct a robust for purchases delivered by mail when it change at a later date. formulary review consistent with the must be provided at the time of Response: Although we agree that this statutory and existing regulatory delivery. Under section 1860D– information may have some value to a parameters, and current guidance. 4(k)(2)(B) of the Act the Secretary has beneficiary in the long-term care setting,

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the primary reason for removing this part of the contract’s service area, and beneficiaries to Part D sponsors by requirement is that it is unworkable also offer a high and low option at a increasing the urban and suburban from a plan operational standpoint different price in the remaining portion percentages to 95 percent, and considering the variable nature of of the contract’s service area. increasing the rural standard to 10 miles generic pricing and the programming We noted that our intention has and 85 percent. This commenter maintenance effort required, and we always been to ensure adequate access believes that the current access continue to believe that the value to the to Part D covered drugs at sponsor level, standards are too lax, especially in rural beneficiary, given the circumstances, not at the plan level. For one, the statute areas. Additionally, this commenter does not justify the burden of explicitly states that access should be noted that measuring distance ‘‘as the maintaining the requirement. ensured at the PDP sponsor level. crow flies’’ when evaluating pharmacy Further, assessing adequacy of access may not be representative of true 8. Access to Covered Part D Drugs pharmacy access is one of the most driving distance in certain locations. (§ 423.120) critical steps in the Part D application Response: Our proposed regulatory In the October 22, 2009 proposed rule, review process and determining access change addressed only the we made corrections to current to Part D covered drugs at the plan level organizational level at which the regulatory requirements that would is not possible during application pharmacy access standards would be align the regulations with the intent of review. This is because plan service applied, not whether a change in those the statute with regard to the level of areas (potentially subsets of Part D standards is warranted. While we analysis that should be conducted for sponsor or organization service areas) appreciate the comment, we will not access to Part D drugs, namely at the are not determined until the time of the address it at this time as it is outside the Part D sponsor level, rather than at the bid submission, which occurs after scope of our proposal. plan level. As we noted in the preamble applications are reviewed. However, However, we wish to allay the to the proposed rule, the statute at sponsor service areas are known at the commenter’s concern that measuring sections 1860D–4(b)(1)(C) and 1860D– time of application submission. distance ‘‘as the crow flies’’ may actually 21(c)(1) of the Act establishes the Our correction would align our underrepresent true driving distance. standards for convenient access for regulations with the intent of the statute Presently, the software used by Part D network pharmacies for PDP sponsors with regard to the level of analysis that sponsors to demonstrate they meet our and other Part D sponsors. This section should be conducted for access to Part retail pharmacy access standards has a of the statute requires that the sponsor D drugs, namely at the Part D sponsor feature that allows distance to be of a PDP shall secure the participation level, rather than at the plan level. We measured as estimated driving distance, in its network of a sufficient number of also noted in the preamble that as a and sponsors are instructed to use this pharmacies that dispense (other than by practical matter and consistent with the feature. mail order) drugs directly to patients to current drafting of the regulation, if the Comment: One commenter suggested ensure convenient access consistent Part D sponsor’s entire service area is that CMS move toward a more with the rules established by the larger than one State, we will continue automated and streamlined process for Secretary, and as long as they are no less to ensure access at no greater than the conducting the initial review and favorable than the TRICARE pharmacy State level for multistate regions. We ongoing monitoring of Part D sponsor’s access standards. These standards are— noted that this approach is necessary to retail pharmacy networks. The • Urban—a pharmacy within 2 miles ensure that pharmacies are not unduly commenter suggests CMS consider of 90 percent of the beneficiaries; clustered in one part of the region. establishing a certification process • Suburban—a pharmacy within 5 Therefore, based on the preceding, we whereby a first tier entity, such as a miles of 90 percent of the beneficiaries; proposed to revise the text of the PBM, may submit one set of access and regulation that discusses pharmacy reports in support of its certification. If • Rural—a pharmacy within 15 miles access in § 423.120(a)(1) through (a)(7) found acceptable by CMS, all Part D of 70 percent of the beneficiaries. to refer to PDP sponsors, MA sponsors using that PBM could We adopted into regulation the organizations offering local and regional demonstrate their compliance with the TRICARE standards, but instead of MA–PD plans, and cost contracts rather pharmacy access standards by specifying them at the contract or PDP than plans. Additionally, since submitting an attestation that the sponsor level, erroneously established § 423.120(a) (defining access network they are using is already CMS- them at the plan level. Specifically, in requirements for Part D drugs) approved. § 423.120(a) of the regulation, which references a definition provided in Response: We appreciate the describes the requirements to assure § 423.112(a) (establishment of PDP comment and note that we are working pharmacy access, we inadvertently used service areas), it was necessary to on developing a more automated system the term ‘‘plans’’ instead of the correct correct the terminology in that location for the submission of pharmacy network terminology of PDP sponsor or other as well. Therefore, we proposed revising information. That said, the issue of our Part D sponsors. This error is § 423.112(a) to specify the establishment review of network adequacy and the problematic when considering the of service areas for PDP sponsors. We processes we use is outside the scope of definitions outlined in § 422.2 (for MA) are adopting the above changes without our proposal, and we therefore decline and § 423.4 (for Part D) because the term further modification into this final rule. to address it in this rule. ‘‘plan’’ is intended to mean a specific Comment: One commenter fully Comment: One commenter urged benefit package offered to beneficiaries supported the proposed revision to the CMS to create retail pharmacy access living in a geographic area. For any regulation clarifying access to Part D standards to ensure that beneficiaries given service area, Part D sponsors drugs be measured at the sponsor level, have the choice of obtaining medication frequently offer multiple plans under rather than at the plan level. therapy management (MTM) services one contract with CMS, and any given Response: We appreciate the support. from their retail community pharmacies. plan may be offered within a subset of Comment: One commenter asked Response: This comment concerns the the Part D sponsor’s total service area. CMS to exercise its statutory authority administration of MTM programs, not For example, a Part D sponsor may offer to adopt regulations that would apply the methodology for the calculation of a high and low option at one price in access standards more favorable to retail pharmacy access standards.

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Therefore, we will not address this Medicare’s Part D enrollees. We were writing. A commenter asked CMS to comment as it concerns an issue outside also concerned that the existing clearly articulate how plans are to the scope of our proposed regulatory requirement would in effect force record, track, and report oral requests. change. enrollees into the Part D appeals process Another commenter suggested allowing despite the fact that the majority of plan sponsors to require the use of plan- 9. Standard Timeframe and Notice these claims could have been paid specific forms for payment requests. Requirements for Coverage within the 30-day reimbursement Response: We appreciate the Determinations Under Part D (§ 423.568) timeframe. Based on our experience and comments we received in support of In the October 22, 2009 proposed rule, previous discussions with Part D plan this proposal, and the commenter’s we proposed to make several changes to sponsors, we determined Part D plan concern about the processes plan § 423.568 related to the standard sponsors generally are capable of sponsors should have in place to record, timeframes and notice requirements for making reimbursement decisions and track, and report oral requests. We agree coverage determinations under Part D. payment within a 14-day period that it is important for plan sponsors to The first change we proposed was a following receipt of reimbursement document and track requests that are technical change that would require Part requests. We believe the proposed submitted orally in order to determine D plan sponsors to accept standard revision to the timeframes for notifying if plan sponsors are processing requests coverage determination requests orally enrollees of payment determinations in a timely manner. Therefore, in this and in writing. This change would not will significantly increase the number of final rule, we are adding a new apply to standard requests for payment, timely payment-related decisions by paragraph (a)(3) to § 423.568, which will which must be submitted in writing plan sponsors, and the revised require plan sponsors to establish and unless the plan sponsor adopts a policy timeframes for making payment will be maintain a method of documenting all for accepting those requests orally. As more meaningful for the typical oral requests and to retain that we explained in the preamble to the Medicare beneficiary who often cannot documentation in the case file. We do proposed rule, we proposed this change afford to wait 30 days to be reimbursed. not agree with the suggestion to require to § 423.568 because section 1860D–4(g) Finally, we proposed to add new the use of plan-specific forms for of the Act requires Part D sponsors to paragraphs (d) and (e) to § 423.568, to payment requests. We have, since the follow the same procedures as MA explain the form and content of inception of the Part D program, organizations with respect to favorable coverage determination required plan sponsors to accept any organization determinations and decisions. In § 423.568(d), we proposed written request submitted by enrollees reconsiderations, and we were requiring plan sponsors to send written and prohibited plan sponsors from proposing to make an identical revision notice of fully favorable decisions to requiring the use of plan-specific to § 422.568 of the MA appeals enrollees. We also proposed to allow request forms. We do not believe there regulations. plan sponsors the option of providing is a compelling reason to depart from We also proposed to revise the the initial notice orally so long as a this standard. During this time, we have timeframe for a Part D plan sponsor to written follow-up notice is sent to the also received numerous requests to notify an enrollee of a payment enrollee within three calendar days of standardize the Part D coverage determination in § 423.568(b), and the oral notification. In § 423.568(e), we determination and appeals processes in proposed to establish a regulatory proposed to require notice of fully order to create consistency and timeframe for making payment to an favorable decisions to include the predictability for Part D enrollees, and enrollee when a decision is partially or conditions of the approval in a readable we are continuously looking to improve fully favorable. The regulation currently and understandable manner. We noted the coverage determination and appeals requires a plan sponsor to notify an these changes were necessary because processes. Allowing each plan to require enrollee of its payment determination prescription drugs are often provided to the use of different forms for different no later than 72 hours after receipt of a beneficiaries on a recurring basis (unlike requests moves us further away from request, and manual guidance requires most MA services which are generally creating a process that is easier for plan sponsors to make payment for fully provided to beneficiaries only once), enrollees to navigate. Although we or partially favorable decisions within and requiring plans to provide the terms understand plan sponsors often need 30 days of the request. The proposed of an approval in writing helps ensure enrollees to submit specific information revisions to § 423.568(b) would require continuity of care for Medicare with reimbursement requests, requiring a Part D plan sponsor to notify an beneficiaries who receive prescription the use of a specific form does not enrollee of a payment decision no later drugs under Part D. guarantee that an enrollee will provide than 14 calendar days after receiving a After reviewing the comments all information a plan sponsor needs to reimbursement request. If the decision received in response to these proposals, process the request (for example, an is partially or fully favorable, the plan in this final rule, we adopt the proposed enrollee may not complete part of the sponsor must also make payment within changes without modification. In form). When a reimbursement request is the same 14-day timeframe. For addition, as explained below, we are not complete, plan sponsors must either example, for partially and fully adding paragraph (a)(3) to § 423.568, obtain the missing information or deny favorable decisions, a plan sponsor must which will require plan sponsors to the request within the applicable both notify the enrollee of the decision establish and maintain a method of decision making timeframe. Because we and make payment no later than 14 documenting all oral requests and are extending the timeframe for calendar days after receiving the retaining the documentation in the case resolving payment requests in this final request). As noted in the preamble, we file. rule, plan sponsors have more time to proposed to revise the reimbursement Comment: Several commenters evaluate payment requests and obtain timeframes because we believe the supported the proposed technical missing information when necessary. existing 72-hour requirement is virtually change that would require Part D plan Comment: We received many impossible for plan sponsors to meet, sponsors to accept standard coverage comments in response to the proposed and as a result, plan sponsors are determination requests orally and in revisions to § 423.568(b), which would issuing perfunctory denials. This writing, except for standard requests for require a Part D plan sponsor to notify outcome is not in the best interest of payment which must be submitted in an enrollee of a payment decision and,

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if appropriate, make payment no later Some commenters raised concerns coverage decisions for non-formulary than 14 calendar days after receiving a about plan sponsors not being able to drugs or drugs subject to a utilization reimbursement request. Some make payment within 14 calendar days management requirement. Furthermore, commenters that supported the 14-day after receiving a reimbursement request using the reimbursement process to timeframe for making a decision in large part because most Part D plan obtain coverage decisions for non- opposed the requirement to make sponsors process reimbursement formulary drugs or drugs subject to a payment within the same 14-day requests under a 30-day billing cycle, utilization management requirement timeframe. The commenters objected which is the industry standard. does not obviate the need to provide because a 14-day payment cycle is not However, we note that plan sponsors medical documentation either consistent with current industry already have prior experience demonstrating that an exception is standards, and moving the payment processing some reimbursement needed or that a utilization management cycle to 14 days would require great requests in less than 30 days. Pursuant requirement has been met. In the former expense to update current processes and to section 171 of MIPPA and the PDP case, if the reimbursement request is systems, and would not offer any real Sponsor Application, Part D plan submitted without a prescriber’s benefit to enrollees who already have sponsors are required to make payment supporting statement, the plan sponsor’s the prescription drugs in dispute. For for certain reimbursement requests from decision making timeframe is tolled these reasons, the commenters out-of-network pharmacies within 14 until the statement is received. Thus, we suggested maintaining the current 30- calendar days. Although the 14 calendar believe enrollees who need prescription day payment timeframe. As an day MIPPA requirement applies to drugs that either are non-formulary, or alternative, some of the commenters reimbursement requests that are are subject to utilization management suggested allowing plan sponsors an submitted electronically, we note the requirements that they cannot meet, additional 14 calendar days to make MIPPA requirement to illustrate that a would be better served by using the payment after a decision has been made. 14-day timeframe for processing exceptions process. Under § 423.568(a), Other commenters suggested that CMS reimbursement requests is not a plan sponsor must respond to a defer implementation of the 14-day unprecedented under the Part D standard exception request within 72 timeframe until 2011. program, and that plan sponsors hours of receiving the request and the We also received support for the currently have systems in place to prescriber’s supporting statement, and proposed 14-day timeframe from a accommodate billing cycles that are less consistent with § 423.572(a), a plan number of commenters, but the than 30 calendar days. As noted in the must respond to an expedited request commenters also opposed extending the preamble to the proposed rule, our within 24 hours of receiving the request 72 hour decision-making timeframe. experience and previous discussions and the prescriber’s supporting The commenters objected because with Part D plan sponsors on this issue statement. extending the timeframe would cause an led us to conclude that plan sponsors Finally, we appreciate some additional financial hardship for are capable of processing commenters’ concerns that the 14-day enrollees who pay out-of-pocket for reimbursement requests and sending timeframe may result in enrollees prescriptions. The commenters argued payment, when required, to enrollees receiving unfavorable payment the proposal would extend the appeals within 14 calendar days after receiving determinations beyond the current 72- process by up to eleven days for a reimbursement request. In the 2009 hour timeframe. Thus, in order to ensure that enrollees are able to access enrollees who receive denials, and Call Letter, we indicated that we would would prevent those enrollees from the appeals process as quickly as exercise our enforcement discretion to obtaining a decision by the Part D possible, we encourage plan sponsors to decline to bring an enforcement action Independent Review Entity before a 30- issue unfavorable determinations sooner for non-compliance with the 72-hour day prescription runs out. For that than 14 days. timeframe in § 423.568 if the plan reason, most of the commenters Therefore, we are finalizing the sponsor processes a reimbursement suggested retaining the 72-hour proposed revisions at § 423.568(b) to request and submits reimbursement decision-making timeframe for require Part D plan sponsors to notify an (when appropriate) within 14 calendar reimbursement requests. As an enrollee of a payment decision no later days after receipt of the request. As a alternative, a few of the commenters than 14 calendar days after receiving a result, plan sponsors have been suggested that CMS maintain a 72-hour reimbursement request. If the decision decision-making timeframe for payment permitted the option of either notifying is partially or fully favorable, the plan requests that involve exceptions, and a enrollees of their reimbursement sponsor must also make payment within 14-day decision-making timeframe for decisions within 72 hours and making the same 14 calendar-day timeframe. all other payment requests. Finally, one payment within 30 days, or, providing Comment: We received a number of commenter believed that a 7-day notice of a reimbursement decision and comments supporting the proposal to timeframe would be acceptable for sending payment (when a decision is allow Part D plan sponsors to make the making payment-related decisions. partially or fully favorable) to the initial notice of favorable standard Response: After careful review and enrollee within 14 calendar days after coverage determination decisions orally, consideration of the numerous receiving a reimbursement request. so long as a written confirmation of the comments and suggestions we received We also understand the concerns decision is mailed to the enrollee within about this provision, we continue to about enrollees receiving decisions as three calendar days of the oral notice. believe that the timeframes established quickly as possible. In particular, some However, one commenter suggested in proposed § 423.568(b) strike the right commenters indicated the need for revising the three calendar day balance between ensuring plan sponsors shorter timeframes when a request requirement to three business days. have enough time to properly adjudicate involves an exception. We agree, but Response: For the reasons noted in reimbursement requests, and creating a note that the reimbursement process our response to a similar comment reimbursement timeframe that does not was intended primarily for use in about the timeframe for providing impose an undue hardship on Medicare resolving out-of-network issues. written follow-up of notice of a fully beneficiaries who often cannot afford to Consequently, we do not believe that it favorable expedited redetermination wait 30 days before being reimbursed. is the most efficient way to obtain decision, we do not agree that it is

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necessary to revise ‘‘calendar days’’ to conditions of the approval in a readable Comment: We received numerous ‘‘business days.’’ and understandable manner. As noted comments supporting the proposal to Comment: We received numerous in the proposed rule, the rationale for require plan sponsors to include the comments supporting the proposal to adding these requirements is consistent conditions of approval in favorable require plan sponsors to include with our rationale for adding form and decision notices. However, one specific information (such as, the content requirements for favorable commenter opposed the proposal and conditions of approval) in favorable standard coverage determination suggested allowing plan sponsors to coverage determination notices. decisions, and in so doing, ensures provide the approval conditions on However, one commenter opposed the enrollees are able to maintain continuity request. A different commenter asked proposed requirement and suggested in their prescription drug treatment. CMS to exempt Special Needs Plans allowing plan sponsors to provide the Finally, we proposed to revise (SNPs) from the written-notice approval conditions on request. § 423.572(c)(2)(i) by requiring plan requirement for favorable decisions Response: As noted above in our sponsors to issue adverse expedited because SNPs hire nurse case managers response to a similar comment relating coverage determination decisions using to make sure an enrollee’s medication to favorable redetermination decisions, CMS approved language in readable and supply is not interrupted. Thus, we believe requiring plan sponsors to understandable form. As noted in the enrollees receiving medications from provide the condition(s) of approval in preamble to the proposed rule, this SNPs do not need to know the writing is an important enrollee proposed change would reconcile a conditions of an approval. protection that helps ensure continuity discrepancy in the regulations by Response: As noted in our responses of care for Medicare beneficiaries who requiring plan sponsors to use the to similar comments, requiring plan receive prescription drugs under Part D, standardized denial notice (Form CMS– sponsors to provide the conditions of and the commenter’s suggested 10146) for both standard and expedited approval in writing is an important approach would diminish that adverse coverage determinations. enrollee protection that helps ensure important protection. Currently, the regulations require the uninterrupted drug coverage for Comment: We received several use of the standardized denial notice Medicare beneficiaries who receive comments asking us to develop a model only for standard adverse coverage prescription drugs under the Part D letter for fully favorable coverage determinations. The only comment we program. We believe implementing the determination decisions under received on this provision was commenters’ suggestions would § 423.568. supportive of the change. Accordingly, diminish this important protection Response: As noted in our response to we are adopting the proposed revision because without this requirement, a similar comment regarding fully to § 423.572(c)(2)(i) as set forth in the enrollees would likely not receive favorable redetermination decisions, we proposed rule without change. timely notice of the coverage limits for will explore developing either a model Comment: We received a number of approvals. Without this information, or standard notice for favorable comments supporting the proposal to enrollees may experience interruptions decisions, and will publish any such allow Part D plan sponsors to make the in coverage. Thus, the best way to notice in Chapter 18 of the Medicare initial notice of favorable expedited ensure that enrollees receive timely Prescription Drug Benefit Manual. coverage determination decisions orally, notice and understand the conditions so long as a written confirmation of the that apply to their approvals is to 10. Expediting Certain Coverage decision is mailed to the enrollee within require plan sponsors to consistently Determinations (§ 423.570) three calendar days of the oral notice. provide this information, in writing, to In the October 22, 2009 proposed rule, However, one commenter suggested all enrollees. we proposed to make a technical change revising the three calendar day Comment: We received several to § 423.570 by removing the cross requirement to three business days, and comments asking us to develop a model reference to § 423.568(a) and inserting a another commenter recommended letter for fully favorable decisions cross-reference to § 423.568(b). This allowing plan sponsors to send the first issued under § 423.572. change is necessary to be consistent notice in writing, but not requiring plan Response: As noted in our response to with the proposed revisions to sponsors to send additional written an earlier comment, we will explore § 423.568. We did not receive any notices when any related refills are developing either a model or comments with regard to our proposed approved. standardized notice for use in issuing revision. Therefore, this final rule Response: For the reasons noted in favorable notices and will publish any adopts this revision without change. our response to a similar comment such notice in Chapter 18 of the about the timeframe for providing Medicare Prescription Drug Benefit 11. Timeframes and Notice written follow-up of notice of a fully Manual. Requirements for Expedited Coverage favorable expedited redetermination Determinations (§ 423.572) decision, we do not agree that it is 12. Clarify Novation Agreements Under The October 22, 2009 proposed rule necessary to revise ‘‘calendar days’’ to Part D (§ 423.551) includes a proposed revision to ‘‘business days.’’ Also, as previously In the October 22, 2009 proposed rule, § 423.572(b) that would require plan noted, we believe a written notice we proposed revisions to§ 423.551 and sponsors to send written notice of fully should follow every favorable decision, proposed adding a new paragraph favorable expedited coverage decisions including favorable decisions to § 423.551(g) to restrict the situations in to enrollees, and allow plan sponsors approve refills. This policy will help to which we will approve the novation of the option of providing the initial notice ensure continuity of care for Medicare a PDP sponsor’s contract. A change in orally so long as a written follow-up beneficiaries who are obtaining refills of ownership of an existing sponsor’s PDP notice is sent to the enrollee within prescription drugs under Part D. We contract(s) can promote the efficient and three calendar days of the oral note that additional favorable decisions effective administration of the Part D notification. We also proposed to add for refills are not necessary if the program. However, over the past few paragraph (c)(2), which would require coverage determination or appeal years several PDP sponsors have notice of a fully favorable expedited decision specifically authorizes refills requested CMS approval of transactions coverage determinations to provide the for the remainder of the plan year. that involve the sale of a piece of the

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sponsor’s contract with CMS or less Response: We believe that there are process should not be used, either in than all of the PDP contracts held by adequate PDP choices for beneficiaries, Part C or Part D, to pick and choose that PDP sponsor. Therefore we have and that restricting novations as profitable markets, but it did not proposed these revisions in order to proposed is in the best interest of the interpret the current Part C regulation restrict a novation to those transfers Part D program. We do not believe that related to the novation process to only involving the selling of the sponsor’s the proposed change would negatively allow novations that include the entire entire line of PDP business, which impact a sponsor’s ability to consolidate MA line of business (that is, all MA would include all PDP sponsor PBPs even if the plans are located in contracts held by a single legal entity). contracts held by the legal entity. We different geographical areas. To the The commenter stated that there are believe that allowing the spin-off of just extent that this comment concerns the unique circumstances where a change of one contract (when the PDP sponsor has application of this policy to novations ownership may be specific to Special more than one PDP contract) or pieces among subsidiaries of the same parent Needs Plans (SNPs) that may be better of a single contract can have a negative organization, CMS agrees that those served under new ownership that has a impact on beneficiary election rights. types of transactions should be specialized model. The commenter We recommended becoming more permitted and would not require the suggested that the proposed provision prescriptive in this area because our transfer of an entire line of Medicare be modified (and our Part C regulations experience gained over the first 4 years business. Novations between the modified as well) to allow for of the program indicates this is subsidiaries of the same parent exceptions, especially with regard to necessary. As we noted in the preamble organization do not involve the buying SNPs. to the proposed rule, our policy goals and selling of beneficiaries; rather, they Response: We have consistently are not served when a sponsor uses the are usually undertaken to accommodate interpreted the Part C regulation to limit novation process to purchase a piece of an organization’s change to its internal novations in situations involving the another sponsor’s contract with CMS for corporate structure. Therefore, we have sale of less than an entity’s entire MA less than the full line of PDP business. modified our proposed regulatory line of business. Also, SNP plans do not We do not agree that picking and language to clarify that the new policy present unique circumstances that choosing which markets a sponsor does not apply to changes of ownership would require an exception to our wishes to serve at any given time and between subsidiaries of the same parent proposed policy change. If a SNP plan to profit from its exit from a given PDP organization. can no longer serve its enrollees, there region is most efficient when a simple Comment: One commenter stated that is existing regulatory authority pursuant nonrenewal for that region is an option no change is needed in the current to which the failing SNP can non-renew available to the sponsor. Moreover, this regulation to accomplish CMS’ policy or terminate its Medicare contract. CMS process should not be used as an goal. The commenter, citing can then exercise its regulatory instrument for moving LIS beneficiaries § 423.552(a)(3)(ii), believed that CMS authority related to plan enrollment to already has authority to determine ensure that affected beneficiaries either when a particular sponsor has missed whether a proposed novation is in the elect or are assigned to an appropriate the benchmark. best interest of the Medicare program new plan. We believe that the change we and that CMS did not need to change Comment: Several commenters proposed creates consistency between the regulation to keep this authority. supported this change to the regulation, the Part C program and the Part D The commenter expressed concern, and agreed with the underlying program, because the Part C regulations however, that the proposed change reasoning used by CMS to make this only permit novations that include the would limit CMS’s flexibility to approve change and become more prescriptive in entire MA line of business (that is, all a novation of some but not all of an this area. MA contracts held by a single legal entity’s Part D contract(s), even if CMS Response: We appreciate these entity). determined that it was in the best comments. We adopt these provisions as interest of the program to approve the Comment: A few commenters stated proposed. As noted below, we amend novation. The commenter added, that if that CMS should allow novations of one § 423.551 to clarify that these provisions CMS does not retain the authority to contract, where a selling sponsor holds do not apply to changes of ownership approve a novation representing less multiple contracts, because otherwise between subsidiaries of the same parent than an organization’s entire line of PDP PDP sponsors will have to resort to organization. business, the acquiring company would holding PDP contracts under different Comment: Several commenters have to terminate the contract, causing legal entity names in order to avoid expressed concern that the proposed substantial member disruption. having to novate all contracts as policy could cause greater disruption for Response: We believe that a change to required under the proposed beneficiaries by limiting sponsors’ the regulation is necessary to provide requirement, or terminating a contract, ability to divest and acquire certain Part clarity to sponsors regarding the which would result in beneficiary D contracts in situations where those circumstances under which a PDP disruption. transactions would have few effects on novation would be approved by CMS. Response: A sponsor is already beneficiaries. The commenters believe Additionally, we believe that afforded ample opportunity to leave a that the proposed change may result in beneficiary disruption in situations particular Medicare market through the Part D sponsors withdrawing plan where a sponsor nonrenews a contract contract non-renewal process. That benefit packages and bid submissions, because it is not eligible to be novated, process does not require that a sponsor prevent acquisitions and mergers, or is minimized by comprehensive non-renew all of its contracts, so there cause mid-year terminations, if the nonrenewal beneficiary rights and is no need for organizations to hold novation option no longer is available in required notifications, and that contracts through multiple legal entities. many situations. The commenters also beneficiary election rights trump any The beneficiary disruption in this believed that this change could impact member disruption that occurs due to a instance would be no more than that CMS efforts to consolidate PBPs and nonrenewal. already contemplated by the Congress service areas under one contract Comment: One commenter stated that and CMS when it adopted and number. it agreed with CMS that the novation implemented a program which featured

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the right of beneficiaries to elect their • The MA program requirements on • Settlement of penalties (§ 422.762); own health and drug plan coverage. appeals processes for contract and Therefore, we believe that limiting determinations and intermediate • Other applicable provisions novation to the entire line of PDP sanctions under the authority in section (§ 422.764). business is the best interest of the Part 1876(i)(1) of the Act to terminate or non- With respect to determinations of the D program. renew contracts, and the authority in amount of CMPs, the provisions in Comment: One commenter asked section 1876(i)(6) of the Act to impose section 1876(i)(6)(B) and (C) of the Act CMS to clarify that the proposed change intermediate sanctions and CMPs (To would govern such amounts. would not prevent a sponsor from the extent that the CMPs in section We are adopting our proposed novating its Part D contract in 1876(i)(6)(B) and (C) of the Act differ changes to § 417.472, § 417.492, connection with sale of an MA–PD Plan from those under Part C, the penalty § 417.494, § 417.500, § 417.640, while retaining the entity’s stand-alone amounts under section 1876 of the Act § 417.640, § 417.642 through § 417.694, Part D Plan contract or vice versa. would continue to control); and and § 417.840 without further Response: We agree that in the • The MA program’s marketing modification in this final rule. Comment: Two organizations scenario described by the commenter, requirements under the authority in expressed concerns about extending the the organization would be permitted to section 1876(c)(3)(C) of the Act to MA requirements for appeals of contract retain a stand-alone PDP sponsor regulate marketing of plans authorized determinations to cost contract plans. contract after it had transferred under section 1876 of the Act and Both commenters point to differences in ownership of all of its Medicare ensure that marketing material is not cost contract plans and MA plans as Advantage contracts, including those misleading. through which it had been offering Part their basis for seeking revisions to our The specific revisions we proposed proposals. D benefits. We believe that the are summarized below. regulation makes this point clear on its One commenter suggested that CMS’ face as the language specifically a. Cost Contract Determinations approach of cross referencing the MA mentions only PDP contracts. (§ 417.492 and 417.494), Civil Money appeals provisions in the cost plan Comment: One commenter Penalties (§ 417.500), and Intermediate requirements is unworkable for three encouraged CMS to reconsider its Sanctions (§ 417.500) reasons: (1) There are provisions of Part proposed position that a Part D contract 422, Subpart N, that would not apply to We proposed requiring cost contracts can only be novated when the ‘‘entire Medicare cost plans, for example, to follow the contract determination line of business’’ is involved. The organizations may not submit an appeal procedures under Subpart N of commenter stated that there are application to obtain a new section 1876 Part 422. We proposed codifying these important differences between Part C contract; (2) there are termination/non- requirements in § 417.492(b)(2), and Part D contracting including the renewal provisions under part 417 that concerning notice of appeal rights, and notion that Part D contracts are national are not addressed under Part 422, for § 417.494, concerning notice of in scope and Part C contracts generally example, the obligation to non-renew a termination. conform to State boundaries. The portion or all of the service area under commenter stated that the suggested We proposed revising § 417.500 to the so called two-plan competition test alignment between Part C and Part D require cost contracts authorized under at § 417.402(c); and (3) simply contract novation policy as discussed in section 1876 of the Act to follow the MA indicating that part 422 references the preamble is not true when the programs requirements for appeals of should be read as Part 417 references practical impact of that policy is CMPs at Subpart T of Part 422. The does not provide the reader with considered. appeals process for CMPs specified at guidance regarding the applicable Response: The commenter has not Subpart T allows for a hearing by an provisions. This commenter asserts that, made clear, and we are unable to Administrative Law Judge (ALJ) and a without specific cross references, the determine on its own, how the stated review of the ALJ’s decision by the reader is left to guess which sections of difference between Part C and D service Departmental Appeals Board. We part 417 would substitute for the areas affects the novation policy we proposed, in new paragraph (c), to sections of part 422 cited in part 422 adopt in this regulation. Therefore, we specify that the amount of CMPs a cost subpart N and that, in some cases, there retain our belief that a change to the contract may be assessed is governed by are no directly analogous provisions regulation to limit PDP novations to the section 1876(i)(6)(B) of the Act, not by under part 417. Thus, it is unclear in entire line of business is in the best the provisions in part 422 of the MA this commenter’s view whether CMS interest of the Part D program. program regulations. intended to create a new requirement Our proposed revisions to the cost for cost plans in a specific provision, or 13. Cost Contract Program Revisions: contracts regulations authorized under whether the provision does not apply. Appeals and Marketing Requirements section 1876 of the Act would ensure The commenter recommends that CMS (§ 417.428, § 417.494, § 417.500, and that these contracts follow the same not simply cross reference subpart N, § 417.640) requirements for intermediate sanctions part 422, in part 417 but revise the Under the authority in section appeals specified in § 422.750 through language in part 417 to incorporate 1876(i)(3)(D) of the Act to impose ‘‘other § 422.764 of the MA program structure that is similar to the part 422 terms and conditions’’ under contracts regulations (subpart O). These sections rules for terminations, but includes authorized by the statute that the concern— relevant part 417 cross references and is Secretary finds ‘‘necessary and • Types of intermediate sanctions and modified to appropriately apply to appropriate,’’ and in implementation of CMPs (§ 422.750); Medicare cost plans. the requirements in section 1876 of the • Bases for intermediate sanctions The second commenter also believed Act set forth below, we proposed in our and CMPs (§ 422.752); that CMS’ proposed approach would not October 22, 2009 proposed rule to apply • Procedures for imposing provide sufficient clarity to cost the following MA program requirements intermediate sanctions and CMPs contracts regarding the requirements to cost contracts authorized under (§ 422.656) that apply to them. For example, there section 1876 of the Act: • Collection of CMPs (§ 422.758); are provisions of part 422, subpart N

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that would not apply to cost contracts, determination provisions would lead the cost contract plan and cost contract and there are termination/non-renewal anyone to believe otherwise. except with regard to any portion of the provisions under part 417 that are not Finally, we believe it is most efficient material or form that is specific to the addressed under part 422. Accordingly, to cross-reference the part 422 particular area, as provided under the commenter recommended that CMS regulations as specified in the proposed § 422.2266. revise the language in part 417 to rule and are, therefore, adopting the We proposed to extend to cost incorporate a structure that is similar to language in that rule. contract plans the following provisions the part 422 rules and is modified to b. Extending MA Marketing at § 422.2268— • Plans may not offer gifts to potential appropriately apply to Medicare cost Requirements to Cost Program Plans enrollees, unless the gifts are of nominal plans. (§ 417.428) Response: We agree with the value (as defined in the CMS Medicare commenters that there are differences As noted above, based on the Marketing Guidelines), are offered to all between cost plan and MA plan authority in section 1876(c)(i)(C) to potential employees without regard to procedures in this area but believe that regulate marketing and the authority in whether or not the beneficiary enrolls, the differences are minimal with respect section 1876(i)(3)(D) to specify new and are not in the form of cash or other to the application of the MA provisions section 1876 contract terms, we monetary rebates; concerning appeals of contract proposed to amend § 417.428, which • Plans may not market any health determinations. We stated clearly in the governs 1876 cost contract program care-related product during a marketing preamble of the proposed rule that the marketing requirements, to require cost appointment beyond the scope agreed part 422 regulations concerning appeals contract plans to follow the MA upon by the beneficiary, and of non-renewals, terminations, and marketing requirements in § 422.2260 et documented by the plan, prior to the imposition of intermediate sanctions seq. (Subpart V). appointment; and CMPs would apply to cost We proposed that cost contracts • Plans may not market additional contracts. Therefore, we believe there authorized under section 1876 of the health-related lines of plan business not should be no ambiguity in this regard. Act follow the same standards, with identified prior to an in-home In other words, if there is no ‘‘analogous respect to definitions concerning appointment without a separate provision’’ under part 417, as one of the marketing materials, as MAOs under appointment that may not be scheduled commenters wrote, cost plans would § 422.2260, including how marketing until 48 hours after the initial follow the part 422 requirements. materials are defined. We also proposed appointment; Concerning the possibility of confusion that the part 417 marketing regulations • Plans may not use a plan name that resulting from different CMPs for cost be revised to provide that, consistent does not include the plan type. The plan plans and MA plans, we did with the requirements regarding review type should be included at the end of acknowledge in the proposed rule, in and distribution of marketing materials the plan name; both the preamble and regulations text at § 422.2262, cost contractors We proposed to extend to cost at § 417.500(c), that CMPs for cost plans authorized under section 1876 of the contract plans authorized under section would be assessed according to the Act submit all such marketing materials 1876 of the Act the following statutory requirements at section to CMS at least 45 days before the date requirements for MAOs under 1876(i)(6)(B) of the Act. We do not agree planned for distribution (10 days if § 422.2272: with the commenter that additional plans use CMS model language, without • Demonstrate to CMS’ satisfaction regulations for part 417 are necessary to any modifications), and that file and use that marketing resources are allocated to capture this distinction. materials, as designated by CMS under marketing to the disabled Medicare With respect to the other the MA marketing regulations, may be population as well as beneficiaries age discrepancies that the commenter released 5 days following their 65 and over. asserts make incorporation of the part submission to CMS. • Establish and maintain a system for 422 regulations ‘‘unworkable,’’ we do We proposed to apply the same confirming that enrolled beneficiaries not believe that there should be any standards with regard to CMS review of have, in fact, enrolled in the plan, and confusion about appeal of contract marketing materials to cost contract understand the rules applicable under determinations as a result of cost plan plans as currently applied to MAOs at the plan. competition requirements. The § 422.2264. Cost contractors authorized • Employ as marketing application of such requirements is under section 1876 of the Act would be representatives only individuals who statutory, and non-renewal of a cost required to comply with MA regulations are licensed by the State to conduct plan based on the statutory requirement that specify the information that cost marketing activities (as defined in the is not appealable. We note that the contract plans must include in CMS Medicare Marketing Guidelines) in current regulations for Part 417 do not marketing materials, and specify that that State, and whom the cost program indicate that such a decision may be the cost contract plan must notify the has informed that State it has appointed, appealed. Concerning the commenter’s general public concerning the plan’s consistent with the appointment process other example of an allegedly enrollment period. Under section provided for under State law. unworkable discrepancy, the fact that 1876(i)(3)(D) of the Act, we also We proposed applying the MA limits there may be no new cost plans and proposed that, in markets with a on independent agent and broker thus no new applications, we note that significant non-English speaking compensation at § 422.2274 to 1876 cost the part 422 contract determinations population, cost contract plans be contract plans. As with MA plans, include not only decisions on new required to provide materials in the compensation would be based on a 6- applications, but determinations language of these individuals. year compensation cycle. Agents and concerning non-renewals and We proposed to specify that if we brokers would receive initial terminations, and thus have relevance to have not disapproved the distribution of compensation (first year of the cycle) cost contracts. The part 417 regulations marketing materials or forms submitted with compensation over each of the are clear that there may be no new cost by a cost contract plan in an area, we successive 5 years to be no more and no plans, as is CMS guidance, and we do are deemed not to have disapproved the less than 50 percent of the initial not believe that the part 422 contract distribution in all other areas covered by aggregate compensation paid for the

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enrollment. If an enrollee moves to plan such plans to limit enrollment to a determine if coverage determination and type distinct from the one in which he particular group, or to waive statutory redetermination requests are timely or she is currently enrolled, the agent/ marketing requirements, and CMS thus forwarded when appropriate, and broker would receive an initial would not have the authority to exempt impose sanctions on plan sponsors that commission and the cycle would begin cost plans from such marketing are not meeting these requirements. anew. Distinct plan types include MA, requirements. We are, therefore, Response: The commenters’ MA–PD, PDP, and cost contract plans adopting the language from the suggestion is outside the scope of the authorized under section 1876 of the proposed rule. Concerning the proposed rule. However, we want to Act. suggestion that CMS update the note our disagreement with the We are adopting our proposed Medicare Marketing Guidelines to commenter’s proposal to allow enrollees changes to § 417.428 without further reflect any difference between cost to request appeals when plan sponsors modification in this final rule. plans and MA plans, we are unsure to fail to make timely decisions. We Comment: All commenters support which specific provisions, if any, the currently require plan sponsors to applying the MA marketing commenter is referring but in revising automatically forward redetermination requirements to cost contract plans. A the guidelines, will point out any requests that are not timely decided to few of these commenters note, however, necessary distinctions between MA and the Part D Independent Review Entity that CMS is not applying one of the cost plan procedures and policies. for review once the decision-making marketing sections (§ 422.2276) which Comment: One commenter timeframe has expired, and we have exempts from the prior review and recommends that CMS amend the cost processes in place to monitor and plan approval requirements marketing plan enrollment regulations to allow performance in this area and impose materials designed for members of an beneficiaries the option of electronic sanctions when necessary. Furthermore, employer group. While one of the enrollment into cost plans in the same the Part D IRE currently tracks the commenters on the employer group manner as MA organizations. volume of cases that are automatically requirement notes that cost contracts are Response: This comment is outside forwarded from plan sponsors. The not eligible to offer 800-series plans for the scope of this rulemaking, and current auto-forwarding rate of 30 their medical benefits, the commenter therefore, is not addressed in this final percent is not insignificant, so it appears notes that cost contracts have always rule. that plans are appropriately auto- been permitted to negotiate with 14. Out of Scope Comments forwarding cases when they miss the employers to offer additional benefits to decision-making timeframes. their employer group members. The Comment: A number of commenters Comment: Numerous commenters commenter believes there is no statutory asked CMS to revise § 423.562(a)(3) to asked CMS to allow public access to the or policy reason for treating cost eliminate the option of posting Form prescription drug compendia used to contracts differently than MA plans CMS–10147 Medicare Prescription Drug determine if a drug may be approved with respect to marketing materials Coverage and Your Rights, also known furnished for employer groups and asks as the Pharmacy Notice, in network under the Part D exceptions process. that all MA marketing provisions, pharmacies. The notice instructs Response: The commenters’ including § 422.2276, apply to cost enrollees to contact their plan sponsors suggestion is outside the scope of the plans. Another commenter believed that to request coverage determinations or proposed rule. We note that any private while it makes sense, in general, to exceptions when they disagree with the or public entity may obtain access to the apply the MA marketing requirements information provided at the pharmacy prescription drug compendia by to cost contract plans, there are several counter. The commenters recommended contracting with the publishers. differences between MA and cost requiring plan sponsors to arrange with Comment: A commenter, in response contract plans, and that these should be network pharmacies to give enrollees to the revisions proposed to § 423.590, reflected in updated Medicare copies of the Pharmacy Notice requested clarification that the Part D Marketing Guidelines. whenever prescription drugs are not Independent Review Entity is Response: In order to permit employer covered or are covered but subject to responsible for completing expedited group health plans to tailor plans best utilization requirements that cannot be reconsideration reviews. suited to their enrollees and to resolved at the point-of-sale, or if an Response: We did not propose to communicate such information to enrollee pays out-of-pocket for revise any of the regulatory provisions enrollees, we have permitted waivers of prescription drugs for either of these pertaining to the Part D reconsideration the requirement that MA-eligible reasons. process, which is conducted by the Part individuals in an MA plan service area Response: The commenters’ D Independent Review Entity for both be eligible to enroll in the plan in order suggestion is outside the scope of the expedited and standard appeals. to permit an MA plan to be composed proposed rule. However, we agree that However, we did propose to revise the solely of members of an employer group receiving a written copy of the Part D expedited redetermination plan (an ‘‘800 series plan’’). Because Pharmacy Notice in any of the situations process conducted by the Part D plan non-employer group members are not described by the commenters is more sponsor. In the related preamble eligible to enroll in such plans, and the beneficial for an enrollee than being discussion, we referenced the expedited employer generally provides referred to a copy of the notice posted reconsideration process conducted by information to group members, we have in the pharmacy. We will consider this MA organizations under § 422.590 to waived certain requirements, such as suggestion for future rulemaking. illustrate a discrepancy between that the prior review and approval Comment: A number of commenters process and the expedited requirement for marketing standards for asked CMS to allow an enrollee to send redetermination process conducted by 800 series plans based on the statutory an appeal request to the Part D Part D plan sponsors under § 423.590. authority to permit such waivers at Independent Review Entity (IRE) when We believe the reference to the MA 1857(i)(1) of the Social Security Act. a coverage determination or expedited reconsideration process may There is no such general waiver redetermination decision is not received have confused the commenter, and authority with respect to other MA timely. The commenters also asked CMS given the impression that we were plans or cost plans that would permit to closely monitor plan compliance to proposing changes to the Part D

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reconsideration process when we were H. Changes To Implement Corrections proposed in our October 22, 2009 not. and Other Technical Changes proposed rule outlined in the Table In this section, we address six below. technical changes to the regulations

TABLE 8—CHANGES TO IMPLEMENT CORRECTIONS AND OTHER TECHNICAL CHANGES

Part 422 Part 423 Provision Subpart Section Subpart Section

Applications of Subpart M to Health Care Subpart M ...... § 417.840 ...... N/A ...... N/A. Prepayment Plans. Generic Notice Requirements ...... Subpart M ...... § 422.622 ...... N/A ...... N/A. § 422.626 ...... Revision to Definition of Gross Covered Pre- N/A ...... N/A ...... Subpart G ...... § 423.308. scription Drug Costs. Application Evaluation Procedures ...... Subpart K ...... § 422.502(c) through Subpart K ...... § 423.503(c) through (d). (d)). Intermediate Sanctions ...... Subpart O ...... § 422.750(a) ...... Subpart O ...... § 423.750(a). Basis for Imposing Intermediate Sanctions Subpart O ...... § 422.752 ...... Subpart O ...... § 423.752. and Civil Money Penalties.

1. Application of Subpart M to Health parallel those available to section 1876 3. Revision to Definition of Gross Care Prepayment Plans (§ 417.840) cost enrollees and Part C enrollees). Covered Prescription Drug Costs We received only one comment on (§ 423.308) In the October 22, 2009 proposed rule, this clarification, and the commenter In the October 22, 2009 proposed rule, we proposed a technical correction to supported our proposed technical the regulations governing Health Care revision. Accordingly, we are revising we proposed to revise the definition of ‘‘ ’’ Prepayment Plans (HCPP) intended to § 417.840 as set forth in the proposed gross covered prescription drug costs ensure that HCPP enrollees have access rule without change. in § 423.308 to correctly reference both to fast-track appeals for comprehensive ‘‘negotiated prices’’ paid to network outpatient rehabilitation facility (CORF) 2. Generic Notice Delivery pharmacies and ‘‘usual and customary services furnished by an HCPP. As we Requirements (§ 422.622 and § 422.626) prices’’ paid to out-of-network explained in the preamble to the In the October 22, 2009 proposed rule pharmacies. Specifically, we proposed October 22, 2009 proposed rule and in (74 FR 54700), we proposed to make to replace the term ‘‘negotiated price’’ the January 28, 2005 MA final rule, we technical revisions to § 422.622 and with the term ‘‘actual cost,’’ which is required cost plans (HMOs), including § 422.626 to ensure that the MA defined at § 423.100 as ‘‘the negotiated HCPPs, that are established under regulations accurately state when plans price for a covered Part D drug when the section 1876 of the Act (Part E) and and providers are responsible for drug is purchased at a network regulated under part 417, to follow the delivering certain notices to enrollees. pharmacy, and the usual and customary MA appeals requirements in subpart M Section 422.622 currently states that price when a beneficiary purchases the of part 422. In applying the MA appeals when a QIO determines that an enrollee drug at an out of network pharmacy procedures to HCPPs by regulation, we may remain in an inpatient setting, the consistent with § 423.124(a).’’ With this adapted and implemented the section MA organization must again provide the correction, the definition of ‘‘gross 1869 appeal rights that apply to Original enrollee with a copy of the Important covered prescription drug costs’’ would Medicare beneficiaries to the Message from Medicare (IM) when the include ‘‘the share of actual costs (as circumstances of beneficiaries enrolled enrollee no longer requires inpatient defined by § 423.100 of this part) in an HCPP. Because HCPPs only hospital care. However, our intent was actually paid by the Part D plan that is provide Part B services, in our January to make delivery of the IM the hospital’s received as reimbursement by the 28, 2005 final rule (70 FR 4194), we responsibility, and the form instructions pharmacy or other dispensing entity.’’ explicitly limited the application of for the IM state this. Similarly, § 422.626 As we noted in the preamble to the subpart M, for the HCPPs, to those of subpart M inadvertently states that October 22, 2009 proposed rule,, the provisions affecting Part B services delivery of the Notice of Medicare Non- January 12, 2009 final rule (74 FR 1494) delivered to HCPP enrollees, and Coverage (NOMNC) is the MA included revisions to the definition of intended to encompass all Part B organization’s responsibility. Again, ‘‘gross covered prescription drug costs’’ services. However, in doing so, we consistent with the form instructions for in the Part D regulations at § 423.308. In inadvertently failed to include the fast- the NOMNC, our intent was to make amending § 423.308 in that final rule, track appeal rights regarding Part B delivery of the notice the provider’s we made a technical error in the services provided by a CORF. In a responsibility. To address these definition of ‘‘gross covered prescription proposed revision to § 417.840, we technical errors, we proposed replacing drug costs’’ (74 FR 1545) by referencing proposed to correct this oversight, and ‘‘MA organization’’ with ‘‘hospital’’ in ‘‘negotiated price’’ as the prices made ensure that HCPP enrollees have access § 422.622, and ‘‘provider’’ in § 422.626. available to Part D beneficiaries at to fast-track appeals for CORF services The only comment we received network pharmacies, and not also furnished by an HCPP. This revision regarding these provisions was referencing ‘‘usual and customary would also ensure that HCPP enrollees supportive of the proposed technical prices,’’ the prices for drugs purchased received the fast track appeal rights revisions. Thus, we are making these at out-of-network pharmacies. When we provided for under section 1869 of the revisions as set forth in the proposed revised the definition of ‘‘gross covered Act with respect to such services (which rule without change. prescription drug costs’’ in that final

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rule, our intent was to clarify that Part notice to the contract applicant organization for specified MA or Part D D sponsors must use the amount indicating the applicant’s right to ‘‘plans.’’ We deleted the words ‘‘for received by the dispensing pharmacy or request reconsideration. In our specified’’ MA or Part D ‘‘plans’’ because other dispensing provider as the basis December 5, 2007 final rule, we those did not conform to the statutory for determining the drug costs that must modified the appeal rights for initial language that applies intermediate be reported to us. The use of the term applications and eliminated the sanctions at the organization level. ‘‘negotiated prices’’ as defined at reconsideration process. However, in We received no comments on these § 423.100 (74 FR 1544) in the definition the final regulations we did not update provisions. Accordingly, we are of ‘‘gross covered prescription drug § 422.502(c)(3)(iii) and adopting these provisions as proposed. ’’ costs clarifies this requirement with § 423.503(c)(3)(iii) to state that the 6. Basis for Imposing Intermediate regards to covered Part D drugs applicant has a right to request a hearing Sanctions and Civil Money Penalties purchased at network pharmacies. and as a result the existing regulations (§ 422.752 and § 423.752) However, by not also referencing ‘‘usual incorrectly provide for a right to and customary prices’’ for covered Part reconsideration. In the October 22, 2009 proposed rule, D drugs purchased at out-of-network In the October 22, 2009 proposed rule, we proposed conforming changes to our pharmacies, we inadvertently omitted we also proposed to delete § 422.502(d) regulation at § 422.752(a)(1), (3), and (4) from the definition of ‘‘gross covered and § 423.503(d). Sections 422.502(d) and § 423.752(a)(1), (3), and (4) to more prescription drug costs’’ the share of and 423.503(d) currently provide that accurately reflect statutory language and drug costs actually paid by Part D we have the ability to oversee the to ensure accuracy, consistency, and sponsors to out-of-network pharmacies. sponsoring organization’s continued uniformity. Specifically, we proposed to Since section 1860D–15(b)(3) of the Act compliance with our requirements and amend § 422.752(a)(1) and defines ‘‘gross covered prescription drug that if the sponsoring organization no § 423.752(a)(1) to conform with costs’’ as ‘‘the costs incurred under the longer meets those requirements, we statutory language and state that we may [Part D] plan, not including will terminate the contract in impose an intermediate sanction if the administrative costs, but including costs accordance with § 422.510 and sponsoring organization fails directly related to the dispensing of § 423.509. We noted that this regulation substantially to provide medically covered part D drugs * * *,’’ these costs is not an appropriate regulation for a necessary items and services that are must include costs incurred for covered section dedicated to the evaluation and required (under law or under the Part D drugs at out-of-network determination procedures for approving contract) to be provided to an individual pharmacies, as well as costs incurred at or denying a contract application. covered under the contract, if the failure network pharmacies. Therefore, we We received no comments on these has adversely affected (or has needed to revise the definition of ‘‘gross provisions. Accordingly, we are substantial likelihood of adversely covered prescription drug costs’’ to adopting these provisions as proposed. affecting) the individual. correctly reference both ‘‘negotiated We also proposed to amend 5. Intermediate Sanctions (§ 422.750(a) § 422.752(a)(3) and § 423.752(a)(3) to prices’’ paid to network pharmacies and and § 423.750(a)) ‘‘usual and customary prices’’ paid to conform with statutory language and out-of-network pharmacies. We received In the October 2009 proposed rule (74 stated that we may impose an two comments, both of which supported FR 203), we made three technical intermediate sanction if the sponsoring the proposed revision to the definition changes to each intermediate sanction organization ‘‘acts’’ to expel or refuses to of ‘‘gross covered prescription drug regulation at § 422.750 (a) and re-enroll a beneficiary in violation of the costs.’’ The commenters agreed with our § 423.750(a) to more accurately reflect provisions of this part. proposed correction to add a reference the statute. First, we changed Additionally, we proposed to amend to ‘‘usual and customary prices’’ paid to § 422.750(a)(1) and § 423.750(a)(1), § 422.752(a)(4) and § 423.752(a)(4) to out-of-network pharmacies in the which stated that we may impose a conform with the statutory language and definition of ‘‘gross covered prescription suspension of enrollment of Medicare state that we may impose an drug costs.’’ Therefore, we are adopting beneficiaries. This regulation did not intermediate sanction if the sponsoring this revision to the definition of ‘‘gross adequately reflect the statutory language organization engages in any practice covered prescription drug costs’’ in which specifies that the enrollment that would reasonably be expected to § 423.308 as proposed. suspension applies to the ‘‘sponsoring have the effect of denying or organization’s enrollment of Medicare discouraging enrollment (except as 4. Application Evaluation Procedures beneficiaries. permitted by this part) by eligible (§ 422.502(c) and (d) and § 423.503(c) We also changed the language of individuals with the organization whose and (d)) § 422.750(a)(2) and § 423.750(a)(2), medical condition or history indicates a In the October 22, 2009 proposed rule, which stated that we may impose a need for substantial future medical we proposed two amendments to suspension of payment to the services. regulations governing the application sponsoring organization for Medicare As we noted in the proposed rule, evaluation procedures at § 422.502(c) beneficiaries who are enrolled in the sections 1857(g) and 1860D–12 of the and (d), and § 423.503(c) and (d). In MA plan. This language does not Act provide a list of the bases for addition, at § 422.502(c)(3)(iii) and conform to the statutory language, intermediate sanctions and civil money § 423.503(c)(3)(iii) we proposed to make which states that suspension of payment penalties. Existing regulations at a technical correction and delete the may be imposed for Medicare § 422.752(a) and § 423.752(a) provide a language ‘‘right to reconsideration’’ and beneficiaries enrolled after the date we similar list of bases for intermediate replace it with ‘‘right to request a notify the organization of the imposition sanctions and civil money penalties. hearing’’. of an intermediate sanction. However, the language provided in As we noted in the preamble to the We also proposed to change § 422.752(a)(1), (3), and (4) and proposed rule, currently, § 422.750(a)(3) and § 423.750(a)(3), § 423.752(a)(1), (3), and (4) does not § 422.502(c)(3)(iii) and which stated we may suspend all adequately conform to the statutory § 423.503(c)(3)(iii) state that if we deny marketing activities to Medicare language in section 1857(g)(1)(A), (C), the application, CMS gives written beneficiaries by a sponsoring and (D) of the Act, respectively.

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First, § 422.752(a)(1) states that we III. Provisions of the Final Rule about membership activities (for may impose an intermediate sanction if Except as otherwise noted below, this example, materials on rules involving the sponsoring organization fails final rule adopts the provisions of the non-payment of premiums, substantially to provide, to a sponsoring proposed rule. The provisions of this confirmation of enrollment or organization enrollee, medically final rule that differ from the proposed disenrollment, or annual notification necessary services that the organization rule are as follows: materials) in the definition of marketing is required to provide (under law or • Changes to Strengthen Our Ability materials. ++ Added a new paragraph under the contract) to a sponsoring to Distinguish for Approval Stronger § 422.2260(6) to specifically exclude organization enrollee, and that failure Applicants for Part C and D Program from the definition of marketing ad hoc adversely affects (or is substantially Participation and to Remove customized or situational enrollee likely to adversely affect) the enrollee. Consistently Poor Performers. communications from the definition of This language is slightly different than • Notice of Intent to Apply. We the language provided in the statute at marketing materials. modified § 422.503(b)(2) and • Use of Standardized Technology section 1857(g)(1)(A) of the Act. § 423.502(b)(2) to clearly indicate that under Part D. At § 423.120, we clarify Second, § 422.752(a)(3) and the decision not to submit an that the effective date for the § 423.752(a)(3) states that we may application after submission of a notice requirement for a unique RxBIN or impose an intermediate sanction if the of intent will not result in any RxBIN/RxPCN combination and a sponsoring organization expels or compliance consequences. • unique Part D Rx identifier for each refuses to reenroll a beneficiary in Compliance Programs under Parts C individual Part D member will be violation of the provisions of this part. and D— January 1, 2012. This language does not include the ++ We made changes made to • Notice of Alternative Medicare word ‘‘acts’’ to expel which is mentioned § 422.502(b)(4)(vi)(B) and Plans Available to Replace in the statute at section 1857(g)(1)(C) of § 423.504(b)(4)(vi)(B) to provide that the Nonrenewing Plans Under Parts C and compliance officer must be an employee the Act. D. of the sponsoring organization, parent • Revised § 422.506 and § 423.507 to Third, § 422.752(a)(4) and organization or corporate affiliate and require that both Part C and Part D § 423.752(a)(4) states that we may clarify that they may not be an organizations inform beneficiaries of impose an intermediate sanction if the employee of a first tier, downstream or both MA and PDP available options. sponsoring organization engages in any related entity of the sponsoring • Made minor technical changes to practice that could reasonably be organization and must be accountable to § 422.254(a)(4), § 423.265(b)(2), expected to have the effect of denying the governing board of the sponsoring § 422.256(b)(4)(i) and § 423(b)(3)(i). or discouraging enrollment of organization. • RADV Appeals Processes. individuals whose medical condition or ++ At § 423.504(b)(4)(vi)(C)(3), we ++ In § 422.2 we are— history indicates a need for substantial adopt a new regulation for the Part D — Removing the definition of future medical services. This language program to specify that first tier, documentation dispute process; and does not match the exact language downstream, and related entities have — Adding the definition of initial contained in section 1857(g)(1)(D) of the met the fraud, waste, and abuse validation contractor (IVC). Act. certification requirements through ++ In § 422.311 we are revising the enrollment into the Medicare program audit dispute and appeals processes. Finally, we made conforming changes • Changes to Improve Data Collection and accreditation as a Durable Medical to § 422.752(c) and § 423.752(c). for Oversight and Quality Assessment Equipment, Prosthetics, Orthotics, and Currently § 422.752(c)(1) and ++ At § 480.140(g), we clarify that § 423.752(c)(1) state that we may impose Supplies (DMEPOS) supplier are QIOs must disclose quality review study civil money penalties for any of the deemed to have met the training and information collected by the QIOs as determinations at § 422.510(a) and educational requirements for fraud, part of the RHQDAPU program, as waste, and abuse. § 423.509(a), except § 422.510(a)(4) and • defined in section 1886(b)(3)(B) of the § 423.509(a)(4). Also, § 422.752(c)(2)(ii) Termination of Contracts under Act, to CMS. and § 423.752(c)(2)(ii) state that OIG Parts C and D. We did not finalize the ++ We also modify § 422.153 to may impose civil money penalties for a modifications to § 422.510(a)(2)(i), indicate that we will acquire quality § 423.509(a)(2)(i) (failure to comply with determination made pursuant to review study information from QIOs as regulatory requirements), § 422.510(a)(4) and § 423.509(a)(4). defined in part 475. § 422.510(a)(2)(ii) and § 423.509(a)(2)(ii) • Since we are proposing elsewhere in CAHPS Survey Administration (failure to comply with performance these proposed regulations to Under Parts C and D. At § 417.492 and standards). redesignate § 422.510(a)(4) and § 422.152, we clarify that all cost • Maximum Allowable Out-of-Pocket § 423.509(a)(4) to § 422.510(a)(2)(iii) and contracts under section 1876 of the Act Cost Amount for Medicare Parts A and § 423.509(a)(2)(iii), we need to conform with 600 or more enrollees in July of the B Services. At § 422.100(f)(4) with one § 422.752 and § 423.752 to these prior year, must contract with approved modification regarding its applicability changes. Therefore, for regulations Medicare Consumer Assessment of to all MA plans. Healthcare Providers and Systems § 422.752(c)(1), § 422.752(c)(2)(ii), • Transition Process Under Part D § 423.752(c)(1), and § 423.752(c)(2)(ii) (CAHPS) survey vendors to conduct the (§ 423.120(b)(3)). At § 423.120(b)(3), we Medicare CAHPS satisfaction survey of we are deleting the reference to are modifying proposed paragraph (iii) § 422.510(a)(4) and § 422.509(a)(4) and Medicare plan enrollees in accordance to clarify that transition notices must be with CMS specifications and submit the replace with a reference to sent to beneficiaries within 3 business survey data to CMS. § 422.510(a)(2)(iii) and days of adjudication of a temporary fill. • Protected Classes of Concern under § 423.509(a)(2)(iii). • Beneficiary Communications Part D. We are not finalizing our We received no comments on these Materials Under Parts C and D proposed revisions to § 423.120(b)(2)(v). provisions. Accordingly, we are ++ Revised paragraph • Pro-rating the Plan Deductible for adopting these provisions as proposed. § 422.2260(5)(vii) to retain materials Part C MSA Enrollments Occurring

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During an Initial Coverage Election cost contracts under section 1876 of the We have now determined that the Period. We are modifying § 422.103(d) Act, private fee-for-service contracts, information collection burden imposed in this final rule to allow beneficiaries and MSA contracts with 600 or more by § 422.108 and § 423.462 is generally who enroll in a MSA plan mid-year to enrollees in July of the prior year) must part of the information being captured also pay a pro-rated deductible. contract with approved Medicare in CMS–10265—Mandatory Insurer Medication Therapy Management Consumer Assessment of Healthcare Reporting information collection request Programs Under Part D—At Providers and Systems (CAHPS) survey (ICR). The OMB control number (OCN) § 423.153(d)(2)(iii), we adopt the vendors to conduct the Medicare is 0938–1074. Therefore, no new ICR is establishment of a specific threshold of CAHPS satisfaction survey of MA plan required. $3,000 for MTM eligibility, instead of enrollees in accordance with CMS The collection approved under OCN relying on the ICL as the proposed target specifications and submit the survey 0938–1074 takes care of virtually all of for MTM eligibility. data to CMS. The burden associated an MAO’s MSP reporting • Standard Timeframe and Notice with the requirement in § 417.472(i) and responsibilities; the MAO is now Requirements for Coverage (j) is detailed in our discussion of reporting on their own primary, Determinations Under Part D. We add § 422.152. commercial insurance coverage. The small number of cases where an MAO paragraph (a)(3) to § 423.568, which will B. ICRs Regarding Apportionment and require plan sponsors to establish and will need to report either a new primary Allocation of Administrative and carrier or the termination of such maintain a method of documenting all General Costs (§ 417.564) oral requests and maintaining the coverage, that is not captured by OCN documentation in the case file. We are not imposing any new 0938–1074 is covered by existing • Novations. We amended § 423.551 reporting requirements. We are simply authority under OCN 0938–0753. Under to provide clarity to sponsors regarding clarifying what costs an HCPP may our previous Part C coordination of the circumstances under which a PDP report in its cost report as benefits policy, we required MAOs to novation would be approved by CMS, administrative costs for reimbursement survey members annually and to report noting that they do not apply to changes from the government. We do not believe results to CMS. of ownership between subsidiaries of that our proposal will result in The reporting burden under our the same parent organization. additional burden on cost plans; previous Part C coordination of benefits therefore, we have not incorporated a policy was to report both survey non- IV. Collection of Information burden increase in the PRA section. responders (approximately 10 percent of Requirements enrollees) and those who reported that C. ICRs Regarding Medicare Secondary they had other third party health Under the Paperwork Reduction Act Payer (MSP) Procedure (§ 422.108 and insurance coverage (less than 2 percent). of 1995, we are required to provide 60- § 423.462) day notice in the Federal Register and MAOs were not required to report to us solicit public comment before a Section 422.108(b)(3) proposes that on members that responded to the collection of information requirement is MA organizations must coordinate survey and said that they did not have submitted to the Office of Management benefits to Medicare enrollees with the other third party health insurance and Budget (OMB) for review and benefits of the primary payers, coverage—over 85 percent. Under the approval. In order to fairly evaluate including reporting, on an ongoing new system MAOs will only have to whether an information collection basis, information obtained in report to CMS those for whom MSP should be approved by OMB, section accordance with requirements in status changes from what is showing on 3506(c)(2)(A) of the Paperwork paragraphs (b)(1) and (b)(2) of this the current COB file. We estimate this Reduction Act of 1995 requires that we section in accordance with CMS will be less than 1 percent. The burden instructions. Similarly, § 423.462 solicit comment on the following issues: of reporting is less now than it was • The need for the information proposed that Part D plan sponsors must before the change, but the actual collection and its usefulness in carrying report creditable new or changed reporting process is new. The new out the proper functions of our agency. primary payer information to the CMS reporting process is slightly more • The accuracy of our estimate of the COB Contractor in accordance with the burdensome than the old process and information collection burden. processes and timeframes specified by we believe the overall burden will be • The quality, utility, and clarity of CMS. In the proposed rule, we similar to what it was before this the information to be collected. estimated the burden associated with change. • Recommendations to minimize the this requirement to be the time and D. ICRs Regarding Disclosure information collection burden on the effort necessary to report the specified Requirements (§ 422.111) affected public, including automated information to CMS on an ongoing collection techniques. basis. We estimated that 624 MA Proposed § 422.111 states that we may The following sections of this organizations and 456 Part D plan require an MA organization to disclose document contain paperwork burden sponsors would need to comply with to its enrollees or potential enrollees, but not all of them are subject to the these requirements, a total of 1,080 the MA organization’s performance and information collection requirements entities. We also estimated that, on contract compliance deficiencies in a (ICRs) under the PRA for reasons noted. average, each entity would produce one manner specified by CMS. report thereby yielding a total of 1,080 Our intent is to invoke this disclosure A. ICRs Regarding Basic Contract reports annually for involved entities. authority when we become aware that Requirements (§ 417.472) We estimated that it would take each an MA organization has serious Proposed § 417.472(i) states that HMO entity an average of 2,885 hours to compliance and performance or CMP must comply with the report the required information to CMS. deficiencies such as those that may lead requirements at § 422.152(b)(5). The estimated annual burden associated to an intermediate sanction or require Proposed § 417.472 states that all with these requirements was 3,115,800 immediate correction and where we coordinated care contracts (including hours, and the cost associated with believe beneficiaries should be local and regional PPOs and contracts meeting these requirements was $77.9 specifically notified. The primary with exclusively SNP benefit packages, million. purpose of this requirement is to

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promote transparency and informed coordinated care plan to comply with CMS has underestimated the amount of choice especially in those situations these requirements. There are 624 MA time, effort, and cost associated with where we believe beneficiaries need or coordinated care plans. The estimated complying with CMS’s RADV appeals should have access to this information. annual burden associated with these processes, as proposed. The burden associated with this requirements was 624,000 hours. The While we acknowledge that there can requirement would be the time and estimated annual cost associated with be differences regarding the exact effort necessary for the MA organization these requirements was $36.9 million. burden estimate CMS developed for to make the aforementioned disclosures. The new quality measures will be RADV appeals, we continue to believe We have not developed a burden identified during CY 2011 at which time that the overall impact analysis we estimate for this requirement because it will go through the PRA review and provided regarding RADV appeals- we do not believe that we will exceed approval process. CMS has begun related procedures is reasonable. To the PRA threshold of 10 organizations drafting the PRA package for the new date MA organizations have not been per any 12 month period. We have quality measures. However, the PRA afforded appeal rights under RADV based this assumption on past package cannot be completed until the audits and CMS has no historical data experience. For example, while this measures have been developed. to verify what we believe is an requirement does not just apply to those Section 422.152(b)(5) requires that all inherently reasonable level of effort and organizations who have been coordinated care contracts (including associated burden-estimate. Also, since sanctioned, in 2009, CMS imposed local and regional PPOs and contracts invoking an MA organization’s appeal intermediate sanctions on a total of 4 with exclusively SNP benefit packages, rights is entirely voluntary on the part sponsoring organizations (which is the cost contracts under section 1876 of the of MA organizations, we likewise have highest number of intermediate Act in Section 417.472, private fee-for- no altogether accurate way to estimate sanctions imposed in any year or 12 service contracts, and PDPs under the level of activity that MA month period from 2006 through 2009) Section 423.156 with 600 or more organizations will undertake in and, it is important to note, that not all enrollees in July of the prior year) must appealing eligible RADV-related audit of the organizations sanctioned in 2009 contract with approved Medicare provisions. Indeed, we think it is were required to make such a CAHPS survey vendors to conduct the entirely possible that various MA disclosure. Additional organizations Medicare CAHPS satisfaction survey of organizations could take altogether (not under sanction) experience MA plan enrollees in accordance with different approaches in requesting an compliance deficiencies, however we CMS specifications, and submit the RADV appeal. For example—some intend to utilize this disclosure survey data to CMS. The burden organizations might employ internal requirement in instances where we associated with this requirement is the resources to process an appeal request become aware of serious deficiencies time and effort necessary to conduct the (for example, employ in-house medical which may lead to the imposition of CAHPS survey and submit the record and legal staff) while other intermediate sanctions and/or require corresponding data to CMS. The organizations could hire external immediate correction. For any of these associated burden is currently approved medical record consultants and/or law instances, we will then evaluate and under OMB control number 0938–0732. firms to process their appeals requests. determine whether it is appropriate that For the CAHPS requirements, the Given this uncertainty, CMS must rely beneficiaries be specifically notified of requirement will go into effect in 2011 upon what we believe are reasonable the underlying deficiencies to achieve when the contracts select approved level of effort and burden-estimates, as our stated goals of promoting vendors to collect and submit CAHPS described in our proposed rules and transparency and/or informed choice. data on their behalf. The data collection finalized here. Therefore, we do not believe that we begins in February 2011. We have In section § 422.311 of the proposed will impose the disclosure requirement revised the currently approved ICR to rules, CMS proposed a multi-step Risk on 10 or more sponsoring organizations include the requirements contained in Adjustment Data Validation (RADV) within any 12-month period which this section. The burden associated with dispute and appeals process. One would not require the development of a these requirements is the time and effort important change to the RADV dispute burden estimate. necessary for an MA organization, and appeal process that we have Section 1876 Cost Plan, or PDP sponsor implemented pursuant to public E. ICRs Regarding Quality Improvement to collect, analyze and report quality comment is removal of the Program (§ 422.152) performance data to CMS. We estimate documentation dispute process Section 422.152(b)(3)(ii) states that that it will require 54 hours per MA described at § 422.311(c)(2)(ii) and MA coordinated care plans must collect, organization or per PDP, to comply with development of a process that would analyze and report quality performance these requirements. The 54 hours allow MA organizations to appeal data indentified by CMS that are of the includes the time to select a CAHPS medical record review determinations same type as those specified under survey vendor and the survey that occur at the IVC level of medical paragraph (b)(3)(i) of this section. administration time of the CAHPS record review. We describe this new Section 422.152(e)(2)(ii) states that MA survey vendor for which the MA or PDP process that we are implementing at organizations offering an MA regional contract pays. There are 624 contracts § 422.311(c) (2). In effect, the new plan or local PPO plan must collect, (both MA and PDPs). The estimated medical record review appeal analyze and report quality performance annual burden associated with these procedures provides MA organizations data identified by CMS that are of the requirements is 54 × 624 = 33,696 hours with two opportunities to appeal—first, same type as those described under for the affected contracts. to appeal RADV medical record review § 422.152(e)(2)(i). The burden associated determinations and second, to appeal with these requirements is the time and F. ICRs Regarding Risk Adjustment Data the RADV payment error calculations. effort necessary for an MA coordinated Validation (RADV) Appeals (§ 422.311) It’s our belief that the level of effort care plan to collect, analyze and report We received comments from an MA necessary to process a request for quality performance data to CMS. In the organization disputing CMS’s burden documentation dispute will be roughly proposed rule, we estimated that it estimate associated with RADV audit the same level of effort necessary to would require 1,000 hours per MA appeals. This organization contends that request Medical record review appeal

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since both processes involve sending appeal their medical record review H. ICRs Regarding General Provisions CMS medical record documentation to determinations found to be in error (70 (§ 422.503 and § 423.504) support identified RADV errors MAOs). We estimate 40 hours by an Section 422.503(b)(4)(vi) and identified pursuant to CMS’s initial attorney costing $60 per hour (Bureau of § 423.504(b)(4)(vi) propose to expand on level of medical record review. Labor Statistics, 1/28/2010), and 20 the existing requirements by providing However, the scope of the eligibility hours by a health care administrator clarification and additional guidance criteria for what CMS will allow MAOs costing $30 per hour (Bureau of Labor with respect to the requirements for to appeal under medical record review Statistics, 1/28/2010); for a total cost of developing, implementing and appeal could be broader when $3,000 in labor costs per MAO per maintaining effective compliance compared with what CMS would have appeal. This equates to an additional programs. The burden associated with allowed under the now removed aggregate annual dollar burden of this requirement is the time and effort documentation dispute process. We × put forth by the sponsoring organization therefore have calculated a new burden $210,000 ($3000 70 audits).Total to prepare a compliance plan that meets estimate for medical record review estimated aggregate annual dollar the requirements of this section. While appeal. burden to the MA industry annually Whereas under documentation equals $520,800 ($310,800 for medical these requirements are subject to the dispute, RADV contract-level audit record preparation + $210,000 for legal PRA, it is currently approved under statistics indicated that approximately preparation of appeal case). The total OCN 0938–1000. 55 percent of RADV audit errors would aggregated burden is 9,450 hours. I. ICRs Regarding Contract Provisions have been of the type that could be G. ICRs Regarding Application (§ 422.504 and 423.505) eligible for documentation dispute, we estimate that fully 100 percent of RADV Requirements (§ 422.501 and § 423.502) Section 422.504 and § 423.505 explicitly state our existing authority to audit errors will be eligible for medical Section 422.501(b) and § 423.502(b) record review appeal. The historical find sponsors out of compliance with require that an organization submitting either MA requirements, Part D contract-level RADV audit error rate to an application under this section for a date is approximately 15 percent. requirements, or both when the particular contract year must first Utilizing the statistics regarding the sponsor’s performance represents an submit a completed Notice of Intent to number of organizations that we expect outlier relative to the performance of to undergo RADV audit (70) annually, Apply by the date established by CMS. other sponsors. Specifically, we estimate that 100 percent of these We will not accept applications from § 422.504(e)(2) and § 423.505(e)(2) state organizations will invoke their medical organizations that do not submit a that HHS, the Comptroller General or record review appeal rights and appeal timely Notice of Intent to Apply. The their designees have the right to audit, their medical record review errors. On purpose of these requirements is to evaluate, and inspect any books, average, CMS audits approximately 200 facilitate CMS systems access earlier so contracts, computer or other electronic beneficiaries per contract; and each that the contract number may be given systems, including medical records and beneficiary selected for testing has out and applications may be submitted documentation of the first tier, approximately 2.5 Hierarchical electronically. While the burden downstream, and related to our contract Condition Categories (or HCCs, which associated with the requirements with the MA organization. These are the base-level unit of analysis under contained in § 422.501(b) and sections contain recordkeeping RADV audits) equating to roughly 500 § 423.502(b), the Notice of Intent to requirements. The burden associated HCCs tested per annual RADV contract- Apply, are subject to the PRA, the with § 422.504(e)(2) and § 423.505(e)(2) level audit. Applying the 15 percent burden associated with these is the time and effort necessary for MA organizations or Part D sponsors to contract-level RADV audit error rate to requirements is already approved under maintain the information on file and the 500 tested HCCs renders an estimate the OMB control numbers for the Part C of 75 HCCs (500 × .15) eligible for make it available to CMS upon request. and Part D applications, 0938–0935 and While these requirements are subject to medical record review appeal per audit. 0938–0936, respectively. This equates to approximately 5,250 the PRA, we believe the associated HCCs (70 audits × 75 HCCs/audit) that Section 422.501(c) and § 423.502(c) burden is exempt under 5 CFR could be appealed annually under propose to revise the current regulation, 1320.3(b)(2). making clear the application standards medical record review appeal. Each J. ICRs Regarding Nonrenewal of for becoming an MA organization or HCC that is appealed will require Contract (§ 422.506 and § 423.507) production of one medical record to Part D plan sponsor. Specifically, overturn the RADV testing error. We § 422.501(c) and § 423.502(c) require Section 422.506 and § 423.507 contain continue to estimate that it will take that applicants complete all parts of a notification requirements for MA approximately 1 hour to prepare the certified application. The burden organizations and Part D plan sponsors. necessary documentation to dispute one associated with the aforementioned Section 422.506(a)(2) and HCC via medical record review appeal. requirements is the time and effort § 423.507(a)(2) require that when an This equates to 5,250 burden hours at necessary for an application to complete organization does not intend to renew its contract, it must notify each approximately $59.20/hour (based on all parts of a certified Part C or Part D Medicare enrollee by mail at least 90 U.S. Dept. of Labor statistics for hourly application. While the burden calendar days before the date on which wages for management analysts)—or, an associated with the requirements annual dollar burden on the MA the nonrenewal is effective. An contained in § 422.501(c) and industry of $310,800. organization will also have to provide CMS also estimates that beyond § 423.502(c) are subject to the PRA, the information about alternative product of medical records, MAOs burden associated with these enrollment options by complying with pursuing medical record review appeal requirements is already approved under at least one of the requirements would incur legal costs in the OMB control numbers for the Part C and specified in § 422.506(a)(2)(ii) or preparation of the formal request for Part D applications, 0938–0935 and § 423.507(a)(2)(ii). In addition, appeal. Again, we assume all MAOs will 0938–0936, respectively. § 422.506(b)(2) and § 423.507(b)(2) state

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that an organization must notify each decision’’ to conform to other those organizations who have been Medicare enrollee by mail at least 90 regulations. Furthermore, we believe the sanctioned, in 2009, CMS imposed calendar days before the date on which associated burden is exempt from PRA intermediate sanctions on a total of 4 the nonrenewal is effective, or at the under 5 CFR 1320.4. Information sponsoring organizations (which is the conclusion of the appeals process. We collected during the conduct of an highest number of intermediate believe that fewer than 10 contracts will administrative action or audit is not sanctions imposed in any year or 12 be terminated on an annual basis, and subject to the PRA. month period from 2006 through 2009) therefore, these requirements are and, it is important to note, that not all N. ICRs Regarding Procedures for exempt from the PRA process. of the organizations sanctioned in 2009 Imposing Intermediate Sanctions and were required to make such a K. ICRs Regarding Request for Hearing Civil Monetary Penalties (§ 422.756 and disclosure. Additional organizations (§ 422.662 and § 423.651) § 423.756) (not under sanction) experience With respect to Medicare contract Section 422.756 and § 423.756 state compliance deficiencies, however we determinations and appeals, § 422.662 before CMS imposes intermediate intend to utilize this disclosure and § 423.651 provide the methods and sanctions, MA organizations and Part D requirement in instances where we time period for when an MA plan sponsors may request a hearing become aware of serious deficiencies organization or Part D plan sponsor may before a CMS hearing officer. A written which may lead to the imposition of request a hearing after a contract request must be received by the intermediate sanctions and require determination or intermediate sanction designated CMS office within 15 immediate correction. For any of these has been imposed. The request for calendar days after the receipt of the instances, we will then evaluate and hearing must be submitted in writing notice of sanction. The burden determine whether it is appropriate that and must be filed within 15 calendar associated with these requirements is beneficiaries be specifically notified of days after the receipt of the notice of the the time and effort necessary to draft the underlying deficiencies to achieve contract determination or intermediate and submit a hearing request to the our stated goals of promoting sanction. This is an existing regulation designated CMS office. This is an transparency and informed choice. and in this rule we are only modifying existing regulation and we are only Therefore, we do not believe that we the language ‘‘after receipt of the hearing modifying the language ‘‘after receipt of will impose the disclosure requirement decision’’ to conform to other the hearing decision’’ to conform to on 10 or more sponsoring organizations regulations. Furthermore, we believe the other regulations. Furthermore, we within any 12-month period which associated burden is exempt from PRA believe the associated burden is exempt would not require the development of a under 5 CFR 1320.4. Information from PRA under 5 CFR 1320.4. burden estimate. collected during the conduct of an Information collected during the administrative action or audit is not conduct of an administrative action or P. ICRs Regarding Validation of Part C subject to the PRA. audit is not subject to the PRA. and Part D Reporting Requirements (§ 422.516 and § 423.514) O. ICRs Regarding Disclosure L. ICRs Regarding Time and Place of In this final rule, we are amending Requirements (§ 423.128) Hearing (§ 422.670 and § 423.655) § 422.516 and § 423.514 to state that Section 422.670 and § 423.655 state Proposed § 423.128 states that we may each Part C and Part D sponsor will be that CMS, an MA organization or a Part require a Part D Plan Sponsor to subject to an independent yearly audit D plan sponsor may request an disclose to its enrollees or potential of Part C and Part D measures (collected extension by filing a written request no enrollees, the Part D Plan Sponsor’s pursuant to our reporting requirements) later than 10 calendar days prior to the performance and contract compliance to determine their reliability, validity, scheduled hearing. The burden deficiencies in a manner specified by completeness, and comparability in associated with these requirements is CMS. accordance with specifications the time and effort necessary for an MA Our intent is to invoke this disclosure developed by CMS. The burden organization or a Part D plan sponsor to authority when we become aware that a associated with this provision is the submit a written extension request to Part D sponsor has serious compliance time and effort of the MA organizations the presiding hearing officer. and performance deficiencies such as and Part D sponsors in procuring an Furthermore, we believe the associated those that may lead to an intermediate auditor and in supporting the auditor as burden is exempt from the PRA under sanction or require immediate well as the time and effort of the auditor 5 CFR 1320.4. Information collected correction and where we believe in conducting the yearly audit. during the conduct of an administrative beneficiaries should be specifically In the proposed rule, we estimated the action is not subject to the PRA. notified. The primary purpose of this total burden hours related to the time requirement is to promote transparency and effort for all auditing organizations M. ICRs Regarding Review by the and informed choice especially in those to perform the annual audit for both Part Administrator (§ 422.692 and § 423.666) situations where we believe C and Part D data validation to be Section 422.692 and § 423.666 state beneficiaries need or should have access 215,840. In addition, we estimated the that CMS, an MA organization or a PDP to this information. The burden total yearly burden for procuring and plan sponsor that has received a hearing associated with this requirement would supporting the auditor would be 85,200 decision may request a review by the be the time and effort necessary for the hours (120 hours per sponsor × 710 Administrator within 15 calendar days Part D sponsor to make the sponsors). Therefore, the total estimated after receipt of the hearing decision. The aforementioned disclosures. We have burden was 301,040 hours. At that time, burden associated with these not developed a burden estimate for this we assumed that the auditing requirements is the time and effort requirement because we do not believe organizations would audit all thirteen necessary to submit a request for the that we will exceed the PRA threshold measures that comprised the Part C Administrator to review a hearing of 10 organizations per any 12 month reporting requirements and all 21 decision. This is an existing regulation period. We have based this assumption sections that comprised the Part D and in this rule we are only modifying on past experience. For example, while reporting requirements. For Part C, two the language ‘‘after receipt of the hearing this requirement does not just apply to of the original thirteen reporting

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requirements were suspended—agent annual basis. The total annual burden S. ICRs Regarding Timeframes and compensation structure and agent associated with this requirement is Notice Requirements for Expedited training and testing. Additionally, two 937,500 hours. Coverage Determinations (§ 423.572) of the remaining eleven Part C measures R. ICRs Regarding Timeframes and If a Part D plan sponsor makes a will not undergo the data validation— completely favorable expedited decision PFFS Plan enrollment Verification Calls Notice Requirements for Standard Coverage Determinations (§ 423.568) under paragraph (b) of this section, it and PFF Provider Payment Dispute must give the enrollee written notice of Resolution Process. We estimate that The Part D plan sponsor must, under the determination. The initial notice Part C reductions alone will reduce the may be provided orally, so long as a annual hourly burden for all auditing paragraph (a)(3), establish and maintain written follow-up notice is sent within organizations to perform the annual a method of documenting all oral 3 calendar days of the oral notification. audit by 66,412 hours (215,840 × 4/13). requests for standard coverage The burden associated with the This reduction leads to an estimate of determinations and retain the requirements listed in § 423.572(b) is 149,428 hours to perform the annual documentation in the case file. the time and effort necessary for a Part audit for Part C measures. The CY2010 The burden associated with this D plan sponsor to notify an enrollee Part D Reporting Requirements PRA requirement is the time and effort (and the prescribing physician or other package approved by OMB in October necessary for Part D plan sponsors to prescriber involved, as appropriate) in 2009 included burden estimates for data maintain the required documentation writing of completely favorable validation and auditing activities. The outlined in this section. We estimate PRA package included the burden for expedited decision. We estimate that the that, on an annual basis, 90 percent of 456 Part D plan sponsors will issue a plans to audit 17 of the 21 Part D all coverage determination requests will reporting sections. This number has combined 87,103 written favorable be standard requests, and three percent now been decreased because only 8 expedited notifications per year. We of those requests will not involve reporting sections will be audited. The further estimate that it will take a Part elimination of 9 reporting sections from reimbursement issues. Of the estimated D plan sponsor 30 minutes to distribute the requirements for data validation and 1,013,881 requests received annually, a single notice. The estimated annual auditing for Part D will result in the we estimate that approximately 90 burden associated with the requirement following reduction in labor hours: 0.5 percent (912,493) will be made orally. in § 423.572(b) is 43,552 hours. hours × 9 sections × 715 plans = 3,218 We estimate that it will take a Part D T. ICRs Regarding Access To Covered hours. plan sponsor 3 minutes to document Part D Drugs (§ 423.120) The combined Part C and Part D and retain the required documentation reductions in data validation in the case file. Thus, it will take each Section 423.120(b)(3)(iv) requires requirements from those in the of the 456 Part D plan sponsors 100 sponsors to provide enrollees with appropriate notice regarding their proposed rule will result in 69,630 hours to maintain the required transition process within three business fewer labor hours. The total estimated documentation on an annual basis, for days after providing a temporary supply labor hours is therefore 301,040 ¥ a total annual burden of 45,625 hours. 69630 = 231,410. of non-formulary Part D drugs If a Part D plan sponsor makes a (including Part D drugs that are on a Q. ICRs Regarding Drug Utilization completely favorable standard decision sponsor’s formulary but require prior Management, Quality Assurance, and under paragraph (d) of this section, it authorization or step therapy under a Medication Therapy Management must give the enrollee written notice of sponsor’s utilization management rules). Programs (MTMPs) (§ 423.153) the determination. Pursuant to The burden associated with this The revisions to § 423.153 state that paragraph (d) of this section, the initial requirement is the time and effort Part D plans must offer a minimum level notice of a favorable decision may be necessary for a Part D plan sponsor to of medication therapy management provided orally, so long as a written provide a notice to beneficiaries services for each beneficiary enrolled in follow-up notice is sent within 3 regarding the transition process. We the MTMP that includes, but is not calendar days of the oral notification. estimate this will result in 1.35 million limited to, annual comprehensive notices that would take an average of 15 The burden associated with the medication reviews with written minutes to prepare. We then estimate requirement in paragraph (d) is the time summaries. The comprehensive medical the total burden to be 337,500 hours. review must include an interactive, and effort necessary for a Part D plan Section 423.120(c)(4) requires Part D person-to-person consultation sponsor to notify an enrollee (and the sponsors to contractually mandate that performed by a pharmacist or other prescribing physician or other their network pharmacies submit claims qualified provider unless the beneficiary prescriber involved, as appropriate) in electronically to the Part D sponsor or is in a long-term care setting. writing of a completely favorable its intermediary on behalf of the Additionally, there must by quarterly standard decision for benefits. We beneficiary whenever feasible unless the targeted medication reviews with estimate that each year, the 456 Part D enrollee expressly requests that a follow-up interventions when plan sponsors will issue a total of particular claim not be submitted to the necessary. approximately 760,411 written favorable Part D sponsor or its intermediary. The burden associated with these standard notifications for benefits. We Section 423.120(c)(4) requires the requirements is the time and effort further estimate that it will take a Part approximately 28 pharmacy claims necessary for Part D sponsors (both MA– D plan sponsor 30 minutes to distribute processors currently responsible for the PDs and PDPs) to conduct the medical a single notice. The estimated annual electronic adjudication of pharmacy reviews with written summaries. We burden associated with the requirement benefits to change their RxBIN or RxBIN estimate that each medical review will in § 423.568(d) is 380,206 hours. For and RxPCN combination if such take an average of 30 minutes to § 423.568, we will update 0938–0964 to identifiers are not already unique to its conduct. Similarly, we estimate that include the burden estimates associated Medicare line of business, and the Part there will be 1,875,000 reviews with this requirement. D cardholder identification number if it conducted by 456 Part D sponsors on an is not already unique to each Medicare

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Part D enrollee. We estimate the annual expedited determination orally, it must support CMS’ burden estimates and hourly burden to be 1,380 hours per mail written confirmation to the questioned the basis of the estimates. processor to make the coding changes enrollee within 3 calendar days of the Response: We believe that we necessary to implement this oral notification. The burden associated provided evidence for both the cost and requirement. We estimate the yearly with this requirement is the time and time estimates in the COI and regulatory burden to be 38,640 hours for CY 2010. effort necessary for a Part D plan impact analysis sections of the October This is a one time only burden for sponsor to follow up an initial oral 2009 proposed rule. The commenter did programming. The collection burden for notification to an enrollee with a written not provide any cost estimates that these provisions will be reflected in a notification. In the proposed rule, we would call into question the validity of revised submission of the ICR approved estimated a burden. We subsequently these estimates. under OMB control number 0938–0964. discovered that appeals notices, V. Annual Information Collection U. ICRs Regarding Timeframes and including those for Part D, are exempt Burden Responsibility for Making from PRA under 5 CFR 1320.4. We will Table X shows our estimates of the Redeterminations (§ 423.590) update 0938–0964 to include the annual reporting and recordkeeping Section 423.590(d)(2) states that if a § 423.590 exclusion language. burden based on the discussion detailed Part D plan sponsor first notifies an Comment: A commenter questioned in sections III.A. through III.V. of this enrollee of an adverse or favorable our evidence of costs or time that final rule.

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($) cost of reporting Hourly labor URDENS B 11. They are included here because they will be in effect for the period of burden (hours) Total annual .1 231,410 138.71 32.1 .25 337,500 21.93 .1 .5 937,500 120.00 112.5 32.2 7.4 .05 45,625 39.45 0.0 .5 380,206 112.5 0.0 41.03 1.8 .5 43,550 41.33 15.6 1.8 0.0 7.4 0.0 0.0 1.8 15.6 1.8 ECORDKEEPING in the section V.C of this final rule. R (hours) response Burden per ...... 5,797,650 ...... 290.6 4.9 295.5 EPORTING AND R NNUAL A Respondents Responses STIMATED OMB 9—E Control No. ABLE T Regulation section(s) Provisions regarding § 422.152(b)(5) and § 423.156 and § 422.516(g) and § 423.514(g) will not go into effect until contract year 20 Total ...... 12,348 4,997,523 Note: § 422.108 and § 423.462 ...... § 422.152(b)(3)(ii) and § 422.152(e)(2)(ii) 0938–1074 ...... § 422.152(b)(5) and § 423.156 0938–New ...... §1.0 422.311(c)(2)25.88 0938–0732 ...... 1,350,000 0 § 422.516(g) and § 423.514(g) 0938–New ...... 38,640 9,450 § 423.120(b)(iv)1,380 ...... 0938–New 1,080 1 § 423.120(c)(3) 0938–0964 710 1,875,000 ...... 0 9,450 52.91 § 423.153 *624 28 0938–0964 28 ...... 912,493 0 § .5 423.568(a)(3) 624 0938–0964 *456 760,411 ...... 0 § 423.568(b) 0938–0964 456 ...... 1,080 87,103 §0 423.572(b) *710 0938–0964 456 ...... 0938–0964 456 624 2,885 624 710 1,000 3,115,800 54 327 624,000 25.00 33,969 59.13 77 91.26 36.9 3.1 0.0 0.0 36.9 3.1 2010–2015. Therefore, the totals in this table will not agree with for CY 2010 RIA Table of costs (Table 10)

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V. Regulatory Impact Analysis (RIA) business entities. They must follow imposes substantial direct requirement minimum enrollment requirements costs on State and local governments, A. Need for Regulatory Action (5,000 in urban areas and 1,500 in non- preempts State law, or otherwise has This final rule makes revisions to the urban areas) and because of the revenue Federalism implications. regulations governing the Medicare from such enrollments, these entities are We estimate this rule is ‘‘economically Advantage (MA) program (Part C) and generally above the revenue threshold significant’’ as measured by the $100 prescription drug benefit program (Part required for analysis under the RFA. million threshold, and hence a major D) based on our continued experience in While a very small rural plan could fall rule under the Congressional Review the administration of the Part C and D below the threshold, we do not believe Act. Accordingly, we have prepared a programs. The revisions strengthen that there are more than a handful of Regulatory Impact Analysis. various program participation and exit such plans. A fraction of MA requirements; strengthen beneficiary organizations and sponsors are Because there are costs to plans and protections; ensure that plan offerings to considered small businesses because of sponsors associated with several beneficiaries include meaningful their non-profit status. HHS uses as its provisions of this rule, we indicate differences; improve plan payment rules measure of significant economic impact general areas affected and specify the and processes; improve data collection on a substantial number of small associated costs. For specific burden for oversight and quality assessment, entities, a change in revenue of more associated with the requirements and implement new policy such as a Part D than 3 to 5 percent. We do not believe the bases for our estimates, see section formulary policy, and clarify program that this threshold would be reached by IV. of this final rule. policy. the requirements in this final rule C. Increase in Costs to MA B. Overall Impact because this rule will have minimal Organizations and Part D Sponsors impact on small entities. Therefore, an We have examined the impact of this analysis for the RFA will not be The provisions of this final rule rule as required by Executive Order prepared because the Secretary has would require MA organizations and 12866 on Regulatory Planning and determined that this final rule will not Part D sponsors an estimated cost of Review (September 30, 1993), the have a significant impact on a approximately $260.3 million for CY Regulatory Flexibility Act (RFA) substantial number of small entities. 2010. (September 19, 1980, Pub. L. 96–354), In addition, section 1102(b) of the Act We believe the following section 1102(b) of the Social Security requires us to prepare a regulatory Act, section 202 of the Unfunded requirements will result in costs to MA impact analysis, if a rule may have a organizations and Part D sponsors Mandates Reform Act of 1995 (Pub. L. significant impact on the operations of 104–4), Executive Order 13132 on between 2010 and 2015: Medicare a substantial number of small rural Secondary Payer Procedures (§ 422.108), Federalism (August 4, 1999), and the hospitals. This analysis must conform to Congressional Review Act (5 U.S.C. CAHPS Survey Costs for MAs and PDPs the provisions of section 604 of the (§ 422.152(b)(5) and § 423.156), Quality 804(2)). RFA. For purposes of section 1102(b) of Executive Order 12866 directs Improvement program the Act, we define a small rural hospital (§ 422.152(b)(3)(ii), § 422.152(e)(2)(ii)), agencies to assess all costs and benefits as a hospital that is located outside of of available regulatory alternatives and, and § 423.156,Validation of Reporting a Metropolitan Statistical Area and has Requirements (§ 422.516 and § 423.514), if regulation is necessary, to select fewer than 100 beds. We are not regulatory approaches that maximize Access to Covered Part D Drugs preparing an analysis for section 1102(b) (§ 423.120(b)(iv)), Pharmacy Use of net benefits (including potential of the Act because we believe and the economic, environmental, public health Standard Technology under Part D Secretary has determined that this rule (§ 423.120(c)(3)), Drug Utilization and safety effects, distributive impacts, will not have a significant impact on the Management, Quality Assurance, and and equity). A regulatory impact operations of a substantial number of Medication Therapy Management analysis (RIA) must be prepared for small rural hospitals. major rules with economically Section 202 of the Unfunded (§ 423.153), Documenting Oral Requests significant effects ($100 million or more Mandates Reform Act of 1995 also for Standard Coverage Determinations in any 1 year). requires that agencies assess anticipated (§ 423.568(a)(3)), Timeframe and Notice The RFA requires agencies to analyze costs and benefits before issuing any Requirements for Standard Coverage options for regulatory relief of small rule whose mandates require spending Determinations (§ 423.568), and entities, if a rule has a significant impact in any 1 year by State, local or tribal Timeframes and Notice Requirements on a substantial number of small governments, in the aggregate, or by the for Expedited Coverage Determinations entities. For purposes of the RFA, small private sector of $100 million in 1995 (§ 423.572(b)). It is true that all of the entities include small businesses, dollars, updated annually for inflation. costs, besides those associated with nonprofit organizations, and small That threshold level is currently $135 MIPPA 176, are labor or capital, governmental jurisdictions. Most million. This final rule is expected to primarily labor. We expect that these hospitals and most other providers and reach this spending threshold. costs will all be reflected in higher bid suppliers are small entities, either by Executive Order 13132 establishes prices that will be federally-funded. nonprofit status or by having revenues certain requirements that an agency Therefore, all the requirements, except of $7.0 million to $34.5 million in any must meet when it promulgates a MIPPA 176, will result in costs to MA 1 year. Individuals and States are not proposed rule and subsequent final rule organizations and Part D sponsors included in the definition of a small that imposes substantial direct between CY 2010 and CY 2015. entity. MA organizations and Part D requirement costs on State and local We believe that the regulatory sponsors, the only entities that will be governments, preempts State law, or provisions implementing the MIPPA affected by the provisions of this rule, otherwise has Federalism implications. 176 provision will result in savings to are not generally considered small We do not believe that this final rule the Medicare Program.

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TABLE 10—ESTIMATED COSTS AND SAVINGS BY PROVISION FOR CYS 2010–2015 [$ in millions]

Calendar year Provision(s) Regulation section(s) Total 2010 2011 2012 2013 2014 2015 (2010–2015)

Medicare Secondary Payer Proce- § 422.108 and §423.462 77.9 77.9 77.9 77.9 77.9 77.9 467.4 dures. Quality Improvement ...... § 422.152(b)(3)(ii) and 36.9 36.9 36.9 36.9 36.9 36.9 221.4 § 422.152(e)(2)(ii). CAHPS Survey Costs for MAs and § 422.152(b)(5) and 0 3.1 3.1 3.1 3.1 3.1 15.5 PDPs. § 423.156. RADV ...... § 422.311 ...... 0.5 0.5 0.5 0.5 0.5 0.5 3.0 Data Validation ...... § 422.516 and § 423.514 0.1 32.1 32.1 32.1 32.1 32.1 160.6 Transition Notification...... § 423.120(b)(iv) ...... 7.4 7.4 7.4 7.4 7.4 7.4 44.4 Pharmacy Use of Standard Tech- § 423.120(c)(3) ...... 5.8 0 0 0 0 0 5.8 nology. Drug Utilization Management...... § 423.153 ...... 112.5 112.5 112.5 112.5 112.5 112.5 675.0 Documenting Oral Requests for Stand- § 423.568(a)(3) ...... 1.8 1.8 1.8 1.8 1.8 1.8 10.8 ard Coverage Determinations. Standard Coverage Determinations § 423.568(b) ...... 15.6 15.6 15.6 15.6 15.6 15.6 93.6 Notification. Expedited Coverage Determinations § 423.572 ...... 1.8 1.8 1.8 1.8 1.8 1.8 10.8 Notification. MIPPA 176 ...... 0 ¥160 ¥340 ¥460 ¥520 ¥570 ¥2,050

Total ...... 260.30 129.60 ¥50.40 ¥170.40 ¥230.40 ¥280.40 ¥341.70

D. Expected Benefits administrative burden of the payment management analysts of $59.20/hour), is Beginning in CY 2013, we expect net reconciliation process. The technical approximately $77.9 million. All labor savings due to the combined impact of correction to the definition of ‘‘gross rate calculations in the RIA are derived these new final provisions. We expect covered prescription drug costs’’ will from the May 2008 wage statistics that the net impact across the 6-year also help PBMs calculate a beneficiary’s supplied by the Department of Labor period from CY 2010 through CY 2015 gross covered prescription drug costs. (DOL), Bureau of Labor Statistics and will be a cost of $308.3 million. The original Medicare savings in include fringe benefits and overhead Many of the new requirements 2007, resulting from the Medicare costs. We expect an MA organization to involve clarifications of existing Secondary Payer (MSP) Procedures were use approximately 1.5 FTEs to regulations and policies. As such, they estimated at $6.5 billion. This included implement Part C MSP procedures should help plans to improve their $2.9 billion recovered or avoided for related to avoiding costs, reporting data, administrative operational functions working-aged individuals, $1.9 billion and collecting from liable third parties which will streamline the Medicare for working-disabled individuals, $877 related to MSP. We estimate the work Advantage and Medicare Prescription million for workers’ compensation, $278 mix to be completed to be 90 percent by Drug programs and strengthen million for ESRD beneficiaries, and the claims analyst and 10 percent by the beneficiary protections within these another $485 million recovered or management analyst. programs. Specifically, we believe that avoided for liability and other insurers. We note that MAOs expenses for the requirements in this final rule will In 2007, there were approximately 8.5 processing claims related to MSP improve coordination of care, increase million MA enrollees and 44 million recoveries are considered part of their quality of data reporting, increase ability total Medicare enrollees (an MA administrative overhead costs. MA to comply with existing regulations and penetration rate of approximately 19 organizations that faithfully pursue and policies, enhance appeal and grievance percent). The $6.5 billion in MSP recover from liable third parties will procedures, and curtail illegal marketing savings can be attributed to the 35.5 have lower medical expenses. Lower practices. Additional benefits include million original Medicare enrollees and medical expenses make such plans more clarification of timeframes and thus equates to approximately $183 per attractive to enrollees. The lower the notification requirements. Some of the original Medicare enrollee. In 2009, MA medical expenses in an MA plan, the new requirements may lead to changes penetration was higher consisting of 11 higher the potential rebate. The rebate is in health plan service areas. million MA enrollees out of calculated as the difference between the We anticipate that several of the approximately 45 million total Medicare cost of Medicare benefits and the requirements in this final rule will be enrollees. This translates to an benchmark for that plan. The beneficial to PBMs in administering the estimated 24 percent MA penetration. benchmark is a fixed amount. Therefore, Part D benefit for Part D sponsors. We assume a similar MSP take up rate as the cost of Medicare benefits Proposed codification of the transition for MA enrollees as that obtained in the decreases with the benchmark process requirements and establishment original 2007 Medicare savings and remaining constant, the rebate amount of the protected classes will assist PBMs therefore project a total MSP savings of increases. That is, as more MSP dollars in applying the Part D requirements approximately $2 billion by 2010. are collected or avoided, medical consistently across Part D plans and The estimated impact of MSP on 624 expenses go down and rebates go up, managing the Part D sponsor’s benefit MA organizations and 456 PDPs based allowing the sponsoring MA packages more efficiently. Establishing on 3.1158 million burden hours at organization to offer potential enrollees cut-off limits for COB and requiring Part approximately $25 per hour (based on additional non-Medicare benefits D sponsors to report other payer U.S. Department of Labor (DOL) funded by rebate dollars. Such non- information in a timely fashion to CMS’ statistics for the hourly wages of claims Medicare benefits include reductions in COB contractors will improve the analysts of $22.20 per hour and for cost sharing. Since cost sharing is

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generally expressed as a percentage of pursuing medical record review appeal The total estimated burden hours medical costs, it will be proportionally would incur legal costs in the related to the time and effort for all lower as overall medical costs go down, preparation of the formal request for auditing organizations to perform the providing MA organizations offering appeal. Again, we assume that all MAO annual audit for both Part C and Part D such plans with an additional will appeal their medical record error data validation is estimated to be competitive edge. determinations (70 organizations.) We 146,210 hours. The mean cost per hour In sections 422.152(b)(3)(ii) and estimate 40 hours by an attorney costing is estimated to be $194.21. Therefore, 422.152(e)(2)(ii), we require MA $60 per hour (Bureau of Labor Statistics, the estimated annual cost for auditing organizations to collect, analyze, and 1/28/2010), and 20 hours by a health contracts involving all 710 sponsors is report quality performance data care administrator costing $30 per hour $28.4 million. The estimated total identified by CMS that are of the same (Bureau of Labor Statistics, January 28, annual cost for auditing contracts and type of data that MA organizations are 2010); for a total cost of $3,000 in labor for the procurement and audit support currently required to collect and report costs per MAO per appeal. When time and effort of the sponsors is $32.1 to CMS. The mean estimated burden per annualized across all contract-specific million ($28.4 million + $3.7 million). MA contract as indicated in section IV. RADV audits, this in turn equates to an The total estimated burden hours, E of this final rule is 1,000 hours. The additional aggregate annual dollar including the hours for sponsors to estimated mean cost per hour for these burden of $210,000 ($3000 × 70 audits). procure contractors, is 231,410. Lastly, MA contracts is $59.20. The mean cost Total estimated aggregate annual dollar there is a one-time cost to develop the per MA contract is $59,200. Since the burden to the MA industry annually software that will allow data entry into number of MA contracts is estimated to equals $520,800 ($310,00 for medical HPMS. This is a Federal cost estimated be 624, the overall estimated cost across record preparation + $210,000 for legal at $100,000 or $0.1 million for CY 2010. × all contracts is $36.9 million (624 preparation of appeal case). Beginning in 2011 MA organizations $59,200). under § 422.152(b)(5), section 1876 Cost In § 422.311 we describe the Risk The validation of reporting plans under § 417.472, and Part D Adjustment Data Validation (RADV) requirements (§ 422.516 and § 423.514) sponsors under § 423.156 will begin dispute and appeals process that focuses on how the sponsor collects, paying for the data collection costs of audited MAOs can voluntarily choose to stores, and reports the new Part C and the CAHPS annual survey. Data participate in. In our proposed rule, we Part D data requirements. Standards and collection is to be performed by a estimated that upwards of 100 MAOs procedures will also focus on how contractor hired by the MAO, section would be selected for contract-level sponsors compile data, and verify 1876 Cost plan or Part D sponsor. The RADV audits annually. We now believe calculations, computer code, and mean estimated burden per contract, as that a more accurate estimate of the algorithms. The estimated mean hourly number of MAOs that will be selected burden per affected Part C and Part D indicated in section IV. of this final rule, for contract-level RADV audits is sponsor to procure an auditing is 54 hours. The 54 hours includes the between 60 and 80 MAOs. Here, we will organization and to support the auditing time to select a vendor and the survey assume that CMS selects 70 MAOs for organization in its data collection efforts administration time of the survey contract-level RADV audit. On average, including staff interviews is 120 hours, vendor that the contract pays. The CMS audits approximately 200 as indicated in section IV.O. of this final estimated cost per contract is $5,023. beneficiaries per contract; and each rule. We believe the auditor, who is Beginning in 2011, the overall estimated beneficiary selected for testing has hired by the plan, will typically have a annual cost across the 624 contracts is approximately 2.5 Hierarchical team consisting of a management $3.1 million. Condition Categories (or HCCs, which analyst, two senior auditors, a senior Section 423.120(b)(iv) requires are the base-level unit of analysis under claims analyst, a senior statistician, an sponsors to provide enrollees with RADV audits) equating to roughly 500 IT systems analyst, a computer appropriate notice regarding their HCCs tested per audit. To date, the programmer, and a word processor. We transition process within a reasonable average contract-level RADV error rate used May 2008 wage statistics supplied amount of time after providing a has been approximately 15 percent. by the DOL, Bureau of Labor Statistics temporary supply of non-formulary Part Thus, we assume a total burden to to develop estimates of direct wages. We D drugs (including Part D drugs that are audited MAOs of approximately 5,250 also added fringe benefits, overhead on a sponsor’s formulary but require HCCs ((500 × .15) 70) that will require costs, and general and administrative prior authorization or step therapy validation medical records (each HCC is expenses using percentages that are under a sponsor’s utilization typically associated with one medical consistent with CMS contracts. Based management rules). In section IV.S. of record.) on our experience and discussions with this final rule, we estimated that 1.35 We continue to estimate that it will program experts, we developed an million notices would be required with take approximately 1 hour to prepare estimate of the blended hourly burden. an average preparation time of 15 the necessary documentation to dispute The estimated mean cost per hour for minutes. As a result, the estimated total one HCC via medical record review these sponsors is $43.14 (wages, fringe burden is calculated at 337,500 hours. appeal. At a per plan-level estimate, this benefits, and overhead). The estimated At an estimated $20.15 in hourly labor equates to $4,440 per medical record mean number of hours per sponsor is cost of reporting, the total cost is $6.8 review appeal. Annualized across all 120. Thus, the mean cost per sponsor to million (337,500 × $20.15). In addition, audited MAOs, this in turn equates to procure and support the auditor is we estimated an additional cost of 5,250 burden hours at approximately $5,177 (1200 × $43.14). Furthermore, printing, supplies, and postage of $0.475 $59.20/hour (based on U.S. Dept. of with the 710 estimated number of per notice. This yields a cost of Labor statistics for hourly wages for sponsors, the overall cost across all $641,250 for the 1.35 million notices. management analysts)—or, an annual sponsors to complete the work involved Therefore, the total cost for sponsors to dollar burden on the MA industry of in procuring and supporting the provide enrollees with appropriate $310,800. auditing contractors is $3.7 million (710 notice regarding their transition process We also estimate that beyond × $5,177). The number of hours is within a reasonable amount of time after production of medical records, MAOs 85,200. providing a temporary supply of

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nonformulary Part D drugs is estimated this change is $1.74 million. In addition, protection for MA enrollees from out of at $7.4 million. the aggregate cost of printing, supplies pocket costs and will lend greater As indicated in section IV.R of this and postage associated for all the predictability and transparency to final rule, developing 760,411 written notices is $41,374. Therefore, the overall benefit packages, so that beneficiaries notices outlining favorable standard total cost for providing written notices will better understand and anticipate coverage determinations (§ 423.568(d)) of an expedited coverage determination their out-of-pocket expenditures. is estimated to result in an annual (§ 423.572(b)) is estimated to be $1.78 However, we do not believe these burden of 380,206 hours. At an million. changes will, by themselves, have a estimated cost of $40.00 per hour, the Since issuance of the October 22, significant impact on plan participation total annual cost of this change is $15.2 2009 proposed rule, PPACA was or significantly increase plan premiums. million. In addition, the aggregate cost enacted. Accordingly, new section We believe the impact on enrollee of printing, supplies and postage 1860D–4(b)(3)(G) of the Act replaces premiums will be limited for several associated for all the notices is section 176 of MIPPA. Section 1860D– reasons. First, we have made a $361,195. Therefore, the overall total 4(b)(3)(G) of the Act requires a PDP voluntary MOOP available for the past cost for providing written notices of a sponsor to include ‘‘all’’ covered part D years (2008, 2009, and 2010). For CY favorable standard coverage drugs—in the categories and classes 2010, the voluntary MOOP for all Parts determination (§ 423.568(d)) is identified by the Secretary as classes and B services was set at $3,400. About estimated to be $15.56 million. and categories of ‘‘clinical concern.’’ It 40 percent of current MA plans have Section § 423.120(c)(3) requires the requires the Secretary to establish adopted the voluntary MOOP while approximately 28 pharmacy claims criteria to determine, as appropriate, remaining competitive (and enrolling processors currently responsible for the categories and classes of drugs of approximately one-third of all MA electronic adjudication of pharmacy ‘‘clinical concern.’’ It provides for an enrollees), and they do not appear to benefits to change their RxBIN or RxBIN exceptions authority similar to the one have incurred significant costs in and RxPCN combination if such included in section 176 of MIPPA. administering a MOOP limit. identifiers are not already unique to its Section 3307 of PPACA further requires Second, as we described elsewhere in Medicare line of business, and the Part that until the Secretary establishes this preamble, it is our intention to set D cardholder identification number if it criteria to determine classes of ‘‘clinical both the MOOP and Parts A and B cost is not already unique to each Medicare concern,’’ the following categories and sharing thresholds at levels that, while Part D enrollee. We estimate the annual classes of drugs shall be identified and affording reasonable financial protection hourly burden to be 1,380 hours per protected as classes of ‘‘clinical for those beneficiaries with high health processor to make the coding changes concern’’: anticonvulsants, care needs, do not result in significant necessary to implement this antidepressants, antineoplastics, new operating costs for MA plans or requirement. The yearly burden is antipsychotics, antiretrovirals, and increased out-of-pocket costs for therefore estimated to be 38,640 hours immunosuppressants for the treatment beneficiaries to the extent that MA plans for CY 2010 (1,380 × 28). This is a one- of transplant rejection. Consistent with pass along any increased costs to their time burden for programming. At an this approach, we are removing from the enrollees in the form of premium average labor cost of $150.00 per hour, regulatory text the criteria specified by increases. We will develop the MOOP we estimate the overall cost in CY2010 section 176 of MIPPA for identifying and Parts A and B cost sharing to be $5.8 million. classes and categories of drugs of thresholds using data provided by our The revisions to § 423.153 state that ‘‘clinical concern,’’ as well as the Office of the Actuary (OACT) to ensure Part D plans must offer a minimum level definitions used to interpret the MIPPA this result. In addition, given a of medication therapy management criteria. We are retaining the exceptions competitive marketplace and Medicare services for each beneficiary enrolled in process in the regulatory text, as new beneficiaries’ sensitivity to premium the MTMP that includes but is not section 1860D–4(b)(3)(G) of the Act amounts, we believe that MA plans may limited to annual comprehensive retains the exceptions process choose instead to modify their benefit medication reviews with written established under section 176 of MIPPA. packages to reduce costs elsewhere. summaries. The burden associated with The estimated cost of implementing Furthermore, we estimate that this requirement was estimated at section 176 of MIPPA for FY 2010 beneficiaries in plans that currently 937,500 hours, as reflected in section budget baseline projections was $4.9 offer the CY 2010 voluntary MOOP limit IV.P of this final rule. At an estimated billion for FY 2010 through 2019. The of $3,400 (about 40 percent of MA average hourly labor cost of $120.00, the removal of the section 176 MIPPA plans) will experience no cost increases total cost is $112.5 million for 2010 criteria eliminates the cost included in as a result of these provisions. In fact, (937,500 × $120.00). the baseline generating savings of $4.9 to the extent they instead choose the Establishing and maintaining a billion for FYs 2010 through 2019. higher, mandatory MOOP limit, we method of documenting all oral requests would expect a net decrease in costs. for standard coverage determinations E. Anticipated Effects—Effects of We estimate that the maximum impact and retaining the documentation in the Maximum Out-of-Pocket Cost (MOOP) of these requirements on beneficiary case file (§ 423.568(a)(3)), are estimated Limit and Cost Sharing Thresholds premiums for those plans that currently to result in an annual burden of 45,625 We are finalizing our proposal to have no MOOP limit of any kind (31 hours. At an estimated cost of $40.00 establish and require local MA plans to percent of all CY 2010 MA plans) would per hour, the estimated total annual cost have a maximum out-of-pocket (MOOP) average $5. The average impact on of this change is $1.8 million. limit on members’ out-of-pocket cost premiums would be lower for plans that As indicated in section IV.S of this sharing, the amount of which will be currently have a nonqualified MOOP— final rule, developing 87,103 written established annually by CMS. In one with an amount higher than the notices for favorable expedited coverage addition, we are finalizing our proposal voluntary MOOP limit of $3400 determination (§ 423.572(b)) is to require cost sharing thresholds for established for CY 2010 and/or that does estimated to result in an annual burden Parts A and B services, the amounts of not include all Parts A and B services. of 43,552 hours. At an estimated cost of which will be determined annually by Approximately 29 percent of all CY $40.00 per hour, the total annual cost of CMS. These changes provide significant 2010 plans had such a MOOP. However,

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given competitive market pressures, we 2. Changing the Standards of Review, burden of proof, under any briefing believe MA plans may instead choose to Clarifying the Standard of Proof and schedule determined by the hearing modify their benefit packages rather Burden of Proof for Appeals, and officer, it must first present evidence than increase premiums. Modifying the Conduct of Hearing for and argument to the hearing officer Contract Decisions (Including Denials of before we present our evidence and Finally, we believe that the many Initial Applications to Contract, Service argument. We considered leaving the advantages for beneficiaries as a result Area Expansions for Existing Contracts, existing regulations unchanged, but of the new MOOP and cost-sharing Contract Non-Renewals and ultimately rejected that option. threshold requirements will outweigh Terminations, and Intermediate 3. Clarify That CMS May Require a ‘‘Test any small premium increases that may Sanctions) result. All MA plan enrollees will be Period’’ During an Enrollment/ protected against high out of pocket We are finalizing our change to the Marketing Sanction costs, and will be better able to compare standards of review and clarification of We are finalizing our proposal that in the standard of proof when an appeal of plans by focusing on differences in instances where an enrollment and/or a contract determination or intermediate premium and plan quality. Furthermore, marketing suspension has been sanction is requested and an evidentiary imposed, we may determine that it is enrollee cost-sharing will be more hearing is conducted. The existing predictable and transparent. As we have appropriate to subject the MA standards of review require the Hearing organization or Part D sponsor to a ‘‘test explained in the preamble of the final Officer to determine whether the rule, our goal is to set cost-sharing limits period’’ whereby the organization or sponsoring organization can sponsor will, for a limited time, engage at a level that should not result in demonstrate ‘‘substantial compliance’’ significant new costs for MA plans or in marketing activities and/or accept with Part C and/or Part D requirements enrollments in order to assist us in beneficiaries. on the ‘‘earliest of’’ the following three making a determination as to whether F. Alternatives Considered dates: the date the organization received the bases for the sanctions have been written notice of contract determination corrected and are not likely to recur. 1. Strengthening CMS’ Ability To Take or intermediate sanction, the date of the We considered leaving the existing Timely, Effective Contract most recent onsite audit, or the date of regulations unchanged. However, we Determinations or Intermediate the alleged breach of current contract or believe the requirements in this final Sanctions (Part C and D) past substantial noncompliance. In rule will strengthen our ability to practice, these standards of review adequately assess compliance with our We are finalizing our modifications to (‘‘substantial compliance’’ and ‘‘earliest requirements. Also, it will help us avoid the regulations which more clearly and of test’’) have led to confusion among situations where we may lift a sanction accurately reflect our existing statutory parties to the hearing and have been based on inadequate testing of an authority to terminate a contract. The difficult for the hearing officer to apply. organization’s systems/processes, only existing enumerated list of Additionally, though the existing to find that the deficiencies have not determinations that are the basis to regulations explicitly state that the been corrected, thereby requiring us to terminate a contract are not all sponsoring organization bears the reinstate the sanction. inclusive. Initially it was our belief that burden of proof, it does not provide the continuing to add to the existing list standard of proof that is to be applied 4. Right for CMS To Require an Independent Audit of Sponsoring may fail to stress to sponsoring by the Hearing Officer. Therefore, we Organizations Under Intermediate organizations that failure to comply have deleted the ‘‘substantial Sanction with all of our regulations and contract compliance’’ and ‘‘earliest of’’ test and and performance requirements may be revise the regulations to explicitly state We are finalizing language in the used to support a termination decision. the standard of proof and provide clear October 2009 proposed rule which After receiving numerous comments standards of review for each type of states that CMS may require sponsoring concerning this provision we have contract determination or intermediate organizations that are under decided, however, not to remove the sanction. intermediate sanctions to hire an First, we have explicitly stated that independent auditor to evaluate enumerated list and instead to add the hearing officer must apply the whether the bases for a sanction have language to provide additional examples ‘‘preponderance of the evidence’’ been corrected and are not likely to of determinations that could support a standard of proof when weighing the recur in order to assist CMS in its decision to terminate a contract. Also, evidence at all hearings for contract determination whether to lift the we have revised the proposed regulatory determinations or intermediate sanction. The purpose of this provision language to clarify that the failure to sanctions. Second, we have clarified the is to provide us with additional comply with the regulatory standards of review, which vary assurances, through a neutral third party requirements contained in parts 422 and according to the type of contract evaluation, whether the sponsoring 423 or failure to meet our performance determination or intermediate sanction. organization is in compliance with CMS requirements, may constitute a basis for In particular, the change makes the requirements and the bases for the CMS to determine that the MA distinction between how the evidentiary sanction have been corrected and are Organization or Part D sponsor meets standard of review is to be applied to not likely to recur. the requirements for contract appeals of CMS determinations Another option we considered was to termination in accordance with the involving Part C or D contract not require sanctioned sponsoring statutory standard. qualification applications, those organizations to hire an independent involving the termination or non- auditor but rather to allow sponsoring renewal of a Part C or D sponsor organizations the discretion to hire an contract, and those involving the independent auditor. We believe that imposition of intermediate sanctions. this alternative proposal is not Finally, we have clarified that because necessary to promulgate in regulation as the sponsoring organization bears the sanctioned sponsoring organizations

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already have the discretion to hire an change is necessary to provide us with 7. Validation of Part C and Part D independent auditor. another tool to strengthen our Reporting Requirements and CAHPS We also considered leaving the compliance and oversight authority and Survey Administration regulations unchanged. However, given provide appropriate transparency our experience with the nature and concerning compliance and/or Several of the required changes extent of some compliance deficiencies performance deficiencies to involve costs to MAOs and Part D (for example, those caused by beneficiaries and the public. sponsors. One such regulatory change information technology issues or lack of was the audit requirement of Part C and adequate internal controls) and the need 6. Reducing Duplicative and Low Part D measures. We considered not to obtain the level of skill and Enrollment Plans (Parts C and D) requiring an audit. However, because experience necessary to conduct an We are implementing regulations to we believe that an audit is necessary to exhaustive evaluation of the correction reduce duplicative benefit packages ensure that the Part C and Part D of these deficiencies, we believe this based upon our authority to add such measures are consistent with our additional assurance and access to additional terms to our contracts with specifications, are reliable, valid, and expertise (such as a qualified Medicare Advantage organizations or comparable, and are credible to independent auditor) is appropriate and Part D plan sponsors as we ‘‘may find stakeholders, this alternative was will benefit both plan sponsors and necessary and appropriate’’ as specified rejected. A second such regulatory CMS. in section 1857(e)(1) of the Act (see also change was requiring MAOs and Part C section 1860D–12(b)(3)(D) of the Act sponsors to assume a portion of the cost 5. The Ability for CMS To Require (incorporating section 1857(e)(1) of the Sponsors To Disclose to Current and of the annual CAHPs survey as a result Act by reference for Part D.)) In of hiring contractors to conduct the data Potential Enrollees Compliance and addition, we are using our authority Performance Deficiencies collection. We considered not requiring under section 1860D–11(d)(2)(B) of the MAOs and Part C sponsors to hire We are finalizing our proposal that we Act as further support to propose contractors to perform the CAHPs data may require certain sponsoring regulations imposing ‘‘reasonable collection. However, we rejected this organizations to disclose their current minimum standards’’ on Part D alternative because we believe that the compliance and/or performance sponsors. benefits obtained through this deficiencies to existing and potential One alternative would be to make no regulatory change outweigh the costs enrollees. Our intent is to invoke this changes to our current regulations incurred by the MAOs and Part C disclosure authority when we become regarding bid submission and review sponsors. We believe these changes aware that an MA organization has and to continue our current efforts to actually benefit the plans by informing serious compliance and/or performance eliminate duplicative or low enrollment deficiencies such as those that may lead plan options. However, since our them of the issues that, from the to an intermediate sanction or require current regulations do not explicitly beneficiaries’ perspectives, needs immediate correction and where we address the issue of eliminating attention. believe beneficiaries should be duplicative or low enrollment plans, we G. Accounting Statement specifically notified. The primary believe that codifying our authority to purpose of this requirement is to do so will provide us with more As required by OMB Circular A–4 promote transparency and informed leverage over plans during the bid (available at http:// choice especially in those situations submission, review, negotiation, and www.whitehouse.gov/omb/circulars/ where we believe beneficiaries need or approval processes. a004/a-4.pdf), in Table 11, we have should have access to this information. Another alternative would be to prepared an accounting statement An additional purpose is to provide provide more detail in regulation text showing the classification of the appropriate incentives for sponsoring regarding the specific criteria we would expenditures associated with the organizations to make improvements to use to eliminate duplicative or low provisions of this final rule. The their operations and also provide enrollment plan options. We believe by accounting statement is based on relevant information to beneficiaries addressing the issue generally in estimates in Table 10 (our best estimate and the public concerning plan choices. regulations text, we maintain our of the costs and savings as a result of the We considered not adding this flexibility to adjust our review processes changes) discounted at the 7 percent disclosure authority to the existing and criteria consistent with current and 3 percent for the time period of CY regulations. However, we believe this market trends. 2010 through CY 2015.

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TABLE 11—ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED EXPENDITURES, FROM CY 2010 TO CY 2015 [$ in millions]

TRANSFERS (MIPPA 176) Category Units discount rate Year dollar Period covered 7% 3%

Annualized Monetized Transfers ...... 2009 ¥$318.64 ¥$331.65 CYs 2010–2015

From Whom To Whom? ...... Federal Government to MAO and Part D Sponsors

TABLE 11—ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED EXPENDITURES, FROM CY 2010 TO CY 2015 [$ in millions]

COSTS (All other provisions) Units discount rate Year dollar Period covered 7% 3%

Annualized Costs to MAOs and Part D Sponsors ...... 2009 $283.86 $284.35 CYs 2010–2015

Compared to the proposed rule, the 42 CFR Part 422 Subpart K—Enrollment, Entitlement, annualized costs to MAOs and Part D and Disenrollment Under Medicare sponsors have decreased from $319.51 Administrative practice and Contract million and $319.46 million, at the 7 procedure, Health facilities, Health and 3 percent annualized discount rates, maintenance organizations (HMO), ■ 2. Section 417.428 is revised to read to $283.86 million and $2284.35 million Medicare, Penalties, Privacy, and as follows: Reporting and recordkeeping at the 7 and 3 percent discount rates for § 417.428 Marketing activities. requirements. the final rule. (a) With the exception of § 422.2276 H. Conclusion 42 CFR Part 423 of this chapter, the procedures and requirements relating to marketing We estimate that the cost of Administrative practice and requirements set forth in subpart V of implementing these provisions will be procedure, Emergency medical services, part 422 of this chapter also apply to $260.3 million in CY 2010. This is $61.4 Health facilities, Health maintenance Medicare contracts with HMOs and million less than the estimated cost in organizations (HMO), Health CMPs under section 1876 of the Act. the proposed rule ($321.7 million). professionals, Medicare, Penalties, (b) In applying those provisions, Sponsors will experience additional Privacy, Reporting and recordkeeping references to part 422 of this chapter costs which they are likely to pass on requirements. must be read as references to this part, and references to MA organizations as to CMS through direct subsidy 42 CFR Part 480 payments and to beneficiaries through references to HMOs and CMPs. increases in premiums as reflected in Health care, Health professions, Subpart L—Medicare Contract their bids. Beginning in CY 2012, we Health records, Peer Review Requirements expect that these provisions will Organizations (PRO), Penalties, Privacy, generate a net savings to the Medicare and Reporting and recordkeeping ■ 3. Section 417.472 is amended by program on an annual basis. For the requirements. adding paragraphs (i) and (j) to read as entire estimated time period, CYs 2010 follows: ■ For the reasons set forth in the through 2015, we estimate the overall preamble, the Centers for Medicare & § 417.472 Basic contract requirements. impact to be a savings of $341.70 million (undiscounted). Medicaid Services amends 42 CFR * * * * * chapter IV as set forth below: (i) The HMO or CMP must comply In accordance with the provisions of with the requirements at § 422.152(b)(5). Executive Order 12866, this final rule PART 417—HEALTH MAINTENANCE (j) All coordinated care contracts was reviewed by the Office of ORGANIZATIONS, COMPETITIVE (including local and regional PPOs, Management and Budget. MEDICAL PLANS, AND HEALTH CARE contracts with exclusively SNP benefit PREPAYMENT PLANS packages, private fee-for-service List of Subjects contracts, and MSA contracts), and all 42 CFR Part 417 ■ 1. The authority citation for part 417 cost contracts under section 1876 of the continues to read as follows: Act, with 600 or more enrollees in July Administrative practice and of the prior year, must contract with procedure, Grant programs—health, Authority: Sec. 1102 and 1871 of the Social approved Medicare Consumer Health care, Health insurance, Health Security Act (42 U.S.C. 1302 and 1395hh), Assessment of Healthcare Providers and secs. 1301, 1306, and 1310 of the Public maintenance organizations (HMO), Loan Systems (CAHPS) survey vendors to Health Service Act (42 U.S.C. 300e, 300e–5, programs—health, Medicare, and conduct the Medicare CAHPS and 300e–9), and 31 U.S.C. 9701. Reporting and recordkeeping satisfaction survey of Medicare plan requirements. enrollees in accordance with CMS

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specifications and submit the survey (iii) For the costs incurred under PART 422—MEDICARE ADVANTAGE data to CMS. paragraphs (b)(1)(i) through (iv) of this PROGRAM ■ 4. Section 417.492 is amended by section that include personnel costs, the ■ revising paragraph (b)(2) to read as organization must be able to identify the 11. The authority citation for part 422 follows: person hours expended for each continues to read as follows: administrative task and the rate of pay Authority: Secs. 1102 and 1871 of the § 417.492 Nonrenewal of contract. for those persons performing the tasks. Social Security Act (42 U.S.C. 1302 and * * * * * Administrative tasks performed and rate 1395hh). (b) * * * of pay for the persons performing those (2) Notice of appeal rights. CMS gives tasks must match in terms of the skill Subpart A—General Provisions the HMO or CMP written notice of its level needed to accomplish those tasks. ■ 12. Section 422.2 is amended by— right to appeal the nonrenewal decision, This information must be made ■ A. Adding the definitions of in accordance with part 422 subpart N available to CMS upon request. ‘‘Attestation process,’’ ‘‘Hierarchical of this chapter, if CMS’s decision was (c) Costs excluded from condition categories,’’ and ‘‘Initial based on any of the reasons specified in administrative costs. In accordance with Validation Contractor.’’ § 417.494(b). section 1861(v) of the Act, the following ■ B. Revising the definition of ‘‘Point of ■ 5. Section 417.494 is amended by costs must be excluded from service.’’ revising paragraph (b)(2) to read as administrative costs: ■ C. Adding the definitions of ‘‘RADV follows: (1) Donations. payment error calculation appeal (2) Fines and penalties. process’’ and ‘‘Risk adjustment data § 417.494 Modification or termination of contract. (3) Political and lobbying activities. validation (RADV) audit. (4) Charity or courtesy allowances. ■ D. Revising the introductory text of * * * * * ‘‘ ’’ (5) Spousal education. the definition of Service area . (b) * * * ■ E. Adding the definition of ‘‘The one (2) If CMS decides to terminate a (6) Entertainment. best medical record’’. contract, it sends a written notice (7) Return on equity. The additions and revisions read as informing the HMO or CMP of its right follows: to appeal the termination in accordance Subpart R—Medicare Contract Appeals with part 422 subpart N of this chapter. § 422.2 Definitions. ■ 8. Section § 417.640 is revised to read * * * * * * * * * * as follows: Attestation process means a CMS- ■ 6. Section 417.500 is revised to read developed RADV audit-related dispute as follows: § 417.640 Applicability. process that enables MA organizations (a) The rights, procedures, and § 417.500 Intermediate sanctions for and undergoing RADV audit to submit CMS- civil monetary penalties against HMOs and requirements relating to contract generated and physician practitioner CMPs. determinations and appeals set forth in signed attestations for medical records part 422 subpart N of this chapter also (a) Except as provided in paragraph with missing or illegible signatures or apply to Medicare contracts with HMOs (c) of this section, the rights, credentials. Physicians/practitioners or CMPs under section 1876 of the Act. procedures, and requirements related to who documented health care services in (b) In applying paragraph (a) of this intermediate sanctions and civil money the specific medical record under RADV section, references to part 422 of this penalties set forth in part 422 subparts review will be allowed to attest that chapter must be read as references to O and T of this chapter also apply to they provided and documented the this part and references to MA Medicare contracts with HMOs or CMPs health care services evidenced in the organizations must be read as references under sections 1876 of the Act. specific medical record. to HMOs or CMPs. (b) In applying paragraph (a) of this * * * * * section, references to part 422 of this § 417.642 through § 417.694 [Removed] Hierarchical condition categories chapter must be read as references to (HCC) means disease groupings ■ this part and references to MA 9. Remove § 417.642 through consisting of disease codes (currently organizations must be read as references § 417.694. ICD–9–CM codes) that predict average to HMOs or CMPs. Subpart U–Health Care Prepayment healthcare spending. HCCs represent the (c) In applying paragraph (a) of this Plans disease component of the enrollee risk section, the amounts of civil money score that are applied to MA payments. penalties that can be imposed are ■ 10. Section 417.840 is revised to read * * * * * governed by section 1876(i)(6)(B) and as follows: Initial Validation Contractor (IVC) (C) of the Act, not by the provisions in means the first level of medical record part 422 of this chapter. § 417.840 Administrative review review under the RADV audit process. procedures. Subpart O—Medicare Payment: Cost * * * * * The HCPP must apply § 422.568 Point of service (POS) means a benefit Basis through § 422.626 of this chapter to— option that an MA HMO plan can offer ■ 7. Section 417.564 is amended by (a) Organization determinations and to its Medicare enrollees as a mandatory adding new paragraphs (b)(2)(iii) and (c) fast-track appeals that affect its supplemental, or optional supplemental to read as follows: Medicare enrollees; and benefit. Under the POS benefit option, (b) Reconsiderations, hearings, the HMO plan allows members the § 417.564 Apportionment and allocation of Medicare Appeals Council review, and option of receiving specified services administrative and general costs. judicial review of the organization outside of the HMO plan’s provider * * * * * determinations and fast-track appeals network. In return for this flexibility, (b) * * * specified in paragraph (a) of this members typically have higher cost- (2) * * * section. sharing requirements for services

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received and, when offered as a the benefits are provided within the first day of the month following the date mandatory or optional supplemental network of providers; on which premium payment is benefit, may also be charged a premium (C) Only for purposes of quality requested, whichever is later. for the POS benefit option. assurance requirements in § 422.152(e), * * * * * * * * * * is offered by an organization that is not (4) * * * RADV payment error calculation licensed or organized under State law as (iii) Exception. If the MA plan offers appeal process means an administrative an HMO; and a visitor/traveler benefit when the process that enables MA organizations (D) Does not permit prior notification individual is out of the service area but that have undergone RADV audit to for out-of-network services—that is, a within the United States (as defined in appeal the CMS calculation of an MA reduction in the plan’s standard cost- § 400.200 of this chapter) for a period of organization’s RADV payment error. sharing levels when the out-of-network consecutive days longer than 6 months Risk adjustment data validation provider from whom an enrollee is but less than 12 months, the MA (RADV) audit means a CMS- receiving plan-covered services organization may elect to offer to the administered payment audit of a voluntarily notifies the plan prior to individual the option of remaining Medicare Advantage (MA) organization furnishing those services, or the enrollee enrolled in the MA plan if— that ensures the integrity and accuracy voluntarily notifies the PPO plan prior (A) The individual is disenrolled on of risk adjustment payment data. to receiving plan-covered services from the first day of the 13th month after the an out-of-network provider. * * * * * individual left the service area (or (2) * * * residence, if paragraph (d)(4)(i)(B) of Service area means a geographic area (i) * * * that for local MA plans is a county or (A) Pays at least for the services this section applies); multiple counties, and for MA regional described in § 422.101, after the enrollee (B) The individual understands and plans is a region approved by CMS has incurred countable expenses (as accepts any restrictions imposed by the within which an MA-eligible individual specified in the plan) equal in amount MA plan on obtaining these services may enroll in a particular MA plan to the annual deductible specified in while absent from the MA plan’s service offered by an MA organization. § 422.103(d); area for the extended period, consistent Facilities in which individuals are (B) Does not permit prior with paragraph (d)(4)(i)(C) of the incarcerated are not included in the notification—that is, a reduction in the section; service area of an MA plan. Each MA plan’s standard cost-sharing levels when (C) The MA organization makes this plan must be available to all MA-eligible the provider from whom an enrollee is visitor/traveler option available to all individuals within the plan’s service receiving plan-covered services Medicare enrollees who are absent for area. In deciding whether to approve an voluntarily notifies the plan prior to an extended period from the MA plan’s MA plan’s proposed service area, CMS furnishing those services, or the enrollee service area. MA organizations may considers the following criteria: voluntarily notifies the MSA plan prior limit this visitor/traveler option to to receiving plan-covered services from enrollees who travel to certain areas, as * * * * * defined by the MA organization, and The one best medical record for the a provider; and who receive services from qualified purposes of Medicare Advantage Risk * * * * * providers who directly provide, arrange Adjustment Validation (RADV) means (3) * * * (iv) Does not permit prior for, or pay for health care; and the clinical documentation for a single (D) The MA organization furnishes all encounter for care (that is, a physician notification—that is, a reduction in the plan’s standard cost-sharing levels when Medicare Parts A and B services and all office visit, an inpatient hospital stay, or mandatory and optional supplemental an outpatient hospital visit) that the provider from whom an enrollee is receiving plan-covered services benefits at the same cost sharing levels occurred for one patient during the data as apply within the plan’s service area; collection period. The single encounter voluntarily notifies the plan prior to furnishing those services, or the enrollee and for care must be based on a face-to-face (E) The MA organization furnishes the voluntarily notifies the PFFS plan prior encounter with a provider deemed services in paragraph (d)(4)(iii)(D) of to receiving plan-covered services from acceptable for risk adjustment and this section consistent with Medicare a provider. documentation of this encounter must access and availability requirements at be reflected in the medical record. * * * * * § 422.112 of this part. ■ 13. Amend § 422.4 by— * * * * * ■ A. Revising paragraphs (a)(1)(v)and Subpart B—Eligibility, Election, and Enrollment (a)(2)(i)(A). Subpart C—Benefits and Beneficiary ■ B. Redesignating paragraph (a)(2)(i)(B) ■ 14. Section 422.74 is amended by Protections as paragraph (a)(2)(i)(C). revising paragraphs (d)(1)(i)(B) and ■ C. Adding new paragraphs (a)(2)(i)(B) ■ (d)(4)(iii) to read as follows: 15. Section 422.100 is amended by— and (a)(3)(iv). ■ A. Revising the introductory text for The revisions and additions read as § 422.74 Disenrollment by the MA paragraph (f). follows: organization. ■ B. In paragraphs (f)(1) and (f)(2) removing the ‘‘;’’ and adding a ‘‘.’’ in its § 422.4 Types of MA plans. * * * * * (d) * * * place. (a) * * * (1) * * * ■ C. Adding new paragraphs (f)(4) (1) * * * (i) * * * through (f)(6). (v) A PPO plan is a plan that— (B) Providing the individual with a The revisions and additions read as (A) Has a network of providers that grace period, that is, an opportunity to follows: have agreed to a contractually specified pay past due premiums in full. The reimbursement for covered benefits with length of the grace period must— § 422.100 General requirements. the organization offering the plan; (1) Be at least 2 months; and * * * * * (B) Provides for reimbursement for all (2) Begin on the first day of the month (f) CMS review and approval of MA covered benefits regardless of whether for which the premium is unpaid or the benefits and associated cost sharing.

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CMS reviews and approves MA benefits (3) Under an HMO plan as an optional (i) The number and geographical and associated cost sharing using supplemental benefit as described in distribution of eligible health care written policy guidelines and § 422.102(b). providers available to potentially requirements in this part and other CMS (c) Ensuring availability and contract with an MAO to furnish plan instructions to ensure all of the continuity of care. An MA HMO plan covered services within the proposed following: that includes a POS benefit must service area of the MA plans. * * * * * continue to provide all benefits and (ii) The prevailing market conditions (4) Except as provided in paragraph ensure access as required under this in the service area of the MA plan. (f)(5), MA local plans (as defined in subpart. Specifically, the number and § 422.2) must have an out-of pocket * * * * * distribution of health care providers maximum for Medicare Parts A and B (f) POS-related data. An MA contracting with other health care plans services that is no greater than the organization that offers a POS benefit (both commercial and Medicare) annual limit set by CMS. through an HMO plan must report operating in the service area of the plan. (5) With respect to a local PPO plan, enrollee utilization data at the plan level (iii) Whether the service area is the limit specified under paragraph by both plan contracting providers (in- comprised of rural or urban areas or (f)(4) applies only to use of network network) and by non-contracting some combination of the two. (iv) Whether the MA plan’s proposed providers. Such local PPO plans must providers (out-of-network) including provider network meet Medicare time include a total catastrophic limit on enrollee use of the POS benefit, in the and distance standards for member beneficiary out-of-pocket expenditures form and manner prescribed by CMS. access to health care providers for both in-network and out-of-network ■ 18. Section 422.108 is amended by including specialties. Parts A and B services that is— revising paragraph (b)(3) to read as (v) Other factors that CMS determines (i) Consistent with the requirements follows: are relevant in setting a standard for an applicable to MA regional plans at acceptable health care delivery network § 422.101(d)(3) of this part; and § 422.108 Medicare secondary payer (MSP) procedures. in a particular service area. (ii) Not greater than the annual limit set by CMS. * * * * * * * * * * (b) * * * (6) Cost sharing for Medicare Part A Subpart D—Quality Improvement and B services specified by CMS does (3) Coordinate its benefits to Medicare enrollees with the benefits of the not exceed levels annually determined ■ 21. Section 422.152 is amended by— primary payers, including reporting, on by CMS to be discriminatory for such ■ A. Revising paragraphs (a)(1) and an ongoing basis, information obtained services. (a)(2). related to requirements in paragraphs * * * * * ■ B. Redesignating paragraph (b)(3)(ii) (b)(1) and (b)(2) of this section in as paragraph (b)(3)(iii). ■ 16. Section 422.103 is amended by accordance with CMS instructions. ■ C. Adding new paragraph (b)(3)(ii). adding a new paragraph (d)(3) to read as * * * * * ■ D. Adding new paragraph (b)(5). follows: ■ 19. Section 422.111 is amended by ■ F. Redesignating paragraphs (e)(2)(ii) § 422.103 Benefits under an MA MSA plan. adding a new paragraph (g) to read as and (e)(2)(iii) as paragraphs (e)(2)(iii) * * * * * follows: and (e)(2)(iv), respectively. ■ H. Adding a new paragraph (e)(2)(ii). (d) * * * § 422.111 Disclosure requirements. The revisions and additions read as (3) Is pro-rated for enrollments * * * * * follows: occurring during a beneficiary’s initial (g) CMS may require an MA coverage election period as described at organization to disclose to its enrollees § 422.152 Quality improvement program. § 422.62(a)(1) of this part or during any or potential enrollees, the MA (a) * * * other enrollments occurring after organization’s performance and contract (1) Have a chronic care improvement January 1. compliance deficiencies in a manner program that meets the requirements of * * * * * specified by CMS. paragraph (c) of this section concerning ■ 17. Section 422.105 is amended by ■ 20. Section 422.112 is amended by elements of a chronic care program and revising paragraphs (b), (c), and (f) to adding a new paragraph (a)(10) to read addresses populations identified by read as follows: as follows: CMS based on a review of current quality performance; § 422.105 Special rules for self-referral and § 422.112 Access to services. (2) Conduct quality improvement point of service option. (a) * * * projects that can be expected to have a * * * * * (10) Prevailing patterns of community favorable effect on health outcomes and (b) Point of service option. As a health care delivery. Coordinated care enrollee satisfaction, meet the general rule, a POS benefit is an option and PFFS MA plans that meet Medicare requirements of paragraph (d) of this that an MA organization may offer in an access and availability requirements section, and address areas identified by HMO plan to provide enrollees with through direct contracting network CMS; and additional choice in obtaining specified providers must do so consistent with * * * * * health care services. The organization the prevailing community pattern of (b) * * * may offer a POS option— health care delivery in the areas where (3) * * * (1) Before January 1, 2006, under a the network is being offered. Factors (ii) Collect, analyze, and report coordinated care plan as an additional making up community patterns of quality performance data identified by benefit as described in section health care delivery that CMS will use CMS that are of the same type as those 1854(f)(1)(A) of the Act; as a benchmark in evaluating a under paragraph (b)(3)(i) of this section. (2) Under an HMO plan as a proposed MA plan health care delivery * * * * * mandatory supplemental benefit as network include, but are not limited to (5) All coordinated care contracts described in § 422.102(a); or the following: (including local and regional PPOs,

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contracts with exclusively SNP benefit Subpart F—Submission of Bids, the same MA organization (or parent packages, private fee-for-service Premiums, and Related Information organization to that MA organization). contracts, and MSA contracts), and all and Plan Approval * * * * * cost contracts under section 1876 of the Act, with 600 or more enrollees in July ■ 24. Section 422.254 is amended by Subpart G—Payments to Medicare of the prior year, must contract with adding new paragraphs (a)(4) and (b)(5) Advantage Organizations approved Medicare Consumer to read as follows: Assessment of Healthcare Providers and ■ 26. Section 422.306 is amended by Systems (CAHPS) survey vendors to § 422.254 Submission of bids. revising paragraph (a) to read as follows: conduct the Medicare CAHPS (a) * * * § 422.306 Annual MA capitation rates. satisfaction survey of Medicare plan (4) Substantial differences between enrollees in accordance with CMS * * * * * bids. An MA organization’s bid (a) Minimum percentage increase rate. specifications and submit the survey submissions must reflect differences in The annual capitation rate for each MA data to CMS. benefit packages or plan costs that CMS local area is equal to the minimum * * * * * determines to represent substantial percentage increase rate, which is the (e) * * * differences relative to a sponsor’s other annual capitation rate for the area for (2) * * * bid submissions. the preceding year increased by the (ii) Collect, analyze, and report (b) * * * national per capita MA growth quality performance data identified by (5) Actuarial valuation. The bid must percentage (defined at § 422.308(a)) for CMS that are of the same type as those be prepared in accordance with CMS the year, but not taking into account any described under paragraph (e)(2)(i) of actuarial guidelines based on generally adjustment under § 422.308(b) for a year this section. accepted actuarial principles. before 2004. * * * * * (i) A qualified actuary must certify the * * * * * plan’s actuarial valuation (which may ■ 22. Section 422.153 is added to reads ■ 27. A new section 422.311 is added to be prepared by others under his or her read as follows: as follows: direction or review). § 422.153 Use of quality improvement (ii) To be deemed a qualified actuary, § 422.311 RADV audit dispute and appeal organization review information. the actuary must be a member of the processes. CMS will acquire from quality American Academy of Actuaries. (a) Risk adjustment data validation improvement organizations (QIOs) as (iii) Applicants may use qualified (RADV) audits. In accordance with defined in part 475 of this chapter only outside actuaries to prepare their bids. § 422.2 and § 422.310(e), CMS annually data collected under section * * * * * conducts RADV audits to ensure risk adjusted payment integrity and 1886(b)(3)(B)(viii) of the Act and subject ■ 25. Section 422.256 is amended by to the requirements in § 480.140(g). accuracy. adding a new paragraph (b)(4) to read as (b) RADV audit results. (1) MA CMS will acquire this information, as follows: organizations that undergo RADV audits needed, and may use it for the following will be issued an audit report post limited functions: § 422.256 Review, negotiation, and medical record review that describes the (a) Enable beneficiaries to compare approval of bids. * * * * * results of the RADV audit as follows: health coverage options and select (i) Detailed enrollee-level information (b) * * * among them. relating to confirmed enrollee HCC (b) Evaluate plan performance. (4) Substantial differences between discrepancies. (c) Ensure compliance with plan bids—(i) General. CMS approves a bid (ii) The contract-level RADV payment requirements under this part. only if it finds that the benefit package error estimate in dollars. (d) Develop payment models. and plan costs represented by that bid (iii) The contract-level payment are substantially different from the MA (e) Other purposes related to MA adjustment amount to be made in organization’s other bid submissions. In plans as specified by CMS. dollars. order to be considered ‘‘substantially (iv) An approximate timeframe for the ■ 23. Section 422.156 is amended by different,’’ as provided under payment adjustment. revising paragraphs (b)(7) and (f) to read § 422.254(a)(4) of this subpart, each bid (v) A description of the MA as follows: must be significantly different from organization’s RADV audit appeal § 422.156 Compliance deemed on the other plans of its plan type with respect rights. basis of accreditation. to premiums, benefits, or cost-sharing (2) Compliance date. The compliance structure. * * * * * date for meeting RADV medical record (ii) Transition period for MA submission requirements for the (b) * * * organizations with new acquisitions. validation of risk adjustment data is the (7) The requirements listed in After a 2-year transition period, CMS due date when MA organizations § 423.165 (b)(1) through (3) of this approves a bid offered by an MA selected for RADV audit must submit chapter for MA organizations that offer organization (or by a parent organization medical records to CMS or its prescription drug benefit programs. to that MA organization) that recently contractors. * * * * * purchased (or otherwise acquired or (3) Medical record review appeal. MA (f) Authority. Nothing in this subpart merged with) another MA organization organizations that do not agree with the limits CMS’ authority under subparts K only if it finds that the benefit package medical record review determinations and O of this part, including but not or plan costs represented by that bid are for audited HCCs may appeal the limited to, the ability to impose substantially different, as provided medical record review determinations of intermediate sanctions, civil money under paragraph (b)(4)(i) of this section, the initial validation contractor to CMS penalties, and terminate a contract with from any benefit package and plan costs in accordance with paragraph (c)(2) of an MA organization. represented by another bid submitted by this section.

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(c) RADV audit dispute and appeal (B) Provides written notice of its (C) The MA organization’s written processes—(1) Attestation process—(i) determination(s) regarding submitted request for medical record review Submission requirements for attestations to the MA organization at determination appeal must specify the attestations. MA organizations— the time CMS issues its RADV audit audited HCC(s) that CMS identified as (A) May submit CMS-generated report. being in error and eligible for medical attestations from physician/ (vii) Effect of CMS’s attestation record review determination appeal, practitioner(s) in order to dispute determination. (A) CMS’ attestation and that the MA organization wishes to signature-related or credential-related determination is final. appeal. RADV errors in accordance with the (B) An MA organization may choose (iii) Manner and timing of a request attestations provisions of this section. to appeal its medical record review for medical record review determination (B) Are not obligated to submit determinations for audited HCCs appeal. (A) At the time CMS issues its attestations to CMS. following initial validation contractor IVC RADV audit report to audited MA (ii) RADV audit-related errors eligible review using a CMS-administered organizations, CMS notifies these MA for attestation process. CMS will only medical record review determination organizations of any RADV HCC errors accept an attestation to support a appeal process. that are eligible for medical record physician or outpatient medical record (2) RADV-related medical record review determination appeal. with a missing signature or missing review errors and documentation (B) MA organizations have 30 credential or both. eligible for medical record review calendar days from date of issuance of determination appeal process: (i) (iii) RADV audit-related errors and the RADV audit report to file a written General rules. (A) In order to be eligible documentation ineligible for attestation request with CMS for medical record for medical record review determination process. review determination appeal. appeal, MA organizations must adhere (A) Attestations from providers for (C) A request for medical record to established RADV audit procedures anything other than signature-related review determination appeal must and RADV appeals requirements. and credential-related errors will not be specify the determinations with which Failure to follow CMS rules regarding permitted. the MA organization disagrees and the the RADV medical record review audit (B) Inpatient provider-type medical reasons for the request for appeal. procedures and RADV appeals records are not eligible for attestation. (iv) Medical record review requirements may render the MA (iv) Manner and timing of a request determination appeal review and organization’s request for appeal for attestation. (A) CMS will provide notification procedures. (A) Designation invalid. MA organizations selected for RADV (B) The medical record review of a hearing officer. CMS designates a audits with attestations and determination appeal process applies hearing officer to conduct the medical accompanying instructions at the time only to error determinations from record review determination appeal. the organization receives its audit review of the one best medical record The hearing officer need not be an ALJ. instructions. submitted by the MA organization and (B) Disqualification of hearing officer. (B) If an organization decides to audited by the RADV initial validation (1) A hearing officer may not conduct a submit attestations completed by contractor (IVC). hearing in a case in which he or she is physicians or other practitioners, the (C) MA organizations that choose to prejudiced or partial to any party or has MA organization must submit the appeal the IVC’s medical record review any interest in the matter pending for attestations to CMS at the same time determination(s) may only submit the decision. that the MA organization is required to IVC-audited one best medical record (2) A party to the hearing who objects submit related medical records for and IVC-reviewed attestation, to the designated hearing officer must RADV audit. previously submitted in accordance notify that officer in writing at the (v) Attestation content. An attestation with paragraph (c)(1) of this section, to earliest opportunity. must accompany and correspond to the CMS for re-review. (3) The hearing officer must consider medical record submitted for RADV (D) MA organizations’ request for the objections, and may, at his or her audit and must meet the following medical record review determination discretion, either proceed with the requirements: appeal may not include additional hearing or withdraw. (A) Contain only CMS-generated documentary evidence beyond the IVC- (i) If the hearing officer withdraws, attestations. audited one best medical record and CMS designates another hearing officer (B) The CMS attestation form may not IVC-reviewed attestation. to conduct the hearing. be altered unless otherwise instructed (ii) RADV-related audit errors and (ii) If the hearing officer does not and agreed-upon in writing by CMS. documentation ineligible for medical withdraw, the objecting party may, after (C) Attestations must be completed record review appeal process. (A) MA the hearing, present objections and and be signed and dated by the eligible organizations may not appeal errors that request that the officer’s decision be risk adjustment physician/practitioner resulted because MA organizations revised or a new hearing be held before whose medical record accompanies the failed to adhere to established RADV another hearing officer. The objections attestation. audit procedures and RADV appeals must be submitted in writing to CMS. (D) Attestations must be based upon requirements. This includes failure by (v) Hearing officer’s review. The medical records that document face-to- the MA organization to meet the hearing officer reviews the IVC-audited face encounters between beneficiaries medical record submission deadline one best medical record and the IVC- and RADV-eligible physicians/ established by CMS. reviewed attestation submitted by the practitioners. (B) Any other documentation MA organization to determine whether (vi) Attestation review and submitted to CMS beyond the one best it supports overturning medical record determination procedures. CMS—(A) medical record and attestation review determination errors listed in the Reviews each submitted attestation to submitted to and audited by the IVC MA organization’s IVC-level RADV determine if it meets CMS requirements will not be reviewed by CMS under the audit report. and is acceptable for use during the medical record review determination (vi) Hearing procedures. (A) CMS medical record review; and appeal process. provides written notice of the time and

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place of the hearing at least 30 calendar (2) Does not make a determination (1) The RADV payment error days before the scheduled date. regarding review within 30 calendar calculation. (B) The hearing is conducted by a days. (2) The evidence and findings upon CMS hearing officer who neither (3) RADV payment error calculation which they were based. receives testimony nor accepts any new appeal process. (i) MA organizations (3) Any other written evidence evidence that was not presented to the may appeal CMS’ RADV payment error submitted by the MA organization. IVC. The CMS hearing officer is limited calculation. (B) CMS ensures that a third party— to the review of the record that was (ii) RADV payment error-related either within CMS or a CMS before the IVC. issues ineligible for appeal. MA contractor—not otherwise involved in (vii) Hearing officer’s decision. As organizations may not— the initial RADV payment error soon as practical after the hearing, the (A) Appeal RADV medical record calculation reviews the written request hearing officer issues a decision which review-related errors as part of the for reconsideration. provides written notice of the hearing RADV payment error calculation appeal (C) The third party recalculates the officer’s review of the appeal of medical process. In accordance with paragraph payment error in accordance with CMS record review determination(s) to the (c)(2) of this section, MA organizations RADV payment calculation procedures MA organization and to CMS. that wish to appeal medical record described in CMS’ RADV payment error (viii) Computations based on hearing review determinations may do so calculation standard operating decision. In accordance with the hearing following issuance of the IVC RADV procedures. officer’s decision, CMS recalculates the audit report of findings. (D) The third party described in MA organization’s RADV payment error (B) Introduce new HCCs to CMS for paragraph (c)(3)(vi)(B) of this section and issues a new RADV audit report to payment consideration in the context of provides his or her determination to a the appellant MA organization. their RADV payment error calculation CMS reconsideration official not (ix) Effect of hearing decision. The appeal. otherwise involved in the RADV hearing officer’s decision is final and (C) Appeal RADV errors that result payment error calculation to review the binding, unless the MA organization from an MA organization’s failure to reconsideration determination. requests review of the hearings officer submit a medical record. (vi) Decision of the CMS appeal determination by the CMS (D) Appeal CMS’ RADV payment reconsideration official. The CMS Administrator. error calculation methodology. reconsideration official informs the MA (x) Review by the CMS Administrator. (iii) Manner and timing of a request organization and CMS in writing of the (A) A MA organization that has received for appeal. (A) MA organizations may decision of the CMS reconsideration a hearing officer decision may request not appeal their RADV error calculation official. review by the CMS Administrator until any appeals of RADV medical (vii) Effect of the CMS reconsideration within 30 calendar days of receipt of the record review determinations filed by official. The written reconsideration hearing officer’s determination. A the MA organization have been decision is final and binding unless a request for CMS Administrator review completed and the decisions are final. request for a hearing is filed by CMS or must be made in writing and filed with (B) At the time CMS issues either its the appellant MA organization in CMS. IVC or post-medical record review accordance with paragraph (c) (4) of this (B) After receiving a request for appeal RADV audit report, CMS notifies section. review, the CMS Administrator has the affected MA organizations in writing of (4) Right to a hearing. CMS or a MA discretion to elect to review the hearing their appeal rights around the RADV organization dissatisfied with the officer’s decision or to decline to review payment error calculation. written decision of the CMS the hearing decision. (C) MA organizations have 30 reconsideration official is entitled to a calendar days from the date of this hearing as provided in this section. (C) If the CMS Administrator elects to notice to submit a written request for (i) Manner and timing for request. A review the hearing decision, the CMS reconsideration of its RADV payment request for a hearing must be made in Administrator— error calculation. writing and filed with CMS within 30 (1) Acknowledges the decision to (iv) Burden of proof. The MA calendar days of the date CMS and the review the hearing decision in writing; organization bears the burden of proof MA organization receives the CMS and in demonstrating that CMS failed to reconsideration officer’s written (2) Reviews the decision and follow its stated RADV payment error reconsideration decision. determine based upon all of the calculation methodology. (ii) Content of request. The written following whether the determination (v) Content of request. The written request for hearing must include a copy should be upheld, reversed, or request for reconsideration must specify of the written decision of the CMS modified: the issues with which the MA reconsideration official and must (i) The hearing record. organization disagrees and the reasons specify the findings or issues in the (ii) Written arguments submitted by for the disagreements. reconsideration decision with which the MA organization or CMS. (A) The written request for either CMS or the MA organization (xi) Notification of Administrator reconsideration may include additional disagrees and the reasons for the determination. (A) The Administrator documentary evidence the MA disagreement. notifies both parties of his or her organization wishes CMS to consider. (iii) Hearing procedures. (A) CMS determination regarding review of the (B) CMS does not accept provides written notice of the time and hearing decision within 30 calendar reconsiderations for issues with the place of the hearing at least 30 calendar days of acknowledging his or her methodology applied in any part of the days before the scheduled date. decision to review the hearing decision. RADV audit. (B) The hearing will be held on the (B) The decision of the hearing officer (vi) Conduct of written record, unless the parties request, is final if the Administrator— reconsideration. (A) In conducting the subject to the hearing officer’s (1) Declines to review the hearing written reconsideration, CMS reviews discretion, a live or telephonic hearing. decision; or all of the following information: The hearing officer may schedule a live

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or telephonic hearing on his/her own (D) The Administrator notifies both ■ B. Adding a new paragraph (c)(2)(iii). motion. parties of his or her determination ■ C. Revising paragraph (c)(3)(iii). (C) The hearing is conducted by the regarding review of the hearing decision ■ D. Removing paragraph (d). CMS hearing officer who neither within 30 calendar days of receiving the The revisions and addition read as receives testimony nor accepts any new request for review. follows: (E) If the Administrator chooses to evidence that was not presented with § 422.502 Evaluation and determination the request for reconsideration. The review, the Administrator’s procedures. CMS hearing officer is limited to the determination is final and binding. (F) The decision of the hearing officer (a) * * * review of the record that was before (1) With the exception of evaluations CMS when CMS made either its initial is final if the Administrator— (1) Declines to review the hearing conducted under paragraph (b) of this RADV payment error calculation section, CMS evaluates an application determination or its post-medical record decision; or (2) Does not make a determination for an MA contract solely on the basis review appeal payment error calculation of information contained in the determination and when the CMS regarding review within 30 calendar days. application itself and any additional reconsideration official issued the information that CMS obtains through written reconsideration decision. Subpart K—Contracts With Medicare other means such as on-site visits. (C) The hearing officer has full power Advantage Organizations (2) After evaluating all relevant to make rules and establish procedures, information, CMS determines whether consistent with the law, regulations, and ■ 28. Section 422.501 is amended by— the applicant’s application meets all the CMS rulings. These powers include the ■ A. Redesignating paragraphs (b) requirements described in this part. authority to dismiss the appeal with through (e) as paragraphs (c) through (f), (b) Use of information from a current prejudice or take any other action which respectively. or prior contract. If an MA organization the hearing officer considers appropriate ■ B. Adding a new paragraph (b). fails during the 14 months preceding the ■ for failure to comply with such rules C. Revising newly redesignated deadline established by CMS for the and procedures. paragraph (c)(1) introductory text and submission of contract qualification (iv) Decision of the CMS Hearing paragraph (c)(2). applications to comply with the Officer. The CMS hearing officer The addition and revisions read as requirements of the Part C program decides whether the reconsideration follows: under any current or prior contract with official’s decision was correct, and § 422.501 Application requirements. CMS under title XVIII of the Act or fails sends a written decision to CMS and the * * * * * to complete a corrective action plan MA organization, explaining the basis (b) Completion of a notice of intent to during the 14 months preceding the for the decision. apply. (1) An organization submitting an deadline established by CMS for the (v) Effect of the Hearing Officer’s application under this section for a submission of contract qualification decision. The hearing officer’s decision particular contract year must first applications, CMS may deny an is final and binding, unless the decision submit a completed Notice of Intent to application based on the applicant’s is reversed or modified by the Apply by the date established by CMS. failure to comply with the requirements Administrator in accordance with CMS will not accept applications from of the Part C program under any current paragraph (c)(5) of this section. organizations that do not first submit a or prior contract with CMS even if the (vi) Review by the CMS Administrator. timely Notice of Intent to Apply. applicant currently meets all of the (A) CMS or a MA organization that has (2) Submitting a Notice of Intent to requirements of this part. received a hearing officer’s decision Apply does not bind that organization to (c) * * * upholding or overturning a CMS initial submit an application for the applicable (2) * * * or reconsideration-level RADV payment contract year. (iii) If CMS does not receive a revised error calculation determination may (3) An organization’s decision not to application within 10 days from the request review by the CMS submit an application after submitting a date of the notice, or if after timely Administrator within 30 calendar days Notice of Intent To Apply will not form submission of a revised application, of receipt of the hearing officer’s the basis of any action taken against the CMS still finds the applicant does not decision. organization by CMS. appear qualified to contract as an MA (B) At his or her discretion, the CMS (c) * * * organization or has not provided enough Administrator can choose to either (1) In order to obtain a determination information to allow CMS to evaluate review or not review a case. on whether it meets the requirements to the application, CMS will deny the (C) If the CMS Administrator chooses become an MA organization and is application. to review the case, the CMS qualified to provide a particular type of (3) * * * Administrator— MA plan, an entity, or an individual (iii) The applicant’s right to request a (1) Acknowledges his or her decision authorized to act for the entity (the hearing in accordance with the to review the hearing officer’s decision applicant) must fully complete all parts procedures specified in subpart N of in writing; and of a certified application, in the form this part. (2) Determines whether to uphold, and manner required by CMS, including ■ 30. Section 422.503 is amended by— ■ reverse, or modify the Hearing Officer’s the following: A. Revising paragraphs (b)(4)(vi). ■ B. Adding new paragraph (b)(7). decision based on his or her review of * * * * * The revisions and addition read as the following: (2) The authorized individual must follows: (i) The Hearing Officer’s decision. thoroughly describe how the entity and (ii) Written documents submitted by MA plan meet, or will meet, all the § 422.503 General provisions. CMS or the MA organization to the requirements described in this part. * * * * * Hearing Officer. * * * * * (b) * * * (iii) Any other any other information ■ 29. Section 422.502 is amended by— (4) * * * included in the record of the Hearing ■ A. Revising paragraphs (a)(1), (a)(2), (vi) Adopt and implement an effective Officer’s decision. and (b). compliance program, which must

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include measures that prevent, detect, employees, the MA organization’s chief to reduce the potential for recurrence, and correct non-compliance with CMS’ executive or other senior administrator, and ensure ongoing compliance with program requirements as well as managers and governing body members, CMS requirements. measures that prevent, detect, and and the MA organization’s first tier, (1) If the MA organization discovers correct fraud, waste, and abuse. The downstream, and related entities. Such evidence of misconduct related to compliance program must, at a training and education must occur at a payment or delivery of items or services minimum, include the following core minimum annually and must be made a under the contract, it must conduct a requirements: part of the orientation for a new timely, reasonable inquiry into that (A) Written policies, procedures, and employee, new first tier, downstream conduct. standards of conduct that— and related entities, and new (2) The MA organization must (1) Articulate the organization’s appointment to a chief executive, conduct appropriate corrective actions commitment to comply with all manager, or governing body member. (for example, repayment of applicable Federal and State standards; (2) First tier, downstream, and related overpayments, disciplinary actions (2) Describe compliance expectations entities who have met the fraud, waste, against responsible employees) in as embodied in the standards of and abuse certification requirements response to the potential violation conduct; through enrollment into the Medicare referenced in paragraph (b)(4)(vi)(G)(1) (3) Implement the operation of the program are deemed to have met the of this section. compliance program; training and educational requirements (3) The MA organization should have (4) Provide guidance to employees for fraud, waste, and abuse. procedures to voluntarily self-report and others on dealing with potential (D) Establishment and potential fraud or misconduct related to compliance issues; implementation of effective lines of the MA program to CMS or its designee. (5) Identify how to communicate communication, ensuring * * * * * compliance issues to appropriate confidentiality, between the compliance (7) Not have terminated a contract by compliance personnel; officer, members of the compliance mutual consent under which, as a (6) Describe how potential committee, the MA organization’s condition of the consent, the MA compliance issues are investigated and employees, managers and governing organization agreed that it was not resolved by the organization; and body, and the MA organization’s first eligible to apply for new contracts or (7) Include a policy of non- tier, downstream, and related entities. service area expansions for a period of intimidation and non-retaliation for Such lines of communication must be 2 years per § 422.508(c) of this subpart. good faith participation in the accessible to all and allow compliance compliance program, including but not issues to be reported including a * * * * * limited to reporting potential issues, method for anonymous and confidential ■ 31. Section 422.504 is amended by— investigating issues, conducting self- good faith reporting of potential ■ A. Redesignating paragraph (e)(1(ii) evaluations, audits and remedial compliance issues as they are identified. and (e)(1)(iii) as paragraph (e)(1)(iii) and actions, and reporting to appropriate (E) Well-publicized disciplinary (e)(1)(iv), respectively. officials. standards through the implementation ■ B. Adding a new paragraph (e)(1)(ii). (B) The designation of a compliance of procedures which encourage good ■ C. Revising newly redesignated officer and a compliance committee faith participation in the compliance paragraph (e)(1)(iii). ■ who report directly and are accountable program by all affected individuals. D. Revising paragraph (i)(2)(i). ■ to the organization’s chief executive or These standards must include policies E. Add a new paragraph (m). other senior management. that— The additions and revisions read as (1) The compliance officer, vested (1) Articulate expectations for follows: with the day-to-day operations of the reporting compliance issues and assist § 422.504 Contract provisions. compliance program, must be an in their resolution, employee of the MA organization, (2) Identify noncompliance or * * * * * (e) * * * parent organization or corporate unethical behavior; and affiliate. The compliance officer may not (3) Provide for timely, consistent, and (1) * * * (ii) Compliance with CMS be an employee of the MA effective enforcement of the standards requirements for maintaining the organization’s first tier, downstream or when noncompliance or unethical privacy and security of protected health related entity. behavior is determined. (2) The compliance officer and the (F) Establishment and implementation information and other personally compliance committee must of an effective system for routine identifiable information of Medicare periodically report directly to the monitoring and identification of enrollees; governing body of the MA organization compliance risks. The system should (iii) The facilities of the MA on the activities and status of the include internal monitoring and audits organization to include computer and compliance program, including issues and, as appropriate, external audits, to other electronic systems; and identified, investigated, and resolved by evaluate the MA organization, including * * * * * the compliance program. first tier entities’, compliance with CMS (i) * * * (3) The governing body of the MA requirements and the overall (2) * * * organization must be knowledgeable effectiveness of the compliance (i) HHS, the Comptroller General, or about the content and operation of the program. their designees have the right to audit, compliance program and must exercise (G) Establishment and evaluate, and inspect any books, reasonable oversight with respect to the implementation of procedures and a contracts, computer or other electronic implementation and effectiveness of the system for promptly responding to systems, including medical records and compliance programs. compliance issues as they are raised, documentation of the first tier, (C)(1) Each MA organization must investigating potential compliance downstream, and entities related to establish and implement effective problems as identified in the course of CMS’ contract with the MA training and education between the self-evaluations and audits, correcting organization. compliance officer and organization such problems promptly and thoroughly * * * * *

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(m)(1) CMS may determine that an provide the MA organization with improvement program as required under MA organization is out of compliance notice specifying the MA organization’s subpart D of this part. with a Part C requirement when the deficiencies and a reasonable (8) Substantially fails to comply with organization fails to meet performance opportunity of at least 30 calendar days the prompt payment requirements in standards articulated in the Part C to develop and implement a corrective § 422.520. statutes, regulations, or guidance. action plan to correct the deficiencies. (9) Substantially fails to comply with (2) If CMS has not already articulated (ii) The MA organization is solely the service access requirements in a measure for determining responsible for the identification, § 422.112 or § 422.114. noncompliance, CMS may determine development, and implementation of its (10) Fails to comply with the that a MA organization is out of corrective action plan and for requirements of § 422.208 regarding compliance when its performance in demonstrating to CMS that the physician incentive plans. fulfilling Part C requirements represents underlying deficiencies have been (11) Substantially fails to comply with an outlier relative to the performance of corrected within the time period the marketing requirements in subpart V other MA organizations. specified by CMS in the notice of this part. ■ 32. Section 422.506 is amended by— requesting corrective action. (12) Fails to comply with the ■ A. Revising paragraph (a)(2)(ii). * * * * * regulatory requirements contained in ■ B. Removing paragraph (a)(2)(iii). ■ 33. Section 422.508 is amended by this part or part 423 of this chapter or ■ C. Revising paragraph (a)(3)(i). adding paragraph (c) to read as follows: both. ■ D. Adding a new paragraph (b)(1)(iv). (13) Fails to meet CMS performance ■ E. Revising paragraph (b)(2)(ii). § 422.508 Modification or termination of requirements in carrying out the ■ F. Removing paragraph (b)(2)(iii). contract by mutual consent. regulatory requirements contained in ■ G. Revising paragraph (b)(3). * * * * * this part or part 423 of this chapter or The revisions and addition read as (c) Agreement to limit new MA both. follows: applications. As a condition of the (b) Notice. If CMS decides to consent to a mutual termination CMS terminate a contract it gives notice of § 422.506 Nonrenewal of contract. will require, as a provision of the the termination as follows: (a) * * * termination agreement language * * * * * (2) * * * prohibiting the MA organization from (2) Expedited termination of contract (ii) Each Medicare enrollee by mail at applying for new contracts or service by CMS. (i) The procedures specified in least 90 calendar days before the date on area expansions for a period of 2 years, paragraph (b)(1) of this section do not which the nonrenewal is effective. The absent circumstances warranting special apply if— MA organization must also provide consideration. (A) CMS determines that a delay in information about alternative ■ 34. Section 422.510 is amended by— termination, resulting from compliance enrollment options by doing one or ■ A. Revising paragraphs (a), (b) with the procedures provided in this more of the following: introductory text, and (b)(2)(i). part prior to termination, would pose an (A) Provide a CMS approved written ■ B. Redesignating paragraphs (b)(2)(ii) imminent and serious risk to the health description of alternative MA plan, and (b)(2)(iii) as (b)(2)(iii) and (b)(2)(iv), of the individuals enrolled with the MA MA–PD plan, and PDP options available respectively. organization; or for obtaining qualified Medicare ■ C. Adding a new paragraph (b)(2)(ii). (B) The MA organization experiences services within the beneficiaries’ region. ■ D. Revising paragraph (c). financial difficulties so severe that its (B) Place outbound calls to all affected The revisions and addition read as ability to make necessary health services enrollees to ensure beneficiaries know follows: available is impaired to the point of who to contact to learn about their § 422.510 Termination of contract by CMS. posing an imminent and serious risk to enrollment options. the health of its enrollees, or otherwise (a) Termination by CMS. CMS may at (3) * * * fails to make services available to the any time terminate a contract if CMS (i) The MA organization notifies its extent that such a risk to health exists; determines that the MA organization Medicare enrollees in accordance with or meets any of the following: paragraph (a)(2)(ii) of this section; and (C) The contract is being terminated (1) Has failed substantially to carry based on the grounds specified in * * * * * out the contract. (b) * * * (2) Is carrying out the contract in a paragraph (a)(4) of this section. (1) * * * manner that is inconsistent with the (ii) CMS notifies the MA organization (iv) The contract must be nonrenewed efficient and effective administration of in writing that its contract will be as to an individual MA plan if that plan this part. terminated on a date specified by CMS. does not have a sufficient number of (3) No longer substantially meets the If a termination is effective in the enrollees to establish that it is a viable applicable conditions of this part. middle of a month, CMS has the right independent plan option. (4) Based on creditable evidence, has to recover the prorated share of the (2) * * * committed or participated in false, capitation payments made to the MA (ii) To each of the MA organization’s fraudulent or abusive activities affecting organization covering the period of the Medicare enrollees by mail at least 90 the Medicare, Medicaid or other State or month following the contract calendar days before the date on which Federal health care programs, including termination. the nonrenewal is effective, or at the submission of false or fraudulent data. * * * * * conclusion of the appeals process if (5) Substantially fails to comply with (c) Opportunity to develop and applicable. the requirements in subpart M of this implement a corrective action plan—(1) (b) * * * part relating to grievances and appeals. General. (i) Before providing a notice of (3) Opportunity to develop and (6) Fails to provide CMS with valid intent to terminate the contract, CMS implement a corrective action plan. data as required under § 422.310. will provide the MA organization with (i) Before providing a notice of intent (7) Fails to implement an acceptable notice specifying the MA organization’s of nonrenewal of the contract, CMS will quality assessment and performance deficiencies and a reasonable

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opportunity of at least 30 calendar days grievance or appeal. Unless otherwise (2) Requests for payment must be to develop and implement a corrective stated in this subpart, the representative made in writing (unless the MA action plan to correct the deficiencies. will have all the rights and organization or entity responsible for (ii) The MA organization is solely responsibilities of an enrollee or party making the determination has responsible for the identification, in filing a grievance, and in obtaining an implemented a voluntary policy of development, and implementation of its organization determination or in dealing accepting verbal payment requests). corrective action plan and for with any of the levels of the appeals * * * * * demonstrating to CMS that the process, subject to the applicable rules (d) Written notice for MA organization underlying deficiencies have been described in part 405 of this chapter. denials. The MA organization must give corrected within the time period § 422.566 [Amended] the enrollee a written notice if— specified by CMS in the notice (1) An MA organization decides to requesting corrective action. ■ 37. Section 422.566 is amended by— deny service or payment in whole or in (2) Exceptions. The MA organization ■ A. Republishing paragraph (b) part, or reduce or prematurely will not be provided with an introductory text. discontinue the level of care for a opportunity to develop and implement ■ B. Revising paragraph (b)(4). previously authorized ongoing course of a corrective action plan prior to ■ C. Redesignating paragraph (b)(5) as treatment. termination if— (b)(6). (2) An enrollee requests an MA (i) CMS determines that a delay in ■ D. Adding a new paragraph (b)(5). organization to provide an explanation ■ termination, resulting from compliance E. In paragraphs (c)(1)(i), and (c)(2)(i) of a practitioner’s denial of an item or with the procedures provided in this removing the parenthetical phrase service, in whole or in part. ‘‘(including his or her authorized part prior to termination, would pose an * * * * * imminent and serious risk to the health representative)’’ is removed and ■ 39. Section 422.574 is amended by of the individuals enrolled with the MA ‘‘(including his or her representative)’’ is revising paragraph (a) to read as follows: organization; added in its place. (ii) The MA organization experiences The revision and addition to read as § 422.574 Parties to the organization financial difficulties so severe that its follows: determination. ability to make necessary health services § 422.566 Organization determinations. * * * * * available is impaired to the point of (a) The enrollee (including his or her posing an imminent and serious risk to * * * * * (b) Actions that are organization representative); the health of its enrollees, or otherwise determinations. An organization * * * * * fails to make services available to the determination is any determination ■ 40. Section 422.622 is amended by extent that such a risk to health exists; made by an MA organization with revising paragraph (f)(3) to read as or (iii) The contract is being terminated respect to any of the following: follows: based on the violation specified in (a)(4) * * * * * § 422.622 Requesting immediate QIO of this section. (4) Reduction, or premature review of the decision to discharge from the discontinuation, of a previously * * * * * inpatient hospital. authorized ongoing course of treatment. ■ * * * * * 35. Section 422.516 is amended by— (5) Reduction of a previously ■ (f) * * * A. Revising the section heading. authorized course of treatment if the ■ B. Adding a new paragraph (g). (3) If the QIO determines that the enrollee believes that continuation of enrollee still requires inpatient hospital The revision and addition to read as the course of treatment is medically follows: care, the hospital must provide the necessary. enrollee with a notice consistent with § 422.516 Validation of Part C reporting * * * * * § 422.620(c) of this subpart when the requirements. ■ 38. Section 422.568 is amended by — hospital or MA organization once again * * * * * ■ A. Redesignating paragraphs (a) determines that the enrollee no longer (g) Data validation. Each Part C through (f) as paragraphs (b) through (g), requires inpatient hospital care. sponsor must subject information respectively. * * * * * collected under paragraph (a) of this ■ B. Adding a new paragraph (a). ■ 41. Section 422.624 is amended by section to a yearly independent audit to ■ C. Revising newly designated revising paragraph (c)(1) to read as determine their reliability, validity, paragraph (d). follows: completeness, and comparability in The addition and revision read as accordance with specifications follows: § 422.624 Notifying enrollees of termination of provider services. developed by CMS. § 422.568 Standard timeframes and notice * * * * * Subpart M—Grievances, Organization requirements for organization determinations. (c) * * * Determinations, and Appeals (a) Method and place for filing a (1) The enrollee (or the enrollee’s representative) has signed and dated the ■ 36. Section 422.561 is amended by request. An enrollee must ask for a notice to indicate that he or she has revising the definition of standard organization determination by received the notice and can comprehend ‘‘Representative’’ to read as follows: making a request with the MA organization or, if applicable, to the its contents; and § 422.561 Definitions. entity responsible for making the * * * * * * * * * * determination (as directed by the MA ■ 42. Section 422.626 is amended by— Representative means an individual organization), in accordance with the ■ A. Redesignating paragraph (f) as appointed by an enrollee or other party, following: paragraph (g). or authorized under State or other (1) The request may be made orally or ■ B. Redesignating paragraph (e)(5) as applicable law, to act on behalf of an in writing, except as provided in paragraph (f) and revising the newly enrollee or other party involved in the paragraph (a)(2) of this section. redesignated paragraph (f).

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The revisions read as follows: § 422.641(b) of this subpart, the MA § 422.670 Time and place of hearing. organization has the burden of proving (a) The hearing officer— § 422.626 Fast-track appeals of service by a preponderance of the evidence that terminations to independent review entities (1) Fixes a time and place for the (IREs). CMS’ determination was inconsistent hearing, which is not to exceed 30 with the requirements of § 422.506 of calendar days after the receipt of the * * * * * this part. (f) Responsibilities of the provider. If request for the hearing; and an IRE reverses an MA organization’s (3) During a hearing to review a (2) Sends written notice to the parties termination decision, the provider must contract determination as described at that informs the parties of the general provide the enrollee with a new notice § 422.641(c) of this subpart, the MA and specific issues to be resolved, the consistent with § 422.624(b) of this organization has the burden of proving burden of proof, and information about subpart. by a preponderance of the evidence that the hearing procedure. CMS’ determination was inconsistent (b)(1) The hearing officer may, on his * * * * * with the requirements of § 422.510 of or her own motion, change the time and Subpart N—Medicare Contract this part. place of the hearing. Determinations and Appeals (4) During a hearing to review the (2) The hearing officer may adjourn or imposition of an intermediate sanction postpone the hearing. ■ 43. Section 422.644 is amended by as described at § 422.750 of this part, the (c)(1) The MA organization or CMS revising paragraph (c) to read as follows: MA organization has the burden of may request an extension by filing a proving by a preponderance of the written request no later than 10 calendar § 422.644 Notice of contract determination. evidence that CMS’ determination was days prior to the scheduled hearing. * * * * * inconsistent with the requirements of (2) When either the MA organization (c) CMS-initiated terminations—(1) § 422.752 of this part. or CMS requests an extension, the General rule. Except as provided in (c) Timing of favorable decisions. hearing officer will provide a one-time (c)(2) of this section, CMS mails notice Notice of any decision favorable to the 15 calendar day extension. to the MA organization 90 calendar days MA organization appealing a (3) Additional extensions may be before the anticipated effective date of determination that it is not qualified to granted at the discretion of the hearing the termination. enter into a contract with CMS must be officer. (2) Exception. If a contract is issued by September 1 for the contract ■ 48. Section 422.676 is amended by terminated in accordance with in question to be effective on January 1 revising paragraph (d) to read as § 422.510(b)(2)(i) of this part, CMS of the following year. follows: notifies the MA organization of the date that it will terminate the MA ■ 45. Section 422.662 is amended by § 422.676 Conduct of hearing. organization’s contract. revising paragraphs (a) and (b) to read * * * * * as follows: * * * * * (d) The MA organization bears the ■ 44. Section § 422.660 is revised to § 422.662 Request for hearing. burden of going forward and must first present evidence and argument before read as follows: (a) Method and place for filing a CMS presents its evidence and request. (1) A request for a hearing must § 422.660 Right to a hearing, burden of argument. proof, standard of proof, and standards of be made in writing and filed by an ■ review. authorized official of the contract 49. Section 422.682 is revised to read as follows: (a) Right to a hearing. The following applicant or MA organization that was parties are entitled to a hearing: the party to the determination under the § 422.682 Witness lists and documents. appeal. (1) A contract applicant that has been Witness lists and documents must be (2) The request for the hearing must determined to be unqualified to enter identified and exchanged at least 5 be filed in accordance with the into a contract with CMS under Part C calendar days before the scheduled requirements specified in the notice. of Title XVIII of the Act in accordance hearing. with § 422.501 and § 422.502. (b) Time for filing a request. A request ■ (2) An MA organization whose for a hearing must be filed within 15 50. Section 422.692 is amended by contract has been terminated under calendar days after the receipt of the revising paragraphs (a) and (c) to read as § 422.510 of this part. notice of the contract determination or follows: (3) An MA organization whose intermediate sanction. § 422.692 Review by the Administrator. contract has not been renewed under * * * * * § 422.506 of this part. (a) Request for review by (4) An MA organization who has had ■ 46. Section 422.664 is amended by Administrator. CMS or an MA an intermediate sanction imposed in revising paragraph (b)(2) to read as organization that has received a hearing accordance with § 422.752(a) through follows: decision may request a review by the Administrator within 15 calendar days (b) of this part. § 422.664 Postponement of effective date (b) Burden of proof, standard of proof, after receipt of the hearing decision as of a contract determination when a request provided under § 422.690(b). Both the and standards of review at a hearing. (1) for a hearing is filed timely. During a hearing to review a contract MA organization and CMS may provide * * * * * determination as described at written arguments to the Administrator (b) * * * § 422.641(a) of this subpart, the for review. applicant has the burden of proving by (2) A contract terminated in * * * * * a preponderance of the evidence that accordance with § 422.510(b)(2)(i) of (c) Notification of Administrator CMS’ determination was inconsistent this part will be terminated on the date determination. The Administrator with the requirements of § 422.501 and specified by CMS and will not be notifies both parties of his or her § 422.502 of this part. postponed if a hearing is requested. determination regarding review of the (2) During a hearing to review a ■ 47. Section 422.670 is revised to read hearing decision within 30 calendar contract determination as described at as follows: days after receipt of request for review.

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If the Administrator declines to review (3) Acts to expel or refuses to re-enroll limited period of time in order to assist the hearing decision or the a beneficiary in violation of the CMS in making a determination as to Administrator does not make a provisions of this part. whether the deficiencies that are the determination regarding review within (4) Engages in any practice that would bases for the intermediate sanctions 30 calendar days, the decision of the reasonably be expected to have the have been corrected and are not likely hearing officer is final. effect of denying or discouraging to recur. * * * * * enrollment (except as permitted by this (A) If, following this time period, CMS determines the deficiencies have ■ 51. Section 422.696 is amended by part) by eligible individuals with the not been corrected or are likely to recur, revising the section heading and organization whose medical condition the intermediate sanctions will remain paragraph heading for paragraph (a) to or history indicates a need for in effect until such time that CMS is read as follows: substantial future medical services. * * * * * assured the deficiencies have been corrected and are not likely to recur. § 422.696 Reopening of a contract ■ 54. Section 422.756 amended by— determination or decision of a hearing (B) The MA organization does not ■ A. Revising paragraph (b). officer or the Administrator. have a right to a hearing under ■ B. Removing paragraph (c). § 422.660(a)(4) of this part to challenge (a) Contract determination.*** ■ C. Redesignating paragraphs (d) CMS’ determination to keep the * * * * * through (f) as paragraphs (c) through (e), intermediate sanctions in effect. respectively. Subpart O—Intermediate Sanctions ■ D. Revising the newly redesignated * * * * * paragraphs (c)(1) and (c)(3). ■ 52. Section 422.750 is amended by Subpart V—Medicare Advantage The revisions read as follows: revising paragraph (a) to read as follows: Marketing Requirements § 422.756 Procedures for imposing ■ § 422.750 Types of intermediate sanctions intermediate sanctions and civil money 55. Section 422.2260 is amended by and civil money penalties. penalties. revising paragraph (5)(vii) of the ‘‘ ’’ (a) The following intermediate * * * * * definition of marketing materials and sanctions may be imposed and will (b) Hearing. (1) The MA organization adding a new paragraph (6) to read as continue in effect until CMS is satisfied may request a hearing before a CMS follows: that the deficiencies that are the basis hearing officer. § 422.2260 Definitions concerning for the sanction determination have (2) A written request must be received marketing materials. been corrected and are not likely to by the designated CMS office within 15 recur: * * * * * calendar days after the receipt of the Marketing materials.*** (1) Suspension of the MA notice. (5) * * * organization’s enrollment of Medicare (3) A request for a hearing under (vii) Membership activities (for beneficiaries. § 422.660 does not delay the date example, materials on rules involving (2) Suspension of payment to the MA specified by CMS when the sanction non-payment of premiums, organization for Medicare beneficiaries becomes effective. confirmation of enrollment or enrolled after the date CMS notifies the (4) The MA organization must follow disenrollment, or nonclaim specific organization of the intermediate the right to a hearing procedure as notification information).— sanction. specified at § 422.660 through § 422.684. (6) Marketing materials exclude ad (3) Suspension of all marketing (c) Effective date and duration of hoc enrollee communications materials, activities to Medicare beneficiaries by sanction—(1) Effective date. The meaning informational materials that— an MA organization. effective date of the sanction is the date (i) Are targeted to current enrollees; * * * * * specified by CMS in the notice. (ii) Are customized or limited to a ■ 53. Section 422.752 is amended by * * * * * subset of enrollees or apply to a specific revising paragraphs (a) introductory (3) Duration of sanction. The sanction situation; text, (a)(1), (a)(3), and (a)(4) to read as remains in effect until CMS is satisfied (iii) Do not include information about follows: that the deficiencies that are the basis the plan’s benefit structure; and (iv) Apply to a specific situation or for the sanction determination have cover claims processing or other § 422.752 Basis for imposing intermediate been corrected and are not likely to sanctions and civil money penalties. operational issues. recur. ■ (a) All intermediate sanctions. For the (i) CMS may require that the MA 56. Section 422.2262 is amended by— ■ violations listed in this paragraph, CMS organization hire an independent A. Revising the section heading. ■ B. Revising paragraphs (a)(1) and (b). may impose one or more of the auditor to provide CMS with additional ■ C. Adding new paragraphs (c) and (d). sanctions specified in § 422.750(a) of information to determine if the this subpart on any MA organization The revisions and additions read as deficiencies that are the basis for the follows: with a contract. The MA organization sanction determination have been may also be subject to other remedies corrected and are not likely to recur. § 422.2262 Review and distribution of authorized under law. The independent auditor must work in marketing materials. (1) Fails substantially to provide accordance with CMS specifications and (a) * * * medically necessary items and services must be willing to attest that a complete (1) Except as provided in paragraph that are required (under law or under and full independent review has been (b) of this section, an MA organization the contract) to be provided to an performed. may not distribute any marketing individual covered under the contract, if (ii) In instances where marketing or materials (as defined in § 422.2260 of the failure has adversely affected (or has enrollment or both intermediate this subpart), or election forms, or make the substantial likelihood of adversely sanctions have been imposed, CMS may such materials or forms available to affecting) the individual. require an MA organization to market or individuals eligible to elect an MA * * * * * to accept enrollments or both for a organization unless—

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(i) At least 45 days (or 10 days if using benefits under a demonstration under in a Part D plan, consistent with this certain types of marketing materials that section 1115 of the Act; or paragraph, unless they elect to decline use, without modification, proposed (ii) Medical assistance under section that enrollment. model language and format, including 1902(a)(10(C) of the Act (medically (ii) Before effectuating such an standardized language and formatting, needy) or section 1902(f) of the Act enrollment, CMS provides notice to as specified by CMS) before the date of (States that use more restrictive such individuals of their choices and distribution the MA organization has eligibility criteria than are used by the advises them to discuss the potential submitted the material or form to CMS SSI program) for any month if the impact of Medicare Part D coverage on for review under the guidelines in individual was eligible for medical their group health plan coverage. The § 422.2264 of this subpart; and assistance in any part of the month. notice informs individuals that they will (ii) CMS does not disapprove the (2) Eligible for Part D in accordance be deemed to have declined to enroll in distribution of new material or form. with § 423.30(a) of this subpart. Part D unless they affirmatively enroll Low-income subsidy-eligible in a Part D plan or contact CMS and * * * * * individual. For purposes of this section, confirm that they wish to be auto- (b) File and use. The MA organization a low-income subsidy eligible enrolled in a PDP. Individuals who elect may distribute certain types of individual means an individual who not to be auto-enrolled, may enroll in marketing material, designated by CMS, meets the definition of full subsidy Medicare Part D at a later time if they 5 days following their submission to eligible (including full benefit dual choose to do so. CMS if the MA organization certifies eligible individuals as set forth in this that in the case of these marketing section) or other subsidy eligible in (iii) All other low income subsidy materials, it followed all applicable § 423.772 of this part. eligible beneficiaries who are qualified marketing guidelines and, when (c) Reassigning low-income subsidy- covered retirees are not enrolled by applicable, used model language eligible individuals. Notwithstanding CMS into PDPs. specified by CMS without modification. § 423.32(e) of this subpart, during the (e) Declining enrollment and (c) Standardized model marketing annual coordinated election period, disenrollment. Nothing in this section materials. When specified by CMS, CMS may reassign certain low-income prevents a low income subsidy eligible organizations must use standardized subsidy-eligible individuals in another individual from— formats and language in model PDP if CMS determines that the further (1) Affirmatively declining enrollment materials. enrollment is warranted. in Part D; or (d) Ad hoc enrollee communication (d) Enrollment rules—(1) General rule. (2) Disenrolling from the Part D plan materials. Ad hoc enrollee Except for low-income subsidy eligible in which the individual is enrolled and communication materials may be individuals who are qualifying covered electing to enroll in another Part D plan reviewed by CMS, which may upon retirees with a group health plan during the special enrollment period review determine that such materials sponsor as specified in paragraph (d)(3) provided under § 423.38. must be modified, or may no longer be of this section, CMS enrolls those (f) Effective date of enrollment for used. individuals who fail to enroll in a Part full-benefit dual eligible individuals. D plan into a PDP offering basic Enrollment of full-benefit dual eligible PART 423—MEDICARE PROGRAM; prescription drug coverage in the area MEDICARE PRESCRIPTION DRUG individuals under this section must be where the beneficiary resides that has a effective as follows: PROGRAM monthly beneficiary premium amount (1) January 1, 2006 for individuals that does not exceed the low-income ■ 57. The authority citation for part 423 who are full-benefit dual-eligible subsidy amount (as defined in continues to read as follows: individuals as of December 31, 2005. § 423.780(b) of this part). In the event Authority: Secs. 1102, 1860D–1 through that there is more than one PDP in an (2) The first day of the month the 1860D–42, and 1871 of the Social Security area with a monthly beneficiary individual is eligible for Part D under Act (42 U.S.C. 1302, 1395w–101 through premium at or below the low-income § 423.30(a)(1) for individuals who are 1395w–152, and 1395hh). premium subsidy amount, individuals Medicaid eligible and subsequently become newly eligible for Part D under Subpart B—Eligibility and Enrollment are enrolled in such PDPs on a random basis. § 423.30(a)(1) on or after January 1, 2006. ■ 58. Section 423.34 is revised to read (2) Individuals enrolled in an MSA as follows: plan or one of the following that does (3) For individuals who are eligible not offer a Part D benefit. Low-income for Part D under § 423.30(a)(1) of this § 423.34 Enrollment of low-income subsidy eligible individuals enrolled in subpart and subsequently become newly subsidy eligible individuals. an MA private fee-for-service plan or eligible for Medicaid on or after January (a) General rule. CMS must ensure the cost-based HMO or CMP that does not 1, 2006, enrollment is effective with the enrollment into Part D plans of low- offer qualified prescription drug first day of the month when the income subsidy eligible individuals coverage or an MSA plan and who fail individuals become eligible for both who fail to enroll in a Part D plan. to enroll in a Part D plan must be Medicaid and Part D. (b) Definitions—Full-benefit dual- enrolled into a PDP plan as described in (g) Effective date of enrollment for eligible individual. For purposes of this paragraph (d)(1) of this section. non-full-benefit dual-eligible section, a full-benefit dual eligible (3) Exception for individuals who are individuals who are low-income individual means an individual who qualifying covered retirees. (i) Full subsidy-eligible individuals. The is— benefit dual eligible individuals who are effective date for non-full-benefit dual- (1) Determined eligible by the State qualifying covered retirees as defined in eligible individuals who are low-income for— § 423.882 of this part, and for whom subsidy-eligible individuals is no later (i) Medical assistance for full-benefits CMS has approved the group health than the first day of the second month under Title XIX of the Act for the month plan sponsor to receive the retirement after CMS determines that they meet the under any eligibility category covered drug subsidy described in subpart R of criteria for enrollment under this under the State plan or comprehensive this part, also are automatically enrolled section.

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■ 59. Section 423.38 is amended by grouping that is reasonable to identify § 423.112 Establishment of prescription revising paragraph (c)(4) to read as the applicable drug products. drug plan sponsor service areas. follows: * * * * * (a) Service area for prescription drug plan sponsors. The service area for a § 423.38 Enrollment periods. Major or life threatening clinical consequences means consequences in prescription drug plan sponsor other * * * * * which serious clinical events may arise than a fallback prescription drug plan (c) * * * as a result of not taking a drug that can sponsor consists of one or more PDP (4) The individual is a full-subsidy lead to patient hospitalization, or a regions as established under paragraphs eligible individual or other subsidy- persistent or significant disability or (b) and (c) of this section. eligible individual as defined in incapacity, or that can result in death. * * * * * § 423.772 of this part. Multiple drugs mean two or more Part ■ 64. Section 423.120 is amended by— * * * * * D drugs. ■ A. Revising paragraph (a). ■ 60. Section 423.44 is amended by— * * * * * ■ B. Redesignating paragraphs (b)(1)(ix) ■ A. Redesignating paragraphs (d)(1)(iii) Restricted access means, for the as paragraph (b)(1)(x). ■ and (d)(1)(iv) as paragraphs (d)(1)(iv) purposes of § 423.120(b)(2)(v)(A) of this C. Adding a new paragraph (b)(1)(ix). ■ and (d)(1)(v), respectively. subpart, an enrollee who but for E. Revising paragraph (b)(3). ■ ■ B. Adding a new paragraph (d)(1)(iii). § 423.120(b0(2)(v) of this subpart F. Redesignating paragraph (c) as ■ C. Redesignating the introductory text urgently requires a Part D drug but is paragraph (c)(1). ■ of paragraph (d)(5) as paragraph waiting for an expedited G. Adding new paragraphs (c)(2) (d)(5)(i). redetermination by a Part D plan or an through (c)(4). ■ D. Adding new paragraph (d)(5)(ii). CMS independent review entity with The revisions and additions read as The revisions and additions read as respect to coverage of that drug. follows: follows: * * * * * § 423.120 Access to covered Part D drugs. § 423.44 Involuntary disenrollment by the Significant need for access to multiple (a) Assuring pharmacy access—(1) PDP. drugs means instances in which — Standards for convenient access to * * * * * (1) There is a need for simultaneous network pharmacies. Except as provided (d) * * * use of drugs within a drug grouping in paragraph (a)(7) of this section, a Part (1) * * * because such drugs work in D sponsor (as defined in § 423.4 of this (iii) The PDP sponsor provides the combination with each other; or part) must have a contracted pharmacy individual with a grace period, that is, (2) There is a strong likelihood of network consisting of retail pharmacies an opportunity to pay past due sequential use of drugs within a class or sufficient to ensure that, for premiums in full. The grace period category within a short period of time beneficiaries residing in each State in a must— due to the unique effects the drugs have PDP sponsor’s service area (as defined (A) Be at least 2 months; and on various individuals. in § 423.112(a) of this part), each State (B) Begin on the first day of the month * * * * * in a regional MA-organization’s service for which the premium is unpaid or the area (as defined in § 422.2 of this part), ■ 62. Section 423.104 by— first day of the month following the date the entire service area of a local MA ■ on which premium payment is A. Revising paragraph (b). organization (as defined in § 422.2 of requested, whichever is later. ■ B. Adding a new paragraph (d)(2)(iii). this chapter) or the entire geographic * * * * * The revision and addition read as area of a cost contract (as defined in (5) * * * follows: § 417.401 of this chapter) all of the following requirements are satisfied: (ii) Special rule. If the individual has § 423.104 Requirements related to not moved from the PDP service area, qualified prescription drug coverage. (i) At least 90 percent of Medicare beneficiaries, on average, in urban areas but has been absent from the service * * * * * area for more than 12 consecutive served by the Part D sponsor live within (b) Availability of prescription drug 2 miles of a network pharmacy that is months, the PDP sponsor must disenroll plan. A PDP sponsor offering a the individual from the plan effective on a retail pharmacy or a pharmacy prescription drug plan must offer the described under paragraph (a)(2) of this the first day of the 13th month after the plan— individual left the service area. section. (1) To all Part D eligible beneficiaries (ii) At least 90 percent of Medicare * * * * * residing in the plan’s service area; and beneficiaries, on average, in suburban Subpart C—Benefits and Beneficiary (2) At a uniform premium, with areas served by the Part D sponsor live Protections uniform benefits and level of cost- within 5 miles of a network pharmacy sharing throughout the plan’s service that is a retail pharmacy or a pharmacy ■ 61. Section 423.100 is amended by area. described under paragraph (a)(2) of this adding the definitions of ‘‘Drug category * * * * * section. or class,’’ ‘‘Major or life threatening (d) * * * (iii) At least 70 percent of Medicare clinical consequences,’’ ‘‘Multiple (2) * * * beneficiaries, on average, in rural areas served by the Part D sponsor live within drugs,’’ ‘‘Restricted access,’’ and (iii) Tiered cost sharing under 15 miles of a network pharmacy that is ‘‘Significant need for access to multiple paragraph (d)(2)(ii) of this paragraph a retail pharmacy or a pharmacy drugs’’ to read as follows: may not exceed levels annually described under paragraph (a)(2) of this determined by CMS to be § 423.100 Definitions. section. discriminatory. * * * * * (2) Applicability of some non-retail Drug category or class means, for the * * * * * pharmacies to standards for convenient purpose of § 423.120(b)(2)(v) of the ■ 63. Section 423.112 is amended by access. Part D sponsors may count I/T/ subpart, the identification of a drug revising paragraph (a) to read as follows: U pharmacies and pharmacies operated

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by Federally Qualified Health Centers of the Act) that provides its enrollees at the network pharmacy that is a mail- and Rural Health Centers toward the with access to covered Part D drugs order pharmacy. standards for convenient access to through pharmacies owned and (b) * * * network pharmacies in paragraph (a)(1) operated by the MA organization or cost (1) * * * of this section. contract, provided the organization’s or (ix) Reviews and approves all clinical (3) Access to non-retail pharmacies. A plan’s pharmacy network meets the prior authorization criteria, step therapy Part D sponsor’s contracted pharmacy access standard set forth— protocols, and quantity limit restrictions network may be supplemented by non- (A) At § 422.112 of this chapter for an applied to each covered Part D drug. retail pharmacies, including pharmacies MA organization; or * * * * * offering home delivery via mail-order (B) At § 417.416(e) of this chapter for (3) Transition process. A Part D and institutional pharmacies, provided a cost contract. sponsor must provide for an appropriate the requirements of paragraph (a)(1) of (ii) An MA organization offering a transition process for enrollees this section are met. private fee-for-service plan described in prescribed Part D drugs that are not on (4) Access to home infusion § 422.4 of this chapter that— its Part D plan’s formulary (including pharmacies. A Part D sponsor’s (A) Offers qualified prescription drug Part D drugs that are on a sponsor’s contracted pharmacy network must coverage; and formulary but require prior provide adequate access to home (B) Provides plan enrollees with authorization or step therapy under a infusion pharmacies consistent with access to covered Part D drugs plan’s utilization management rules). written policy guidelines and other dispensed at all pharmacies, without The transition process must: CMS instructions. A Part D plan must regard to whether they are contracted (i) Be applicable to all of the ensure that such network pharmacies, at network pharmacies and without following: a minimum meet all the following charging cost-sharing in excess of that (A) New enrollees into Part D plans requirements: described in § 423.104(d)(2) and (d)(5). following the annual coordinated (i) Are capable of delivering home- (8) Pharmacy network contracting election period. infused drugs in a form that can be requirements. In establishing its (B) Newly eligible Medicare enrollees administered in a clinically appropriate contracted pharmacy network, a Part D from other coverage. fashion. sponsor offering qualified prescription (C) Individuals who switch from one (ii) Are capable of providing infusible drug coverage— plan to another after the start of the Part D drugs for both short-term acute (i) Must contract with any pharmacy contract year. care and long-term chronic care that meets the Part D sponsor’s standard (D) Current enrollees remaining in the therapies. terms and conditions; and (iii) Ensure that the professional plan affected by formulary changes. services and ancillary supplies (ii) May not require a pharmacy to (ii) Ensure access to a temporary necessary for home infusion therapy are accept insurance risk as a condition of supply of drugs within the first 90 days in place before dispensing Part D home participation in the Part D sponsor’s of coverage under a new plan. This 90 infusion drugs. contracted pharmacy network. day timeframe applies to retail, home (iv) Provide delivery of home infusion (9) Differential cost-sharing for infusion, long-term care and mail-order drugs within 24 hours of discharge from preferred pharmacies. A Part D sponsor pharmacies, an acute care setting, or later if so offering a Part D plan that provides (iii) Ensure the provision of a prescribed. coverage other than defined standard temporary fill when an enrollee requests (5) Access to long-term care coverage may reduce copayments or a fill of a non-formulary drug during the pharmacies. A Part D sponsor must offer coinsurance for covered Part D drugs time period specified in paragraph standard contracting terms and obtained through a preferred pharmacy (b)(3)(ii) of this section (including Part conditions, including performance and relative to the copayments or D drugs that are on a plan’s formulary service criteria for long-term care coinsurance applicable for such drugs but require prior authorization or step pharmacies that CMS specifies, to all when obtained through a non-preferred therapy under a plan’s utilization long-term care pharmacies in its service pharmacy. Such differentials are taken management rules). area. The sponsor must provide into account in determining whether the (A) In the outpatient setting, the one- convenient access to long-term care requirements under § 423.104(d)(2) and time, temporary supply of non- pharmacies consistent with written (d)(5) and § 423.104(e) are met. Any formulary Part D drugs (including Part policy guidelines and other CMS cost-sharing reduction under this D drugs that are on a sponsor’s instructions. section must not increase CMS formulary but require prior (6) Access to I/T/U pharmacies. A payments to the Part D plan under authorization or step therapy under a Part D sponsor must offer standard § 423.329. sponsor’s utilization management rules) contracting terms and conditions (10) Level playing field between mail- must be for at least 30 days of conforming to the model addendum that order and network pharmacies. A Part D medication, unless the prescription is CMS develops, to all I/T/U pharmacies sponsor must permit its Part D plan written by a prescriber for less than 30 in its service area. The sponsor must enrollees to receive benefits, which may days and requires the Part D sponsor to provide convenient access to I/T/U include a 90-day supply of covered Part allow multiple fills to provide up to a pharmacies consistent with written D drugs, at any of its network total of 30 days of medication. policy guidelines and other CMS pharmacies that are retail pharmacies. A (B) In the long-term care setting, the instructions. Part D sponsor may require an enrollee temporary supply of non-formulary Part (7) Waiver of pharmacy access obtaining a covered Part D drug at a D drugs (including Part D drugs that are requirements. CMS waives the network pharmacy that is a retail on a sponsor’s formulary but require requirements under paragraph (a)(1) of pharmacy to pay any higher cost-sharing prior authorization or step therapy this section in the case of either of the applicable to that covered Part D drug under a sponsor’s utilization following: at the network pharmacy that is a retail management rules) must be for up to 93 (i) An MA organization or cost pharmacy instead of the cost-sharing days in 31 day supply increments, with contract (as described in section 1876(h) applicable to that covered Part D drug refills provided, if needed, unless a

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lesser amount is actually prescribed by § 423.132 Public disclosure of maximum number of drugs a Part D the prescriber. pharmaceutical prices for equivalent drugs. plan sponsor may require for targeted (iv) Ensure written notice is provided * * * * * enrollment. to each affected enrollee within 3 (c) Waiver of public disclosure (iii) Are likely to incur the following business days after adjudication of the requirement. CMS waives the annual Part D drug costs: temporary fill. requirement under paragraph (a) of this (A) For 2011, costs for covered Part D (v) Ensure that reasonable efforts are section in any of the following cases: drugs greater than or equal to $3,000. made to notify prescribers of affected * * * * * (B) For 2012 and subsequent years, enrollees who receive a transition notice (5) A long-term care network costs for covered Part D drugs in an under paragraph (b)(3)(iv) of this pharmacy. amount greater than or equal to $3000 section. * * * * * increased by the annual percentage (c) * * * (d) Modification of timing specified in § 423.104(d)(5)(iv) of this (2) When processing Part D claims, a requirement. CMS modifies the part. Part D sponsor or its intermediary must requirement under paragraph (b) of this * * * * * comply with the electronic transaction section under circumstances where ■ 68. Section 423.156 is revised to read standards established by 45 CFR CMS deems compliance with this as follows: 162.1102. CMS will issue guidance on requirement to be impossible or the use of conditional fields within such impracticable. § 423.156 Consumer satisfaction surveys. standards. Part D contracts with 600 or more (3) A Part D sponsor must require its Subpart D—Cost Control and Quality enrollees as of July of the prior year network pharmacies to submit claims to Improvement Requirements must contract with approved Medicare Consumer Assessment of Healthcare the Part D sponsor or its intermediary ■ 67. Section 423.153 is amended by— Providers and Systems (CAHPS) survey whenever the card described in ■ A. Adding paragraphs (d)(1)(v) vendors to conduct the Medicare paragraph (c)(1) of this section is through (vii). presented or on file at the pharmacy ■ B. Revising paragraph (d)(2). CAHPS satisfaction survey of Part D unless the enrollee expressly requests The additions and revisions read as plan enrollees in accordance with CMS that a particular claim not be submitted follows: specifications and submit the survey to the Part D sponsor or its data to CMS. intermediary. § 423.153 Drug utilization management, ■ 69. Section 423.165 is amended by— quality assurance, and medication therapy ■ A. Removing paragraph (b)(4). (4) Beginning January 1, 2012, a part management programs (MTMPs). D sponsor must assign and exclusively ■ B. Revising paragraph (f). use a unique— * * * * * The revision reads as follows: (d) * * * (i) Part D BIN or RxBIN and Part D (1) * * * § 423.165 Compliance deemed on the processor control number (RxPCN) (v) Must enroll targeted beneficiaries basis of accreditation. combination in its Medicare line of using an opt-out method of enrollment * * * * * business; and only. (f) Authority. Nothing in this section (ii) Part D cardholder identification (vi) Must target beneficiaries for limits CMS’ authority under subparts K number (RxID) to each Medicare Part D enrollment in the MTMP at least and O of this part, including, but not enrollee to clearly identify Medicare quarterly during each plan year. limited to the ability to impose Part D beneficiaries. (vii) Must offer a minimum level of intermediate sanctions, civil money ■ 65. Section 423.128 is amended by medication therapy management penalties, and terminate a contract with adding a new paragraph (f) to read as services for each beneficiary enrolled in a Part D plan sponsor. follows: the MTMP that includes all of the following: Subpart F—Submission of Bids and § 423.128 Dissemination of Part D plan (A) Interventions for both Monthly Beneficiary Premiums: Plan information. beneficiaries and prescribers. Approval * * * * * (B) Annual comprehensive (f) Disclosure requirements. CMS may medication reviews with written ■ 70. Section 423.265 is amended by require a Part D plan sponsor to disclose summaries. The comprehensive medical revising paragraph (b) to read as follows: to its enrollees or potential enrollees, review must include an interactive, the Part D plan sponsor’s performance person-to-person consultation § 423.265 Submission of bids and related information. and contract compliance deficiencies in performed by a pharmacist or other a manner specified by CMS. qualified provider unless the beneficiary * * * * * ■ is in a long-term care setting. (b) Bid submission—(1) General. Not 66. Section 423.132 is amended by— later than the first Monday in June, each ■ A. Revising the introductory text of (C) Quarterly targeted medication reviews with follow-up interventions potential Part D sponsor must submit paragraph c. bids and supplemental information ■ when necessary. B. In paragraphs (c)(2) and (c)(3), (2) Targeted beneficiaries. Targeted described in this section for each Part D ‘‘ ’’ ‘‘ ’’ removing the ; and adding a . in its beneficiaries for the MTMP described in plan it intends to offer in the subsequent place. paragraph (d)(1) of this section are calendar year. ■ C. In paragraph (c)(4), removing ‘‘; enrollees in the sponsor’s Part D plan (2) Substantial differences between and’’ and adding a ‘‘.’’ in its place. who meet all of the following: bids. Potential Part D sponsors’ bid ■ D. Redesignating paragraph (c)(5) as (i) Have multiple chronic diseases, submissions must reflect differences in (c)(6). with three chronic diseases being the benefit packages or plan costs that CMS ■ E. Adding a new paragraph (c)(5). maximum number a Part D plan sponsor determines to represent substantial ■ F. Revising paragraph (d). may require for targeted enrollment. differences relative to a sponsor’s other The revisions and additions read as (ii) Are taking multiple Part D drugs, bid submissions. In order to be follows: with eight Part D drugs being the

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considered ‘‘substantially different,’’ changed primary payer information to § 423.466 Timeframes for coordination of each bid must be significantly different the CMS Coordination of Benefits benefits. from the sponsor’s other bids with Contractor in accordance with the (a) Retroactive claims adjustments, respect to beneficiary out-of-pocket processes and timeframes specified by underpayment refunds, and costs or formulary structures. CMS. overpayment recoveries. Whenever a * * * * * ■ 74. Section 423.464 is amended by sponsor receives information that necessitates a retroactive claims ■ 71. Section 423.272 is amended by adding new paragraphs (a)(3), (e)(1)(vi), adjustment, the sponsor must process adding a new paragraph (b)(3) to read as (g), and (h) to read as follows: the adjustment and issue refunds or follows: § 423.464 Coordination of benefits with recovery notices within 45 days of the § 423.272 Review and negotiation of bid other providers of prescription drug sponsor’s receipt of complete and approval of plans submitted by coverage. information regarding claims potential Part D sponsors. (a) * * * adjustment. * * * * * (3) Retroactive claims adjustments, (b) Coordination of benefits. Part D (b) * * * underpayment reimbursements, and sponsors must coordinate benefits with (3) Substantial differences between overpayment recoveries as described in SPAPs, other entities providing bids—(i) General. CMS approves a bid paragraph (g) of this section and prescription drug coverage, only if it finds that the benefit package § 423.466(a) of this subpart. beneficiaries, and others paying on the beneficiaries’ behalf for a period not to or plan costs represented by that bid are * * * * * substantially different as provided exceed 3 years from the date on which (e) * * * the prescription for a covered Part D under § 423.265(b)(2) of this subpart (1) * * * from the benefit package or plan costs drug was filled. (vi) Does not engage in midyear plan represented by another bid submitted by or noncalendar year plan enrollment Subpart K—Application Procedures the same Part D sponsor. changes on behalf of a substantial and Contracts With PDP Sponsors (ii) Transition period for PDP number of its members when authorized sponsors with new acquisitions. After a ■ to do so on the beneficiary’s behalf. 76. Section 423.502 is amended by— 2-year transition period, as determined ■ A. Redesignating paragraphs (b) by CMS, CMS approves a bid offered by * * * * * through (d) as (c) through (e), a PDP sponsor (or by a parent (g) Responsibility to account for other respectively organization to that PDP sponsor) that providers of prescription drug coverage ■ B. Adding a new paragraph (b). recently purchased (or otherwise when a retroactive claims adjustment ■ C. Revising newly redesignated acquired or merged with) another Part D creates an overpayment or paragraph (c)(1) introductory text and sponsor if it finds that the benefit underpayment. When a Part D sponsor paragraph (c)(2). package or plan costs represented by makes a retroactive claims adjustment, The addition and revisions reads as that bid are substantially different from the sponsor has the responsibility to follows: account for SPAPs and other entities any benefit package or plan costs § 423.502 Application requirements. represented by another bid submitted by providing prescription drug coverage in the same Part D sponsor (or parent reconciling the claims adjustments that * * * * * (b) Completion of a notice of intent to organization to that Part D sponsor. create overpayments or underpayments. In carrying out these reimbursements apply. (1) An organization submitting an * * * * * and recoveries, Part D sponsors must application under this section for a particular contract year must first Subpart G—Payments to Part D Plan also account for payments made and for submit a completed Notice of Intent to Sponsors for Qualified Prescription amounts being held for payment by Apply by the date established by CMS. Drug Coverage other individuals or entities. Part D sponsors must have systems to track and CMS will not accept applications from § 423.308 [Amended] report adjustment transactions and to organizations that do not submit a ■ support all of the following: timely Notice of Intent to Apply. 72. Section 423.308 is amended in (2) Submitting a Notice of Intent to paragraph (1) of the definition of ‘‘gross (1) Adjustments involving payments by other plans and programs providing Apply does not bind that organization to covered prescription drug costs’’ by submit an application for the applicable removing the phrase ‘‘The share of prescription drug coverage have been made. contract year. negotiated prices’’ and adding in its (3) An organization’s decision not to place ‘‘The share of actual costs’’. (2) Reimbursements for excess cost- submit an application after submitting sharing and premiums for low-income Subpart J—Coordination Under Part D an Notice of Intent to Apply will not subsidy eligible individuals have been form the basis of any action taken Plans With Other Prescription Drug processed in accordance with the Coverage against the organization by CMS. requirements in § 423.800(c). (c) * * * (3) Recoveries of erroneous payments ■ (1) In order to obtain a determination 73. Section 423.462 is amended by— for enrollees as specified in ■ A. Redesignating the existing text as on whether it meets the requirements to § 423.464(f)(4) have been sought. become a Part D plan sponsor, an entity, paragraph (a). (h) Reporting requirements. A Part D ■ B. Adding a paragraph heading for or an individual authorized to act for sponsor must report credible new or the entity (the applicant), must fully paragraph (a) and new paragraph (b). changed supplemental prescription drug The additions read as follows: complete all parts of a certified coverage information to the CMS application in the form and manner § 423.462 Medicare secondary payer Coordination of Benefits Contractor in required by CMS, including the procedures. accordance with the processes and following: (a) General rule. *** timeframes specified by CMS. * * * * * (b) Reporting requirements. A Part D ■ 75. A new § 423.466 is added to (2) The authorized individual must sponsor must report credible new or subpart J to read as follows: describe thoroughly how the entity is

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qualified to meet the all requirements ■ A. Revising paragraph (b)(4)(vi) the compliance program, including described in this part. ■ B. Redesignating paragraph (b)(6) as issues identified, investigated, and * * * * * paragraph (b)(7). resolved by the compliance program. ■ C. Adding a new paragraph (b)(6). (3) The governing body of the Part D ■ 77. Section 423.503 is amended by— The revision and addition read as plan sponsor must be knowledgeable ■ A. Revising paragraphs (a)(1), (a)(2), follows: about the content and operation of the and (b). compliance program and must exercise ■ B. Adding a new paragraph (c)(2)(iii). § 423.504 General provisions. reasonable oversight with respect to the ■ C. Revising paragraph(c)(3)(iii). * * * * * implementation and effectiveness of the ■ D. Removing paragraph (d). (b) * * * compliance programs. The revisions and addition read as (4) * * * (C)(1) Each Part D plan sponsor must follows: (vi) Adopt and implement an effective establish, implement and provide § 423.503 Evaluation and determination compliance program, which must effective training and education for its procedures for applications to be include measures that prevent, detect, employees including, the chief determined qualified to act as a sponsor. and correct noncompliance with CMS’ executive and senior administrators or (a) * * * program requirements as well as managers; governing body members; (1) With the exception of evaluations measures that prevent, detect, and and first tier, downstream, and related conducted under paragraph (b) of this correct fraud, waste, and abuse. The entities. section, CMS evaluates an entity’s compliance program must, at a (2) The training and education must application solely on the basis of minimum, include the following core occur at a least annually and be a part information contained in the requirements: of the orientation for new employees (A) Written policies, procedures, and application itself and any additional including, the chief executive and standards of conduct that— information that CMS obtains through senior administrators or managers; (1) Articulate the Part D plan on-site visits. governing body members; and first tier, sponsor’s commitment to comply with (2) After evaluating all relevant downstream, and related entities. all applicable Federal and State information, CMS determines whether (3) First tier, downstream, and related standards; entities who have met the fraud, waste, the application meets all the (2) Describe compliance expectations requirements described in this part. and abuse certification requirements as embodied in the standards of through enrollment into the Medicare (b) Use of information from a current conduct; or prior contract. If a Part D plan program or accreditation as a Durable (3) Implement the operation of the Medical Equipment, Prosthetics, sponsor fails during the 14 months compliance program; preceding the deadline established by Orthotics, and Supplies (DMEPOS) are (4) Provide guidance to employees deemed to have met the training and CMS for the submission of contract and others on dealing with potential qualification applications (or in the case educational requirements for fraud, compliance issues; waste, and abuse. of a fallback entity, the previous 3-year (5) Identify how to communicate contract) to comply with the (D) Establishment and compliance issues to appropriate implementation of effective lines of requirements of the Part D program compliance personnel; under any current or prior contract with communication, ensuring (6) Describe how potential confidentiality, between the compliance CMS under title XVIII of the Act or fails compliance issues are investigated and to complete a corrective action plan officer, members of the compliance resolved by the Part D plan sponsor; and committee, the Part D plan sponsor’s during the 14 months preceding the (7) Include a policy of non- deadline established by CMS for the employees, managers and governing intimidation and non-retaliation for body, and the Part D plan sponsor’s first submission of contract qualification good faith participation in the applications, CMS may deny an tier, downstream, and related entities. compliance program, including but not Such lines of communication must be application based on the applicant’s limited to reporting potential issues, failure to comply with the requirements accessible to all and allow compliance investigating issues, conducting self- issues to be reported including a of the Part D program under any current evaluations, audits and remedial or prior contract with CMS even if the method for anonymous and confidential actions, and reporting to appropriate good faith reporting of potential applicant currently meets all of the officials. requirements of this part. compliance issues as they are identified. (B) The designation of a compliance (E) Well-publicized disciplinary (c) * * * officer and a compliance committee standards through the implementation (2) * * * who report directly and are accountable of procedures which encourage good (iii) If CMS does not receive a revised to the Part D plan sponsor’s chief faith participation in the compliance application within 10 days from the executive or other senior management. program by all affected individuals. date of the notice, or if after timely (1) The compliance officer, vested These standards must include policies submission of a revised application, with the day-to-day operations of the that— CMS still finds the applicant does not compliance program, must be an (1) Articulate expectations for appear qualified to contract as a Part D employee of the Part D plan sponsor, reporting compliance issues and assist plan sponsor or has not provided parent organization or corporate in their resolution; enough information to allow CMS to affiliate. The compliance officer may not (2) Identify non-compliance or evaluate the application, CMS denies be an employee of the Part D plan unethical behavior; and the application. sponsor’s first tier, downstream or (3) Provide for timely, consistent, and (3) * * * related entity. effective enforcement of the standards (iii) The applicant’s right to request a (2) The compliance officer and the when non-compliance or unethical hearing in accordance with the compliance committee must behavior is determined. procedures specified in subpart N of periodically report directly to the (F) Establishment and implementation this part. governing body of the Part D plan of an effective system for routine ■ 78. Section 423.504 is amended by— sponsor on the activities and status of monitoring and identification of

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compliance risks. The system should identifiable information of Medicare section’’ and add the reference include internal monitoring and audits enrollees; ‘‘paragraph (b)(2)(ii) of this section’’ in and, as appropriate, external audits, to (iii) The facilities of the Part D its place. evaluate the Part D plan sponsors, sponsor to include computer and other ■ H. Revising paragraph (b)(3). including first tier entities’, compliance electronic systems; and The revisions and addition read as with CMS requirements and the overall * * * * * follows: effectiveness of the compliance (f) * * * § 423.507 Nonrenewal of a contract. program. (3) All data elements included in all (G) Establishment and its drug claims for purposes deemed (a) * * * implementation of procedures and a necessary and appropriate by the (2) * * * system for promptly responding to Secretary, including, but not limited to (ii) Each Medicare enrollee by mail at compliance issues as they are raised, the following: least 90 calendar days before the date on which the nonrenewal is effective. The investigating potential compliance * * * * * sponsor must also provide information problems as identified in the course of (i) * * * about alternative enrollment options by self-evaluations and audits, correcting (2) * * * such problems promptly and thoroughly (i) HHS, the Comptroller General, or doing one or more of the following: to reduce the potential for recurrence, their designees have the right to audit, (A) Provide a CMS approved written and ensure ongoing compliance with evaluate, and inspect any books, description of alternative MA plan and CMS requirements. contracts, computer or other electronic PDP options available for obtaining (1) If the Part D sponsor discovers systems, including medical records and qualified prescription drug coverage evidence of misconduct related to documentation of the first tier, within the beneficiaries’ region. payment or delivery of prescription downstream, and related entities related (B) Place outbound calls to all affected drug items or services under the to CMS’ contract with the Part D enrollees to ensure beneficiaries know contract, it must conduct a timely, sponsor. who to contact to learn about their enrollment options. reasonable inquiry into that conduct; * * * * * (2) The Part D sponsor must conduct (m)(1) * * * * * * * * appropriate corrective actions (for (iii) * * * (b) * * * example, repayment of overpayments (C) Plan identifier elements on the (1) * * * and disciplinary actions against claim are encrypted or unavailable for (iii) The contract must be nonrenewed responsible individuals) in response to release to external entities with the as to an individual PDP if that plan does the potential violation referenced above. exception of HHS grantees that CMS not have a sufficient number of (3) The Part D plan sponsor should determines meet all of the following enrollees to establish that it is a viable have procedures to voluntarily self- criteria: independent plan option. report potential fraud or misconduct (1) The plan identifier is essential to (2) * * * related to the Part D program to CMS or the study. (ii) To each of the Part D plan its designee. (2) The study is key to the mission of sponsor’s Medicare enrollees by mail at * * * * * the sponsoring agency. least 90 calendar days before the date on (6) Not have terminated a contract by (3) The study provides significant which the nonrenewal is effective, or at mutual consent under which, as a benefit to the Medicare program. the conclusion of the appeals process if condition of the consent, the Part D plan (4) The requestor attests that any applicable. sponsor agreed that it was not eligible public findings or publications will not * * * * * to apply for new contracts or service identify plans. (3) Opportunity to develop and area expansions for a period up to 2 * * * * * implement a corrective action plan. (i) years per § 423.508(e) of this subpart. (n)(1) CMS may determine that a Part Before providing a notice of intent of * * * * * D plan sponsor is out of compliance nonrenewal of the contract, CMS will ■ 79. Section 423.505 is amended by— with a Part D requirement when the provide the Part D plan sponsor with ■ A. Redesignating paragraph (e)(1)(ii) sponsor fails to meet performance notice specifying the Part D sponsor’s and (e)(1)(iii) as paragraph (e)(1)(iii) and standards articulated in the Part D deficiencies and reasonable opportunity (e)(1)(iv), respectively. statutes, regulations, or guidance. of at least 30 calendar days to develop ■ B. Adding a new paragraph (e)(1)(ii). (2) If CMS has not already articulated and implement a corrective action plan ■ C. Revising newly redesignated a measure for determining to correct the deficiencies. paragraph (e)(1)(iii). noncompliance, CMS may determine (ii) The Part D plan sponsor is solely ■ D. Revising paragraph (f)(3) that a Part D sponsor is out of responsible for the identification, introductory text. compliance when its performance in development, and implementation of its ■ E. Revising paragraphs (i)(2)(i) and fulfilling Part D requirements represents corrective action plan and for (m)(1)(iii)(C). an outlier relative to the performance of demonstrating to CMS that the ■ F. Add a new paragraph (n). other Part D sponsors. underlying deficiencies have been The additions and revisions read as ■ 80. Section 423.507 is amended by— corrected within the time period follows: ■ A. Revising paragraph (a)(2)(ii) specified by CMS in the notice ■ B. Removing paragraph (a)(2)(iii). requesting corrective action. § 423.505 Contract provisions. ■ C. Adding a new paragraph (b)(1)(iii). * * * * * * * * * * ■ D. Revising paragraph (b)(2)(ii). ■ 81. Section 423.508 is amended by (e) * * * ■ E. Removing (b)(2)(iii). adding a new paragraph (e) to read as (1) * * * ■ F. Redesignating paragraph (b)(2)(iv) follows: (ii) Compliance with CMS as (b)(2)(iii). requirements for maintaining the ■ G. In newly redesignated paragraph § 423.508 Modification or termination of privacy and security of protected health (b)(2)(iii), removing the reference contract by mutual consent. information and other personally ‘‘paragraphs (b)(2)(ii) and (iii) of this * * * * *

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(e) Agreement to limit new Part D and waste program requirements as opportunity to develop and implement applications. As a condition of the specified in subparts D and K of this a corrective action plan prior to consent to a mutual termination, CMS part. termination if— will require, as a provision of the (11) Fails to comply with the (i) CMS determines that a delay in termination agreement language regulatory requirements contained in termination, resulting from compliance prohibiting the Part D plan sponsor from this part. with the procedures provided in this applying for new contracts or service (12) Fails to meet CMS performance part prior to termination, would pose an area expansions for a period up to 2 requirements in carrying out the imminent and serious risk to the health years, absent circumstances warranting regulatory requirements contained in of the individuals enrolled with the Part special consideration. this part. D plan sponsor; ■ 82. Amend § 423.509 by— (b) Notice. If CMS decides to (ii) The Part D plan sponsor ■ A. Revising paragraphs (a), paragraph terminate a contract it gives notice of experiences financial difficulties so (b) introductory text, and paragraph the termination as follows: severe that its ability to make necessary (b)(2)(i). * * * * * health services available is impaired to ■ B. Redesignating paragraphs (b)(2)(ii) (2) Expedited termination of contract the point of posing an imminent and and (b)(2)(iii) as (b)(2)(iii) and (b)(2)(iv), by CMS. (i) The procedures specified in serious risk to the health of its enrollees, respectively. (b)(1) of this section do not apply if— or otherwise fails to make services ■ C. Adding a new paragraph (b)(2)(ii). (A) CMS determines that a delay in available to the extent that such a risk ■ D. Revising paragraph (c). termination, resulting from compliance to health exists; or The revisions and addition read as with the procedures provided in this (iii) The contract is being terminated follows: part prior to termination, would pose an based on the violation specified in (a)(4) § 423.509 Termination of contract by CMS. imminent and serious risk to the health of this section. of the individuals enrolled with the Part * * * * * (a) Termination by CMS. CMS may at D plan sponsor; ■ any time terminate a contract if CMS (B) The Part D plan sponsor 83. Section 423.514 is amended by— ■ determines that the Part D plan sponsor experiences financial difficulties so A. Revising the section heading. meets any of the following: severe that its ability to make necessary ■ B. Adding a new paragraph (g). (1) Has failed substantially to carry health services available is impaired to The revision and addition to read as out the contract. the point of posing an imminent and follows: (2) Is carrying out the contract in a serious risk to the health of its enrollees, manner that is inconsistent with the § 423.514 Validation of Part D reporting or otherwise fails to make services efficient and effective administration of requirements. available to the extent that such a risk this part. * * * * * to health exists; or (3) No longer substantially meets the (C) The contract is being terminated (g) Data validation. Each Part D applicable conditions of this part. based on the violation specified in sponsor must subject information (4) Based on credible evidence, has paragraph (a)(4) of this section. collected under paragraph (a) of this committed or participated in false, (ii) CMS notifies the MA organization section to a yearly independent audit to fraudulent, or abusive activities in writing that its contract will be determine its reliability, validity, affecting the Medicare, Medicaid, or terminated on a date specified by CMS. completeness, and comparability in other State or Federal health care If a termination in is effective in the accordance with specifications programs, including submission of false middle of a month, CMS has the right developed by CMS. or fraudulent data. (5) Substantially fails to comply with to recover the prorated share of the Subpart L—Effect of Change of the requirements in subpart M of this capitation payments made to the Part D Ownership or Leasing of Facilities part relating to grievances and appeals. plan sponsor covering the period of the During Term of Contract (6) Fails to provide CMS with valid month following the contract risk adjustment, reinsurance and risk termination. ■ 84. Section 423.551 is amended by corridor related data as required under * * * * * adding a new paragraph (g) to read as § 423.322 and § 423.329 (or, for fallback (c) Opportunity to develop and follows: implement a corrective action plan—(1) entities, fails to provide the information § 423.551 General provisions. in § 423.871(f)). General. (i) Before providing a notice of (7) Substantially fails to comply with intent to terminate the contract, CMS * * * * * the service access requirements in will provide the Part D plan sponsor (g) Sale of beneficiaries not permitted. § 423.120. with notice specifying the Part D plan (1) CMS will only recognize the sale or (8) Substantially fails to comply with sponsor’s deficiencies and a reasonable transfer of an organization’s entire PDP either of the following: opportunity of at least 30 calendar days line of business, consisting of all PDP (i) Marketing requirements in subpart to develop and implement a corrective contracts held by the PDP sponsor with V of this part. action plan to correct the deficiencies. the exception of the sale or transfer of (ii) Information dissemination (ii) The Part D plan sponsor is solely a full contract between wholly owned requirements of § 423.128 of this part. responsible for the identification, subsidiaries of the same parent (9) Substantially fails to comply with development, and implementation of its organization which will be recognized the coordination with plans and corrective action plan and for and allowed by CMS. programs that provide prescription drug demonstrating to CMS that the (2) CMS will not recognize or allow a coverage as described in subpart J of this underlying deficiencies have been sale or transfer that consists solely of the part. corrected within the time period sale or transfer of individual (10) Substantially fails to comply with specified by CMS in the notice beneficiaries, groups of beneficiaries the cost and utilization management, requesting corrective action. enrolled in a pharmacy benefit package, quality improvement, medication (2) Exceptions. The Part D plan or one contract if the sponsor holds therapy management and fraud, abuse sponsor will not be provided with an more than one PDP contract.

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Subpart M—Grievances, Coverage (1) Use approved notice language in a (2) If the determination is not Determinations, and Appeals readable and understandable form. completely favorable to the enrollee, the (2) State the specific reasons for the notice must— ■ 85. Section 423.568 is revised to read denial. (i) Use approved language in a as follows: (i) For drug coverage denials, describe readable and understandable form; both the standard and expedited (ii) State the specific reasons for the § 423.568 Standard timeframe and notice denial; requirements for coverage determinations. redetermination processes, including the enrollee’s right to, and conditions (iii) Inform the enrollee of his or her (a) Method and place for filing a for, obtaining an expedited right to a redetermination; request. An enrollee must ask for a redetermination and the rest of the (iv) Describe— standard coverage determination by (A) Both the standard and expedited appeals process. making a request with the Part D plan redetermination processes, including (ii) For payment denials, describe the sponsor in accordance with the the enrollee’s right to request an standard redetermination process and following: expedited redetermination; (1) Except as specified in paragraph the rest of the appeals process. (B) Conditions for obtaining an (a)(2) of this section, the request may be (3) Inform the enrollee of his or her expedited redetermination; and made orally or in writing. right to a redetermination. (C) Other aspects of the appeal (2) Requests for payment must be (4) Comply with any other notice process. requirements specified by CMS. made in writing (unless the Part D plan * * * * * (h) Effect of failure to meet the sponsor has implemented a voluntary ■ 88. Section 423.590 is amended by— adjudicatory timeframes. If the Part D policy of accepting oral payment ■ A. Redesignating paragraph (d)(2) as plan sponsor fails to notify the enrollee requests). paragraph (d)(3). (3) The Part D plan sponsor must of its determination in the appropriate ■ B. Adding a new paragraph (d)(2). establish and maintain a method of timeframe under paragraphs (b) or (c) of ■ C. Revising the introductory text of documenting all oral requests and retain this section, the failure constitutes an paragraph (g). the documentation in the case file. adverse coverage determination, and the ■ D. Adding a new paragraph (h). (b) Timeframe for requests for drug plan sponsor must forward the The revisions and additions read as benefits. When a party makes a request enrollee’s request to the IRE within 24 follows: for a drug benefit, the Part D plan hours of the expiration of the adjudication timeframe. § 423.590 Timeframes and responsibility sponsor must notify the enrollee (and for making redeterminations. the prescribing physician or other ■ 86. Section 423.570 is amended by prescriber involved, as appropriate) of revising paragraph (d)(1) to read as * * * * * (d) * * * its determination as expeditiously as the follows: (2) Confirmation of oral notice. If the enrollee’s health condition requires, but Part D plan sponsor first notifies an no later than 72 hours after receipt of § 423.570 Expediting certain coverage determinations. enrollee of an adverse or favorable the request, or, for an exceptions expedited redetermination orally, it request, the physician’s or other * * * * * must mail written confirmation to the prescriber’s supporting statement. (d) * * * enrollee within 3 calendar days of the (c) Timeframe for requests for (1) Make the determination within the oral notification. payment. When a party makes a request 72-hour timeframe established in for payment, the Part D plan sponsor § 423.568(b) for a standard * * * * * must notify the enrollee of its determination. The 72-hour period (g) Form and content of an adverse determination and make payment (when begins on the day the Part D plan redetermination notice. The notice of applicable) no later than 14 calendar sponsor receives the request for any adverse determination under days after receipt of the request. expedited determination, or, for an paragraphs (a)(2), (b)(2), (d)(1) or (d)(2) (d) Written notice for favorable exceptions request, the physician’s or of this section must— decisions by a Part D plan sponsor. If a other prescriber’s supporting statement. * * * * * Part D plan sponsor makes a completely * * * * * (h) Form and content of a completely favorable redetermination notice. The favorable decision under paragraph (b) ■ 87. Section 423.572 is amended by notice of any completely favorable of this section, it must give the enrollee revising paragraphs (b) and (c) to read determination under paragraphs (a)(1), written notice of the determination. The as follows: initial notice may be provided orally, so (d)(1) or (d)(2) of this section must long as a written follow-up notice is § 423.572 Timeframes and notice explain the conditions of the approval sent within 3 calendar days of the oral requirements for expedited coverage in a readable and understandable form. notification. determinations. Subpart N—Medicare Contract (e) Form and content of the approval * * * * * Determinations and Appeals notice. The notice of any approval (b) Confirmation of oral notice. If the under paragraph (d) of this section must Part D plan sponsor first notifies an ■ 89. Section 423.642 is amended by explain the conditions of the approval enrollee of an adverse or favorable revising paragraph (c) to read as follows: in a readable and understandable form. expedited determination orally, it must (f) Written notice for denials by a Part mail written confirmation to the § 423.642 Notice of contract determination. D plan sponsor. If a Part D plan sponsor enrollee within 3 calendar days of the * * * * * decides to deny a drug benefit, in whole oral notification. (c) CMS-initiated terminations—(1) or in part, it must give the enrollee (c) Content of the notice of expedited General rule. Except as provided in written notice of the determination. determination. (1) If the determination (c)(2) of this section, CMS mails notice (g) Form and content of the denial is completely favorable to the enrollee, to the Part D plan sponsor 90 calendar notice. The notice of any denial under the notice must explain the conditions days before the anticipated effective paragraph (f) of this section must meet of the approval in a readable and date of the termination. the following requirements: understandable form.

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(2) Exception. If a contract is enter into a contract with CMS must be (3) Additional extensions may be terminated in accordance with issued by September 1 for the contract granted at the discretion of the hearing § 423.509(b)(2)(i) of this part, CMS in question to be effective on January 1 officer. notifies the Part D plan sponsor of the of the following year. ■ 94. Section 423.658 is amended by date that it will terminate the Part D ■ 91. Section 423.651 is amended by revising paragraph (d) to read as plan sponsor’s contract. revising paragraphs (a) and (b) to read follows: * * * * * as follows: § 423.658 Conduct of hearing. ■ 90. Section 423.650 is revised to read § 423.651 Request for hearing. as follows: * * * * * (a) Method and place for filing a (d) The Part D sponsor bears the § 423.650 Right to a hearing, burden of request. (1) A request for a hearing must burden of going forward and must first proof, standard of proof, and standards of be made in writing and filed by an present evidence and argument before review. authorized official of the contract CMS presents its evidence and (a) Right to a hearing. The following applicant or Part D plan sponsor that argument. parties are entitled to a hearing: was the party to the determination ■ (1) A contract applicant that has been under the appeal. 95. Section 423.661 is revised to read as follows: determined to be unqualified to enter (2) The request for the hearing must into a contract with CMS under Part D be filed in accordance with the § 423.661 Witnesses lists and documents. of Title XVIII of the Act in accordance requirements specified in the notice. with § 423.502 and § 423.503 of this Witness lists and documents must be (b) Time for filing a request. A request part. identified and exchanged at least 5 (2) A Part D sponsor whose contract for a hearing must be filed within 15 calendar days prior to the scheduled has been terminated under § 423.509 of calendar days after the receipt of the hearing. notice of the contract determination or this part. ■ (3) A Part D sponsor whose contract intermediate sanction. 96. Section 423.666 is amended by has not been renewed in accordance * * * * * revising paragraphs (a) and (c) to read as follows: with § 423.507 of this part. ■ 92. Section 423.652 is amended by (4) A Part D sponsor who has had an revising paragraph (b)(2) to read as § 423.666 Review by the Administrator. intermediate sanction imposed in follows: (a) Request for review by accordance with § 423.752(a) and (b) of Administrator. CMS or a Part D plan this part. § 423.652 Postponement of effective date (b) Burden of proof, standard of proof, of a contract determination when a request sponsor that has received a hearing and standard of review at hearing. (1) for a hearing is filed timely. decision may request a review by the During a hearing to review a contract * * * * * Administrator within 15 calendar days determination as described at (b) * * * after receipt of the hearing decision as provided under § 423.665(b) of this § 423.641(a) of this subpart, the (2) A contract terminated in subpart. Both the Part D plan sponsor applicant has the burden of proving by accordance with § 423.509(b)(2)(i) of and CMS may provide written a preponderance of the evidence that this part will be terminated on the date arguments to the Administrator for CMS’ determination was inconsistent specified by CMS and will not be review. with the requirements of § 423.502 and postponed if a hearing is requested. * * * * * § 423.503 of this part. * * * * * (c) Notification of Administrator (2) During a hearing to review a ■ contract determination as described at 93. Section 423.655 is revised to read determination. The Administrator § 423.641(b) of this part, the Part D plan as follows: notifies both parties of his or her sponsor has the burden of proving by a § 423.655 Time and place of hearing. determination regarding review of the hearing decision within 30 calendar preponderance of the evidence that (a) The hearing officer— CMS’ determination was inconsistent days after receipt of request for review. (1) Fixes a time and place for the with the requirements of § 423.507 of If the Administrator declines to review hearing, which is not to exceed 30 this part. the hearing decision or the (3) During a hearing to review a calendar days after the receipt of request Administrator does not make a contract determination as described at for the hearing; determination regarding review within § 423.641(c) of this subpart, the Part D (2) Sends written notice to the parties 30 calendar days, the decision of the plan sponsor has the burden of proving that informs the parties of the general hearing officer is final. and specific issues to be resolved, the by a preponderance of the evidence that * * * * * burden of proof, and information about CMS’ determination was inconsistent ■ 97. Section 423.668 is amended by with the requirements of § 423.509 of the hearing procedure. (b)(1) The hearing officer may, on his revising the section heading and the this part. paragraph heading for paragraph (a) to (4) During a hearing to review the or her own motion, change the time and read as follows: imposition of an intermediate sanction place of the hearing. as described at § 423.750 of this part, the (2) The hearing officer may adjourn or § 423.668 Reopening of a contract Part D sponsor has the burden of postpone the hearing. determination or decision of a hearing proving by a preponderance of the (c)(1) The Part D plan sponsor or CMS officer or the Administrator. evidence that CMS’ determination was may request an extension by filing a (a) Contract determination. *** inconsistent with the requirements of written request no later than 10 calendar * * * * * § 423.752 of this part. days prior to the scheduled hearing. (c) Timing of favorable decision. (2) When either the Part D plan Subpart O—Intermediate Sanctions Notice of any decision favorable to the sponsor or CMS requests an extension Part D sponsor appealing a the hearing officer will provide a one- ■ 98. Section 423.750 is amended by determination that it is not qualified to time 15-calendar day extension. revising paragraph (a) to read as follows:

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§ 423.750 Types of intermediate sanctions § 423.756 Procedures for imposing Subpart P—Premium and Cost-Sharing and civil money penalties. intermediate sanctions and civil money Subsidies for Low-Income Individuals (a) The following intermediate penalties. sanctions may be imposed and will * * * * * ■ 101. Section 423.773 by revising continue in effect until CMS is satisfied (b) Hearing. (1) The Part D plan paragraph (c)(2) to read as follows: that the deficiencies that are the basis sponsor may request a hearing before a § 423.773 Requirements for eligibility. for the sanction determination have CMS hearing officer. * * * * * been corrected and are not likely to (2) A written request must be received (c) * * * recur: by the designated CMS office within 15 (2) CMS notifies an individual treated (1) Suspension of the Part D plan calendar days after the receipt of the as a full-subsidy eligible under this sponsor’s enrollment of Medicare notice. paragraph (c) that he or she does not beneficiaries. (3) A request for a hearing under need to apply for the subsidies under (2) Suspension of payment to the Part § 423.650 of this part does not delay the this subpart, and, at a minimum, is D plan sponsor for Medicare date specified by CMS when the deemed eligible for a full subsidy as beneficiaries enrolled after the date sanction becomes effective. follows: CMS notifies the organization of the (4) The Part D plan sponsor must (i) For an individual deemed eligible intermediate sanction. follow the right to a hearing procedure between January 1 and June 30 of a (3) Suspension of all marketing as specified at § 423.650 through calendar year, the individual is deemed activities to Medicare beneficiaries by a § 423.662 of this part. eligible for a full subsidy for the Part D plan sponsor. (c) * * * remainder of the calendar year. * * * * * (1) Effective date. The effective date of (ii) For an individual deemed eligible ■ 99. Section 423.752 is amended by the sanction is the date specified by between July 1 and December 31 of a revising the paragraphs (a) introductory CMS in the notice. calendar year, the individual is deemed text, (a)(1), (a)(3), and (a)(4) to read as * * * * * eligible for the remainder of the follows: calendar year and the following (3) Duration of sanction. The sanction calendar year. § 423.752 Basis for imposing intermediate remains in effect until CMS is satisfied sanctions and civil money penalties. that the deficiencies that are the basis * * * * * ■ 102. Section 423.800 is amended by (a) All intermediate sanctions. For the for the sanction determination have adding a new paragraph (e) to read as violations listed in this paragraph (a), been corrected and are not likely to follows: CMS may impose one or more of the recur. sanctions specified in § 423.750(a) of (i) CMS may require that the Part D § 423.800 Administration of subsidy this subpart on any Part D plan sponsor plan sponsor hire an independent program. with a contract. The Part D plan sponsor auditor to provide CMS with additional * * * * * may also be subject to other remedies information to determine if the (e) Timeframe for refunds and authorized under law. deficiencies that are the basis for the recoveries due to retroactive (1) Fails substantially to provide sanction determination have been adjustments to cost sharing. Sponsors medically necessary items and services corrected and are not likely to recur. must process retroactive adjustments to that are required (under law or under The independent auditor must work in cost-sharing for low-income subsidy the contract) to be provided to an accordance with CMS specifications and eligible individuals and any resulting individual covered under the contract, if must be willing to attest that a complete refunds and recoveries in accordance the failure has adversely affected (or has and full independent review has been with the timeframe specified in the substantial likelihood of adversely performed. § 423.466(a) of this part. affecting) the individual. (ii) In instances where marketing or * * * * * enrollment or both intermediate Subpart V—Part D Marketing Requirements (3) Acts to expel or refuses to re-enroll sanctions have been imposed, CMS may require a Part D plan sponsor to market a beneficiary in violation of the ■ 103. Section 423.2260 is amended by provisions of this part. or to accept enrollments or both for a limited period of time in order to assist revising paragraph (5)(vii) of the (4) Engages in any practice that would CMS in making a determination as to definition ‘‘marketing materials’’ and reasonably be expected to have the whether the deficiencies that are the adding a new paragraph (6) to read as effect of denying or discouraging bases for the intermediate sanctions follows: enrollment (except as permitted by this have been corrected and are not likely part) by eligible individuals with the § 423.2260 Definitions concerning to recur. organization whose medical condition marketing materials. or history indicates a need for (A) If, following this time period, * * * * * substantial future medical services. CMS determines the deficiencies have Marketing materials. *** not been corrected or are likely to recur, * * * * * (5) * * * the intermediate sanctions will remain (vii) Membership activities (for ■ 100. Section 423.756 is amended by— in effect until such time that CMS is example, materials on rules involving ■ A. Revising paragraph (b). assured the deficiencies have been non-payment of premiums, ■ B. Removing paragraph (c). corrected and are not likely to recur. confirmation of enrollment or ■ C. Redesignating paragraphs (d) (B) The Part D plan sponsor does not disenrollment, or nonclaim-specific through (f) as paragraphs (c) through (e), have a right to a hearing under notification information). respectively. § 423.650(a)(4) of this subpart to (6) Marketing materials exclude ad ■ D. Revising the newly redesignated challenge CMS’ determination to keep hoc enrollee communications materials, paragraphs (c)(1) and (c)(3). the intermediate sanctions in effect. meaning informational materials that— The revisions read as follows: * * * * * (i) Are targeted to current enrollees;

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(ii) Are customized or limited to a (c) Standardized model marketing (g) The QIO must disclose to CMS subset of enrollees or apply to a specific materials. When specified by CMS, quality review study information situation; organizations must use standardized collected as part of the Reporting (iii) Do not include information about formats and language in model Hospital Quality Data for Annual the plan’s benefit structure; and materials. Payment Update program, under section (iv) Apply to a specific situation or (d) Ad hoc enrollee communication 1886(b)(3)(B)(viii) of the Act following cover member-specific claims materials. Ad hoc enrollee hospital review of the data. The quality processing or other operational issues. communication materials may be review study information must include reviewed by CMS, which may upon identifiers of MA plan beneficiaries, ■ 104. Section 423.2262 is amended review determine that such materials hospitals, practitioners, and services by— must be modified, or may not longer be when CMS requests this information for ■ A. Revising paragraph (a)(1)(i). used. the sole purpose of conducting activities ■ B. Adding new paragraphs (c) and (d) related to MA organizations as PART 480—ACQUISITION, described in § 422.153 of this chapter. to read as follows: PROTECTION, AND DISCLOSURE Authority: § 423.2262 Review and distribution of QUALITY IMPROVEMENT marketing materials. ORGANIZATION REVIEW (Catalog of Federal Domestic Assistance INFORMATION Program No. 93.773, Medicare—Hospital (a) * * * Insurance; and Program No. 93.774, (1) * * * ■ 105. The authority citation for part Medicare—Supplementary Medical (i) At least 45 days (or 10 days if using 480 continues to read as follows: Insurance Program) certain types of marketing materials that Authority: Secs. 1102 and 1871 of the Dated: March 11, 2010. use, without modification, proposed Social Security Act (42 U.S.C. 1302 and Charlene Frizzera, model language and format, including 1395hh). standardized language and formatting, Acting Administrator, Centers for Medicare ■ 106. Section 480.140 is amended by & Medicaid Services. as specified by CMS) before the date of adding a new paragraph (g) to read as distribution, the Part D sponsor submits Approved: April 2, 2010. follows: the material or form to CMS for review Kathleen Sebelius, under the guidelines in § 423.2264 of § 480.140 Disclosure of quality review Secretary. this subpart; and study information. [FR Doc. 2010–7966 Filed 4–6–10; 4:15 pm] * * * * * * * * * * BILLING CODE 4120–01–P

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Part III

Department of the Interior 48 CFR Chapter 14 Acquisition Regulation Rewrite; Interim Final Rule

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DEPARTMENT OF THE INTERIOR rule does not impose any new 4. Small Business Regulatory requirements on DOI contractors. All Enforcement Fairness Act (SBREFA) Office of the Secretary changes are minor and are consistent This rule is not a major rule under 5 with the FAR. We are providing an 48 CFR Chapter 14 U.S.C. 804(2), the Small Business opportunity for the public to comment Regulatory Enforcement Fairness Act. RIN 1093–AA11 on this interim rule and will carefully This rule: consider and respond to any comments a. Does not have an annual effect on that we receive. We have found good Acquisition Regulation Rewrite the economy of $100 million or more. cause to publish this rule without prior b. Will not cause a major increase in AGENCY: Office of the Secretary, Interior. proposal. We have determined that it costs or prices for consumers, ACTION: Interim final rule. would be impracticable, unnecessary, individual industries, Federal, State, or and contrary to the public interest to SUMMARY: The Department of the local government agencies, or delay publication of this rule in final Interior (DOI) is taking interim final geographic regions. form pending an opportunity for public action on administrative changes to the c. Does not have significant adverse comment. Department of the Interior Acquisition effects on competition, employment, Regulation (DIAR). This action revises II. Procedural Matters investment, productivity, innovation, or the DIAR, 48 CFR Chapter 14, but does the ability of U.S.-based enterprises to not impose any new requirements on 1. Public Availability of Comments compete with foreign-based enterprises. DOI contractors. The revisions in this Public availability of comments 5. Unfunded Mandates Reform Act interim final rule will make minor corrections to and streamline DOI Before including your address, phone This rule does not impose an acquisition processes to be consistent number, e-mail address, or other unfunded mandate on State, local, or with and non-duplicative of the Federal personal identifying information in your tribal governments or the private sector Acquisition Regulation (FAR). Some comment, you should be aware that of more than $100 million per year. The DIAR coverage is being revised and your entire comment—including your rule will not have a significant or obsolete material is being removed. FAR personal identifying information—may unique effect on State, local, or tribal clauses are now available that provide be made publicly available at any time. governments or the private sector. A coverage for the DIAR clauses that are While you can ask us in your comment statement containing the information removed by this rule. to withhold your personal identifying required by the Unfunded Mandates DATES: This rule is effective on May 17, information from public review, we Reform Act (2 U.S.C. 1531 et seq.) is not 2010. Submit comments by June 14, cannot guarantee that we will be able to required. do so. 2010. 6. Takings (Executive Order 12630) ADDRESSES: You may submit comments 2. Regulatory Planning and Review Under the criteria in Executive Order on the rulemaking through the Federal (Executive Order 12866) 12630, this proposed rule does not have eRulemaking Portal at http:// significant takings implications. This www.regulations.gov. Please use the This document is not a significant rule and is not subject to review by the rule does not impose conditions or Regulation Identifier Number (RIN) limitations on the use of any private 1093–AA11 in your message. Follow the Office of Management and Budget under Executive Order 12866. property; consequently, a takings instructions on the Web site for implication assessment is not required. submitting comments. (1) This rule will not have an effect of FOR FURTHER INFORMATION CONTACT: $100 million or more on the economy. 7. Federalism (Executive Order 13132) Tiffany A. Schermerhorn, Senior It will not adversely affect in a material Under the criteria in Executive Order Procurement Analyst, Office of way the economy, productivity, 13132, this rule does not have Acquisition and Property Management, competition, jobs, the environment, Federalism implications. This rule does Office of the Secretary, telephone (202) public health or safety, or State, local, not substantially or directly affect the 513–0747, fax (202) 219–4244, or e-mail or tribal governments or communities. relationship between Federal and State [email protected]. (2) This rule will not create a serious governments or impose costs on States SUPPLEMENTARY INFORMATION: inconsistency or otherwise interfere or localities. A Federalism Assessment with an action taken or planned by is not required. I. Background another agency. This rule revises the Department of 8. Civil Justice Reform (Executive Order (3) This rule does not alter the 12988) the Interior Acquisition Regulation budgetary effects or entitlements, grants, (DIAR) in order to update references to user fees, or loan programs or the rights This rule complies with the other federal and Departmental or obligations of their recipients. requirements of Executive Order 12988. directives, remove obsolete material and Specifically, this rule: references, and clarify and streamline (4) This rule does not raise novel legal (a) Meets the criteria of section 3(a) internal policies and procedures. or policy issues. requiring that all regulations be This rule is a result of the DIAR 3. The Regulatory Flexibility Act reviewed to eliminate errors and Rewrite Project. DOI is undertaking this ambiguity and be written to minimize project to revise the DIAR to maintain The Department of the Interior litigation; and consistency with the FAR and make certifies that this rule will not have a (b) Meets the criteria of section 3(b)(2) other administrative changes. No DOI significant economic effect on a of the Order. clauses are being changed, with the substantial number of small entities exception of the removal of obsolete under the Regulatory Flexibility Act (5 9. Paperwork Reduction Act of 1995 clauses. We view this as a U.S.C. 601 et seq.). This rule will not This rule does not contain an noncontroversial amendment and impose any new requirements on small information collection, as defined by the anticipate no adverse comment. This entities. Paperwork Reduction Act.

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10. National Environmental Policy Act PART 1403—IMPROPER BUSINESS PART 1442—CONTRACT This rule does not constitute a major PRACTICES AND PERSONAL ADMINISTRATION AND AUDIT Federal action significantly affecting the CONFLICTS OF INTEREST SERVICES quality of the human environment. A PART 1404—ADMINISTRATIVE PART 1443—CONTRACT detailed statement under the National MATTERS MODIFICATIONS SUBCHAPTER B—COMPETITION AND PART 1444—[RESERVED] Environmental Policy Act of 1969 is not ACQUISITION PLANNING PART 1445—GOVERNMENT required. PART 1405—PUBLICIZING CONTRACT PROPERTY 11. Data Quality Act ACTIONS PART 1446—QUALITY ASSURANCE PART 1406—COMPETITION PART 1447—[RESERVED] In developing this rule we did not PART 1448—VALUE ENGINEERING conduct or use a study, experiment, or REQUIREMENTS PART 1407—ACQUISITION PART 1449—TERMINATION OF survey requiring peer review under the PLANNING CONTRACTS Data Quality Act (Pub. L. 106–554). PART 1408—REQUIRED SOURCES OF PART 1450—EXTRAORDINARY 12. Effects on the Energy Supply SUPPLIES AND SERVICES CONTRACTUAL ACTIONS AND PART 1409—CONTRACTOR THE SAFETY ACT This rule is not a significant energy QUALIFICATIONS PART 1451—USES OF GOVERNMENT action under the definition in Executive PARTS 1410—1412 [RESERVED] SOURCES BY CONTRACTORS Order 13211. A Statement of Energy SUBCHAPTER C—CONTRACTING PART 1452—SOLICITATION Effects is not required. METHODS AND CONTRACT PROVISIONS AND CONTRACT 13. Clarity of This Regulation TYPES CLAUSES PART 1413—SIMPLIFIED SUBCHAPTER A—GENERAL We are required by Executive Orders ACQUISITION PROCEDURES 12866 and 12988 and by the PART 1401—DEPARTMENT OF THE PART 1414—SEALED BIDDING INTERIOR ACQUISITION REGULATION Presidential Memorandum of June 1, PART 1415—CONTRACTING BY SYSTEM 1998, to write all rules in plain NEGOTIATION language. This means that each rule we PART 1416—TYPES OF CONTRACTS Subpart 1401.1—Purpose, Authority, publish must: PART 1417—SPECIAL CONTRACTING Issuance (a) Be logically organized; METHODS (b) Use the active voice to address Sec. PART 1418—[RESERVED] 1401.105–3 Copies. readers directly; SUBCHAPTER D—SOCIOECONOMIC (c) Use clear language rather than PROGRAMS Subpart 1401.2—Administration jargon; PART 1419—SMALL BUSINESS 1401.201 Maintenance of the Federal (d) Be divided into short sections and PROGRAMS Acquisition Regulation (FAR). sentences; and PARTS 1420—1421 [RESERVED] 1401.201–1 The Civilian Agency (e) Use lists and tables wherever PART 1422—APPLICATION OF LABOR Acquisition Council (CAAC). possible. LAWS TO GOVERNMENT Subpart 1401.3—Agency Acquisition If you feel that we have not met these ACQUISITIONS Regulations requirements, send us comments by one PART 1423—[RESERVED] 1401.301 Policy. of the methods listed in the ADDRESSES PART 1424—PROTECTION OF 1401.301–70 Definitions. section. To better help us revise the PRIVACY AND FREEDOM OF 1401.303 Publication and codification. rule, your comments should be as INFORMATION 1401.304 Agency control and compliance specific as possible. For example, you PART 1425—FOREIGN ACQUISITION procedures. should tell us the numbers of the PART 1426—OTHER 1401.370 Acquisition Managers’ sections or paragraphs that you find SOCIOECONOMIC PROGRAMS Partnership. unclear, which sections or sentences are SUBCHAPTER E—GENERAL Subpart 1401.4—Deviations from the FAR too long, which sections where you feel CONTRACTING REQUIREMENTS and DIAR lists or tables would be useful, etc. PART 1427—PATENTS, DATA, AND 1401.403 Individual deviations. COPYRIGHTS List of Subjects in 48 CFR Chapter 14 1401.404 Class deviations. PART 1428—BONDS AND INSURANCE 1401.405 Deviations pertaining to treaties Government Procurement. PART 1429—TAXES and executive agreements. PART 1430—COST ACCOUNTING Dated: March 22, 2010. Subpart 1401.6—Career Development, STANDARDS ADMINISTRATION Pamela K. Haze, Contracting Authority, and Responsibilities PART 1431—CONTRACT COST Deputy Assistant Secretary, Budget, Finance, PRINCIPLES AND PROCEDURES 1401.601 General. Performance and Acquisition. PART 1432—CONTRACT FINANCING 1401.602 Contracting officers. ■ For the reasons set out in the 1401.602–1 Authority. PART 1433—PROTESTS, DISPUTES, 1401.602–3 Ratification of unauthorized preamble, we are revising Chapter 14 of AND APPEALS commitments. Title 48 Code of Federal Regulations to SUBCHAPTER F—SPECIAL 1401.603 Selection, appointment and read as follows: CATEGORIES OF CONTRACTING termination of appointment. Title 48—Federal Acquisition PART 1434—[RESERVED] 1401.603–1 General. Regulations System PART 1435—RESEARCH AND 1401.603–2 Selection. CHAPTER 14—DEPARTMENT OF THE DEVELOPMENT CONTRACTING 1401.603–3 Appointment. INTERIOR PART 1436—CONSTRUCTION AND 1401.670 Contracting officers’ SUBCHAPTER A—GENERAL ARCHITECT–ENGINEER representatives. 1401.670–1 Contract clause. PART 1401—DEPARTMENT OF THE CONTRACTS INTERIOR ACQUISITION PART 1437—SERVICE CONTRACTING Subpart 1401.70—Acquisition Reviews REGULATION SYSTEM PARTS 1438—1441 —[RESERVED] 1401.7000 Scope of subpart. PART 1402—DEFINITIONS OF WORDS SUBCHAPTER G—CONTRACT 1401.7001 Review and approval of contract AND TERMS MANAGEMENT actions.

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1401.7001–1 Review and approval by 301 and 40 U.S.C. 486(c). This authority 1401.304 Agency control and compliance Assistant Secretaries. has been delegated to the Assistant procedures. 1401.7001–2 Legal review by the Office of Secretary—Policy, Management and (a)(1) The DIAR System is under the the Solicitor. Budget under Part 209, Chapter 4.1A of direct oversight and control of the 1401.7001–3 Administrative review and Director, PAM, who is responsible for approval by bureaus and offices. the Departmental Manual (209 DM 1401.7001–4 Acquisition performance 4.1A). reviewing and preparing the issuance of all Department-wide and bureau-wide measurement systems. 1401.301–70 Definitions. 1401.7001–5 Acquisition Management acquisition regulations published in the Reviews (AMRs). (a) ‘‘Implement,’’ as used in this Federal Register to ensure compliance subpart, means coverage that expands with FAR Part 1. Review procedures are Authority: Sec. 205(c), 63 Stat. 390, 40 U.S.C. 486(c); and 5 U.S.C. 301. upon or specifically indicates the contained in Part 401 of the manner of compliance with related Departmental Manual (401 DM) and Subpart 1401.1—Purpose, Authority, higher level coverage. paragraph (a)(3) of this section. One Issuance (b) ‘‘Supplement,’’ as used in this copy of all material issued shall be subpart, means material for which there furnished to the Director, PAM, at the 1401.105–3 Copies. is no counterpart in higher-level time of issuance. Copies of the Department of the coverage. (2) The Director, PAM, is also Interior Acquisition Regulation (DIAR) responsible for reviewing and issuing and Department-wide internal guidance 1401.303 Publication and codification. unpublished Department-wide internal may be obtained from the Office of (a)(1) Implementing and guidance under the DIAR System. Acquisition and Property Management, supplementing regulations issued under (3) A bureau wishing to issue bureau- Office of the Secretary, U.S. Department the DIAR System are codified under wide regulations shall submit a request of the Interior, 1849 C Street (MS 2607– Chapter 14 in Title 48, Code of Federal to the Director, PAM, for authority to MIB), NW., Washington, DC 20240. Regulations and shall parallel the FAR proceed with the regulation. The request Additional information on DOI may be in format, arrangement, and numbering shall include a justification for the obtained on the Internet at http:// system. regulation and a proposed outline of the www.doi.gov/pam. (2)(i) Department-wide regulations are regulation and the significant contents assigned parts 1401 through 1479 under of the coverage to be included. The Subpart 1401.2—Administration 48 CFR, Chapter 14. Director, PAM, shall review the request to determine whether the regulation 1401.201 Maintenance of the Federal (ii) Where material in the FAR Acquisition Regulation (FAR). requires no implementation, there will should be considered for inclusion in be no corresponding number in the the DIAR or FAR. If a determination is 1401.201–1 The Civilian Agency DIAR. Thus, there are gaps in the DIAR made that the regulation is appropriate Acquisition Council (CAAC). sequence of numbers where the FAR, as for inclusion in the DIAR or FAR, PAM The Department of the Interior is written, is deemed adequate. will process the regulation accordingly. represented on the CAAC by a member Supplemental material shall be If a determination is made that the of the Office of Acquisition and numbered as specified in FAR 1.303. regulation is appropriate for inclusion Property Management (PAM). (3) Bureau-wide regulations are in bureau-wide regulations only, the authorized for codification in Director, PAM, shall assign an appendix Subpart 1401.3—Agency Acquisition Appendices to Chapter 14, as assigned to 48 CFR Chapter 14 and authorization Regulations by the Director, PAM, in accordance shall be granted for the bureau to 1401.301 Policy. with 1401.304(a)(3). proceed with the regulation in (b) Regulations implementing the FAR accordance with the procedures (a)(1) Subject to the authorities in referenced in 1401.301(b). Rulemaking paragraph (c) of this section, the or DIAR are numbered using Parts 1401 through 1479. Supplemental material is notices shall be submitted to the Department issues acquisition Director, PAM, for processing of AS/ regulations which implement or numbered using Parts 1480 through 1499. Numbers for implementing or PMB approval under 401 DM 1.4C(3), supplement the FAR under the DIAR before the appropriate program System. The regulation, as part of the supplementing regulations by bureaus/ offices are preceded by a prefix to the Assistant Secretary signs them. FAR system, is issued in accordance (4) HCAs are responsible for with the policy in FAR 1.301(a)(1). number 14 (indicating Chapter 14– DIAR) for the organization indicated by establishing and implementing formal (2) Subject to the authorities in procedures for oversight and control of paragraph (c) of this section, the lettered appendices as follows: (1) Bureau of Indian Affairs—BIA all unpublished bureau-wide internal Department also issues internal guidance issued to implement FAR or guidance and instructions under the (2) Bureau of Reclamation—WBR (3) National Business Center—NBC DIAR requirements. The Director, PAM, DIAR System in accordance with the shall review and approve these policy in FAR 1.301(a)(2). (4) Bureau of Land Management— LLM procedures and they shall include: (b) Public participation in (i) Provisions for centralized issuance (5) U.S. Geological Survey—WGS promulgating acquisition regulations, of all guidance and instructions using a which are published in the Federal (6) Office of Surface Mining directives system; Register, shall follow the Department’s Reclamation & Enforcement—LSM (ii) Methods for periodic review and rulemaking procedures prescribed in (7) Minerals Management Service— updating of all issuances; Part 318, Chapter 5 of the Departmental LMS (iii) Distribution processes which Manual (318 DM 5) and the procedures (8) National Park Service—FNP ensure timely receipt by all affected in FAR Subpart 1.5. (9) U.S. Fish and Wildlife Service— contracting offices; and (c) Regulations and internal guidance FWS (iv) Provisions for maintaining under the DIAR System are issued (c) e.g., FAR 1.3 then DIAR 1401.3 compliance with FAR 1.304. pursuant to the authority of the [Department level] then in Appendix A, (b) The Director, PAM, is responsible Secretary of the Interior under 5 U.S.C. BIA 1401.3 [Bureau level]. for evaluating coverage under the DIAR

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System to determine applicability to the information required in FAR the Department’s Federal Acquisition other agencies and for recommending 1.405(d). Certification in Contracting (FAC–C) coverage to the FAR Secretariat for (b) For deviations not authorized by Program Manual. Director, PAM, is the inclusion in the FAR. FAR 1.405(b) or (c), the Director, PAM, approving authority for all new and shall process the request for deviation reinstated FAC–C certifications. BPCs 1401.370 Acquisition Managers’ through the FAR Secretariat. are authorized to approve renewal FAC– Partnership. (c) Deviations authorized or requested C certifications. (a) The Acquisition Managers’ under paragraph (d) or (e) of this section Partnership (AMP) is a forum for DOI’s shall be submitted by the HCA to the 1401.603–3 Appointment. senior acquisition management Director, PAM for further action. Purchase card holders may be community to work cooperatively and appointed in writing or in accordance continuously to improve the Subpart 1401.6—Career Development, with the bureau/office procedures management, efficiency and Contracting Authority, and within the constraints of DOI Integrated effectiveness of its procurement services Responsibilities Charge Card Program Policy Manual in support of DOI’s mission. located at http://www.doi.gov/pam/ 1401.601 General. (b) The AMP consists of the BPCs and chargecard. Additional guidance is representatives from PAM and OSDBU. (a) The authority and responsibility available in the GSA Smart Pay program (c) The AMP Charter provides that the vested in the Secretary to contract for at http://www.gsa.gov/smartpay. authorized supplies and services is Chairperson and Associate Chairperson 1401.670 Contracting officers’ are leadership roles that will rotate delegated to Assistant Secretaries. (b) The contracting authority and representatives. annually. The AMP Chairperson responsibility delegated to Assistant When a CO elects to appoint an determines when the partnership will Secretaries may be redelegated to heads individual to act as an authorized meet and develops meeting agendas. of bureaus and offices under their representative in the administration of a The Chairperson will distribute the supervision in accordance with 200 DM contract, such appointment must be meeting minutes to all members. 3. Such redelegations are published in made in accordance with the DOI Subpart 1401.4—Deviations from the bureau chapters of the Part 200 series of Contracting Officers’ Representative FAR and DIAR the Departmental Manual. Manual available at http://www.doi.gov/ (c) Bureau heads and assistant or pam/Acqworkfor.html. 1401.403 Individual deviations. associate heads thereof (known as HCAs 1401.670–1 Contract clause. (a) The Director, PAM, is authorized as defined in 1402.1) may redelegate Insert the clause at 1452.201–70 in to approve deviations of FAR provisions contracting authority only as prescribed solicitations and contracts under which (see FAR 1.4) or DIAR provisions which in 1401.603. a COR or COTR will be appointed. affect only one contracting action. 1401.602 Contracting officers. Complete the fill-in before award. (b) Requests for deviations under paragraph (a) of this section shall be 1401.602–1 Authority. Subpart 1401.70—Acquisition Reviews submitted by the BPC and include Information on the limits of CO’s justification for the deviation. authority shall be maintained by the 1401.7000 Scope of subpart. (c) A copy of the approved deviation HCA as required in FAR 1.602–1. This subpart sets forth requirements shall be included in the contract file. for review and approval of contract 1401.602–3 Ratification of unauthorized actions and the conduct of acquisition 1401.404 Class deviations. commitments. management reviews. (a) The Director, PAM, is authorized (a) The HCA may redelegate to approve class deviations of FAR or ratification authority to the CCO as 1401.7001 Review and approval of DIAR provisions which affect more than defined in Subpart 1402.1 and contract actions. one contracting action. implemented in bureau procedures. 1401.7001–1 Review and approval by (b) Requests for deviations under (b) Legal concurrence is required prior Assistant Secretaries. paragraph (a) of this section shall be to ratification of unauthorized actions Contract actions shall be reviewed submitted by the HCA and include for amounts greater than the and approved by Assistant Secretaries justification for the deviation and the micropurchase threshold. as prescribed in 211–255 DM. Their number of contracting actions which (c) Nonratifiable commitments shall approvals shall be obtained before will be affected. be coordinated with the SOL. requesting any other approvals (c) For a FAR class deviation the 1401.603 Selection, appointment and prescribed in the DIAR. Director, PAM, shall consult with the termination of appointment. CAAC, as required in FAR 1.404(a)(1), 1401.7001–2 Legal review by the Office of before authorizing the deviation. 1401.603–1 General. the Solicitor. (d) A copy of each approved class BPCs are authorized to select and The Office of the Solicitor (SOL) will deviation shall be referenced in the appoint COs and terminate their review for legal sufficiency selected contract file. appointment as prescribed in the types and portions of contract actions (e) Recommended revisions to the Department’s Certificate of from Bureaus and offices as required by FAR and a copy of each approved class Appointment (COA) Manual. Copies of the FAR, DIAR, and Department-wide FAR deviation shall be transmitted to the manual may be obtained at http:// policy. COs may request SOL advice or the FAR Secretariat by the Director, www.doi.gov/pam/Acqworkfor.html. guidance on acquisition-related matters PAM, as required in FAR 1.404. at any time. Matters related to legal 1401.603–2 Selection. sufficiency reviews that cannot be 1401.405 Deviations pertaining to treaties COs, regardless of series or resolved between the respective CO and and executive agreements. organizational placement, must be SOL Attorney-Advisor must be (a) The Director, PAM, is responsible certified at a level commensurate with submitted for resolution to the HCA and for transmitting to the FAR Secretariat their appointment level, as prescribed in the Assistant Solicitor for Acquisitions

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and Intellectual Property, Washington, PART 1402—DEFINITIONS OF WORDS BPC Bureau Procurement Chief DC. AND TERMS BUDS Business Utilization Development Specialist 1401.7001–3 Administrative review and Subpart 1402.1—Definitions CA Competition Advocate approval by bureaus and offices. Sec. CAAC Civilian Agency Acquisition (a) Administrative review and 1402.101 Definitions. Council approval requirements for contract 1402.170 Acronyms. CAS Cost Accounting Standards actions shall be established by the HCA Authority: Sec. 205(c), 63 Stat. 390, 40 CASB Cost Accounting Standards and issued as internal bureau U.S.C. 486(c); and 5 U.S.C. 301. Board procedures. At a minimum, the review CBCA Civilian Board of Contract and approval requirements must Subpart 1402.1—Definitions Appeals address a representative percentage of 1402.101 Definitions. CCO Chief of the Contracting Office the overall contract actions within a CERCLA Comprehensive bureau/office. The procedures shall As used in this part: Environmental Response, include: Bureau procurement chief (BPC) is Compensation and Liability Act defined as the senior GS–1102 official in CFR Code of Federal Regulations (1) Identifying the type and dollar a bureau or office. His/her authority amounts of the actions to be reviewed CIO Chief Information Officer may be delegated, unless specified CO Contracting Officer based on the volume and nature of the otherwise, to the CCO. If the BPC is also contracting office workload; COA Certificate of Appointment the CO for an action requiring approval COI Conflicts of Interest (2) Designating the stage(s) in the of the BPC, then approval shall be at the COR Contracting Officer’s acquisition process when the review(s) HCA level. Representative shall be performed; Chief of the contracting office (CCO) COTR Contracting Officer’s Technical (3) Establishing review and approval is defined as the senior GS–1102 within Representative levels based on the type and dollar a contracting office unless otherwise DISP Defense Industrial Security amount of the action and the specified by bureau/office regulation. If Program capabilities of the reviewing office; the CCO is also the Contracting Officer DM Departmental Manual (4) Specifying what information is (CO) for an action requiring approval of DOI Department of the Interior required to review the action, which the CCO, then approval shall be at a DOL Department of Labor includes creating a review and approval level above the CCO in accordance with EC Electronic Commerce form and mechanism for following up bureau procedures. FAR Federal Acquisition Regulation on the correction of deficiencies noted Contracting activity is defined as an FBMS Financial Business Management in the review; and office with delegated procurement System (5) Providing for periodic review of authority. Within the Office of the FPDS—NG Federal Procurement Data procedures and revision as required, to Secretary (OS), the Office of Inspector System—Next Generation assure necessary controls are General (OIG) is a contracting activity. GAO Government Accountability maintained. The National Business Center (NBC) Office contracts for the OS. GIDEP Government-Industry Data 1401.7001–4 Acquisition performance Head of the agency (also called Exchange Program measurement systems. ‘‘agency head’’) is defined as the GPE Government Point of Entry (a) The acquisition performance Secretary of the Interior and the GPO Government Printing Office measurement system is a three-pronged Assistant Secretary—Policy, GSA General Services Administration approach that includes self assessment, Management and Budget (AS/PMB). GSBCA General Services Board of statistical data for validation and Head of the contracting activity (HCA) Contract Appeals flexible quality reviews and assessment is defined as the assistant or associate HCA Head of the Contracting Activity techniques. This system is required to: administrative head of each bureau and IT Information Technology IPMD Interior Property Management (1) Evaluate the effectiveness and office who has overall responsibility for Directives efficiency of bureau and office managing contracting. In reference to MBDA Minority Business acquisition systems; the OS, the HCAs are the Assistant Inspector General for Management and Development Agency (2) Assess the adequacy of policies, Policy and the Director, NBC. The OCIO Office of Chief Information procedures and regulations governing authority of the HCA may be Officer the acquisition process; and redelegated to the BPC unless otherwise OIG/IG Office of Inspector General/ (3) Identify and implement changes specified. Inspector General necessary to improve the systems. Senior procurement executive is OFPP Office of Federal Procurement (b) HCA’s are responsible for ensuring defined as the Director, Office of Policy contracting activity compliance with Acquisition and Property Management OHA Office of Hearings and Appeals law and regulations through the review (PAM). OMB Office of Management and and oversight process. Budget 1402.170 Acronyms. OS Office of the Secretary 1401.7001–5 Acquisition Management A&E Architect & Engineering OSDBU Office of Small and Reviews. ACMIS Acquisition Career Disadvantaged Business Utilization Acquisition Management Reviews Management Information System PAM Office of Acquisition and (AMRs) are to be conducted using the AMP Acquisition Manager’s Property Management Government Accountability Office’s Partnership PMO Property Management Officer (GAO) ‘‘Framework for Assessing the AMR Acquisition Management Review PNM Procurement Negotiation Acquisition Function at Federal AS/PMB Assistant Secretary—Policy, Memorandum Agencies’’ available at http:// Management and Budget SAT Simplified Acquisition Threshold www.gao.gov/new.items/d05218g.pdf. BPA Blanket Purchase Agreement SBA Small Business Administration

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SOL Office of the Solicitor Subpart 1403.1—Safeguards (c) During the evaluation process, TFM Treasury Financial Manual each evaluator and advisor is 1403.101 Standards of conduct. responsible for ensuring that there are U.S.C. United States Code 1403.101–3 Agency regulations. no financial or employment interests VECP Value Engineering Change that conflict or give the appearance of (a) Policy. DOI regulations governing Proposal conflicting with his or her duty to the conduct and responsibilities of evaluate proposals impartially and PART 1403—IMPROPER BUSINESS regular and special employees are objectively. Examples of situations that PRACTICES AND PERSONAL contained in 43 CFR Part 20. Additional may be prohibited or represent a CONFLICTS OF INTEREST guidance is contained in the DOI potential COI include: publication ‘‘Ethics Guide for (1) Financial interest, including stocks Subpart 1403.1—Safeguards Department of the Interior Employees.’’ and bonds, in a firm that submits, or is Sec. Copies of the Guide can be obtained expected to submit, an offer in response 1403.101 Standards of conduct. from the Bureau/Office Ethics Office or to the solicitation; 1403.101–3 Agency regulations. on the Internet at http://www.doi.gov/ (2) Outstanding financial 1403.101–70 Technical evaluators and ethics/. With regard to the provisions of commitments to any actual or potential advisors. 43 CFR Part 20, officials who participate offeror; 1403.104 Procurement integrity. personally and substantially in DOI (3) Employment in any capacity, even 1403.104–2 Applicability. procurements (as defined in FAR 3.104– if otherwise permissible, by any actual 1403.104–4 Disclosure, protection and 3), may not solicit or accept any gift, or potential offeror; marking of contractor bid or proposal gratuity, favor, entertainment, loan or (4) Employment within the last 12 information and source selection anything of monetary value from a months by an actual or potential offeror; information. competing contractor during the (5) Any non-vested pension or re- 1403.104–7 Violations or possible conduct of a procurement. employment rights, or interest in profit violations. (b)(1) Officials may not accept or sharing or stock bonus plans arising out solicit from any competing contractor of past employment by an actual or Subpart 1403.2—Contractor Gratuities to any services that involve the potential offeror; or Government Personnel development of specifications, (6) Employment of any member of the 1403.203 Reporting suspected violations of statements of work, evaluation criteria, immediate family by an actual or the Gratuities clause. or formal cost estimates to be used in a potential offeror. 1403.204 Treatment of violations. procurement unless such services are (d) Bureaus shall include a notice formally contracted for pursuant to the similar to the following in all Subpart 1403.3—Reports of Suspected correspondence notifying employees of Antitrust Violations FAR and DIAR, and until the organizational COI provisions in FAR appointments to serve as technical 1403.303 Reporting suspected antitrust Subpart 9.5 have been fully addressed. evaluators or advisors, formally called violations. This does not preclude COs from Technical Evaluation Panels (TEP) and/ Subpart 1403.4—Contingent Fees issuing formal Requests for Comment or Source Evaluation Boards (SEB): 1403.405 Misrepresentations or violations (RFC) or draft RFPs. You shall not solicit or accept any gift, of the Covenant Against Contingent Fees. (2) IT resources shall not be accepted, gratuity, favor, entertainment, loan, or installed or utilized by the Department anything of monetary value from a competing Subpart 1403.5—Other Improper Business on a no cost, free of charge basis (this contractor involved in any action for which Practices you participate personally and substantially includes donated equipment but not under this delegation of authority. You are 1403.570 Restrictions on contractor public domain software), except as also reminded of other conduct prohibitions advertising. permitted by law. in FAR 3.104–3, including negotiating with 1403.570–1 Policy. competing contractors for future 1403.570–2 Procedures. 1403.101–70 Technical evaluators and employment, disclosure of contractor bid or 1403.570–3 Contract clause. advisors. proposal information or source selection (a) Technical evaluators and advisors, information, and post-Government Subpart 1403.6—Contracts With including members of proposal employment restrictions. Government Employees or Organizations Such notice shall include an Owned or Controlled by Them evaluation committees, must render impartial, technically sound, and acknowledgement of receipt signed and returned by the employee. 1403.602 Exceptions. objective assistance and advice. 1403.603 Responsibilities of the contracting (b) With the exception of contracting 1403.104 Procurement integrity. officer. personnel, proposal evaluators and 1403.104–2 Applicability. Subpart 1403.7—Voiding and Rescinding advisors are not required to file a Contracts Confidential Financial Disclosure Construction contracts (or Report (SF450) unless they occupy subcontracts in such cases where the 1403.704 Policy. tribal contractor has subcontracted the 1403.705 Procedures. positions identified in 43 CFR 20.735.30(b). Therefore, when an activity) awarded under the authority of Subpart 1403.8—Limitation on the Payment individual is appointed as an evaluator the Indian Self-Determination and of Funds to Influence Federal Transactions or advisor, he/she must sign and return Education Assistance Act, Public Law 1403.804 Policy. to the CO a Conflict of Interest 93–638, as amended, are subject to the 1403.806 Processing suspected violations. Certificate in a format approved by the provisions promulgated under that Act. Subpart 1403.10—Contractor Code of HCA. If a potential COI exists, the 1403.104–4 Disclosure, protection, and Business Ethics and Conduct appointee must not be allowed to marking of contractor bid or proposal evaluate or advise on an offeror’s information and source selection 1403.1004 Contract clause. proposal until the conflict has been information. Authority: Sec. 205(c), 63 Stat. 390, 40 resolved with the servicing Ethics (a) The following classes of persons U.S.C. 486(c); and 5 U.S.C. 301. Counselor. may be authorized access to contractor

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bid or proposal information and source provide a copy of the reported violation Subpart 1403.3—Reports of Suspected selection information to the extent and recommended action to the OIG in Antitrust Violations necessary to accomplish their requisite accordance with Part 111 DM 3. The duties and responsibilities with respect 1403.303 Reporting suspected antitrust CO, in consultation with the SOL and violations. to a particular procurement: the OIG, must justify the compelling (a) Reports on suspected violations of (1) Individuals who generate contract circumstances for immediate award and antitrust laws as required by FAR 3.303 requirements, including program and obtain approval to proceed from the shall be prepared by the CO, reviewed technical experts involved in the BPC without the power of redelegation. development of statements of work, by the SOL, and submitted by the HCA Copies of the determination to proceed directly to the Attorney General, specifications or similar documents; with the award will be sent to the (2) Contracting personnel acting in Department of Justice. A copy of this Director, PAM, for submission to the support of the CO; submission must also be sent to the AS/PMB. (3) Secretarial, clerical and Deputy Assistant Inspector General for administrative personnel of the Investigations. Subpart 1403.2—Contractor Gratuities (b) Depending on the nature of the contracting activity directly involved in to Government Personnel the procurement; suspected violation or the disposition of (4) Supervisors in the CO’s chain of 1403.203 Reporting suspected violations the matter, the HCA may recommend command; of the Gratuities clause. debarment or suspension in accordance (5) Attorneys in the SOL; with FAR 9.406–2(a)(2) or 9.407–2(a)(2) (6) OIG contract auditors, and When suspected violations of the and Subpart 1409.4. auditors of other agencies such as the clause at FAR 52.203–3, Gratuities, Subpart 1403.4—Contingent Fees Defense Contract Audit Agency (DCAA) become known to a Federal Government and DHHS when requested to perform employee, the matter shall be reported, 1403.405 Misrepresentation or violations contract audits by the OIG; in writing, to the cognizant CO or the of the Covenant Against Contingent Fees. (7) Engineers and other technical CO’s supervisor, as appropriate. The (a) In addition to notifying the CO, the support personnel who provide support report shall clearly state the alleged matter must also be reported to the to the CO; circumstances surrounding the incident Deputy Assistant Inspector General for (8) Small Business Technical or incidents in which the contractor Investigations and the HCA. Advisors and BUDS; offered or gave a gratuity to a Federal (b) The HCA may recommend (9) SBA personnel responsible for Government employee and intended to debarment and suspension in reviewing determinations related to set- obtain a contract or favorable treatment accordance with Subpart 1409.4. aside acquisitions, determining the under a contract because of the gratuity. (c) The CCO shall consult with the small business status of offerors, The date(s), location(s) and name(s) of SOL and OIG prior to forwarding a processing applications for Certificates all parties involved in the incident shall report of suspected fraudulent or of Competency, reviewing be included in the report. criminal violations to the Department of subcontracting plans, or awarding Justice for action. contracts under the 8(a) program; 1403.204 Treatment of violations. (10) Personnel in DOL responsible for Subpart 1403.5—Other Improper making eligibility determinations or for (a) The CO will provide the contractor Business Practices processing preaward EEO clearances; with a formal notice that summarizes the events involving the suspected 1403.570 Restrictions on contractor (11) Personnel who review bid advertising. protests in the GAO and the CBCA; violation and affords the contractor the (12) Personnel serving on technical opportunity to take the action(s) listed 1403.570–1 Policy. evaluation boards or source selection under FAR 3.204(b). The notice shall Award of a contract does not signify evaluation boards; contain a time limit for reply and shall endorsement of the supplies or services (13) Contract clearance personnel; be sent by certified mail return receipt purchased, nor does it signify agreement (14) Departmental and bureau/office requested. The CO will submit the with any views espoused by officials of Competition Advocates; report, additional documentary the awardee. It is vital to the integrity (15) Personnel in the Congressional evidence and other pertinent of the procurement system to avoid even liaison offices; information to the HCA for disposition the appearance of an improper (16) Agency ethics official and with a recommended course of action. A preference toward a particular vendor. servicing Ethics Counselors; copy of this submission must also be Therefore, contractors shall not be (17) Members of Congress and sent to the Deputy Assistant Inspector permitted to publicize, or otherwise members of their staff. (See also DIAR General for Investigations. In circulate, promotional materials that 1405.403.); and consultation with the SOL and the OIG, state or imply Governmental (18) Anyone specifically authorized and based on the results of any further endorsement of a product, service or by the CO. discussion with the contractor, its position which the contractor 1403.104–7 Violations or possible counsel or witnesses, the HCA may represents. violations. make a recommendation to the Director, 1403.570–2 Procedures. (a)(1) The CO’s determination that PAM, pursuant to FAR 3.204(c) and If a contractor requests a there is no impact on the procurement shall provide formal notice to the determination as to the propriety of due to a possible violation of the contractor of such recommendation. such promotional material, the response Procurement Integrity Act and decision (b) If the decision involves the shall be coordinated with the cognizant to proceed with contract award shall termination of a contract (see FAR Public Affairs Office and Ethics Officer. receive concurrence from an individual 3.204(c)(1)), the CO will be responsible 1403.570–3 Contract clause. one level above the CO. for implementing the decision. (2) In case of nonconcurrence with the CO’s shall include the clause at CO’s determination, the HCA shall 1452.203–70, Restriction on

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Endorsements, in all solicitations, and rescinding contracts in accordance Subpart 1404.4—Safeguarding contracts and agreements which are not with the requirements of FAR 3.705(e). Classified Information Within Industry executed in accordance with FAR Parts 12 or 13. Subpart 1403.8—Limitation on the 1404.402 General. Payment of Funds to Influence Federal (a) The DOI has entered into an Subpart 1403.6—Contracts With Transactions agreement with the DOD to be covered Government Employees or by the National Industrial Security Organizations Owned or Controlled by 1403.804 Policy. Program (NISP). The agreement is Them The BPC shall receive copies of contained in 443 DM 1, Appendix 1. (b) Classified acquisitions or contracts 1403.602 Exceptions. contractor disclosures and forward them (see FAR 4.401) shall be subject to the The HCA, without the power of to the Director, PAM, for submission to Congress. instructions contained in the DOD redelegation, is authorized to except a publications listed in FAR 4.402(b). contract from the policy in FAR 3.601. 1403.806 Processing suspected violations. However, no exceptions may be granted 1404.403 Responsibilities of contracting where the proposed contractor is owned Suspected violations shall be referred officers. or controlled by a Government to the HCA. The HCA, in consultation (a) For proposed solicitations that employee or one or more members of with the SOL and OIG, shall act in may require access to Departmental the employee’s immediate family and accordance with FAR 3.807. classified information, the CO shall the employee or any subordinate is consult with the Office of Managing serving as a procurement official on the Subpart 1403.10—Contractor Code of Risk and Public Safety for guidance on proposed contract. Business Ethics and Conduct NISP in accordance with 443 DM 1. (b) For proposed contracts where the 1403.603 Responsibilities of the 1403.1004 Contract clause. contractor provides service for the contracting officer. (a) In all awards expected to exceed handling and transmission of registered The CO shall prepare a written $3,000,000, including options, for or certified mail at activities that determination and findings for the which performance is expected to customarily receive and transmit signature of the HCA when requesting exceed 120 days, except purchases classified information (see FAR 4.401), authorization to allow a contract award conducted in accordance with FAR Part the contractor shall be cleared to the to a Government employee or business 12 and contracts to be performed degree of SECRET. This clearance shall concern or other organization owned or entirely outside the United States, be obtained through the Office of substantially owned or controlled by replace ‘‘$5,000,000’’ with ‘‘$3,000,000’’ Managing Risk and Public Safety in one or more Government employees. accordance with 442 DM 8. in paragraph (d) of FAR 52.203–14. (c) For proposed contracts where Subpart 1403.7—Voiding and (b) Insert the following into paragraph guard services are assigned to safeguard Rescinding Contracts (b)(3) of the same clause: ‘‘Downloadable Department activities in possession of 1403.704 Policy. hotline posters as well as instructions classified information (see FAR 4.401), for obtaining a hard copy poster are review and approval shall be obtained The HCA is authorized to declare void available at http://www.doioig.gov/ from the Office of Managing Risk and and rescind contracts in accordance hotline.’’ Public Safety in accordance with 442 with the procedures in FAR 3.705. DM 8. 1403.705 Procedures. PART 1404—ADMINISTRATIVE MATTERS Subpart 1404.7—Contractor Records (a) Reporting. The facts concerning Retention any final conviction for any violation of Subpart 1404.4—Safeguarding Classified 18 U.S.C. 201–224 involving or relating Information within Industry 1404.702 Applicability. to any contract awarded by a bureau or Sec. In addition to the clauses listed at office shall be set forth in a report and 1404.402 General. FAR 4.702, the policies and procedures submitted by the HCA to the Civil 1404.403 Responsibilities of contracting at FAR 4.7 shall also apply to records Division of the Department of the officers. generated under contracts containing Justice. The report shall also contain a the clause at 1452.215–70, Examination recommendation to initiate a debarment Subpart 1404.7—Contractor Records of Records by the Department of the action. If debarment is recommended, Retention Interior. the procedures in 1409.406–3(a) shall be 1404.702 Applicability. followed. Copies of the report shall be Subpart 1404.8—Contract Files Subpart 1404.8—Contract Files provided to Director, PAM, and the 1404.802 Contract files. Deputy Assistant Inspector General for 1404.802 Contract files. Investigations for informational 1404.804 Closeout of contract files. In addition to the requirements in purposes. 1404.804–70 Release of claims. FAR 4.802, files shall also be (b) Notice of Proposed Action. Based 1404.805 Disposal of contract files. maintained in accordance with the upon review of the report in paragraph Subpart 1404.70—Deposit of Contract provisions of 380 DM 3. (a) of this section and after consultation Publications 1404.804 Closeout of contract files. with the SOL and the OIG, as 1404.7001 General. 1404.804–70 Release of claims. appropriate, the HCA shall give notice 1404.7002 Policy. of the proposed action to the contractor 1404.7003 Exceptions. (a) The CO shall insert the clause at in accordance with the requirements of 1404.7004 Procedures. 1452.204–70, Release of Claims, in all FAR 3.704(c). construction, architect and engineering, (c) Final Agency Decision. The HCA Authority: Sec. 205(c), 63 Stat. 390, 40 and cost-reimbursement contracts that shall make the final decision on voiding U.S.C. 486(c); and 5 U.S.C. 301. exceed the SAT. The Release of Claims

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clause may be inserted in other types of Departmental Library, 1849 C Street, Subpart 1405.3—Synopses of Contract contracts when the CO determines that NW., MS–2258, Main Interior Bldg., Awards the release is necessary to protect the Washington, DC 20240. interests of the Government. 1405.303 Announcement of contract (b) A transmittal letter shall awards. (b) Form DI–137, Release of Claims, accompany the copies and identify the (a) The CO shall report the following shall be used to obtain a release of sender and the publication(s). The information to the cognizant bureau claims. bibliographic information required by congressional affairs officer for 481 DM 1.3B(4) shall be also included 1404.805 Disposal of contract files. notification to Congress 24 hours prior with the submission of all translations. Disposition of files shall be to the award of a contract expecting to accomplished in accordance with 384 SUBCHAPTER B—COMPETITION AND exceed $500,000: DM. ACQUISITION PLANNING (1) Proposed award date; (2) Contractor name and address; Subpart 1404.70—Deposit of Contract PART 1405—PUBLICIZING CONTRACT (3) Geographical location of contract Publications ACTIONS performance; (4) Description of the contracted 1404.7001 General. Subpart 1405.2—Synopses of Proposed Contract Actions work; The DOI Departmental Library is (5) Dollar amount of contract; and responsible for maintaining a complete Sec. (6) Contractor business size and collection of Departmental publications. 1405.202 Exceptions. whether the firm is minority-owned or As used in this Subpart, the term 1405.207 Preparation and transmittal of is a disadvantaged business concern. synopses. ‘‘Departmental publication’’ means any (b) With the concurrence of the Office publication or report produced under a Subpart 1405.3—Synopses of Contract of Congressional and Legislative Affairs, DOI contract or Interagency agreement. Awards the HCA may waive the announcement 1405.303 Announcement of contract of sensitive awards. 1404.7002 Policy. awards. The CO shall direct the contractor, in Subpart 1405.4—Release of Subpart 1405.4—Release of Information the technical instructions, to Information acknowledge Federal sponsorship in the 1405.403 Requests from members of 1405.403 Requests from Members of final report or publication by placing Congress. 1405.404 Release of long-range acquisition Congress. the following statement on the title estimates. For purposes of this subpart, the page: 1405.404–1 Release procedures. ‘‘This publication was funded by U.S. agency head is the HCA with the power Department of the Interior, (Name of Subpart 1405.5—Paid Advertisements of redelegation to the BPC. Bureau/Office), Washington, DC, under 1405.502 Authority. 1405.404 Release of long-range contract numberlllllll.’’ Authority: Sec. 205(c), 63 Stat. 390, 40 acquisition estimates. U.S.C. 486(c); and 5 U.S.C. 301. 1404.7003 Exceptions. 1405.404–1 Release procedures. The following types of publications Subpart 1405.2—Synopses of (a) The authority to release are excluded from the requirements of Proposed Contract Actions acquisition requirements anticipated in this Subpart: the coming year is delegated to the (a) Internal documents required for 1405.202 Exceptions. OSDBU and the HCA with redelegation administrative or operational purposes The AS/PMB is authorized to approve limited to the BPC. The Government that have no public interest, the written determination documenting cost estimate shall not be revealed. The educational, scientific, or research the reasons why a synopsis is not expected dollar values shall be value; appropriate or reasonable. The CO shall advertised as falling within dollar (b) Classified publications and prepare the determination, submit it to ranges rather than specific dollar material otherwise marked prohibiting the HCA and then to the Director, PAM, amounts. unauthorized disclosure; for AS/PMB approval. (b) Classified information shall only (c) Tentative drafts such as be released in accordance with the preliminary planning reports that will 1405.207 Preparation and transmittal of procedures in 442 DM. appear later in revised or final form; synopses. Subpart 1405.5—Paid Advertisements (d) Journal and magazine articles; or In addition to the synopsis (e) Disclosure materials containing information generally required under 1405.502 Authority. any description, specification, data, FAR 5.207, as a best business practice, (a) The CO shall obtain written plan, or drawing of any unpatented it is recommended each synopsis of a invention upon which a patent authorization of the HCA before placing proposed contract action under other an advertisement in a newspaper to application is likely to be filed, unless than full and open competition include an opinion by the SOL, or his/her duly advertise a contracting opportunity. the location where the offeror may (b) Advertisements placed in media authorized designee, has been rendered obtain: other than newspapers do not require which finds that the interests of the (a) A description of specific advance authorization. Government will not be prejudiced by qualifications the Government requires disclosure of such materials. of the product or service to meet the PART 1406—COMPETITION 1404.7004 Procedures. Government’s minimum needs; and REQUIREMENTS (a) The CO shall direct the contractor, (b) The factors the Government will Subpart 1406.2—Full and Open Competition in the technical instructions, to provide use to evaluate the product or service After Exclusion of Sources two copies of each publication or report information prospective contractors Sec. produced under a contract to: U.S. provide under the proposed contract 1406.202 Establishing or maintaining Department of the Interior, action. alternate sources.

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Subpart 1406.3—Other Than Full and Open Government’s needs based on the Subpart 1407.3—Contractor Versus Competition evaluation results. The evaluation Government Performance 1406.302 Circumstances permitting other results shall be included in the than full and open competition. justification as required by FAR 6.303– 1407.301 Policy. 1406.302–1 Only one responsible source 2(a)(8) if it is determined that only one 404 DM, Procurement Planning, and no other supplies or services will source can meet the Government’s addresses the requirements of OMB satisfy agency requirements. needs. Circular A–76. 1406.302–7 Public interest. (b) The procedure in paragraph (a) of 1406.303 Justifications. 1407.307 Appeals. this section is not required for proposed 1406.303–70 Additional requirements. Department appeal procedures 1406.304 Approval of the justification. contract actions to be awarded under the authority in FAR 6.302–2 when the required by OMB Circular A–76 are Subpart 1406.5—Competition Advocates CO determines that preparation and codified in 43 CFR Part 4, Subpart M. 1406.501 Requirement. approval of the justification would PART 1408—REQUIRED SOURCES OF 1406.502 Duties and responsibilities. unreasonably delay the acquisition. SUPPLIES AND SERVICES Authority: Sec. 205(c), 63 Stat. 390, 40 Under these circumstances, a U.S.C. 486(c); and 5 U.S.C. 301. justification may be prepared and Subpart 1408.1—Excess Personal Property approved after award in accordance Sec. Subpart 1406.2—Full and Open with FAR 6.303–1(d). 1408.102 Policy. Competition After Exclusion of Sources 1406.304 Approval of the justification. Subpart 1408.8—Acquisition of Printing and Related Supplies A class justification shall be approved 1406.202 Establishing or maintaining in accordance with bureau procedures. 1408.802 Policy. alternative sources. Copies of approved class justifications Authority: Sec. 205(c), 63 Stat. 390, 40 HCAs are authorized to approve the shall be promptly transmitted to PAM. U.S.C. 486(c); and 5 U.S.C. 301. determinations and findings (D&Fs) to establish or maintain an alternative Subpart 1406.5—Competition Subpart 1408.1—Excess Personal source or sources for supplies or Advocates Property services. 1406.501 Requirement. 1408.102 Policy. Subpart 1406.3—Other Than Full and (a) The competition advocate for DOI Inquiries on available excess or Open Competition is located within PAM’s staff. surplus personal property should be Applicable correspondence should be directed to the PMO or the designee in 1406.302 Circumstances permitting other addressed to PAM, Attention: each Bureau or Office. than full and open competition. Competition Advocate. (b) Competition Advocates for each Subpart 1408.8—Acquisition of 1406.302–1 Only one responsible source Printing and Related Supplies and no other supplies or services will bureau and office shall be as designated satisfy agency requirements. by the CAO–AS/PMB. 1408.802 Policy. For contracts that will be awarded 1406.502 Duties and responsibilities. (a) Duplicating is the mass using this authority, the notices PAM is responsible for preparing and reproduction of materials beyond the required by FAR 5.201 shall have been submitting the annual report required capabilities of typical office copiers. published and any bids, proposals, by FAR 6.502(b)(2). Bureau Competition Volumes are of sufficient mass quotations, or capability statements Advocates shall furnish certain quantities up to 5,000 single-page and must have been considered. information, as may be required, to 25,000 production units in the aggregate 1406.302–7 Public interest. assist PAM in preparing the report. of multiple pages. Such duplicating units shall require Departmental The CO shall prepare the D&F and PART 1407—ACQUISITION PLANNING approval to be processed through the complete the justification to support use Department of the Interior Publishing of public interest authority for other Subpart 1407.1—Acquisition Plans Council (DOIPC). than full and open competition and 1407.102 Policy. (b) Copying is distinguished from submit it through the HCA to the ‘‘duplicating’’ in that such work is Director, PAM, for further action. Subpart 1407.3—Contractor Versus Government Performance administrative in nature, produced on 1406.303 Justifications. 1407.301 Policy. office copying equipment and produced 1407.307 Appeals. as necessary, in limited quantities. 1406.303–70 Additional requirements. Volumes typically range from 1 to 500 Authority: Sec. 205(c), 63 Stat. 390, 40 single-pages to 2,500 production units (a) If other than full and open U.S.C. 486(c); and 5 U.S.C. 301. competition is recommended by the in the aggregate of multiple pages. This office initiating an acquisition Subpart 1407.1—Acquisition Plans volume standard is referred to as the requirement, the recommendation shall: ‘‘500/2500’’ rule. Reproduction work (1) Be in writing; 1407.102 Policy. exceeding the ‘‘500/2500’’ rule is (2) Accompany the requisition; DOI has implemented its acquisition duplicating, and requires a waiver from (3) Contain the information required planning system in 404 DM. This the nearest servicing GPO office. by FAR 6.303–2; and system meets the criteria prescribed in Employees should consult with their (4) Request the CO to conduct a FAR Subpart 7.1, 375 DM, OCIO bureau printing officer or the DOIPC market survey by issuing a synopsis of Program Management, and 376 DM, representative to secure such a waiver. the proposed contract action (see Automated Data Processing. Each of (c) The DOIPC has been designated as 1405.207). The initiating office shall these addresses strategic planning for the Department’s liaison with the Joint evaluate and document all responses to OCIO and planning for acquisition of Committee on Printing and GPO. the notice. The CO shall prepare the federal information processing Requirements for printing and related D&F that only one source can meet the resources. supplies shall be coordinated with the

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DOIPC or the designated bureau Conviction, for the purposes of this appropriate, the Debarring Official shall publications liaison officer in subpart, means: initiate proposed debarment by taking accordance with 314 DM 1. (a) A judgment or any other the actions listed in FAR 9.406–3(c) and determination of guilt of a criminal advising the contractor of DOI’s process PART 1409—CONTRACTOR offense by any court of competent for contesting the action. QUALIFICATIONS jurisdiction, whether entered upon a (c) Decision-making process. verdict or plea, including a plea of nolo (1) For debarment actions based upon Subpart 1409.2—Qualifications a conviction, civil judgment, or in Requirements contendere; or, (b) Any other resolution that is the which there is no genuine dispute over Sec. functional equivalent of a judgment, material facts, consistent with FAR 1409.202 Policy. including probation before judgment 9.406–3(d)(1), the Debarring Official 1409.206 Acquisitions subject to and deferred prosecution. A disposition shall make a decision on the basis of the qualifications requirements. 1409.206–1 General. without the participation of the court is information in the administrative the functional equivalent of a judgment record, including any contractor Subpart 1409.4—Debarment, Suspension only if it includes an admission of guilt. submissions. Where the proceeding and Ineligibility Debarring Official refers to the includes an oral presentation of matters 1409.403 Definitions. Director, PAM. The Debarring Official is in opposition (PMIO) to the Debarring 1409.404 Excluded Parties List System the official authorized to impose Official, the PMIO will be conducted in (EPLS). debarment or suspension. The Debarring an informal business meeting format 1409.405 Effect of listing. Official also may settle a debarment or and tape recorded for the administrative 1409.405–1 Continuation of current suspension action at any time if it is in record. contracts. 1409.406 Debarment. the best interest of the Government. (2) For actions listed under FAR 1409.406–1 General. Suspending Official refers to the 9.406–3(b)(2), upon concluding from a 1409.406–3 Procedures. Director, PAM. contractor’s information in response to the action notice that facts material to 1409.407 Suspension. 1409.404 Excluded Parties List System 1409.407–1 General. (EPLS). the existence of cause for debarment are 1409.407–3 Procedures. genuinely in dispute, the Debarring (a) PAM is responsible for Official may refer the disputed material Subpart 1409.5—Organizational and accomplishing the actions required in Consultant Conflicts of Interest facts to another official for fact-finding. FAR 9.404(c). The hearing shall be conducted in 1409.503 Waiver. (b) COs should access the EPLS online accordance with Debarment Program 1409.506 Procedures. at http://www.epls.gov. fact-finding procedures. Authority: Sec. 205(c), 63 Stat. 390, 40 1409.405 Effect of listing. (i) The fact-finding proceeding will be U.S.C. 486(c); and 5 U.S.C. 301. When a CO finds that a compelling transcribed. The fact-finding official will file the original copy of the Subpart 1409.2—Qualifications reason exists to conduct business with transcript with the case record. The Requirements a contractor listed on the EPLS, the HCA shall submit the determination and reporter’s fees and other direct costs 1409.202 Policy. findings to the Director, PAM, for associated with the hearing shall be (a) The HCA is the official responsible approval. borne by the bureau or office initiating for establishing the qualification the debarment action, except in the case requirement in FAR 9.202(a)(1). This 1409.405–1 Continuation of current of actions initiated by the OIG. For contracts. authority is not redelegable. actions initiated by the OIG, the costs (b) The HCA is the approval official The HCA, without authority to will be borne by the bureau(s) and/or referenced in FAR 9.202(e). redelegate, is authorized to take the office(s) out of which the matter arose. actions listed in FAR 9.405–1. A transcript of the proceedings shall be 1409.206 Acquisitions subject to made available to the contractor as 1409.406 Debarment. qualification requirements. provided under FAR 9.406–3(b)(2)(ii). 1409.206–1 General. 1409.406–1 General. (ii) Subject to the provisions of 43 CFR Part 1, the contractor, and any The HCA is the approval official The Director, PAM, is authorized to specifically named affiliate, may be referenced in FAR 9.206–1(b). make the statement regarding debarment by another agency’s debarring official represented by counsel or any duly Subpart 1409.4—Debarment, under the conditions in FAR 9.406–1(c). authorized representative. Witnesses Suspension, and Ineligibility may be called by either party. The 1409.406–3 Procedures. proceedings shall be conducted 1409.403 Definitions. (a) Investigation and referral. expeditiously and in such a manner that As used in this subpart: Whenever a cause for debarment, as each party will have a full opportunity Case Representative refers to the listed in FAR 9.406–2. becomes known to present all information considered individual who prepares and forwards to a DOI employee, the matter shall be pertinent to the proposed debarment. A the action referral memorandum to the referred by the case representative to the transcript of the proceedings shall be Debarring and Suspending Official and Debarring Official, in consultation, as made available to the contractor under provides additional assistance in the appropriate, with the HCA involved, the the condition in FAR 9.406–3(b)(2)(ii). course of action resolution. Debarment SOL, and OIG. The case representative (iii) The fact-finding official will and Suspension actions may be referred will review the matter and, as prepare findings of fact, certify the to the Debarring and Suspending warranted, prepare and submit to the entire hearing record and provide said Official for consideration from different Debarring Official for consideration an findings and record to the Debarring sources, as appropriate. The HCA, or Action Referral Memorandum (ARM) Official. The fact-finding official shall designee, may refer matters. The Office with supporting documentation. not make any recommendations unless of Inspector General (OIG) may also (b) Notice of Proposed Debarment. the Debarring Official has expressly refer actions. Based upon review of the ARM, as requested such recommendations in

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writing. Following receipt of the contractor of the Department’s process may be resolved through an findings of fact, the Debarring Official for contesting the action. administrative agreement at any stage of shall complete debarment proceedings (c) Decision making process. the proceedings. and issue a written debarment decision. (1) For suspension actions based upon (d) Administrative Agreements. (d) Administrative Agreements. an indictment or equivalent charging Matters may be resolved through an Matters may be resolved through document, or where there is no genuine administrative agreement at any stage of administrative agreement at any stage of dispute over material facts, consistent proceedings in resolution of a proceedings of a debarment action with FAR 9.407–3(d), or in which suspension action where a contractor where a contractor agrees to appropriate additional proceedings to determine agrees to appropriate terms. The specific terms. The specific effect of disputed material facts have been effect of administrative agreements that administrative agreements that denied on the basis of DOJ advice, the incorporate terms regarding eligibility incorporate terms regarding eligibility Suspending Official shall make a for DOI contracting will vary with the for DOI contracting will vary with the decision on the basis of the information terms of the agreements. In general, terms of the agreements. In general, in the administrative record, including such agreements resolve suspension such agreements resolve debarment any submission by the contractor. concerns and thereby terminate award concerns and thereby terminate any Where the proceeding includes an oral ineligibility. An administrative imposed or pending award ineligibility. PMIO to the Suspending Official, the agreement resolving a suspension action In the event of an agreement, PAM will PMIO will be conducted in an informal may by its terms be an interim notify COs of the agreement and its business meeting format and tape agreement. In the event of an agreement, terms. recorded for the administrative record. PAM will notify COs of the agreement (e) Administrative Appeal. (2) For actions listed under FAR and its terms. Administrative review of the Debarring 9.407–3(b)(2), when the Debarring (e) Administrative Appeal. Official’s decision under FAR 9.406– Official concludes from information in a Administrative review of the 3(e) may be sought as follows: contractor’s response to the proposed Suspending Official’s decision under (1) The contractor may within thirty action notice that facts material to the FAR 9.407–3(d) may be sought as existence of a cause for debarment are (30) days of receipt of the decision, follows: genuinely in dispute, the Suspending (1) The contractor may within thirty request the Debarring Official to Official may refer the disputed material (30) days of receipt of the decision, ask reconsider the decision for clear facts to another official for hearing and the Suspending Official to reconsider material errors of fact or law which findings of fact. the decision for clear material errors of would change the outcome of the (i) The hearing shall be conducted in fact or law which would change the matter. accordance with Suspension Program outcome of the matter. (2) The Debarring Official may fact-finding procedures. (2) The Suspending Official may in exercise his/her discretion and stay the (ii) The fact-finding proceeding will the exercise of discretion stay the debarment pending reconsideration be transcribed. The reporter’s fees and debarment pending reconsideration review. The Debarring Official will other direct costs associated with the review. The Suspending Official will notify the contractor in writing of the hearing shall be borne by the bureau or notify the contractor in writing of the decision on reconsideration. office initiating the suspension referral, decision on reconsideration. (3) A review request under this except in the case of actions initiated by (3) A review request under this section must be in writing, clearly state the OIG. For actions initiated by the section must be submitted in writing; the specific findings believed to be in OIG, costs will be borne by Bureaus clearly state the specific findings error and include the reasons or legal and/or offices out of which the matter believed to be in error, and include the bases for the position. arose. A transcript of the proceedings reasons or legal bases for the position. 1409.407 Suspension. shall be made available to the contractor under the condition in FAR 9.407– Subpart 1409.5—Organizational and 1409.407–1 General. 3(b)(2)(ii). Consultant Conflicts of Interest The Director, PAM, is authorized to (iii) Subject to the provisions of 43 1409.503 Waiver. CFR Part 1, the contractor, and any make the determination in FAR 9.407– (a) The Director, PAM, is authorized specifically named affiliates, may be 1(d). to waive any general rule or procedure represented by counsel or any duly in FAR Subpart 9.5, when such action 1409.407–3 Procedures. authorized representative. Witnesses is in the Government’s interest. (a) Investigation and referral. may be called by either party. The (b) Request for waivers shall be made Whenever a cause for suspension, as proceedings shall be conducted by the HCA, through the appropriate listed in FAR 9.407–2, becomes known expeditiously and in such a manner that SOL, to the Director, PAM. Each request to a DOI employee, the matter shall be each party will have a full opportunity shall include: referred by the case representative to the to present all information considered (1) An analysis of the facts involving Suspending Official, in consultation, as pertinent to the suspension. the potential or actual conflict, appropriate, with the HCA involved, the (iv) The fact-finding official will including benefits and detriments to the SOL, and the OIG. The case prepare findings of fact, certify the Government and prospective representative will review the matter entire hearing record and provide said contractor(s); and, if warranted, prepare and submit to findings and record to the Suspending (2) A discussion of the factors which the Debarring Official for consideration Official. The fact-finding official shall preclude avoiding, neutralizing or an Action Referral Memorandum (ARM) not make any recommendations unless mitigating the conflict; and with supporting documentation. the Suspending Official has expressly (3) Identification of the provision(s) in (b) Notice of Suspension. After review requested such recommendations in FAR Subpart 9.5 to be waived. of the ARM, if appropriate, the writing. Following receipt of the Debarring Official shall initiate a findings of fact, the Suspending Official 1409.506 Procedures. suspension by taking the actions listed shall complete suspension proceedings If the CO determines that contractor in FAR 9.407–3(c), and advising the and issue a written decision. Matters performance of the contemplated work

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is likely to create an organizational (d) Each contracting activity shall Subpart 1414.2—Solicitation of Bids conflict of interest, then the contracting develop more specific procedures for officer shall refer the documentation of use of purchase cards. 1414.201 Preparation of invitation for bids. the potential conflict and proposed 1414.201–70 Alternate bids. Subpart 1413.3—Simplified Acquisition resolution prepared in accordance with (a) Solicitations for supplies or Methods 7.105(b)(18) to the HCA for approval. services (other than construction) shall Referrals to the HCA shall be initiated 1413.305 Imprest fund. specify whether alternate bids are by the CO and reviewed by the SOL. permitted, provide instructions for PARTS 1410–1412—[RESERVED] 1413.305–2 Agency responsibilities. submitting alternate bids and clearly indicate how alternate bids will be Policy governing the use and SUBCHAPTER C—CONTRACTING evaluated. METHODS AND CONTRACT TYPES administration of imprest funds within (b) The clause set forth in 1452.236– the Department are contained in 330 71 may be used in non-construction PART 1413—SIMPLIFIED ACQUISITION DM, in addition to the policies and contracts where additive and deductive PROCEDURES regulations outlined in FAR 13.305–1. alternate bids will be permitted. HCAs shall establish written procedures Subpart 1413.2—Micro-Purchase for designation, by name, of personnel Subpart 1414.4—Opening of Bids and Sec. authorized to approve requisitions and Award of Contract 1413.201 General. make purchases using imprest funds. 1414.404 Rejection of bids. 1413.202–70 Policy. The procedures shall include a periodic Subpart 1413.3—Simplified Acquisition review of imprest fund transactions by 1414.404–1 Cancellation of invitations Methods acquisition personnel. after opening. 1413.305 Imprest Fund. The CCO is authorized to make the 1413.305–4 Procedures. 1413.305–2 Agency responsibilities. written determination to cancel the IFB 1413.305–4 Procedures. The individual authorized to make before award but after bid opening. 1413.306 Standard Form 44, Purchase purchases using imprest funds shall be 1414.407 Mistakes in bids. order—invoice—voucher. responsible for compliance with the Authority: Sec. 205(c), 63 Stat. 390, 40 procedures and documentation 1414.407–3 Other mistakes disclosed U.S.C. 486(c); and 5 U.S.C. 301. requirements of FAR 13.305–4. before award. (a) The HCA is authorized to make the Subpart 1413.2—Micro-Purchase 1413.306 Standard Form 44, Purchase administrative determinations under order-invoice-voucher. 1413.201 General. FAR 14.407–3, except as set forth in HCAs are responsible for establishing paragraph (b) of this section. This The procedures set forth in the bureau procedures to control the use of authority is not redelegable. Federal Supply Schedule for the SF 44 and accounting for all (b) The CCO has the authority Government-wide Commercial Credit purchases made using the form. Bureau outlined in FAR 14.407–3(c) to make the Card Services, Treasury Financial written determination permitting a procedures shall include instructions Manual, TFM 4–4500, and ‘‘U.S. bidder to withdraw a bid, after review covering: Department of Interior Handbook for by the SOL. Utilization of Government Wide (a) Maintenance of a list of designated (c) The CO shall submit a report on Commercial Credit Card’’ issued by individuals authorized to make suspected or alleged mistakes in bids PAM contain guidance on using purchases using the form; together with the supporting data to the Government-wide purchase card (b) Controls for issuing the form to BPC, who will forward it to the HCA. services. authorized individuals; and The CO may also include a report on bids where evidence of the intended bid 1413.202–70 Policy. (c) Review of purchase transactions is clear and convincing but the bidder (a) The purchase card shall be used in using the form to assure compliance has not requested permission to correct preference to other methods of with authorized procedures. the bid. Incomplete reports may result procurement for purchases up to $3,000. in a delay in obtaining a determination. PART 1414—SEALED BIDDING Other small purchase methods (BPAs, (d) The BPC is responsible for imprest funds, third-party drafts, SF–44 Sec. maintaining records of administrative forms, and purchase orders) may be determinations. Subpart 1414.2—Solicitation of Bids used in lieu of the Government 1414.407–4 Mistakes after award. purchase card when it is more cost- 1414.201 Preparation of invitations for bids. The CO is authorized to make the effective or practicable. 1414.201–70 Alternate bids. administrative determinations outlined (b) The purchase card shall be issued Subpart 1414.4—Opening of Bids and in 14.407–4 after receiving concurrence primarily to personnel outside of Award of Contract from the SOL. procurement offices to purchase 1414.404 Rejection of bids. products and services up to the micro- 1414.404–1 Cancellation of invitations after PART 1415—CONTRACTING BY purchase threshold ($2,000 for opening. NEGOTIATION construction). 1414.407 Mistakes in bids. Subpart 1415.2—Solicitation and Receipt of (c) The purchase card may be used in 1414.407–3 Other mistakes disclosed before Proposals and Information award. procurement offices for purchases up to Sec. 1414.407–4 Mistakes after award. the simplified acquisition threshold 1415.201 Exchanges with industry before ($50,000 if not interim FACNET Authority: Sec. 205(c), 63 Stat. 390, 40 receipt of proposals. certified) not to exceed individual U.S.C. 486(c); and 5 U.S.C. 301. 1415.207 Handling proposals and warrant limitations. information.

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1415.207–70 Department of the Interior Interior. COs and other government locked in file cabinets or drawers when proposal and information handling personnel evaluating a proposal shall not in use by committee members and procedures. not refuse to consider the proposal advisors. 1415.207–71 Confidentiality of proposal because it contains information (c) The CO shall be the single point evaluation. 1415.209 Solicitation provisions and identified as trade secret information or of contact regarding communications contract clauses. confidential commercial or financial received from outside parties relating to 1415.209–70 Examination of records by the information. the acquisition and the evaluation and Department of the Interior. (c) Failure to mark. The Government selection process. Any committee assumes no liability for the disclosure or member or advisor who receives a Subpart 1415.3—Source Selection use of information contained in a communication from any outside party 1415.303 Responsibilities. proposal if not marked in accordance shall, without discussion, immediately 1415.305 Proposal evaluation. with 1452.215–71. If a request under the refer the party to the CO. The CO will Subpart 1415.4—Contract Pricing Freedom of Information Act is made for then determine what further action shall 1415.404 Proposal analysis. information in a proposal not marked in be taken, if any, in responding to the 1415.404–2 Information to support proposal accordance with 1452.215–71, the communication. Requests for analysis. offeror concerned shall be notified information made pursuant to the 1415.404–4 Profit. promptly of the request and given an Freedom of Information Act shall be 1415.406 Documentation. opportunity to provide its position to referred to the CO for reply. Proposal 1415.406–70 Department of the Interior the Government. However, failure of an evaluation committee members and price negotiation memorandum (PNM). offeror to mark information contained in advisors shall not contact any offeror Subpart 1415.6—Unsolicited Proposals a proposal as trade secret information or whose proposal is under evaluation. All 1415.606 Agency procedures. confidential commercial and financial communications with offerors shall be Authority: Sec. 205(c), 63 Stat. 390, 40 information will be treated by the handled by the CO. U.S.C. 486(c); and 5 U.S.C. 301. Government as evidence that the (d) Bureaus and offices may only information is not exempt from release proposals outside the Subpart 1415.2—Solicitation and disclosure under the Freedom of Government for evaluation or advice in Receipt of Proposals and Information Information Act, absent a showing that accordance with the following the failure to mark was due to unusual requirements: 1415.201 Exchanges with industry before or extenuating circumstances, such as a (1) Decisions to release proposals receipt of proposals. showing that the offeror had intended to outside the Government for evaluation (a) Use of a presolicitation conference mark, but that markings were omitted or advice shall be approved in writing shall be approved at one level above the from the offeror’s proposal due to by the HCA; CO. clerical error. (2) Outside evaluators and advisors (b) A CO may issue a solicitation for (d) Solicitation provision. The shall sign a Conflict of Interest information or planning purposes provision at 1452.215–71, Use and Certificate and a Confidentiality without a written justification and Disclosure of Proposal Information— Certificate in a format approved by the without obtaining a higher level of Department of the Interior, shall be HCA; approval. inserted in all requests for proposals (3) Any authorized restrictive legends 1415.207 Handling proposals and and requests for quotations. placed on the proposal by the information. prospective contractor or subcontractor, 1415.207–71 Confidentiality of proposal or by the Government shall be applied 1415.207–70 Department of the Interior evaluation. to any reproduction or abstracted proposal and information handling (a) The safeguarding of evaluation information made by the outside procedures. data and information, including evaluator or advisor; (a) General. This section establishes proposals, is essential in order to (4) Upon completing the evaluation, procedures that must be used in preserve the integrity of the proposal all copies of the proposal, as well as any addition to those prescribed in FAR evaluation process. During the selection abstracts thereof, shall be returned to 15.207, for the use and disclosure of process, no member or advisor of any the Government office which initially trade secret information and committee appointed to evaluate furnished them for evaluation; and confidential commercial and financial proposals shall discuss or disclose any (5) All determinations to release the information contained in solicited information on the number, identity or proposal outside the Government shall proposals. content of proposals received to any take into consideration requirements for (b) Marking of solicited proposals. A other party (including supervisors) avoiding individual conflicts of interest solicited proposal may contain trade without the written approval of the CO. (see 1403.101) and organizational secrets or confidential commercial or 18 U.S.C. 1905 prohibits the conflicts of interest (see 1409.5 and FAR financial information which the offeror, unauthorized disclosure of business, Subpart 9.5), and the competitive or its subcontractors, prefers not to be confidential or trade secret information relationship, if any, between the disclosed to the public or used by the unless authorized by law. prospective contractor or subcontractor Government for any purpose other than (b) At the initial meeting of the and the prospective outside evaluator. evaluation of the proposal. To notify the committee, the CO shall brief all (e) If outside individuals will be Government of trade secrets and members and advisors on the sensitivity voting members of the evaluation confidential commercial or financial of the evaluation process and the committee or otherwise participate in information contained in a proposal, prohibition against unauthorized other than an advisory capacity, then offerors must mark the cover page of the disclosure of information. At this the committee must be constituted as a proposal and each affected page of the meeting each member and advisor shall Federal Advisory Committee in proposal with the legends specified in sign a Confidentiality Certificate. During accordance with the Federal Advisory the solicitation provision at 1452.215– the proposal evaluation process, all Committee Act (PL 92–463) and 308 DM 71, Use and Disclosure of Proposal proposals, evaluation notes, scoring 2. Since the Secretary must appoint Information—Department of the sheets, and other materials shall be such committees in consultation with

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the Office of Management and Budget, (c) Upon receipt of the audit report, 1413.106 and FAR 13.106 shall be there should be very few occasions the CO and the price analyst (if followed. when use of outside individuals as assigned), shall discuss any questions (c) Procedures. When the CO prepares voting members is justified. regarding the report’s contents with the the memorandum prescribed in FAR (f) Outside evaluators will usually cognizant auditor. If a question cannot 15.406–3, the following additional serve as advisors to the proposal be resolved or agreement cannot be information shall be included to the evaluation committee and as such, are reached on a recommendation in the extent it applies to the contract action. consultants. Consultants may be report, the CO shall prepare a written Information already contained in the appointed as special employees in statement for the contract file contract file or in a previous PNM shall accordance with 5 U.S.C. 3109 or documenting the decision on the matter. be referenced by location: contracted for in accordance with A copy of the statement shall be (1) A discussion of the reason(s) why 1437.1. promptly forwarded to the Assistant sealed bidding is not appropriate as (g) Additional restrictions on the Inspector General for Auditing for required by FAR 6.401 (or cross- disclosure of acquisition evaluation information. reference the file location of the existing information are listed in FAR Subpart explanation); 1415.404–4 Profit. (2) A memorandum identifying the 5.4. (a) DOI’s policy is to use a structured type of contract used and why it was 1415.209 Solicitation provisions and approach for determining the profit or selected as required by FAR 16.103(d). contract clauses. fee prenegotiation objective in The file location of any required acquisition actions that require cost determination and findings authorizing 1414.209–70 Examination of records by analysis based on the profit analysis use of this type of contract (see Part the Department of the Interior. factors in FAR 15.905, as implemented 1416); The CO shall insert the clause at and supplemented in this section. (3) A history of the contract action 1452.215–70, Examination of Records (b) In addition to the factors listed in including: Whether the action was by the Department of the Interior, in all FAR 15.404–4(d), one additional factor, synopsized or the basis for exemption contracts requiring the clause at FAR ‘‘Other Costs,’’ will be used in evaluating under FAR 5.202, and file location of 52.215–2 Audit and Records, and determining a weighted profit or the synopsis; consideration given to the Negotiation, as prescribed in FAR fee. For further guidance also refer to use of set-asides and file location of DI– 15.209(b). the Armed Services Pricing Manual 1886 (see Subpart 1419.2); solicitation (ASPM No. 1). The ‘‘Other Costs’’ factor issuance date, closing date for receipt of Subpart 1415.3—Source Selection shall include the contribution of all proposals and extensions; (iv) sources 1415.303 Responsibilities. other direct costs including travel, solicited (reference file location); late direct support and hiring of consultants proposal or proposal modification (a) The HCA shall determine when a for contract performance. information required by FAR 15.208; formal source selection process will be (c) Form DI–1920, Structured and the file location of ‘‘Justification for used and shall establish implementing Approach for Profit/Fee Objective— Other Than Full and Open procedures. Department of the Interior shall be used Competition,’’ if applicable. (b) The formal source selection to calculate the profit or fee objective. (4) Evaluation of proposal(s), procedures shall include designating the 1415.406 Documentation. including: Evaluation factors used and CO as the individual responsible for the weights (FAR 15.304); results of initial proper control and appropriate release 1415.406–70 Department of the Interior proposal evaluation (FAR 15.305); of proprietary and source selection price negotiation memorandum (PNM). determination of competitive range information after source selection. (a) Policy. In addition to the (FAR 15.306); results of written or oral 1415.305 Proposal evaluation. information required in FAR 15.406–3, discussions conducted (FAR 15.306); the PNM prepared by the CO shall discussion of final proposal revisions The CCO is authorized to make the include the information in paragraph (c) received (FAR 15.307) and results of determination to reject all proposals. of this section to the extent such final proposal evaluation; and basis for Subpart 1415.4—Contract Pricing information is applicable to the source selection. For formal source negotiation. selection procedures (see 1415.303), 1415.404 Proposal analysis. (b) Applicability. (1) The CO shall information on the source selection prepare a PNM documenting the plan, and the source selection decision 1415.404–2 Information to support negotiation of the initial contract award proposal analysis. including supporting documentation and any subsequent modifications required by FAR 15.308. The CO shall initiate an audit by affecting price, cost or fee, including (5) If cost or pricing data were not sending a completed form DI–1902, revisions to the prices of contracts required, the cost or price analysis Request for Audit, to the Assistant awarded through sealed bidding performed in accordance with FAR Inspector General for Auditing, OIG (see procedures. A PNM is not required for 15.404–1. 1453.215–70). unilateral modifications such as (6) If cost or pricing data were (a) The CO shall allow at least 30 exercising fixed price options or issuing required, the cost analysis (FAR 15.404– working days in assigning a realistic change orders. The memorandum is 1(c)) performed; and cost realism deadline for receipt of the audit report. required for concluding changes and analysis (FAR 15.404–1(d)) and In exceptional circumstances 20 settlements of claims and for issuing technical analysis (FAR 15.404–1(e)) working days may be allowed but the orders under Blanket Ordering performed, as applicable to the circumstances shall be documented in Agreements, task orders and delivery procurement. the contract file. orders that involve the negotiation of (7) If an audit report was required (b) Upon receipt of a DI–1902, the OIG prices, estimated quantities or amounts. (FAR 15.404–2), COs shall specifically will conduct the audit or arrange for its (2) For simplified acquisitions describe actions taken in response to conduct by the cognizant audit agency conducted pursuant to FAR Part 13, the significant audit findings, including the in accordance with 360 DM 3.7. documentation requirements of monetary value and decisions made

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with regard to any of the audit’s PART 1416—TYPES OF CONTRACTS FAR 17.402, shall require advance questioned costs; i.e., COs shall identify discussion with the Director, PAM, the value of the questioned costs, Subpart 1416.2—Fixed-Price Contracts prior to approval by the HCA. This indicate whether they will allow or Sec. authority may not be redelegated. disallow them, and provide an 1416.203 Fixed-price contracts with Documentation shall include the economic price adjustment. circumstances requiring such action. explanation for their decisions. For 1416.203–4 Contract clauses. purposes of this section, ‘‘significant Subpart 1417.5—Interagency ’’ ‘‘ ’’ Subpart 1416.4—Incentive Contracts audit finding and questioned cost are Acquisitions Under the Economy Act defined as those findings and/or costs 1416.405 Contract clauses. cited or questioned in an external audit Authority: Sec. 205(c), 63 Stat. 390, 40 1417.502 General. because of their relationship to U.S.C. 486(c); and 5 U.S.C. 301. (a) The HCA, with authority to unallowable costs claimed, a failure to redelegate to the BPC, is authorized to Subpart 1416.2—Fixed-Price Contracts comply with regulations or the terms of make the determination prescribed in the contract, mathematical errors, and/ 1416.203 Fixed-price contracts with FAR 17.503 in accordance with the or the duplication of costs. Questions economic price adjustment. requirements in FAR 17.502. The CO shall prepare the determination, and for and/or disagreements between the CO, 1416.203–4 Contract clauses. price analyst (if assigned) and cognizant actions exceeding $100,000, obtain legal An economic price adjustment clause auditor as to an audit report’s review from the SOL before submitting based on actual cost of labor or material interpretation or recommendations it to the HCA for signature. Class may be used after approval by the BPC, ‘‘ ’’ determinations may be utilized where regarding significant audit finding without the power of redelegation. and/or ‘‘questioned costs’’ shall be appropriate. (b) Bureaus and offices shall develop clarified or resolved and appropriately Subpart 1416.4—Incentive Contracts procedures governing the use of documented. If a disagreement cannot interagency acquisitions under the be resolved or agreement cannot be 1416.405 Contract clauses. The BPC, without the power of Economy Act that are consistent with reached, the CO shall prepare a written the FAR and this subpart 1417.5, and statement in the PNM that discusses the redelegation, is authorized to approve an award fee clause to use in a which adequately protect the issue(s) in question and supports a final Department’s interests. decision on the matter. solicitation when a cost-plus-award-fee contract is contemplated. (8) The basis for determining profit or Subpart 1417.6—Management and fee as prescribed in FAR Subpart PART 1417—SPECIAL CONTRACTING Operating Contracts 15.404–4 and form DI–1920 (or file METHODS 1417.602 Policy. location). Subpart 1417.2—Options (a) The AS/PMB is authorized to (d) Approval. The PNM shall be Sec. approve the CO’s determination to enter signed and dated by the contract 1417.203 Solicitations. into, extend or renew any management specialist or contract negotiator who 1417.206 Evaluation. and operating contract. conducted the negotiation and approved (b) The CO shall prepared requests for Subpart 1417.4—Leader Company authorization to enter into, extend or by the CO. Contracting renew any management and operating (e) Distribution. Whenever field 1417.402 Limitations. contract shall be prepared by the CO pricing support has been obtained, Subpart 1417.5—Interagency Acquisitions and submitted by the HCA through the copies of related PNMs shall be Under the Economy Act Director, PAM for approval by the AS/ forwarded to the Assistant Inspector 1417.502 General. PMB. The request shall be submitted General for Auditing, OIG, not later than prior to solicitation for the requirement 15 days after the execution of the Subpart 1417.6—Management and and shall: Operating Contracts resulting contract, modification or close- (1) Reference the statutory authority out action. 1417.602 Policy. for the requirement; 1417.605 Award, renewal and extension. (2) Discuss the relationship between Subpart 1415.6—Unsolicited Proposals Authority: Sec. 205(c), 63 Stat. 390, 40 the requirement and the limitations in U.S.C. 486(c); and 5 U.S.C. 301. FAR 17.603; 1415.606 Agency procedures. (3) Include a copy of the proposed The contact point for the receipt and Subpart 1417.2—Options contract schedule and evaluation factors coordination of unsolicited proposals is 1417.203 Solicitations. for; and (4) If a noncompetitive procurement is the contracting office, which will Option quantities in excess of the 50 acknowledge and review the proposal proposed, include a copy of the percent limit may, in unusual Justification for Other than Full and contents and determine the proper circumstances, be approved by the CCO. activity within the bureau/office to Open Competition. (c) The HCA shall be responsible for evaluate and process the proposal. The 1417.206 Evaluation. The determination in FAR 17.206(b) conducting the reviews required by FAR policy or contracting office shall 17.602(c) and taking required actions acknowledge unsolicited proposals and shall be approved by the CCO prior to soliciting offers. within the time limit prescribed. forward each one to the processing (d) The CO shall request authorization activity in an expeditious manner. Each Subpart 1417.4—Leader Company under paragraph (a) of this section for bureau/office shall establish procedures Contracting solicitation of offers for cost comparison for receipt, reproduction and purposes under OMB Circular A–76 (see disposition of unsolicited proposals 1417.402 Limitations. FAR 7.3) for: consistent with the requirements of FAR Use of leader company contracting for (1) Operation, maintenance, or 15.6. a product, subject to the limitations in support of a Government-owned or

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controlled special production or testing Subpart 1419.2—Policies (d) HCAs without authority to facility; or redelegate shall: (2) Any other commercial or 1419.201 General policy. (1) Appoint a full-time BUDS (e.g., industrial service activity which, if HCAs, without the power of procurement analyst or other non- performed by a contractor, would result redelegation, shall be responsible for the operational contract person), for each in a management and operating contract establishment of annual goals. The contracting office where: as defined under FAR Subpart 17.6. purpose of these goals is to increase (i) Annual contract obligations participation of small business and regularly exceed $20 million or 1417.605 Award, renewal and extension. small disadvantaged businesses in represent a substantial part of the The CO shall review each contract and subcontract opportunities. bureau’s total contracting program; and, management and operating contract Goals for contract awards to minority (ii) The number, type, and size of prior to any extension or exercise of a business enterprises and women-owned contract transactions provide sufficient renewal option. Any extension or businesses shall also be developed. opportunities for small business and renewal of a management and operating (a) All program goals must comply small disadvantaged business contract shall first be authorized as with the criteria established by OSDBU participation. required in 1417.602. and shall reflect improvement in (2) Appoint a part-time BUDS (e.g., PART 1418—[RESERVED] participation of small businesses and procurement analyst or other non- small disadvantaged businesses. The operational contract person), for each SUBCHAPTER D—SOCIOECONOMIC goal setting process shall be conducted contracting office where the nature of PROGRAMS as follows: the contracting program requires such (1) Proposed goals are to be submitted action to ensure accomplishment of PART 1419—SMALL BUSINESS by contracting activities to OSDBU by annual program goals; PROGRAMS August 15th for the next fiscal year. To (e) Each BUDS shall perform the Subpart 1419.2—Policies the greatest extent possible, the goals duties listed at FAR 19.201(d)(5)(6), and shall be based on advance acquisition (10), 405 DM 1, and in the BUDS Sec. 1419.201 General policy. plans (see Subpart 1407.1), budget Standard Operating Procedures 1419.202 Specific policies. justifications, and past performance. Handbook (405 DM 2). (2) OSDBU shall be responsible for 1419.202–70 Acquisition screening and 1419.202 Specific policies. BUDS recommendations. consolidating bureau and office goals, Subpart 1419.5—Set-Asides for Small performing trend analysis, and 1419.202–70 Acquisition screening and Business submitting proposed Departmental goals BUDS recommendations. to SBA, and the Minority Business 1419.503 Setting aside a class of (a) For open market acquisitions acquisitions for small business. Development Agency (MBDA), estimated to exceed the SAT, the DI 1419.503–70 Class set-aside for Department of Commerce. Form 1886, ‘‘Acquisition Screening and construction acquisitions. (3) Bureau and office goals shall be Review Form,’’ shall be completed by 1419.505 Rejecting Small Business negotiated and finalized with the the CO and signed as indicated in Block Administration recommendations. OSDBU based on current plans and 20 of the form. The completed form 1419.506 Withdrawing or modifying small budget projections. OSDBU shall shall be placed in the solicitation/ business set-asides. negotiate final Departmental goals with contract file prior to requesting Subpart 1419.6—Certificates of SBA, and MBDA. quotations, publication of a FedBizOpps Competency and Determinations of (4) Since goals are expressed as a solicitation notice, or publication of a Responsibility percentage of planned acquisition notice of intent to award a sole source 1419.602 Procedures. dollars, final budget approvals may contract. 1419.602–1 Referral. change specific dollar goals. (b) For open market acquisitions Subpart 1419.7—The Small Business (b) HCAs may request revision of estimated to be greater than the micro- Subcontracting Program goals from OSDBU when final budget purchase threshold and less than the 1419.705 Responsibilities of the contracting approvals result in a change of plus or SAT that are not reserved for small officer under the subcontracting minus 15% in planned acquisition business or proceeding under the 8(a) assistance program. dollars or in instances when a program, the DI Form 1886 shall be 1419.705–2 Determining the need for a disproportionate change in the mix of completed as specified in paragraph (a) subcontracting plan. products or services is required. The of this section. 1419.705–3 Preparing the solicitation. goal setting process with the Bureau/ (c) Open market acquisitions, 1419.705–6 Postaward responsibilities of Offices shall be completed by December including charge card transactions, the contracting officer. 31st of each year. estimated to be less than the micro- Subpart 1419.8—Contracting with the Small (c) In accordance with 111 DM 8, purchase threshold are not routinely Business Administration (the 8(A) program) OSDBU is responsible for performing all screened, but may be upon request by 1419.803 Selecting acquisitions for the 8(a) functions and duties prescribed in FAR the purchaser. program. 19.201(d) and for: (d) For Federal Supply Schedule 1419.810 SBA Appeals. (1) Developing and maintaining competitions estimated to exceed the Subpart 1419.9—Contracting Opportunities policies, procedures, regulations, and SAT and for which the source list for Women-Owned Small Businesses guidelines for the effective contains less than three small 1419.901 Policy. administration of the Department’s businesses, the DI Form 1886 shall be small business and small disadvantaged completed as specified in paragraph (a) Subpart 1419.10—Small Business business programs; and, of this section. Competitiveness Demonstration Program (2) Providing functional direction and (e) Federal Supply Schedule buys 1419.1003 Purpose. policy guidance to personnel in the below the SAT are not routinely Authority: Sec. 205(c), 63 Stat. 390, 40 implementation of the programs under screened, but may be upon request by U.S.C. 486(c); and 5 U.S.C. 301. paragraph (c)(1) of this section. the CO.

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(f) If the proposed method of appeal of a contracting officer’s set-aside 1419.705–6 Postaward responsibilities of acquisition is non-competitive, the recommendation. the contracting officer. Justification for Other than Full and In addition to the actions specified in Open Competition shall be attached to 1419.506 Withdrawing or modifying small business set-asides. FAR 19.705–6, the CO shall also be the DI Form 1886. responsible for the following: (g) Advance acquisition plans The HCA is authorized, without the developed pursuant to FAR Part 7 shall power of redelegation, to resolve (a) Forwarding a copy of each be attached to the DI Form 1886. disagreements between the CO and the approved subcontracting plan to BUDS concerning withdrawals or (h) The CO shall document the OSDBU within 10 working days after modifications of individual or class set- rationale for not accepting a BUDS approval of the plan. asides as prescribed in FAR 19.506. recommendation on DI Form 1886, OSDBU shall be provided timely (b) Ensuring that the contractor under ‘‘Notes.’’ (See FAR 19.202.) notification of such disagreements and forwards the original copy of the Disagreements between the CO and the the recommendation of the BUDS in Standard Form 295, Summary BUDS concerning the decision to use a order to provide assistance in resolving Contracting Report, to the Department of set aside or the 8(a) program shall be the disagreement. the Interior, Director, OSDBU, 18th & C resolved by the BPC. The BPC shall Streets, NW., Washington, DC 20240, annotate the resolution, with signature, Subpart 1419.6—Certificates of Rm. 2747. in the ‘‘Notes’’ section of the form. The Competency and Determinations of (c) Forwarding a copy of the Standard BPC may consult with the OSDBU to Responsibility obtain assistance in resolving the Form 294, Subcontracting Report for disagreement. 1419.602 Procedures. Individual Contracts, received from individual contractors, within 10 Subpart 1419.5—Set-Asides for Small 1419.602–1 Referral. working days, to OSDBU. The CO shall obtain approval from the Business (d) Conducting on-site business and CCO for all determinations documenting 1419.503 Setting aside a class of a responsive small business’ lack of economic development program acquisitions. responsibility prior to submission to the management reviews (see 405 DM 1) of appropriate SBA office. A copy of the a prime contractor’s small and 1419.503–70 Class set-aside for disadvantaged business subcontracting construction acquisitions. determination shall be sent to OSDBU. program. Reviews shall be conducted as (a) Acquisitions for construction (as Subpart 1419.7—The Small Business required based on problems perceived defined in FAR 2.101) estimated to cost Subcontracting Program such as insufficient progress in meeting $2 million or less shall be set-aside on subcontracting goals. The result of the a class basis for exclusive participation 1419.705 Responsibilities of the review shall be documented in writing by small business concerns. This class contracting officer under the using the format shown at 1453.303–70. set-aside does not apply when: subcontracting assistance program. At the discretion of the CO, the BUDS (1) The acquisition is procured using 1419.705–2 Determining the need for a may conduct the reviews. In addition to simplified acquisition procedures; subcontracting plan. required bureau/office internal (2) Use of a set-aside is precluded by The CO’s determination that no the Small Business Competitiveness distribution, a copy of the review report subcontract possibilities exist for a shall be submitted to OSDBU within 60 Demonstration Program (SBCDP) (See proposed contractual action shall be FAR 19.10); calendar days after completion of the reviewed by the BUDS prior to the review. (3) A non-competitive acquisition has approval by a level above the CO, and been approved under the procedures of a copy shall be forwarded to OSDBU Subpart 1419.8—Contracting with the FAR 6.3; within 5 working days of execution, but Small Business Administration (The (4) Work is to be performed outside in no case later than the date of contract 8(a) Program) the U.S.; or award. The BUDS may contact OSDBU (5) The BPC determines that adequate and consider any comments or 1419.803 Selecting acquisitions for the competition is not likely to be obtained recommendations offered. 8(a) Program. if the acquisition is restricted to small business concerns, applying the 1419.705–3 Preparing the solicitation. The CO shall first screen the requirements of FAR 19.202–2. In solicitations containing subcontract acquisition for suitability for award to (b) The use of such set-asides is plan requirements, COs should consider SBA under the Section 8(a) program, contingent upon current policy in effect evaluating offered subcontract plans and before taking action under FAR 19.501, under application of the SBCDP (See the offerors’ past subcontracting 19.502 or 1419.503–70. After selecting FAR 19.10). compliance and accomplishments in the acquisitions suitable for the 8(a) evaluation and selection of proposals. program, the contracting office shall 1419.505 Rejecting Small Business This would be particularly appropriate provide SBA appropriate advance Administration recommendations. for acquisitions known to offer acquisition planning information for all (a) A written justification in support significant subcontracting opportunities acquisitions found to be suitable for the of the CO’s decision to reject the set- for small, small disadvantaged, and 8(a) program (See also 1407.1). aside recommendation shall be women-owned businesses or which approved by the HCA. It shall then be include work previously performed by a 1419.810 SBA appeals. forwarded for sequential review through small business. When used, this factor AS/PMB, without the power of the Director, OSDBU and the Director, must be evaluated in such a way that redelegation, is authorized to issue the PAM, for action by the AS/PMB. the relative ranking or scoring of small decision on an SBA appeal of a CO’s (b) As prescribed in FAR 19.505, the business offerors is not adversely Section 8(a) decision. AS/PMB is authorized to reply to the affected by the lack of a subcontract Administrator of SBA on any SBA plan.

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Subpart 1419.9—Contracting 1422.804 Affirmative action programs. 1422.406–8 Investigations. Opportunities for Women-Owned Small 1422.804–2 Construction. (a) Labor standards investigations Businesses 1422.805 Procedures. required by FAR 22.406–8 shall be the 1422.807 Exemptions. responsibility of the CO. 1419.901 Policy. Subpart 1422.10—Service Contract Act of (b) The CO’s report of violations shall In support of the Department’s policy 1965, As Amended be submitted to the HCA, who is to facilitate, preserve, and strengthen 1422.1003 Applicability. authorized to take the actions prescribed women’s business enterprises: 1422.1003–4 Administrative limitations, in FAR 22.406–8(d). (a) Annual goals for contract awards variations, tolerances and exemptions. (c) The HCA shall forward all referrals to women-owned businesses shall be Subpart 1422.13—Special Disabled through the OIG to the Attorney established as prescribed in 1419.201(b); Veterans, Veterans of the Vietnam Era, and General. and Other Eligible Veterans 1422.406–9 Withholding from or (b) Small women-owned businesses 1422.1305 Waivers. shall be considered for subcontracting suspension of contract payments. opportunities under FAR 19.702, and Subpart 1422.14—Employment of Workers HCAs shall establish procedures for with Disabilities subcontract awards shall be reported as collection and disposition of funds prescribed in FAR 19.704. 1422.1403 Waivers. withheld under FAR 22.406–9, (c) OSDBU, in accordance with 111 Authority: Sec. 205(c), 63 Stat. 390, 40 including liquidated damages. U.S.C. 486(c); and 5 U.S.C. 301. DM 8, is assigned the responsibility for 1422.406–13 Semiannual enforcement carrying out the Department’s women- reports. owned business enterprise program. Subpart 1422.1—Basic Labor Policies PAM is responsible for submitting the 1422.101 Labor relations. Subpart 1419.10—Small Business report required by FAR 22.406–13 to Competitiveness Demonstration 1422.101–1 General. DOL. In accordance with DOL Program The HCA may designate programs or memoranda, PAM requires bureaus to requirements for which notice of labor submit the required reports by April 15 1419.1003 Purpose. disputes is necessary. and October 15 for the reporting periods OSDBU is responsible for establishing of October 1 through March 31 and the 10 targeted industry categories and 1422.101–3 Reporting labor disputes. April 1 through September 30, monitoring DOI’s participation. Labor disputes that may interfere with respectively. contract performance shall be reported PARTS 1420–1421—[RESERVED] to the SOL and the HCA. Subpart 1422.6—Walsh-Healey Public Contracts Act PART 1422—APPLICATION OF LABOR 1422.101–4 Removal of items from 1422.604 Exemptions. LAWS TO GOVERNMENT contractors’ facilities affected by work stoppages. ACQUISITIONS 1422.604–2 Regulatory exemptions. Prior to initiating any action for Subpart 1422.1—Basic Labor Policies removal of items from contractors’ The AS/PMB is authorized to request the Secretary of Labor to exempt Sec. facilities, the CO shall obtain advice 1422.101 Labor relations. from SOL. contracts from the Walsh-Healey Public 1422.101–1 General. Contracts Act under FAR 22.604–2(b). A 1422.101–3 Reporting labor disputes. 1422.103 Overtime. written finding justifying the exemption shall be prepared by the CO and 1422.101–4 Removal of items from 1422.103–4 Approvals. contractors’ facilities affected by work submitted by the HCA to the Director, stoppages. The CO shall obtain approval for the PAM for further action. 1422.103 Overtime. use of overtime from the CCO after 1422.103–4 Approvals. consultation with the cognizant program Subpart 1422.8—Equal Employment office. Subpart 1422.3—Contract Work Hours and Opportunity Safety Standards Act Subpart 1422.3—Contract Work Hours 1422.803 Responsibilities. 1422.302 Liquidated damages and overtime and Safety Standards Act The CO shall forward matters pay. 1422.302 Liquidated damages and involving the applicability of EO 11246 Subpart 1422.4—Labor Standards for overtime pay. to the HCA for resolution. This Contracts Involving Construction (a) HCAs are authorized to take the authority is granted to the HCA without 1422.404 Davis-Bacon Act wage action in FAR 22.302(c) the power of redelegation. determinations. (b) Funds withheld or collected for 1422.404–6 Modifications of wage 1422.804 Affirmative action programs. determinations. liquidated damages shall be disposed of 1422.804–2 Construction. 1422.406–8 Investigations. in accordance with procedures under 1422.406–9 Withholding from or 1422.406–9. Bureau contracting offices are suspension of contract payments. responsible for maintaining (including 1422.406–13 Semiannual enforcement Subpart 1422.4—Labor Standards for updates and revisions) lists of reports. Contracts Involving Construction geographic areas subject to affirmative Subpart 1422.6—Walsh-Healey Public 1422.404 Davis-Bacon Act wage action requirements. Contracts Act determinations. 1422.805 Procedures. 1422.604 Exemptions. 1422.404–6 Modifications of wage Copies of the poster ‘‘Equal 1422.604–2 Regulatory exemptions. determinations. Employment Opportunity is the Law’’ Subpart 1422.8—Equal Employment The HCA is authorized to request an (National Stock No. 7690–00–926–8988) Opportunity extension for awards not made within may be ordered from the GSA supply 1422.803 Responsibilities. 90 days after bid opening. depot.

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1422.807 Exemptions. PART 1423—[RESERVED] Subpart 1425.7—Prohibited Sources (a) The Director, PAM shall make the 1425.701 Restriction on acquisition of determination that a contract is essential PART 1424—PROTECTION OF supplies or services from prohibited sources. to the national security and that the PRIVACY AND FREEDOM OF INFORMATION award of the contract without Subpart 1425.10—Additional Foreign complying with one of the requirements Subpart 1424.1—Protection of Individual Acquisition Regulations of FAR 22.8 is necessary to national Privacy 1425.1001 Waiver of right to examination of security. Sec. records. (b) Requests for exemptions shall be 1424.102 General. Authority: Sec. 205(c), 63 Stat. 390, 40 submitted in writing by the CO, through 1424.103 Procedures. U.S.C. 486(c); and 5 U.S.C. 301. 1424.104 Contract clauses. the HCA, to the Director, PAM. 1425.003 Definitions. Subpart 1424.2—Freedom of Information Subpart 1422.10—Service Contract Act Act. Impracticable, as used in this subpart, of 1965, as Amended 1424.203 Policy. includes reasons other than cost, and availability. 1422.1003 Applicability. Authority: Sec. 205(c), 63 Stat. 390, 40 U.S.C. 486(c); and 5 U.S.C. 301. Manufacture, as used in this subpart, 1422.1003–4 Administrative limitations, means completion of an end product in variations, tolerances and exemptions. Subpart 1424.1—Protection of the form required to meet specifications. Individual Privacy It includes only direct incorporation of The CO shall submit requests for 1424.102 General. components into the end products to determination regarding application of alter the original material and establish the Service Contract Act and Procedures for implementing the the identity/character of the end exemptions directly to DOL, Privacy Act of 1974 and Departmental product, and excludes other supplies, Administrator of the Wage and Hour regulations under 43 CFR Part 2, materials, and requirements such as Division. Subpart D, are contained in 383 DM. testing, manuals, related equipment, etc. 1424.103 Procedures. Subpart 1422.13—Special Disabled Subpart 1425.1—Buy American Act— Veterans, Veterans of the Vietnam Era, When required by FAR 24.103(b)(2), Supplies and Other Eligible Veterans the CO shall provide the contractor with a copy of the Department’s Privacy Act 1425.103 Exceptions. 1422.1305 Waivers. regulations codified in 43 CFR Part 2, (a) The AS/PMB is authorized to make Subpart D. (a) The Director, PAM is authorized the determination that a foreign end to: 1424.104 Contract clauses. item will be acquired for Government (1) Waive any or all terms of the The clause at FAR 52.224–1, Privacy use because preference for a U.S. item clause at FAR 52.222–35, Equal Act Notification, as prescribed in FAR would be inconsistent with the public Opportunity for Special Disabled 24.104(a), shall be supplemented in interest. Such determinations shall be prepared by the CO and submitted by Veterans, Veterans of the Vietnam Era, accordance with 1452.224–1. the HCA to the Director, PAM for and Other Eligible Veterans, under the further action. conditions prescribed in FAR Subpart 1424.2—Freedom of Information Act 22.1305(a), and (b) The Director, PAM is authorized to 1424.203 Policy. make the determination that an article, (2) Waive any requirement in FAR material or supply not included in the Subpart 22.13 as prescribed in FAR (a) The Department’s implementation list under FAR 25.104 is not mined, 22.1305(b). of the Freedom of Information Act is produced, or manufactured in the U.S. (b) Requests for waivers, under codified in regulations under 43 CFR in sufficient and reasonably available paragraph (a) of this section, shall be Part 2, Subparts A and B. commercial quantities of satisfactory made in writing by the CO through the (b) It is the policy of the Department quality. Determinations shall be HCA to the Director, PAM for further to alert prospective contractors which prepared by the CO and submitted by action. place restrictions on the disclosure and the BPC for approval. use of proposal data that certain data may be subject to disclosure under a (c) Contracting activities which have Subpart 1422.14—Employment of information justifying the removal of an Workers with Disabilities Freedom of Information Act request. (See 1415.207 and 1452.215–71.) item from the list under FAR 25.104 1422.1403 Waivers. shall submit such information to the PART 1425—FOREIGN ACQUISITION Director, PAM for further disposition. The Director, PAM is authorized to waive any or all of the terms of the Sec. 1425.105 Determining reasonableness of cost. clause at FAR 52.222–36, Affirmative 1425.003 Definitions. Action for Workers with Disabilities, Subpart 1425.1—Buy American Act— (a) In unusual circumstances, the under the conditions prescribed in FAR Supplies Director, PAM may authorize the use of 22.1403(a), and waive any requirement 1425.103 Exceptions. evaluation differentials other than those in FAR Subpart 22.14 as prescribed in 1425.105 Determining reasonableness of prescribed in FAR 25.105 for a FAR 22.1403(b). Requests for waivers cost. particular acquisition. shall be made in writing by the CO Subpart 1425.2—Buy American Act— (b) Requests for use of other through the HCA to the Director, PAM. Construction Materials evaluation differentials shall be 1425.202 Exceptions. submitted by the HCA to the Director, 1425.206 Noncompliance. PAM for further action.

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Subpart 1425.2—Buy American Act— Subpart 1426.71—Minority Business for the special programs and services Construction Materials Reports provided by the United States to Indians 1426.7100 Scope of subpart. because of their status as Indians. 1425.202 Exceptions. 1426.7101 Definitions. On or near an Indian reservation (a)(1) The CO may determine the 1426.7102 Minority Business Development means on a reservation or the distance reasonableness of cost as determined by Agency (MBDA–91) Plan and Reports. within that area surrounding an Indian 1426.7102–1 Statutory basis. the formula in 1425.203–70. reservation(s) that a person seeking 1426.7102–2 Requirements. employment could reasonably be (2) The Director, PAM has the 1426.7103 The Comprehensive authority to make the determination that Environmental Response, Compensation, expected to commute to and from in the use of U.S. construction material would and Liability Act (CERCLA) (Superfund course of a work day. Minority Contractors Utilization Report). be impracticable. Failure of the Director, 1426.7002 Statutory requirements. PAM to issue a determination within 30 1426.7103–1 Statutory basis. 1426.7103–2 Requirements. Section 7(b) of the Indian Self- days after receipt of a request will be Determination and Education deemed approval for use of the cited Authority: Sec. 205(c), 63 Stat. 390, 40 U.S.C. 486(c); and 5 U.S.C. 301. Assistance Act requires that any foreign material. contract or subcontract entered into (3) For items not on the list at FAR Subpart 1426.70—Indian Preference pursuant to that Act, the Act of April 16, 25.108(d), the CCO may make the non- 1934 (48 Stat. 596; 25 U.S.C. 452), as availability determination if the items 1426.7000 Scope of subpart. amended (the Johnson-O’Malley Act), or cost less than the SAT. The HCA may This subpart prescribes policies and any other Act authorizing contracts with make the non-availability determination procedures for implementation of Indian organizations or for the benefit of when the cost of the items exceeds the Section 7(b) of the Indian Self- Indians shall require that, to the greatest SAT. Determination and Education extent feasible: (b) [Reserved] Assistance Act (Pub. L. 93–638, 88 Stat. (a) Preferences and opportunities for 2205, 25 U.S.C. 450e(b)). training and employment in connection 1425.206 Noncompliance. with the administration of such 1426.7001 Definitions. The CO will report, in writing, any contracts shall be given to Indians, and For purposes of this subpart the use of non-excepted, foreign (b) Preference in the award of following definitions shall apply: construction materials by contractors, subcontracts in connection with the Indian means a person who is a administration of such contracts shall be subcontractors and suppliers through member of an Indian Tribe. If the the HCA to the Director, PAM for given to Indian organizations and to contractor has reason to doubt that a Indian-owned economic enterprises as debarment action in accordance with person seeking employment preference Subpart 1409.4. defined in Section 3 of the Indian is an Indian, the contractor shall grant Financing Act of 1974 (Sec. 3, Pub. L. Subpart 1425.7—Prohibited Sources the preference but shall require the 93–262; 88 Stat. 77; 25 U.S.C. 1452). individual within thirty (30) days to 1425.701 Restriction on acquisition of provide evidence from the Tribe 1426.7003 Applicability and contract supplies or services from prohibited concerned that the person is a member clause. sources. of the Tribe. (a) The CO shall insert the clause at The AS/PMB is authorized to request Indian organization means that 1452.226–70, Indian Preference— permission from the Office of Foreign governing body of any Indian Tribe or Department of the Interior, in Assets Control (OFAC) for DOI use of entity established or recognized by such solicitations issued and contracts supplies and services from the sources governing body in accordance with the awarded by: described in FAR 25.701. Requests shall Indian Financing Act of 1974 (88 Stat. (1) The Bureau of Indian Affairs; be prepared by the CO and submitted 77; 25 U.S.C. 1451). (2) A contracting activity other than through the HCA to the Director, PAM. Indian-owned economic enterprise the Bureau of Indian Affairs when the means any Indian-owned commercial, contract is entered into pursuant to an Subpart 1425.10—Additional Foreign industrial, or business activity act specifically authorizing contracts Acquisition Regulations established or organized for the purpose with Indian organizations; and, of profit provided that such Indian (3) A contracting activity other than 1425.1001 Waiver of right to examination ownership shall constitute not less than the Bureau of Indian Affairs where the of records. 51 percent of the enterprise. work to be performed is specifically for The Director, PAM is authorized to Indian reservation includes Indian the benefit of Indians and is in addition make the determinations prescribed in reservations, public domain Indian to any incidental benefits which might FAR 25.1001(b). Determinations shall be allotments, former Indian reservations otherwise accrue to the general public. prepared by the CO and submitted in Oklahoma, and land held by (b) The CO shall insert the clause at through the HCA to the Director, PAM. incorporated Native groups, regional 1452.226–71, Indian Preference corporations, and village corporations Program—Department of the Interior, in PART 1426—OTHER under the provisions of the Alaska all solicitations issued and contracts SOCIOECONOMIC PROGRAMS Native Claims Settlement Act, (85 Stat. awarded by a contracting activity which may exceed $50,000, which contain the Subpart 1426.70—Indian Preference 688; 43 U.S.C. 1601 et seq.). Indian Tribe means an Indian Tribe, clause required by paragraph (a) of this Sec. band, nation, or other recognized group section and where it is determined by 1426.7000 Scope of subpart. or community, including any Alaska the CO, prior to solicitation, that the 1426.7001 Definitions. 1426.7002 Statutory requirements. Native village or regional or village work under the contract will be 1426.7003 Applicability and contract corporation as defined in or established performed in whole or in part on or near clause. pursuant to the Alaska Native Claims an Indian reservation(s). The Indian 1426.7004 Compliance enforcement. Settlement Act (85 Stat. 688; 43 U.S.C. Preference Program clause may also be 1426.7005 Tribal preference requirements. 1601), which is recognized as eligible included in solicitations issued and

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contracts awarded by a contracting Order 12432 entitled ‘‘Minority Business 1426.7102–2 Requirements. activity which may not exceed $50,000, Enterprise Development’’ and the (a) MBDA–91 Plan. The BPC is but which contain the clause required Comprehensive Environmental required to submit the Plan on form by paragraph (a) of this section and Response, Compensation and Liability MBDA–91 to the OSDBU by no later which, in the opinion of the CO, offer Act (CERCLA), also known as than November 15 of each year. Section substantial opportunities for Indian ‘‘Superfund.’’ 1 of the form, ‘‘Procurement Program employment, training or subcontracting. 1426.7101 Definitions. Activities,’’ will be completed by 1426.7004 Compliance enforcement. OSDBU. Sections 2 through 5 must be For purposes of this subpart the completed by bureaus and offices. (a) The CO is responsible for following definitions shall apply: conducting periodic reviews of the (b) MBDA–91 Reports. The BPC must Contract means a contract or contractor to ensure compliance with submit reports to the OSDBU within 30 subcontract awarded pursuant to the the requirements of the clauses days following the end of a fiscal FAR, as well as federal financial prescribed in 1426.7003. These reviews quarter. Reports are cumulative from assistance, including a subcontract, may be conducted with the assistance of October 1 of the reporting fiscal year, cooperative agreement, grant, the Indian Tribe(s) concerned. and monetary figures should be rounded (b) Complaints of noncompliance subagreement or subgrant. to whole dollars in each section of the with the requirements of the clauses Minority business enterprise means a report. prescribed under 1426.7003 received in business which is at least 51% owned (c) ‘‘Negative report’’ means when the writing by the contracting activity shall by one or more minority individuals, or Bureau had no reportable activity be promptly investigated by the CO. A in the case of any publicly owned during the quarter. Submit such a report written disposition of the complaint business, at least 51% of the voting using the MBDA–91 report form. shall be prepared by the CO. stock is owned by one or more minority individuals. The daily business 1426.7103 The Comprehensive 1426.7005 Tribal preference requirements. operations are likewise managed by the Environmental Response, Compensation, (a) Where the work under a contract minority owner. and Liability Act (CERCLA) (Superfund Minority Contractors Utilization Report). is to be performed on an Indian Minority individual means a U.S. reservation, the CO may supplement the citizen who has been subjected to racial 1426.7103–1 Statutory basis. clause at 1452.226–71, Indian or ethnic prejudice or cultural bias Paragraph 105 of CERCLA requires Preference Program—Department of the because of their identity as members of the President of the United States to Interior, by adding specific Indian this group without regard to their consider the availability of qualified preference requirements of the Tribe on individual qualities. Such groups minority business enterprises in whose reservation the work is to be include, but are not limited to: Black awarding contracts under the Act and performed. The supplemental Americans; Hispanic Americans; Native report annually to Congress on the requirements shall be jointly developed Americans; Asian-Pacific Americans; extent of such awards, including the for the contract by the CO and the Tribe. and other groups whose members are efforts made to encourage the Supplemental preference requirements U.S. citizens and are found to be participation of such firms in programs must represent a further implementation disadvantaged by the Small Business carried out under the act. The of the requirements of Section 7(b) of Administration pursuant to Section 8(d) Environmental Protection Agency has Public Law 93–638 and must be of the Small Business Act as amended delegated responsibility for preparing approved by the SOL for legal (15 U.S.C. 637(d)), or the Secretary of sufficiency before being added to a the report, which includes contracts for Commerce. solicitation and resultant contract. Any Superfund hazardous waste clean-up supplemental preference requirements (a) Native Americans are persons awarded by other agencies. to be added to the clause at 1452.226– having origins in any of the original 1426.7103–2 Requirements. 71 shall be included in the solicitation peoples of North America or the and clearly identified in order to ensure Hawaiian Islands; in particular, The contracting offices shall report uniform understanding of the additional American Indians, Eskimos, Aleuts and designated projects funded with EPA requirements by all prospective bidders Native Hawaiians. monies, involving the actual award of or offerors. (b) Asian-Pacific Americans—persons contracts, subcontracts, financial (b) Nothing in this section shall be having origins from Japan, China, the assistance instruments, subagreements, interpreted to preclude Tribes from Philippines, Vietnam, Korea, Samoa, etc. by DOI. Do not include independently developing and Guam, the U.S. Trust Territories of the Departmental projects covered by enforcing their own tribal preference Pacific, Northern Marianas, Laos, Superfund and funded solely with requirements. Such independently Cambodia, Taiwan, Thailand, Malaysia, Departmental appropriations. The BPC developed tribal preference Indonesia, Singapore, Brunei, Republic must submit one of the following requirements shall not, except as of the Marshall Islands, or the Federated reports inclusive of all projects, as provided in paragraph (a) of this States of Micronesia. applicable, to the OSDBU by no later section, become a requirement in than November 8 of each year: contracts covered under this subpart 1426.7102 Minority Business Development Agency (MBDA–91) Plan and Reports. (a) EPA Forms 6005–3 and 6005–3A 1426.70 and must not hinder the for applicable Superfund contract Government’s right to award contracts 1426.7102–1 Statutory basis. awards, including partial awards to and to administer their provisions. Executive Order 12432, dated July 14, minority businesses. Subpart 1426.71—Minority Business 1983, established the requirement for (b) EPA Form 6005–3A only, for Reports the Department of Commerce (i.e., applicable Superfund contract awards MBDA) to collect information on when no awards were made to minority 1426.7100 Scope of subpart. acquisition and financial assistance firms, to report the efforts made to This subpart sets forth reporting awards to minority businesses, as well promote minority business participation requirements established by Executive as credit assistance to such firms. in the designated projects.

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(c) ‘‘Negative Report’’ when the determinations to use exceptions under written notice to the contractor after reporting Bureau did not award FAR 27.303(e)(1) shall be forwarded to consultation with the Assistant Solicitor contracts using Superfund monies. the Assistant Solicitor for Acquisitions for Acquisitions and Intellectual and Intellectual Property for submission Property. The notice shall be prepared Subchapter E—General Contracting to the Secretary of Commerce and, if and signed by the Associate Solicitor for Requirements required, to the Chief Counsel for the General Law Division. Within the Advocacy of the Small Business time constraints, if the Associate PART 1427—PATENTS, DATA, AND Administration. The determinations Solicitor for the General Law Division COPYRIGHTS shall include all supporting determines any information submitted Subpart 1427.2—Patents and Copyrights documentation. by the contractor (assignee or exclusive licensee) after notice of march-in is Sec. 1427.304 Procedures. 1427.201 Patent and copyright infringement received raises a genuine dispute over liability. 1427.304–1 General. material facts, a fact-finding hearing 1427.201–2 Contract clauses. (a)(1) Exceptions. The Associate shall be conducted by OHA. The 1427.202 Royalties. Associate Solicitor for the General Law 1427.202–3 Adjustment of royalties. Solicitor for the General Law Division shall issue a decision on the appeal of Division shall issue a final Subpart 1427.3—Patent Rights Under a small business concern or nonprofit determination, after consideration of Government Contracts organization of the use of exceptions any further written or oral arguments 1427.303 Contract clauses. under FAR 27.303(e)(1). from the parties. An unfavorable 1427.304 Procedures. (2) If the Associate Solicitor for the determination to a contractor (assignee 1427.304–1 General. General Law Division determines that or exclusive licensee) shall be subject to 1427.304–4 Appeals. the appeal notice raises a genuine appeal. 1427.306 Licensing background patent (d) Licenses and assignments under rights to third parties. dispute over the material facts, a fact- finding hearing shall be conducted by contracts with nonprofit organizations. Authority: Sec. 205(c), 63 Stat. 390, 40 COs may approve contractor requests for U.S.C. 486(c); and 5 U.S.C. 301. OHA. The hearing shall be conducted at a location convenient to the parties assignment of rights or exclusive licenses after obtaining the advice of the Subpart 1427.2—Patents and concerned as determined by the Assistant Solicitor for Acquisitions and Copyrights Director, OHA, and on a date and time stated. The contractor may be Intellectual Property. Solicitations 1427.201 Patent and copyright represented by counsel or any duly containing FAR clause 52.227–11 shall infringement liability. authorized representative. Witnesses state that contractors should forward such requests to the CO. 1427.201–2 Contract clauses. may be called by either party. The Approval to exempt specific United proceedings shall be conducted 1427.304–4 Appeals. States patents from the patent expeditiously and in such a manner that (a) The CO is authorized to make any indemnity clause shall be obtained from each party will have a full opportunity of the determinations listed after the CCO with legal review and to present all information considered consultation with the Assistant Solicitor concurrence. pertinent to the determination. A for Acquisitions and Intellectual transcribed record of the proceedings Property. 1427.202 Royalties. shall be made and shall be made (b) Determinations made under 1427.202–3 Adjustment of royalties. available at cost to the contractor upon paragraph (a) of this section shall be request, unless the requirement for the considered final decisions under the The CO shall report to the Assistant transcribed record is waived by mutual Solicitor for Acquisitions and Contract Disputes Act and may be agreement of the contractor and OHA. appealed to the CBCA in accordance Intellectual Property the results of any (3) OHA shall prepare written action taken in compliance with FAR with the procedures in DIAR Subpart findings of fact and transmit them to the 1433.2. 27.202–3. Associate Solicitor for the General Law Division. 1427.306 Licensing background patent Subpart 1427.3—Patent Rights Under rights to third parties. Government Contracts. (4) OHA may hear oral arguments after fact-finding provided that the Any proposed determination to be 1427.303 Contract clauses. contractor, its counsel or other duly made to require third party licensing (a) The HCA is authorized to make the authorized representative, is present in shall be submitted by the HCA through determination to sublicense foreign order to have the opportunity to make the Assistant Solicitor for Acquisitions governments or international arguments and rebuttal. The Associate and Intellectual Property for signature of organizations, as prescribed in FAR Solicitor for the General Law Division the AS/PMB. The contractor may 27.303(b)(3). shall issue a decision. request a public hearing on the record (b) If one of the exceptions in FAR (b) Greater rights determinations. prior to the above determination. In 27.303(e)(1) is used, then insert clause Determinations on requests for greater such cases, the proposed determination 1452.227–70, Appeals of Use of rights in subject inventions by and the contractor’s request for a Exceptions. The exception in FAR contractors shall be made by the HCA hearing shall be referred to OHA. OHA 27.303(e)(1)(ii) to use alternative after consultation with the Assistant shall conduct public hearings as set provisions restricting or eliminating a Solicitor for Acquisitions and forth in 1427.304–1(a)(4) and shall contractor’s right to retain title to any Intellectual Property. Appeals of such forward its findings and subject invention shall be made by the determinations shall be made to the recommendations to the AS/PMB for a HCA, after consultation with the CBCA. final determination. The final Assistant Solicitor for Acquisitions and (c) Exercise of march-in-rights. After determination shall inform the Intellectual Property. notification to the contractor of contractor of the right to judicial review (c) Within 30 days after contract information warranting the exercise of within sixty (60) days of the AS/PMB award the CO shall forward copies of march-in rights, the CO shall prepare a determination.

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PART 1428—BONDS AND INSURANCE of the Interior, in solicitations and the Director, PAM, without the power of contracts when a fixed-price contract for redelegation, for a determination. PAM Subpart 1428.3—Insurance operation of aircraft is anticipated and must report any waivers granted on a where the Government is using a fiscal year basis to the CASB in Sec. 1428.301 Policy. contractor-furnished pilot. accordance with FAR 30.201–5(e). (b) The CO shall insert the clause at 1428.306 Insurance under fixed-price 1430.202 Disclosure requirements. contracts. 1452.228–72, Liability for Loss or 1428.306–70 Insurance for aircraft services Damage—Department of the Interior, in 1430.202–2 Impracticality of submission. contracts. solicitations and contracts when a fixed- The CO shall prepare any request to 1428.311 Solicitation provision and price contract for use of aircraft is award a contract without the required contract clause on liability insurance anticipated and where the Government contractor submission of the Form No. under cost-reimbursement contracts. does not have a property interest and is 1428.311–1 Contract clause. CASB–DS–1, Disclosure Statement, and using a Government-furnished pilot. submit it through the HCA, to the 1428.311–2 Agency solicitation provisions (c) The CO shall insert the clause at and contract clauses. Director, PAM, and to the Secretary for 1452.228–73, Liability for Loss or approval. The Secretary, without the Authority: Sec. 205(c), 63 Stat. 390, 40 Damage (Property Interest)—Department power of redelegation, must file a report U.S.C. 486(c); and 5 U.S.C. 301. of the Interior, in solicitations and to CASB within 30 days in accordance contracts when a fixed-price contract for Subpart 1428.3—Insurance with 48 CFR 9903.202–2 (FAR use of aircraft is anticipated and where Appendix). 1428.301 Policy. the Government has a property interest It is the policy of DOI to insure its in the aircraft and is using a PART 1431—CONTRACT COST own risks only when such action is in Government-furnished pilot (e.g., a lease PRINCIPLES AND PROCEDURES the best interest of the Government. with purchase option). Circumstances where contractors are Subpart 1431.1—Applicability PART 1429—TAXES required to carry insurance are listed Sec. 1431.101 Objectives. under FAR 28.301 and 28.306. In these Subpart 1429.3—State and Local Taxes circumstances, the CO shall insert the Sec. Authority: Sec. 205(c), 63 Stat. 390, 40 clause at 1452.228–70, Liability 1429.303 Application of State and local U.S.C. 486(c); and 5 U.S.C. 301. Insurance— Department of the Interior, taxes to Government contractors and in solicitations and contracts. subcontractors. Subpart 1431.1—Applicability 1428.306 Insurance under fixed-price Authority: Sec. 205(c), 63 Stat. 390, 40 1431.101 Objectives. contracts. U.S.C. 486(c); and 5 U.S.C. 301. Individual deviations concerning cost principles and procedures shall require 1428.306–70 Insurance for aircraft Subpart 1429.3—State and Local Taxes the approval of the cognizant Assistant services contracts. 1429.303 Application of State and local Secretary, with further redelegation (a) Policy. The CO shall insert taxes to Government contractors and authorized. Redelegation is limited to minimum insurance requirements in subcontractors. the BPC. aircraft services contracts in order to Contractors to be treated as agents of protect the Government and its the Government for the purposes set PART 1432—CONTRACT FINANCING contractors. forth in FAR 29.303(a) shall require the (b) Applicability. The clauses Subpart 1432.1—Non-Commercial Item written review and approval of the AS/ Purchase Financing prescribed in section 1428.311–2 are PMB. The HCA shall submit requests for applicable to all fixed-price contracts Sec. approval through SOL, to the Director, 1432.102 Description of contract financing involving use of aircraft with either a PAM, for further action. contractor-furnished or a Government- methods. furnished pilot except for one-time PART 1430—COST ACCOUNTING Subpart 1432.3—Loan Guarantees for charters when Government exposure is STANDARDS ADMINISTRATION Defense Production minimal and time limitations are 1432.304 Procedures. present. Subpart 1430.2—CAS Program 1432.304–2 Certificate of eligibility. Requirements 1428.311 Solicitation provision and Subpart 1432.4—Advance Payments for Sec. Non-Commercial Items contract clause on liability insurance under 1430.201 Contract requirements. cost-reimbursement contracts. 1430.201–5 Waiver. 1432.402 General. 1432.407 Interest. 1428.311–1 Contract clause. 1430.202 Disclosure requirements. 1430.202–2 Impracticality of submission. The CO shall modify the clause at Subpart 1432.5—Progress Payments Based on Costs FAR 52.228–7, Insurance—Liability to Authority: Sec. 205(c), 63 Stat. 390, 40 Third Persons, in accordance with U.S.C. 486(c); and 5 U.S.C. 301. 1432.501 General. 1452.228–7, and insert in solicitations 1432.501–2 Unusual progress payments. Subpart 1430.2—CAS Program 1432.502–2 Contract finance office and contracts as prescribed in FAR Requirements clearance. 28.311–1. 1430.201 Contract requirements. Subpart 1432.6—Contract Debts 1428.311–2 Agency solicitation provisions 1432.602 Responsibilities. and contract clauses. 1430.201–5 Waiver. 1432.610 Compromising debts. The following DOI clauses shall be The CO shall prepare requests to used as prescribed: waive contractor compliance with CAS Subpart 1432.9—Prompt Payment (a) The CO shall insert the clause at prescribed in FAR 30.201–5 and 48 CFR 1432.903 Responsibilities. 1452.228–71, Aircraft and General 9903.201–5(e) (FAR Appendix). The CO Authority: Sec. 205(c), 63 Stat. 390, 40 Public Liability Insurance—Department shall submit the request for waiver to U.S.C. 486(c); and 5 U.S.C. 301.

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Subpart 1432.1—Non-Commercial Item Subpart 1432.6—Contract Debts Subpart 1433.1—Protests Purchase Financing 1432.602 Responsibilities. 1433.102 General. 1432.102 Description of contract financing 344 DM contains policy, standards, For protests filed with GAO, the SOL methods. and guidelines for collection of debts shall be responsible for handling all bid Use of progress payments based on a within DOI. Each bureau and office is protest matters. Any communications to percentage or stage of completion are responsible for developing an internal GAO shall be coordinated with the authorized for construction contracts. debt collection system and prescribing regional and/or field solicitor and the Assistant Solicitor, Acquisitions and Progress payments for other than internal procedures for collection of Intellectual Property. construction, alteration, and repair debts, including debts covered under contracts require the CO to write a FAR Subpart 32.6. 1433.103 Protests to the agency. determination that: 1432.610 Compromising debts. For protests filed with the agency, the (a) Payments based on costs would be CO shall coordinate with the regional The CO may recommend compromise impracticable; and and/or field solicitor and the Assistant of contractor actions pursuant to FAR (b) Adequate measures exist for Solicitor, Acquisitions and Intellectual 32.610, but shall consult 344 DM and Property, prior to making the protest determining quality standards and the SOL for further action. decision and before suspending or percentage of work accomplished. Subpart 1432.9—Prompt Payment terminating a contract award as a result Subpart 1432.3—Loan Guarantees for of the protest. When a protest is denied Defense Production 1432.903 Responsibilities. by the CO, the decision issued shall The CO may modify the timing of advise the protester that the decision 1432.304 Procedures. payment specified in paragraph (a)(1)(i) may be appealed to the GAO. All protest decisions must also contain a notice that 1432.304–2 Certificate of eligibility. and (ii) of the clause FAR 52.232–26, Prompt Payment for Fixed-Price appeals to GAO must include a copy of Guaranteed loan applications shall be Architect-Engineer Contracts, and/or the CO’s protest decision. authorized and transmitted to the paragraph (a)(1)(i) and (ii) of the clause 1433.104 Protests to GAO. Federal Reserve Board by the AS/PMB, at FAR 52.232–27, Prompt Payment for (a) General procedure. (1) A protester in accordance with FAR 32.304–2(h). Construction Contracts, as appropriate, shall furnish a copy of its complete to provide for a period shorter than 30 protest simultaneously to the CO and Subpart 1432.4—Advance Payments days (but not less than 7 days) for for Non-Commercial Items the Assistant Solicitor, Acquisitions and making contract financing payments Intellectual Property. Upon being 1432.402 General. based on geographical site location, telephonically advised by the GAO of workload, contractor ability to submit a the receipt of a protest, the SOL shall The HCA is authorized to approve proper request for payment, or other inform the appropriate contracting determinations and findings, as well as factors. When considering a activity which shall immediately notify contract terms, for advance payments. modification to these FAR standard(s), the CO. For protests concerning Federal The CO shall submit a recommendation the CO should alert the finance and Information Processing (FIP) for approval or disapproval of the program officials involved in the acquisitions, the SOL shall also inform contractor’s request to the HCA through payment process to ensure that such the Director, Office of Information the head of the bureau finance office. shorter contract payment terms to be Resources Management (PIR), who, in specified in the solicitation and 1432.407 Interest. turn, shall notify the appropriate bureau resulting contract will be met. A CO Information Resources Management The HCA may authorize advance determination justifying a shorter contact and GSA official. The CO shall payments without interest pursuant to payment period must be documented in prepare the protest report as required by FAR 32.407. writing, and incorporated into the FAR 33.104(a)(3). solicitation/contract file. (2) The SOL will furnish promptly Subpart 1432.5—Progress Payments GAO’s written notice of the protest to PART 1433—PROTESTS, DISPUTES, Based on Costs the cognizant contracting activity AND APPEALS which, in turn, shall promptly transmit 1432.501 General. Subpart 1433.1—Protests copies to the CO. The CO shall begin 1432.501–2 Unusual progress payments. Sec. notification as prescribed in FAR 1433.102 General. 33.104(a)(2). The notification letters The CO shall obtain the advance 1433.103 Protests to the agency. shall contain a specified period of time approval of the HCA, or designee, before 1433.104 Protests to GAO. for submission of comments and providing a progress payment rate 1433.106 Solicitation provisions and include instructions that any comments higher than the customary rates as contract clauses. submitted to the GAO should also be defined in FAR 32.501–1. Advance Subpart 1433.2—Disputes and Appeals submitted simultaneously to the CO and approval to provide progress payment the Assistant Solicitor, Acquisitions and 1433.203 Applicability. rates higher than the customary rates Intellectual Property. Copies of the CO’s shall not be delegated lower than the 1433.209 Suspected fraudulent claims. 1433.211 Contracting officer’s decision. notification letters shall be sent CCO. 1433.213 Obligation to continue concurrently to the Assistant Solicitor, performance. Acquisitions and Intellectual Property. 1432.502–2 Contract finance office 1433.214 Alternative dispute resolution clearance. (3)(i) The contracting activity shall (ADR). have no more than 15 working days The CO shall obtain approval of the 1433.215 Contract clauses. from the date of telephonic notification bureau finance office prior to taking Authority: Sec. 205(c), 63 Stat. 390, 40 by the SOL to deliver the protest report actions listed in FAR 32.502–2. U.S.C. 486(c); and 5 U.S.C. 301. to the Assistant Solicitor, Acquisitions

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and Intellectual Property. For reports 1433.106 Solicitation provisions and SUBCHAPTER F—SPECIAL involving use of the 10 working day contract clauses. CATEGORIES OF CONTRACTING express option, the SOL shall establish The provision at FAR 52.233–2, PART 1434—[RESERVED] the report delivery date after Service of Protest, as prescribed in FAR consultation with the contracting 33.106, shall be modified in accordance activity. PART 1435—RESEARCH AND (ii) If required, the SOL shall make the with the instructions in DIAR 1452.233– DEVELOPMENT CONTRACTING request for an extension in the report 2. due date. Authority: Sec. 205(c), 63 Stat. 390, 40 (iii) In addition to the requirements of Subpart 1433.2—Disputes and Appeals U.S.C. 486(c); and 5 U.S.C. 301. FAR 33.104(a)(3), the report shall be 1433.203 Applicability. 1435.010 Scientific and technical reports. appropriately titled and dated; shall cite the GAO file number; and shall be (a) The CO shall prepare any If a Research and Development (R&D) signed by the CO. Reports shall be determination that application of the contract results involve classified or prepared with the assistance of the local Contract Disputes Act to contracts with national security information, the CO attorney-advisor of the SOL. A a foreign or international organization shall follow the agency procedures statement shall be included giving an would not be in the public interest and prescribed in DIAR 1404.403 prior to making the results available. Copies of estimate of the length of time an award forward it to the HCA for review. The publications and reports are also may be delayed without significant HCA shall be responsible for submitting expense or difficulty in performance. If required to be sent to the DOI the determination through the Director, Departmental Library, 1849 C Street, appropriate, the report shall contain a PAM, to the AS/PMB for approval. statement regarding any urgency for the NW., MS–2258, Main Interior Building, acquisition and the extent to which a (b) The CBCA is authorized by the Washington, DC 20240. delay in award may result in significant Contract Disputes Act or by the Secretary to consider and determine an PART 1436—CONSTRUCTION AND performance difficulties or additional ARCHITECT–ENGINEER CONTRACTS expense to the Government. The appeal from a decision of a CO on a contracting activity shall submit the claim arising under or relating to a Subpart 1436.2—Special Aspects of CO’s report to the Assistant Solicitor, contract made by DOI. Contracting for Construction Acquisitions and Intellectual Property, 1433.209 Suspected fraudulent claims. Sec. who will then submit it to GAO and 1436.209 Construction contracts with provide a copy to each interested party The CO shall refer all matters relating architect-engineer firms. who responded to the notification to suspected fraudulent claims by a 1436.270 Preparation of solicitations and pursuant to FAR 33.104(a)(2). contracts for construction. contractor or individual to the OIG for 1436.270–1 Uniform contract format. (b) Protests before award. (1) The further action or investigation. 1436.270–2 Part I—The Schedule. finding to award, notwithstanding 1436.270–3 Part II—Contract clauses. protest, shall be written by the CO, 1433.211 Contracting officer’s decision. 1436.270–4 Part III—Documents, exhibits reviewed by the SOL, and approved by The CO’s decision shall reference the and other attachments. the HCA. A copy of the approved 1436.270–5 Part IV—Representations and Civilian Board of Contract Appeals, 6th instructions. written finding shall be placed in the Floor, 1800 M Street, NW., Washington, contract file. Subpart 1436.5—Contract Clauses (2) The SOL shall be responsible for DC 20036, and its rules of procedure at http://www.cbca.gsa.gov. 1436.570 Prohibition against use of lead- notifying GAO of the finding to award based paint. notwithstanding protest. 1433.213 Obligation to continue 1436.571 Additive and deductive items. (c) Protests after award. (1) The CO performance. shall notify the SOL prior to suspending Subpart 1436.6—Architect-Engineer Services or terminating the awarded contract. If the CO considers financing (2) The written finding to authorize continued contractor performance to be 1436.602 Selection of firms for architect- continued contract performance, in the best interest of the Government, engineer contracts. notwithstanding protest, shall be the CO shall prepare and forward a 1436.602–1 Selection criteria. written by the CO, reviewed by the SOL, determination to the HCA for approval. 1436.602–2 Evaluation boards. and approved by the HCA. 1436.602–3 Evaluation board functions. (3) The SOL shall be responsible for 1433.214 Alternative dispute resolution 1436.602–4 Selection authority. notifying GAO of the finding to (ADR). 1436.602–5 Short selection processes for continue contract performance not contracts not to exceed the simplified DOI strongly encourages the use of acquisition threshold. withstanding protest. ADR in the resolution of disputes in lieu (d) Notice to GAO. The CO shall 1436.603 Collecting data on and appraising of litigation or adjudication. Efforts shall firms’ qualifications. prepare the report required by FAR be made to resolve disputes in an 33.104(g), and coordinate it with the Authority: Sec. 205(c), 63 Stat. 390, 40 expeditious and financially responsible Assistant Solicitor, Acquisitions and U.S.C. 486(c); and 5 U.S.C. 301. manner. Intellectual Property, and the Director, Subpart 1436.2—Special Aspects of PAM, prior to HCA signature (signature 1433.215 Contract clauses. Contracting for Construction level not redelegable). For protests regarding FIP acquisitions, the CO shall The Disputes clause contained in FAR 1436.209 Construction contracts with also coordinate the report with the 52.233–1 shall be used with its architect-engineer firms. Director, PIR. After signature, the report Alternate I in all solicitations and Approval to award a contract for shall be forwarded to the Assistant contracts. construction to a firm or its subsidiaries Solicitor for Acquisitions and that designed the project shall be made Intellectual Property for transmission to by the HCA only after discussion with GAO. Director, PAM, and with legal

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concurrence. The request for approval (e) Section E, Inspection and Subpart 1436.5—Contract Clauses prepared by the CO shall include the acceptance. Include inspection, reason(s) why award to the design firm acceptance, quality assurance, and 1436.570 Prohibition against use of lead- is required; an analysis of the facts reliability requirements (See FAR Part based paint. involving potential or actual 46). (a) Definitions. As used in this organizational conflicts of interest, (f) Section F, Deliveries or section, ‘‘residential structure:’’ means including benefits and detriments to the performance. Include Suspension of any house, apartment, or structure Government and the prospective Work, Liquidated Damages, intended for human habitation contractor; and the measures which are Commencement, Prosecution, and including any institutional structure to be taken to avoid, neutralize or Completion of Work, Variation in where persons reside such as an mitigate conflicts of interest. A copy of Quantity clauses (See FAR Part 12). orphanage, boarding school dormitory, the documentation shall be forwarded to day care center, or extended care (g) Section G, Contract administration PAM at the time of consultation. facility. data. Include Contracting Officer’s (b) The CO shall insert the clause at 1436.270 Preparation of solicitations and Representative/Technical contracts for construction. Representative identification, and any 1452.236–70, Prohibition Against Use of required administration information Lead-Based Paint, in solicitations and 1436.270–1 Uniform contract format. (e.g., accounting and appropriation contracts when construction of (a) COs shall prepare solicitations and data). residential structures or rehabilitation (including dismantling, demolition, or contracts for construction using the (h) Section H, Special contract uniform contract format outlined in removal) of residential structures is requirements. Include any special contemplated. Table 1436–1. contract requirements which are not (b) If any section of the uniform included in other sections of the 1436.571 Additive and deductive items. contract format does not apply, the CO uniform contract format. If it appears that funds available for a should so mark that section in the construction project may be insufficient solicitation. Upon award, the CO shall 1436.270–3 Part II—Contract clauses. for all the desired features, the CO may not physically include Part IV in the For Section I, Contract clause, include provide in the solicitation for a base bid resulting contract, but shall retain it in any clauses required by law or by the item covering the work as specified and the contract file. FAR (including Subpart 36.5), the DIAR for one or more additive or deductive (including Subpart 1436.5), and any bid items which add or omit specified TABLE 1436–1—UNIFORM CONTRACT additional bureau-wide or local clauses features of the work in a stated order of FORMAT expected to be included in any resulting priority. Such solicitations shall include contract which are not included in other Section Title a provision substantially as set forth in sections of the uniform contract format. 1452.236–71, and the low bidder and Part I—The Schedule 1436.270–4 Part III—Documents, exhibits the bid items to be awarded shall be and other attachments. determined as provided in the A ...... Solicitation/contract form. provision. B ...... Bid schedule. For Section J, List of documents, C ...... Specifications/Drawings. exhibits, and other attachments, include Subpart 1436.6—Architect-Engineer D ...... Packaging and marking. wage determinations (See FAR 22.404), Services E ...... Inspection and acceptance. SF–24—Bid Bond (See FAR 28.101), F ...... Deliveries or performance. and other attachments by listing the 1436.602 Selection of firms for architect- G ...... Contract administration data. title, date and number for each engineer contracts. H ...... Special contract requirements. document. Part IV—Representations and Instructions 1436.602–1 Selection criteria. 1436.270–5 Part IV—Representations and (a) The CO may include specific K ...... Representations, certifications, instructions. evaluation criteria to be used in the and other statements of offerors. The CO shall prepare the evaluation of potential contractors, in L ...... Instructions, conditions, and no- representations and instructions as accordance with the requirements of tices to offerors. follows: FAR 36.602–1. M ...... Evaluation factors for award. (a) Section K, Representations, (b) HCAs are authorized to approve certifications, and other statements of the use of design competition. 1436.270–2 Part I—The Schedule. offerors. Include provisions requiring 1436.602–2 Evaluation boards. The CO shall prepare the Schedule as representations, certifications, or HCAs shall establish procedures for follows: submission of other information by an providing permanent or ad hoc offeror. (a) Section A, Solicitation/contract architect-engineer evaluation boards. form. Use SF 1442, Solicitation, Offer, (b) Section L, Instructions, conditions, Bureau procedures shall provide for the and Award (Construction, Alteration or and notices to offerors. Include other appointment of private practitioners of Repair), as prescribed in FAR 36.701(a). provisions or instructions to offerors architecture, engineering, or related (b) Section B, Bid schedule. Bid which are not included in other sections professions when such action is schedule. of the uniform contract (e.g., FAR determined by the HCA to be essential (c) Section C, Specifications/ 52.214–19 if using sealed bidding). to meet the Government’s minimum Drawings. Include specifications and (c) Section M, Evaluation factors for needs. drawings (See FAR Part 11) or reference award. Identify all factors that will be other location in the uniform contract considered in awarding the contract 1436.602–3 Evaluation board functions. format (e.g. Section J, attachment ___). (See, for example, FAR 14.201–8 for The selection report shall be prepared (d) Section D, Packaging and Marking. sealed bidding; FAR 15.304 for for HCA approval, in accordance with Not applicable. competitive proposals). bureau/office procedures.

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1436.602–4 Selection authority. with quality services on time and within (iii) Are Government employees The HCA is authorized to serve as the budget; currently performing the task to be designated selection authority. (2) Ensure that requirements are contracted out? If so, has OMB Circular clearly defined and appropriate A–76 been consulted? 1436.602–5 Short selection processes for performance standards are included in (3) Cost Effectiveness. If the response contracts not to exceed the simplified the contract; acquisition threshold. to any of the following questions is (3) Utilize the checklist in paragraph negative, the agency may not have a At each occurrence, CO approval shall (b) of this section, or bureau substitute, valid requirement or not be obtaining be obtained prior to the utilization of to ensure compliance with general the requirement in the most cost either of the short selection processes policies and the specific guidance in effective manner. used for architect-engineer contracts not OFPP Policy Letters 92–1, Inherently (i) Is the statement of work written so expected to exceed the simplified Governmental Functions, 91–2, Service that it supports the need for a specific acquisition threshold. Contracting, and 89–1, Conflicts of service? 1436.603 Collecting data on and Interest Policies Applicable to (ii) Is the statement of work written so appraising firms’ qualifications. Consultants; that it permits adequate evaluation of (4) Work in close collaboration with contractor versus in-house cost and HCAs who require architect-engineer the beneficiaries of the services being services shall use their established performance? purchased to ensure that contractor (iii) Are the choices of contract type, procedures to collect data on and performance meets contract appraising firms’ qualifications. quality assurance plan, competition requirements and performance strategy, or other related acquisition PART 1437—SERVICE CONTRACTING standards;. strategies and procedures in the (b) Following is a checklist to aid acquisition plan appropriate to ensure Subpart 1437.1—Service Contracts— analysis and review of requirements for good contractor performance to meet the General service contracts. user’s needs? Sec. (1) General. (iv) If a cost reimbursement contract (i) Is the statement of work complete, 1437.102 Policy. is contemplated, is the acquisition plan with a clear-cut division of 1437.103 Contracting officer responsibility. adequate to ensure that the contractor 1437.170 Special service contract responsibility between the contracting will have the incentive to control costs requirements. parties? (ii) Is it stated in terms the market can under the contract? Subpart 1437.70—Appraisal Services— (v) Is the acquisition plan adequate to (Real Property) satisfy? (iii) Does the statement of work address the cost effectiveness of using 1437.7000 Scope of subpart. contractor support (either long-term or 1437.7001 Contractor qualification encompass all commercially available services that can meet the actual short-term) versus in-house requirements. performance? 1437.7002 Appraisal standards. functional need (eliminates any nonessential preferences that may (vi) Is the cost estimate, or other Subpart 1437.71—Information Collection thwart full and open competition)? supporting cost information, adequate to Services (iv) Is the statement of work enable the contracting office to 1437.7100 Scope of subpart. performance-based to the maximum effectively determine whether costs are 1437.7101 General. extent possible (i.e., is the acquisition reasonable? 1437.7102 Clauses. structured around the purpose of the (vii) Is the statement of work adequate Authority: Sec. 205(c), 63 Stat. 390, 40 work to be performed, as opposed to to describe the requirement in terms of U.S.C. 486(c); and 5 U.S.C. 301. either the manner by which the work is what is to be performed as opposed to to be performed or a broad and how the work is to be accomplished? Subpart 1437.1—Service Contracts— imprecise statement of work? Does the (viii) Is the acquisition plan adequate General statement of work follow OFPP to ensure that there is proper 1437.102 Policy. Pamphlet IV, A Guide to Writing and consideration given to quality and best The HCA is responsible for Administering Performance Statements value? establishing internal review and of Work for Service Contracts (4) Control. If the response to any of approval procedures for service (Supplement 2 to OMB Circular A–76)?, the following questions is negative, contracts in accordance with OFPP as described in OFPP Pamphlet IV?) there may be a control problem. Policy Letter 93–1, Management (2) Inherently Governmental (i) Are there sufficient resources to Oversight of Service Contracting. Functions. If the response to the first evaluate contractor performance when Special attention shall be directed to question below is affirmative, the the statement of work requires the avoidance of contracting for inherently contract requirement is for an inherently contractor to provide advice, analysis governmental functions, as well as Governmental function that Government and evaluation, opinions, alternatives, contract administration in the area of officials must perform. If the response to or recommendations that could incurred cost monitoring to complement the second question below is significantly influence agency policy work progress monitoring. affirmative, the contract may be for an development or decision-making? inherently governmental function. (ii) Does the quality assurance plan 1437.103 Contracting officer (i) Is the requirement for a function provide for adequate monitoring of responsibility. that is listed in Appendix A of OFPP contractor performance? (a) While recognizing that program Policy Letter 92–1? (iii) Is the statement of work written officials are responsible for accurately (ii) If the function is not listed in so that it specifies a contract deliverable describing the need to be filled or the Appendix A, do any of the factors in the or requires progress reporting on problem to be solved through the totality of the circumstances analysis contractor performance? service contract, COs shall: discussed in section 7(b) of the Policy (iv) Is agency expertise adequate to (1) Award and administer contracts in Letter 92–1 indicate that the function independently evaluate the contractor’s a manner that will provide the customer may be inherently governmental? approach, methodology, results,

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options, conclusions or appropriate to obtain the required (b) The standards in paragraph (a) of recommendations? services? this section shall be made a part of all (v) Is the requirement for a function (iv) Will the requirement be obtained solicitations and resulting contracts for or service absent from the list in through the use of full and open real property appraisal services Appendix B of OFPP Policy Letter 92– competition? procured for condemnation purposes. 1? If it is similar to a function or service on that list, greater management 1437.170 Special service contract Subpart 1437.71—Information requirements. scrutiny may be required. Collection Services (5) Conflicts of Interest. If the The following types of services shall 1437.7100 Scope of subpart. response to any of the following be acquired as specified in the following questions is affirmative, there may be a Departmental regulations: This subpart prescribes policies and conflict of interest. (a) Aircraft-related services and procedures for acquiring information (i) Can the potential offeror perform maintenance shall be acquired as collection services which are subject to under the contract in such a way as to prescribed in 353 DM; the requirements of the Paperwork devise solutions or make (b) Audiovisual services, including Reduction Act of 1980 (44 U.S.C. 3501 recommendations that would influence motion pictures, slide shows and et seq.) the award of future contracts to that videotape recordings, shall be acquired 1437.7101 General. contractor? as prescribed in 471 DM 1; (ii) If the requirement is for support (c) Information-technology services The Paperwork Reduction Act of 1980 services (such as system engineering or shall be acquired as prescribed in 376 requires that no federal agency shall technical direction), were any of the DM 4; conduct or sponsor the collection of potential offerors involved in (d) Guard services for safeguarding information, upon identical items, from developing the system design classified information shall be acquired ten or more public respondents unless specifications or in the production of as prescribed in 442 DM 8; prior approval is obtained from OMB. (e) Printing services shall be acquired the system? 1437.7102 Clauses. (iii) Has a potential offeror as prescribed in 314 DM 1; participated in earlier work involving (f) Contracts which require collection The CO shall insert the clause at the same program or activity that is the of identical information from ten or 1452.237–70, Information Collection— subject of the present contract wherein more members of the public shall be Department of the Interior, in all the offeror had access to source cleared as prescribed in 381 DM 12. solicitations and contracts which are selection or propriety information not subject to the Paperwork Reduction Act Subpart 1437.70—Appraisal Services of 1980. available to other offerors competing for (Real Property) the contract? (iv) Will the contractor be evaluating 1437.7000 Scope of subpart. PARTS 1438–1441—[RESERVED] a competitor’s work? This subpart prescribes policies and SUBCHAPTER G—CONTRACT (v) Does the contract allow the procedures for acquiring real property MANAGEMENT contractor to accept its own products or appraisal services. activities on behalf of the Government? PART 1442—CONTRACT (vi) Will the work under this contract 1437.7001 Contractor qualification ADMINISTRATION AND AUDIT put the contractor in a position to requirements. SERVICES influence government decision-making, (a) Prior to award of a contract for real e.g., developing regulations that will property appraisal services when the Subpart 1442.2—Contract Administration affect the contractor’s current or future services are required in support of court Services business? actions, the CO shall coordinate with Sec. (vii) Will the work under this contract the appropriate Solicitor’s office and 1442.202 Assignment of contract effect the interests of the contractor’s obtain written concurrence from the administration. other clients? Assistant U.S. Attorney assigned to (viii) Are any of the potential offerors, represent the Government in the matter Subpart 1442.6—Corporate Administrative or their personnel who will perform the that the source to be selected possesses Contracting Officer contract, former agency officials who— the necessary qualifications for adequate 1442.602 Assignment and location. while employed by the agency— contract performance. This requirement Authority: Sec. 205(c), 63 Stat. 390, 40 personally and substantially shall be treated as a special standard of U.S.C. 486(c); and 5 U.S.C. 301. participated in the development of the responsibility (See FAR 9.104–2). requirement for, or the procurement of, (b) The CO shall include the Subpart 1442.2—Contract these services within the past two years? requirements of paragraph (a) of this Administration Services (6) Competition. If the response to any section in all solicitations for real 1442.202 Assignment of contract of the following questions is negative, property appraisal services which may administration. completion may be unnecessarily be subject to future court action. limited. (a) The decision to withhold normal (i) Is the statement of work defined so 1437.7002 Appraisal standards. individual contract administration as to avoid overly restrictive (a) All real property appraisals for functions is delegated to one level above specifications or performance condemnation purposes shall be the CO. standards? consistent with requirements of the (b) The delegation of authority to (ii) Is the contract formulated in such Interagency Land Acquisition issue orders under provisioning a way as to avoid creating a continuous Conference publication ‘‘Uniform procedures in existing contracts and and dependent arrangement with the Appraisal Standards for Federal Land under basic ordering agreements for same contractor? Acquisitions’’ published by the items and services identified in the (iii) Is the use of an indefinite Government Printing Office and schedule must be approved at one level quantity or term contract arrangement available at http://www.gpoaccess.gov. above the CO.

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Subpart 1442.6—Corporate Subpart 1446.7—Warranties made at the place or places specified in Administrative Contracting Officer 1446.704 Authority for use of warranties. the contract for performance of 1446.708 Warranties of data. Government quality assurance (See FAR 1442.602 Assignment and location. Authority: Sec. 205(c), 63 Stat. 390, 40 46.401(b)) as prescribed in FAR 46.402 The BPC has the authority to approve U.S.C. 486(c); and 5 U.S.C. 301. or FAR 46.403, as appropriate and for the appointment of a Corporate acceptance in accordance with FAR Administrative Contracting Officer. Subpart 1446.1—General 46.503. (c) If the CO elects to use a PART 1443—CONTRACT 1446.170 Government-Industry Data contractor’s certificate of conformance MODIFICATIONS Exchange Program (GIDEP). (See FAR 46.315) under the conditions (a) COs shall encourage contractors Subpart 1443.2—Change Orders prescribed in FAR 46.504, the certificate and subcontractors to participate in the Sec. may be used as the basis of Government GIDEP, a cooperative program managed acceptance. 1443.205 Contract clauses. and funded by the U.S. Government to Authority: Sec. 205(c), 63 Stat. 390, 40 exchange engineering, failure § 1446.671 Inspection, receiving and U.S.C. 486(c); and 5 U.S.C. 301. experience, metrology, product acceptance certification. information, and reliability-maintain Subpart 1443.2—Change Orders As prescribed in DIAR 1446.670, the ability data on products, components following documentation shall be 1443.205 Contract clauses. (including construction materials), completed via manual or electronic BPCs may establish procedures, when manufacturing processes, environmental means for each delivery of supplies or appropriate, for authorizing the CO to issues associated with those services in accordance with Bureau vary the 30-day period for submission of manufacturing processes, recycling and procedures: waste prevention. requests for adjustment in the clauses INSPECTION, RECEIVING AND prescribed by FAR 43.205. (b) The GIDEP is managed for the U.S. Government by the Department of the ACCEPTANCE CERTIFICATION PART 1444—[RESERVED] Navy. GIDEP participants are not subject The listed items or services have to any fees or assessments other than the been: ____ inspected, ____ received, and PART 1445—GOVERNMENT costs associated with dissemination of ____ accepted and they conform to the PROPERTY information by other than electronic contract except as noted below or on means. attached documents. Subpart 1445.3—Authorizing the Use and (c) An application to participate in the ______Rental of Government Property Signature and typed name of GIDEP may be obtained at http:// authorized Government representative. Sec. www.gidep.org. COs shall include Date ____ 1445.302 Contracts with foreign information on GIDEP in solicitation governments or international documents and during discussions at Subpart 1446.7—Warranties organizations. preaward and postaward conferences. Authority: Sec. 205(c), 63 Stat. 390, 40 1446.704 Authority for use of warranties. U.S.C. 486(c); and 5 U.S.C. 301. Subpart 1446.4—Government Contract The CCO is authorized to make the Quality Assurance written determination to use a warranty Subpart 1445.3—Authorizing the Use in an acquisition. and Rental of Government Property 1446.401 General. 1446.708 Warranties of data. 1445.302 Contracts with foreign Inspection of supplies or services governments or international organizations. shall be documented as prescribed in Warranties of data shall only be used DIAR Subpart 1446.6. The HCA, after coordinating with the after consultation with the SOL. cognizant PMO, shall establish Subpart 1446.5—Acceptance PART 1447—[RESERVED] procedures to recover use costs when foreign governments or international 1446.501 General. PART 1448—VALUE ENGINEERING organizations request use of Acceptance of supplies or services Government production and research shall be documented as prescribed in Subpart 1448.1—Policies and Procedures property. DIAR Subpart 1446.6. Sec. 1448.102 Policies. PART 1446—QUALITY ASSURANCE Subpart 1446.6—Material Inspection and Receiving Reports Authority: Sec. 205(c), 63 Stat. 390, 40 Subpart 1446.1—General U.S.C. 486(c); and 5 U.S.C. 301. Sec. 1446.670 Inspection, receiving and 1446.170 Government-Industry Data acceptance reports. Subpart 1448.1—Policies and Exchange Program (GIDEP). (a) Except for simplified acquisitions Procedures Subpart 1446.4—Government Contract (See FAR 46.404) and unless otherwise 1448.102 Policies. Quality Assurance prescribed by bureau procedures, the The HCA shall establish procedures documentation in DIAR 1446.671 shall 1446.401 General. for processing and evaluating VECP’s as be inserted on each commercial prescribed in FAR Subpart 48.1 and 369 Subpart 1446.5—Acceptance shipping document or packing list, DM, Value Engineering. 1446.501 General. whether by manual or electronic means, Subpart 1446.6—Material Inspection and for supplies or services and shall be PART 1449—TERMINATION OF Receiving Reports signed by the authorized Government CONTRACTS 1446.670 Inspection, receiving and representative as required in FAR acceptance reports. 46.401(f) and Subpart 46.5. Subpart 1449.1—General Principles 1446.671 Inspection, receiving and (b) The documentation required in Sec. acceptance certification. paragraph (a) of this section shall be 1449.106 Fraud or other criminal conduct.

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1449.107 Audit of prime contract § 1450.103 Contract adjustments. PART 1451—USES OF GOVERNMENT settlement proposals and subcontract § 1450.103–6 Disposition. SOURCES BY CONTRACTORS settlements. § 1450.104 Residual powers. 1449.111 Review of proposed settlements. § 1450.104–2 General. Subpart 1451.1—Contractor Use of § 1450.104–3 Special procedures for Government Supply Sources Subpart 1449.4—Termination for Default unusually hazardous or nuclear risks. 1449.402 Termination of fixed-price Sec. Authority: Sec. 205(c), 63 Stat. 390, 40 1451.102 Authorization to use Government contracts for default. U.S.C. 486(c); and 5 U.S.C. 301. 1449.402–3 Procedure for default. supply sources. Authority: Sec. 205(c), 63 Stat. 390, 40 Subpart 1450.1—Extraordinary Authority: Sec. 205(c), 63 Stat. 390, 40 U.S.C. 486(c); and 5 U.S.C. 301. Contractual Actions U.S.C. 486(c); and 5 U.S.C. 301. Subpart 1449.1—General Principles 1450.101 General. Subpart 1451.1—Contractor Use of Government Supply Sources 1449.106 Fraud or other criminal conduct. 1450.101–2 Policy. When fraud or other criminal conduct Requests for extraordinary contractual 1451.102 Authorization to use Government is suspected, the CO will submit a actions shall be submitted by the HCA supply sources. to the Director, PAM, for further action. report documenting the incident to the If the CO decides to authorize a BPC for transmittal to the OIG. 1450.101–3 Records. contractor to use Government supply Informational copies will be forwarded The records of actions taken under sources under the conditions prescribed to the HCA and the Director, PAM. FAR Part 50 shall be maintained by the in FAR 51.102, a written request for a 1449.107 Audit of prime contract Director, PAM. FEDSTRIP activity address code (See settlement proposals and subcontract FPMR 101–26.203) shall be made 1450.102 Delegation of and limitations on settlements. through the acquisition office FEDSTRIP exercise of authority. Requests for audits pursuant to FAR point of contact. 49.107 shall be sent to the Assistant 1450.102–1 Delegation of authority. PART 1452—SOLICITATION Inspector General for Auditing, in The AS/PMB shall approve all actions PROVISIONS AND CONTRACT accordance with the procedures in 360 under FAR Part 50, except for actions in CLAUSES DM 2.3. excess of $55,000, actions which increase the contract price without 1449.111 Review of proposed settlements. Sec. consideration, and indemnification 1452.000 Scope of part. All proposed settlement agreements actions, which shall be approved by the shall be reviewed by the SOL and Secretary. Subpart 1452.2—Text of Provisions and approved at one level above the CO. Clauses Settlement agreements of $250,000 or 1450.103 Contract adjustments. 1452.200 Scope of subpart. more shall be approved by the BPC. 1450.103–6 Disposition. 1452.203–70 Restrictions on Endorsements. Subpart 1449.4—Termination for The CO shall submit the 1452.204–70 Release of Claims. Default Memorandum of Decision including the 1452.215–70 Examination of Records by contractor’s request, contractor the Department of the Interior. 1449.402 Termination of fixed-price information in support of the request 1452.215–71 Use and Disclosure of contracts for default. required by FAR 50.103–4, the results of Proposal Information—Department of the the CO’s investigation required by FAR 1449.402–3 Procedure for default. Interior. 50.103–5, and the information required 1452.224–1 Privacy Act Notification. In addition to the requirements of by FAR 50.103–6 to the SOL for review. 1452.226–70 Indian Preference. FAR 49.402–3(g), the notice of If the SOL concurs with the 1452.226–71 Indian Preference Program. termination shall contain instructions Memorandum of Decision, the 1452.227–70 Appeals of Use or Exceptions. regarding the disposition of any Memorandum of Decision will be 1452.228–7 Insurance—Liability to Third Government property in the possession submitted through the HCA to the Persons. of the contractor, and, in the case of Director, PAM, for further action. 1452.228–70 Liability Insurance. construction contracts, materials, 1452.228–71 Aircraft and General Public appliances, and structures that may be 1450.104 Residual powers. Liability Insurance. on the construction site. The notice 1450.104–2 General. 1452.228–72 Liability for Loss or Damage— Department of the Interior. shall also contain a statement Proposals for the exercise of residual concerning the liability of the contractor 1452.228–73 Liability for Loss or Damage powers shall be processed using the (Property Interest). or its surety for any liquidated damages procedures referred to in FAR 50.104– (See FAR 49.402–7). 1452.233–2 Service of Protest. 2. 1452.236–70 Prohibition Against Use of PART 1450—EXTRAORDINARY 1450.104–3 Special procedures for Lead-based Paint. CONTRACTUAL ACTIONS AND THE unusually hazardous or nuclear risks. 1452.236–71 Additive or Deductive Items. SAFETY ACT The CO shall submit the proposed 1452.237–70 Information Collection. 1452.237–71 Utilization of Woody Memorandum of Decision including the Subpart 1450.1—Extraordinary Contractual Biomass. Actions contractor’s request for indemnification and the information required from the Authority: Sec. 205(c), 63 Stat. 390, 40 Sec.p; CO, to the SOL for review and approval. U.S.C. 486(c); and 5 U.S.C. 301. § 1450.101 General. § 1450.101–2 Policy. If the SOL approves the proposed 1452.000 Scope of part. § 1450.101–3 Records. Memorandum of Decision, it shall be § 1450.102 Delegation of and limitations on submitted through the HCA, to the This part prescribes Department of the exercise of authority. Director, PAM, for approval or Interior provisions and clauses for use § 1450.102–1 Delegation of authority. disapproval by the Secretary. in acquisition.

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Subpart 1452.2—Text of Provisions 1452.215–71 Use and Disclosure of proposal, except that (i) if a contract is and Clauses Proposal Information—Department of the awarded to the offeror as a result of or in Interior. connection with submission of the proposal, 1452.200 Scope of subpart. As prescribed in 1415.207–70, insert the Government shall have the right to use the following provision: the information as provided in the contract, This subpart sets forth the texts of all and (ii) if the same information is obtained DIAR provisions and clauses. Consistent USE AND DISCLOSURE OF from another source without restriction it with the numbering scheme prescribed PROPOSAL INFORMATION— may be used without restriction. in FAR 52.101 and the approach used in DEPARTMENT OF THE INTERIOR (e) If a request under the Freedom of FAR Subpart 52.2, this subpart is (APR 1984) Information Act seeks access to information arranged by subject matter, in the same in a proposal identified as trade secret order as, and keyed to, the parts of the (a) Definitions. For the purposes of this information or confidential commercial and provision and the Freedom of Information financial information, full consideration will DIAR in which provisions and clause Act (5 U.S.C. 552), the following terms shall be given to the offeror’s view that the requirements are addressed. have the meaning set forth below: information constitutes trade secrets or (1) ‘‘Trade Secret’’ means an unpatented, 1452.203–70 Restrictions on confidential commercial or financial secret, commercially valuable plan, Endorsements. information. The offeror will also be appliance, formula, or process, which is used promptly notified of the request and given an As prescribed in 1403.570–3, insert for making, preparing, compounding, treating opportunity to provide additional evidence the following clause: or processing articles or materials which are and argument in support of its position, trade commodities. unless administratively unfeasible to do so. RESTRICTION ON ENDORSEMENTS— (2) ‘‘Confidential commercial or financial If it is determined that information claimed DEPARTMENT OF THE INTERIOR information’’ means any business information by the offeror to be trade secret information (JUL 1996) (other than trade secrets) which is exempt or confidential commercial or financial from the mandatory disclosure requirement information is not exempt from disclosure The Contractor shall not refer to contracts of the Freedom of Information Act, 5 U.S.C. under the Freedom of Information Act, the awarded by the Department of the Interior in 552. Exemptions from mandatory disclosure offeror will be notified of this determination commercial advertising, as defined in FAR which may be applicable to business prior to disclosure of the information. 31.205–1, in a manner which states or information contained in proposals include (f) The Government assumes no liability for implies that the product or service provided exemption (4), which covers ‘‘commercial the disclosure or use of information is approved or endorsed by the Government, and financial information obtained from a contained in a proposal if not marked in or is considered by the Government to be person and privileged or confidential,’’ and accordance with paragraphs (b) and (c) of this superior to other products or services. This exemption (9), which covers ‘‘geological and provision. If a request under the Freedom of restriction is intended to avoid the geophysical information, including maps, Information Act is made for information in a appearance of preference by the Government concerning wells.’’ proposal not marked in accordance with toward any product or service. The (b) If the offeror, or its subcontractor(s), paragraphs (b) and (c) of this provision, the Contractor may request the Contracting believes that the proposal contains trade offeror concerned shall be promptly notified Officer to make a determination as to the secrets or confidential commercial or of the request and given an opportunity to propriety of promotional material. financial information exempt from disclosure provide its position to the Government. under the Freedom of Information Act, (5 (End of clause) However, failure of an offeror to mark U.S.C. 552), the cover page of each copy of information contained in a proposal as trade the proposal shall be marked with the 1452.204–70 Release of Claims. secret information or confidential following legend: commercial or financial information will be As prescribed in 1404.804–70, insert ‘‘The information specifically identified on ______treated by the Government as evidence that the following clause: pages of this proposal constitutes the information is not exempt from trade secrets or confidential commercial and disclosure under the Freedom of Information RELEASE OF CLAIMS—DEPARTMENT financial information which the offeror Act, absent a showing that the failure to mark believes to be exempt from disclosure under OF THE INTERIOR (JUL 1996) was due to unusual or extenuating the Freedom of Information Act. The offeror circumstances, such as a showing that the After completion of work and prior to final requests that this information not be offeror had intended to mark, but that payment, the Contractor shall furnish the disclosed to the public, except as may be markings were omitted from the offeror’s Contracting Officer with a release of claims required by law. The offeror also requests proposal due to clerical error. against the United States relating to this that this information not be used in whole or contract. The Release of Claims form (DI– part by the government for any purpose other (End of provision) 137) shall be used for this purpose. The form than to evaluate the proposal, except that if 1452.224–1 Privacy Act Notification. provides for exception of specified claims a contract is awarded to the offeror as a result from operation of the release. of or in connection with the submission of (a) As prescribed in 1424.104, the (End of clause) the proposal, the Government shall have the clause at FAR 52.224–1, Privacy Act right to use the information to the extent Notification, shall be modified before 1452.215–70 Examination of Records by provided in the contract.’’ insertion into solicitations and contracts the Department of the Interior. (c) The offeror shall also specifically by— identify trade secret information and As prescribed in 1415.209–70, insert (1) Changing the title of the clause to confidential commercial and financial read ‘‘PRIVACY ACT NOTIFICATION the following clause: information on the pages of the proposal on (JUL 1996) (DEVIATION)’’; and EXAMINATION OF RECORDS BY THE which it appears and shall mark each such page with the following legend: (2) Adding the following sentence to DEPARTMENT OF THE INTERIOR ‘‘This page contains trade secrets or the end of the clause: (APR 1984) confidential commercial and financial ‘‘Applicable Department of the For purposes of the Examination of information which the offeror believes to be Interior regulations concerning the Records by the Comptroller General clause of exempt from disclosure under the Freedom Privacy Act are set forth in 43 CFR 2, this contract (FAR 52.215–1), the Secretary of of Information Act and which is subject to Subpart D. The CFR is available for the Interior, the Inspector General, and their the legend contained on the cover page of public inspection at the Departmental ’’ duly authorized representative(s) from the this proposal. Library, Main Interior Bldg., 1849 C St. Department of the Interior shall have the (d) Information in a proposal identified by an offeror as trade secret information or NW, Washington DC, at each of the same access and examination rights as the regional offices of bureaus of the Comptroller General of the United States. confidential commercial and financial information shall be used by the Government Department and at many public (End of clause) only for the purpose of evaluating the libraries.’’

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(b) As prescribed in FAR 52.103(a) utilization of small business concerns, small Contractor agrees to establish and conduct an and 52.107(f), the clause at FAR 52.252– business concerns owned and controlled by Indian preference program which will 6, Authorized Deviation in Clauses, socially and economically disadvantaged expand the opportunities for Indian individuals, or labor surplus area concerns. organizations and Indian-owned economic shall be inserted into solicitations and (e) As used in this clause: contracts containing the clause in enterprises to receive a preference in the (1) ‘‘Indian’’ means a person who is a awarding of subcontracts and which will paragraph (a) of this section. member of an Indian Tribe. If the Contractor expand opportunities for Indians to receive has reason to doubt that a person seeking preference for training and employment in 1452.226–70 Indian Preference. employment preference is an Indian, the As prescribed in 1426.7003(a), insert connection with the work to be performed contractor shall grant the preference but shall under this contract. In this connection, the the following clause in solicitations require the individual within thirty (30) days Contractor shall — issued and contracts awarded by the to provide evidence from the Tribe (1) Designate a liaison officer who will: Bureau of Indian Affairs except those concerned that the person is a member of that (i) Maintain liaison with the Government pursuant to Title I and to Indian Tribes Tribe. and Tribe(s) on Indian preference matters; (2) ‘‘Indian organization’’ means the and Indian Organizations under Title II (ii) Supervise compliance with the governing body of any Indian Tribe or entity provisions of this clause; and of Public Law 93–638 (25 U.S.C. 450 et established or recognized by such governing seq. and 25 U.S.C. 455 et seq., body in accordance with the Indian (iii) Administer the Contractor’s Indian respectively); a contracting activity Financing Act of 1974 (88 Stat. 77; 25 U.S.C. preference program. other than the Bureau of Indian Affairs 1451); and (2) Advise its recruitment sources in when the contract is entered into (3) ‘‘Indian-owned economic enterprise’’ writing and include a statement in all means any Indian-owned commercial, advertisements for employment that Indian pursuant to an act specifically applicants will be given preference in authorizing contracts with Indian industrial, or business activity established or organized for the purpose of profit provided employment and training incident to such organizations, and a contracting activity that such Indian ownership shall constitute employment. other than the Bureau of Indian Affairs not less than 51 percent of the enterprise. (3) Not less than twenty (20) calendar days when the work to be performed is (4) ‘‘Indian Tribe’’ means an Indian Tribe, prior to commencement of work under this specifically for the benefit of Indians band, nation, or other organized group or contract, post a written notice in the Tribal and is in addition to any incidental community, including any Alaska Native office of any reservations on which or near benefits which might otherwise accrue village or regional or village corporation as where the work under this contract is to be to the general public. defined in or established pursuant to the performed, which sets forth the Contractor’s Alaska Native Claims Settlement Act (85 Stat. employment needs and related training INDIAN PREFERENCE— 668; 43 U.S.C. 1601) which is recognized as opportunities. The notice shall include the DEPARTMENT OF THE INTERIOR eligible for the special programs and services approximate number and types of employees (APR 1984) provided by the United States to Indians needed, the approximate dates of because of their status as Indians. employment; the experience or special skills (a) The Contractor agrees to give (f) The Contractor agrees to include the required for employment, if any; training preferences to Indians who can perform the provisions of the clause including this opportunities available; and all other work required regardless of age (subject to paragraph (f) in each subcontract awarded pertinent information necessary to advise existing laws and regulations), sex, religion, under this contract. prospective employees of any other or tribal affiliation for training and (g) In the event of noncompliance with this employment requirements. The Contractor employment opportunities under this clause, the Contractor’s right to proceed may shall also request the Tribe(s) on or near contract and, to the extent feasible consistent be terminated in whole or in part by the whose reservation(s) the work is to be with the efficient performance of this Contracting Officer and the work completed performed to provide assistance to the contract, training and employment in a manner determined by the Contracting Contractor in filling its employment needs preferences and opportunities shall be Officer to be in the best interests of the and training opportunities. The Contracting provided to Indians regardless of age (subject Government. Officer will advise the Contractor of the to existing laws and regulations), sex, (End of clause) religion, or tribal affiliation who are not fully name, location, and phone number of the Tribal officials to contact in regard to the qualified to perform under this contract. The 1452.226–71 Indian Preference Program. Contractor also agrees to give preference to posting of notices and requests for Tribal As prescribed in 1426.7003(b), insert assistance. Indian organizations and Indian-owned the following clause in all solicitations economic enterprises in the awarding of any (4) Establish and conduct a subcontracting subcontracts consistent with the efficient and contracts awarded by the program which gives preference to Indian performance of this contract. The Contractor contracting activity that may exceed organizations and Indian-owned economic shall maintain such records as are necessary $50,000, contain the clause at 1452.226– enterprises as subcontractors and suppliers to indicate compliance with this paragraph. 70, and where it is determined by the under this contract. Consistent with the (b) In connection with the Indian Contracting Officer, prior to solicitation, efficient performance of this contract, the employment preference requirements of this that the work under the contract will be Contractor shall give public notice of existing clause, the Contractor shall also provide subcontracting opportunities by soliciting performed in whole or in part on or near bids or proposals only from Indian opportunities for training incident to such an Indian reservation(s). The clause may employment. Such training shall include on- organizations or Indian-owned economic the-job, classroom, or apprenticeship training also be included in solicitations issued enterprises. The Contractor shall request which is designed to increase the vocational and contracts awarded by a contracting assistance and information on Indian firms effectiveness of an Indian employee. activity not exceeding $50,000 that qualified as suppliers or subcontractors from (c) If the Contractor is unable to fill its contain the clause at 1452.226–70 and the Tribe(s) on or near whose reservation(s) training and employment needs after giving which, in the opinion of the Contracting the work under the contract is to be full consideration to Indians as required by Officer, offer substantial opportunities performed. The Contracting Officer will this clause, those needs may be satisfied by for Indian employment, training, and advise the Contractor of the name, location, and phone number of the Tribal officials to selection of persons other than Indians in subcontracting. accordance with the clause of this contract be contacted in regard to the request for entitled ‘‘Equal Opportunity.’’ INDIAN PREFERENCE PROGRAM— assistance and information. Public notices (d) If no Indian organizations or Indian- DEPARTMENT OF THE INTERIOR and solicitations for existing subcontracting owned economic enterprises are available for (APR 1984) opportunities shall provide an equitable awarding of subcontracts in connection with opportunity for Indian firms to submit bids the work performed under this contract, the (a) In addition to the requirements of the or proposals by including— Contractor agrees to comply with the clause of this contract entitled ‘‘Indian (i) A clear description of the supplies or provisions of this contract involving Preference—Department of the Interior,’’ the services required including quantities,

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specifications, and delivery schedules which year after final payment under this contract, THIRD PERSONS (APR 1984) facilitate the participation of Indian firms; or for such longer period as may be required (DEVIATIONS)’’; and (ii) A statement indicating the preference by any other clause of this contract or by (2) changing the first sentence in will be given to Indian organizations and applicable law or regulation. subparagraph (c)(2) of the clause to read: Indian-owned economic enterprises in (b) For purpose of this clause, the accordance with Section 7(b) of Public Law following definitions of terms shall apply: ‘‘For certain liabilities (and expenses 93–638; (88 Stat. 2205; 25 U.S.C. 450e(b)); (1) The terms ‘‘Indian,’’ ‘‘Indian Tribe,’’ incidental to such liabilities) to third (iii) Definitions for the terms ‘‘Indian ‘‘Indian Organization, and ‘‘Indian-owned persons not compensated by insurance organization’’ and ‘‘Indian-owned economic economic enterprise’’ are defined in the or otherwise but subject to the enterprise’’ as prescribed under the ‘‘Indian clause of this contract entitled ‘‘Indian ‘Limitation of Cost’ or ‘Limitation of Preference—Department of the Interior’’ Preference.’’ Funds’ clause of this contract.’’ clause of this contract; (2) ‘‘Indian reservation’’ includes Indian (b) As prescribed in FAR 52.103(a) (iv) A representation to be completed by reservations, public domain Indian the bidder or offeror that it is an Indian allotments, former Indian reservations on and 52.107(f), the clause at FAR 52.252– organization or Indian-owned economic Oklahoma, and land held by incorporated 6, Authorized Deviations in Clauses, enterprise; and Native groups, regional corporations, and shall be inserted into solicitations and (v) A closing date for receipt of bids or village corporations under the provisions of contracts containing the clause in proposals which provides sufficient time for the Alaska Native Claims Settlement Act, (85 paragraph (a) of this section. preparation and submission of a bid or Stat. 688; 43 U.S.C. 1601 et seq.). proposal. If after soliciting bids from Indian (3) ‘‘On or near an Indian Reservation’’ 1452.228–70 Liability Insurance. organizations and Indian-owned economic means on a reservation or reservations or As prescribed in 1428.301, insert the enterprises, no responsible bid is received, within that area surrounding an Indian following clause: the Contractor shall comply with the reservation(s) where a person seeking requirements of paragraph (d) of the ‘‘Indian employment could reasonably be expected to LIABILITY INSURANCE— Preference—Department of the Interior’’ commute to and from in the course of a work DEPARTMENT OF THE INTERIOR clause of this contract. If one or more day. (JUL 1996) responsible bids are received, award shall be (c) Nothing in the requirements of this made to the low responsible bidder if the bid clause shall be interpreted to preclude Indian (a) The Contractor shall procure and price is determined to be reasonable. If the Tribes from independently developing and maintain during the term of this contract and low responsive bid is determined to be enforcing their own Indian preference any extension thereof liability insurance in unreasonable as to price, the Contractor shall requirements. Such requirements must not form satisfactory to the Contracting Officer by attempt to negotiate a reasonable price and hinder the Government’s right to award an insurance company which is acceptable to award a subcontract. If a reasonable price contracts and to administer their provisions. the Contracting Officer. The named insured cannot be agreed upon, the Contractor shall (d) The Contractor agrees to include the parties under the policy shall be the comply with the requirements of paragraph provisions of this clause including this Contractor and the United States of America. (d) of the ‘‘Indian Preference—Department of paragraph (d) in each subcontract awarded The amounts of the insurance shall be not the Interior’’ clause of the contract. under this contract and to notify the less than as follows: (5) Maintain written records under this Contracting Officer of such subcontracts. $___each person* contract which indicate: (e) In the event of noncompliance with this $___each occurrence* (i) The names and addresses of all Indians clause, the Contractor’s right to proceed may $___property damage* seeking employment for each employment be terminated in whole or in part by the (b) Each policy shall have a certificate position available under this contract; Contracting Officer and the work completed evidencing the insurance coverage. The (ii) The number and types of positions in a manner determined by the Contracting insurance company shall provide an filled by Indians and non-Indians, and the Officer to be in the best interest of the endorsement to notify the Contracting Officer name, address and position of each Indian Government. 30 days prior to the effective date of employed under this contract; (End of clause) cancellation or termination of the policy or (iii) For those positions where there are certificate; or modification of the policy or both Indian and non-Indian applicants, and 1452.227–70 Appeals of Use or certificate which may adversely affect the a non-Indian is selected for employment, the Exceptions. interest of the Government in such insurance. reason(s) why the Indian applicant was not The certificate shall identify the contract selected; As prescribed in 1427.303(d)(1), insert the following clause: number, the name and address of the (iv) Actions taken to give preference to Contracting Officer, as well as the insured, Indian organizations and Indian-owned APPEALS OF USE OF EXCEPTIONS the policy number and a brief description of economic enterprises for subcontracting (JUL 1996) contract services to be performed. The opportunities which exist under this contractor shall furnish the Contracting contract; If the Contractor appeals the Contracting Officer with a copy of an acceptable (v) Reasons why preference was not given Officer determination to use one of the insurance certificate prior to beginning the to Indian firms as subcontractors or suppliers exceptions described in FAR 27.303(d)(1), work. for each requirement where it was such appeal shall be made by written notice determined by the Contractor that such specifically identifying the basis for the *These amounts to be set by the Contracting preference would not be consistent with the appeal within 30 working days from the Officer. efficient performance of the contract, and receipt of the determination. Such appeal (End of clause) (vi) The names and addresses of all Indian shall be mailed to the Associate Solicitor for organizations and Indian-owned economic General Law, U.S. Department of the Interior, 1452.228–71 Aircraft and General Public enterprises contacted, and receiving Washington, DC 20240, who is designated as Liability Insurance. subcontract awards under this contract. the appeals official. As prescribed in 1428.306–70(c)(1), (6) The Contractor shall submit to the (End of clause) insert the following clause: Contracting Officer for approval a semiannual report which summarizes the 1452.228–7 Insurance—Liability to Third AIRCRAFT AND GENERAL PUBLIC Contractor’s Indian preference program and Persons. LIABILITY INSURANCE indicates the number and types of available (a) As prescribed in 1428.311–2, the DEPARTMENT OF THE INTERIOR positions filled and dollar amounts of all (MAR 1989) subcontracts awarded to Indian organizations clause at FAR 52.228–7, Insurance— and Indian-owned economic enterprises and Liability to Third Persons, shall be (a) The Contractor, at the Contractor’s all other firms. modified before insertion into expense, agrees to maintain, during the (7) Records maintained pursuant to this solicitations and contracts by: continuance of this contract, aircraft liability clause will be kept available for review by (1) changing the title of the clause to and general public liability insurance with the Government until expiration of one (1) read: ‘‘INSURANCE—LIABILITY TO limits of liability for:

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(1) Bodily injury to or death of aircraft be made, however, for loss or damage to the amount of such compensation shall be passengers of not less than $75,000 for any aircraft resulting from: credited to the Government in determining one passenger and a limit for each occurrence (i) Normal wear and tear, the amount of the Government’s liability in any one aircraft of at least an amount equal (ii) Negligence or fault in maintenance of under this clause; except that this shall not to the sum produced by multiplying $75,000 the aircraft by the Contractor, or apply to proceeds of insurance received by 75 percent of the total number of (iii) A defect in construction of the aircraft solely as an advance of insurance pending passenger seats installed in the aircraft; or a component thereof. determination of Government liability, or for (2) Bodily injury to or death of persons (e) If damage to the aircraft is established an increment of value of the aircraft beyond (excluding passengers) of not less than to be the fault of the Government, rental the value for which the Government is $75,000 for any one person in any one payments to the Contractor during the repair responsible. occurrence and $300,000 for occurrence; and period will be made as set forth elsewhere in (e) In the event of loss or damage, the (3) Property damage of not less than this contract. The Government may, at its Government shall be subrogated to all rights $100,000 for each occurrence; or option, make necessary repairs or return the of recovery by the Contractor against third (4) a single limit of liability for each aircraft to the Contractor for repair. In the parties for such loss or damage and such occurrence equal to or greater than the event the aircraft is lost, destroyed, or rights shall be immediately assigned to the combined required minimums set forth in damaged so extensively as to be beyond Government. Except as the Contracting paragraphs (a)(1) through (3) of this clause. repair, no rental payment will be made to the Officer may permit in writing, the Contractor (b) The Contractor also agrees to maintain Contractor thereafter. shall neither release nor discharge any third worker’s compensation and other legally (f) Any failure to agree as to the party from liability for such loss or damage required insurance with respect to the responsibility of the Government or the nor otherwise compromise or adversely affect Contractor’s own employees and agents. Contractor under this clause shall, after a the Government’s subrogation or other rights (End of clause) final finding and determination by the hereunder. The Contractor shall cooperate Contracting Officer, be considered a dispute with the Government in any suit or action 1452.228–72 Liability for Loss or within the meaning of the ‘‘Disputes’’ clause undertaken by the Government against any Damage—Department of the Interior. of this contract. such third party. As prescribed in 1428.306–70(c)(2), (End of clause) (f) Any failure to agree as to the insert the following clause: responsibility of the Government or the 1452.228–73 Liability for Loss or Damage Contractor under this clause shall, after a LIABILITY FOR LOSS OR DAMAGE— (Property Interest). final finding and determination by the DEPARTMENT OF THE INTERIOR As prescribed in 1428.311–2(c), insert Contracting Officer, be considered a dispute (APR 1984) the following clause: within the meaning of the ‘‘Disputes’’ clause of this contract. (a) The Contractor shall indemnify and LIABILITY FOR LOSS OR DAMAGE (End of clause) hold the Government harmless from any and (PROPERTY INTEREST)— all loss or damage to the aircraft furnished DEPARTMENT OF THE INTERIOR 1452.233–2 Service of Protest. under this contract except as provided in paragraph (d) of this clause. For the purpose (APR 1984) As prescribed in 1433.106, the of fulfilling its obligation under this clause, (a) The Government assumes all risk and provision at FAR 52.233–2, Service of the Contractor shall procure and maintain liability for damage to or loss of the aircraft Protest, shall be modified before during the term of this contract, and any for the term of this contract, while the aircraft insertion into solicitations and contracts extensions thereof, full insurance acceptable is in the Government’s possession, except for; by changing the title of the provision to to the Contracting Officer. The Contractor’s (1) Normal wear and tear to the aircraft, or read: ‘‘SERVICE OF PROTEST insurance coverage shall apply to pilots (2) Loss which occurs as a result of DEPARTMENT OF THE INTERIOR (JUL furnished by the Government who operate negligence or fault in maintenance of the 1996) (DEVIATION)’’; and adding the the aircraft. The contractor may request a list aircraft by the Contractor, or of Government pilots by name and (3) Loss resulting from a latent defect in the following sentence to the end of the qualification who are potential pilots. construction of the aircraft or a component provision: (b) Prior to the commencement of work thereof. ‘‘(c) A copy of the protest served on hereunder, the Contractor shall furnish to the (b) In the event of damage to the aircraft, the Contracting Officer shall be Contracting Officer a copy of the insurance the Government may, at its option, make the simultaneously furnished by the policy or policies or a certificate of insurance necessary repairs with its own facilities, or protester to the Department of the issued by the underwriter(s) showing that the by contract, or pay the Contractor the Interior Assistant Solicitor, Acquisitions coverage required by this clause has been reasonable cost of repair of the aircraft. if and Intellectual Property, 1849 C Street, obtained. damage to the aircraft is established to be the (c) Each policy or certificate evidencing the fault of the Government, rental payments to NW., Room 6511, Washington, DC insurance shall contain an endorsement the Contractor during the repair period will 20240.’’ which provides that the insurance company be made as set forth elsewhere in this 1452.236–70 Prohibition Against Use of will notify the Contracting Officer 30 days contract. Lead-based Paint. prior to the effective date of any cancellation (c) In the event the aircraft is lost, or termination of any policy or certificate or destroyed, or damaged so extensively as to be As prescribed in 1436.570(b), insert any modification of a policy or certificate beyond repair, no rental payment will be the following clause: which adversely affects the interests of the made to the Contractor thereafter, but the Government in such insurance. The notice Government will pay to the Contractor a sum PROHIBITION AGAINST USE OF shall be sent by registered mail and shall equal to the fair market value of the aircraft LEAD-BASED PAINT—DEPARTMENT identify this contract, the name and address just prior to such loss, destruction, or OF THE INTERIOR (JUL 1996) of the contracting office, the policy, and the extensive damage, less the salvage value of Paint containing more than .06 percent by insured. the aircraft. weight of lead in paint, or the equivalent (d) If the aircraft is damaged or destroyed (d) The Contractor certifies that the measure of lead in the dried film of paint while in the custody and control of the contract price does not include any cost already applied, shall not be used in the Government, the Government will reimburse attributable to insurance or to any reserve construction or rehabilitation of residential the Contractor for the deductible stipulated fund it has established to protect its interests structures under this contract or any in the insurance coverage (if any) as follows: in or use of the aircraft, regardless of whether resulting subcontracts. (1) In-Motion Accidents—Up to 5 percent or not the insurance coverage applies for the of the current insured value of the aircraft period during which the Government has (End of clause) stated in the policy, or $10,000, whichever is possession of the aircraft. If, in the event of less. loss or damage to the aircraft, the Contractor 1452.236–71 Additive or Deductive Items. (2) Not In-Motion Accidents—Up to $250 receives compensation for such loss or As prescribed in 1436.571, insert the per accident. Such reimbursement shall not damage, in any form, from any source, the following provision:

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ADDITIVE OR DEDUCTIVE ITEMS— (OMB) pursuant to the Paperwork Reduction timber/vegetative sales contract before DEPARTMENT OF THE INTERIOR Act of 1980. The Contractor agrees to provide removal may be authorized. (JUL 1996) all information requested by the Contracting (d) If required by law, regulation or Bureau Officer which is necessary to obtain approval policy, the Government will prepare a So that the Government may obtain the from OMB. timber/vegetative sales notice and/or most desirable features of work within the (End of clause) prospectus, including volume estimates, limit of its funds available at time of bid appraised value and any appropriate special evaluation, award may be made to the bidder 1452.237–71 Utilization of Woody provisions. having the lowest total of the base bid and Biomass. (e) The contractor must treat any woody a combination of additive and deductive biomass not removed in accordance with the items. All bids shall be evaluated on the basis As prescribed in § 1437.7202, insert the following clause: specifications in the service contract. of the same additive and deductive bid items (f) The sales contract and service contract using the order of priority of the items listed UTILIZATION OF WOODY BIOMASS are severable; default or termination under in the schedule. (MAY 2005) either contract does not remove the (End of provision) contractor from payment or performance (a) The contractor may remove and utilize obligations under the other contract. 1452.237–70 Information Collection. woody biomass, if: (g) Definitions: As prescribed in 1437.7102, insert the (1) Project work is progressing as Timber/vegetative sales contract and/or scheduled; and following clause: notice means the agency-specific authorized (2) Removal is completed before contract contract instrument for the sale, barter, INFORMATION COLLECTION— expiration. exchange, billing or other compensation for DEPARTMENT OF THE INTERIOR (b) To execute this option, the contractor the payment, removal, and/or transportation (JUL 1996) must submit a written request to the of woody biomass material. Government. Woody biomass means the trees and woody If performance of this contract requires the (c) Following receipt of the written request, plants, including limbs, tops, needles, leaves, contractor to collect information on identical and if appropriate, the Government and the and other woody parts, grown in a forest, items from ten or more public respondents, contractor will negotiate and execute a woodland, or rangeland environment, that no action shall be taken or funds expended separate timber/vegetative sales contract. are the by-products of management, in the solicitation or collection of such Payment under the timber/vegetative sales restoration and/or hazardous fuel reduction information until the contractor has received contract must be at a price equal to or greater treatment. from the Contracting Officer written than the appraised value of the woody notification that approval has been obtained biomass. The contractor must make any [FR Doc. 2010–7967 Filed 4–14–10; 8:45 am] from the Office of Management and Budget appropriate payment specified in the related BILLING CODE P

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Part IV

The President Proclamation 8497—Honoring the Victims of the Montcoal, West Virginia, Mine Disaster Executive Order 13536—Blocking Property of Certain Persons Contributing to the Conflict in Somalia

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Federal Register Presidential Documents Vol. 75, No. 72

Thursday, April 15, 2010

Title 3— Proclamation 8497 of April 12, 2010

The President Honoring the Victims of the Montcoal, West Virginia, Mine Disaster

By the President of the United States of America

A Proclamation As a mark of respect for the memory of those who perished in the mine explosion in Montcoal, West Virginia, I hereby order, by the authority vested in me by the Constitution and the laws of the United States of America, that the flag of the United States shall be flown at half-staff at all public buildings and grounds and at all military facilities and naval stations of the Federal Government in the State of West Virginia until sunset on April 18, 2010. IN WITNESS WHEREOF, I have hereunto set my hand this twelfth day of April, in the year of our Lord two thousand ten, and of the Independence of the United States of America the two hundred and thirty-fourth.

[FR Doc. 2010–8864 Filed 4–14–10; 11:15 am] Billing code 3195–W0–P

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Executive Order 13536 of April 12, 2010

Blocking Property of Certain Persons Contributing to the Conflict in Somalia

By the authority vested in me as President by the Constitution and the laws of the United States of America, including the International Emergency Economic Powers Act (50 U.S.C. 1701 et seq.) (IEEPA), the National Emer- gencies Act (50 U.S.C. 1601 et seq.) (NEA), section 5 of the United Nations Participation Act, as amended (22 U.S.C. 287c) (UNPA), and section 301 of title 3, United States Code, I, BARACK OBAMA, President of the United States of America, find that the deterioration of the security situation and the persistence of violence in Somalia, and acts of piracy and armed robbery at sea off the coast of Somalia, which have repeatedly been the subject of United Nations Secu- rity Council resolutions (including Resolution 1844 of November 20, 2008; Resolution 1846 of December 2, 2008; Resolution 1851 of December 16, 2008; and Resolution 1897 of November 30, 2009), and violations of the arms embargo imposed by the United Nations Security Council in Resolution 733 of January 23, 1992, and elaborated upon and amended by subsequent resolutions (including Resolution 1356 of June 19, 2001; Resolution 1725 of December 6, 2006; Resolution 1744 of February 20, 2007; Resolution 1772 of August 20, 2007; Resolution 1816 of June 2, 2008; and Resolution 1872 of May 26, 2009), constitute an unusual and extraordinary threat to the national security and foreign policy of the United States, and I hereby declare a national emergency to deal with that threat. I hereby order: Section 1. (a) All property and interests in property that are in the United States, that hereafter come within the United States, or that are or hereafter come within the possession or control of any United States person, including any overseas branch, of the following persons are blocked and may not be transferred, paid, exported, withdrawn, or otherwise dealt in: (i) the persons listed in the Annex to this order; and (ii) any person determined by the Secretary of the Treasury, in consultation with the Secretary of State: (A) to have engaged in acts that directly or indirectly threaten the peace, security, or stability of Somalia, including but not limited to: (1) acts that threaten the Djibouti Agreement of August 18, 2008, or the political process; or (2) acts that threaten the Transitional Federal Institutions, the African Union Mission in Somalia (AMISOM), or other international peace- keeping operations related to Somalia; (B) to have obstructed the delivery of humanitarian assistance to Somalia, or access to, or distribution of, humanitarian assistance in Somalia; (C) to have directly or indirectly supplied, sold, or transferred to Somalia, or to have been the recipient in the territory of Somalia of, arms or any related materiel, or any technical advice, training, or assistance, includ- ing financing and financial assistance, related to military activities; (D) to have materially assisted, sponsored, or provided financial, material, logistical, or technical support for, or goods or services in support of, the activities described in subsections (a)(ii)(A), (a)(ii)(B), or (a)(ii)(C) of

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this section or any person whose property and interests in property are blocked pursuant to this order; or (E) to be owned or controlled by, or to have acted or purported to act for or on behalf of, directly or indirectly, any person whose property and interests in property are blocked pursuant to this order. (b) I hereby determine that, among other threats to the peace, security, or stability of Somalia, acts of piracy or armed robbery at sea off the coast of Somalia threaten the peace, security, or stability of Somalia. (c) I hereby determine that, to the extent section 203(b)(2) of IEEPA (50 U.S.C. 1702(b)(2)) may apply, the making of donations of the type of articles specified in such section by, to, or for the benefit of any person whose property and interests in property are blocked pursuant to subsection (a) of this section would seriously impair my ability to deal with the national emergency declared in this order, and I hereby prohibit such donations as provided by subsection (a) of this section. (d) The prohibitions in subsection (a) of this section include but are not limited to: (i) the making of any contribution or provision of funds, goods, or services by, to, or for the benefit of any person whose property and interests in property are blocked pursuant to this order; and (ii) the receipt of any contribution or provision of funds, goods, or services from any such person. (e) The prohibitions in subsection (a) of this section apply except to the extent provided by statutes, or in regulations, orders, directives, or licenses that may be issued pursuant to this order, and notwithstanding any contract entered into or any license or permit granted prior to the effective date of this order. Sec. 2. (a) Any transaction by a United States person or within the United States that evades or avoids, has the purpose of evading or avoiding, causes a violation of, or attempts to violate any of the prohibitions set forth in this order is prohibited. (b) Any conspiracy formed to violate any of the prohibitions set forth in this order is prohibited. Sec. 3. For the purposes of this order: (a) the term ‘‘person’’ means an individual or entity; (b) the term ‘‘entity’’ means a partnership, association, trust, joint venture, corporation, group, subgroup, or other organization; (c) the term ‘‘United States person’’ means any United States citizen, permanent resident alien, entity organized under the laws of the United States or any jurisdiction within the United States (including foreign branches), or any person in the United States; (d) the term ‘‘Transitional Federal Institutions’’ means the Transitional Federal Charter of the Somali Republic adopted in February 2004 and the Somali federal institutions established pursuant to such charter, and includes their agencies, instrumentalities, and controlled entities; and (e) the term ‘‘African Union Mission in Somalia’’ means the mission author- ized by the United Nations Security Council in Resolution 1744 of February 20, 2007, and reauthorized in subsequent resolutions, and includes its agen- cies, instrumentalities, and controlled entities. Sec. 4. For those persons whose property and interests in property are blocked pursuant to this order who might have a constitutional presence in the United States, I find that because of the ability to transfer funds or other assets instantaneously, prior notice to such persons of measures to be taken pursuant to this order would render those measures ineffectual. I therefore determine that for these measures to be effective in addressing the national emergency declared in this order, there need be no prior notice of a listing or determination made pursuant to section 1(a) of this order.

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Sec. 5. The Secretary of the Treasury, in consultation with the Secretary of State, is hereby authorized to take such actions, including the promulgation of rules and regulations, and to employ all powers granted to the President by IEEPA and the UNPA, as may be necessary to carry out the purposes of this order. The Secretary of the Treasury may redelegate any of these functions to other officers and agencies of the United States Government consistent with applicable law. All agencies of the United States Government are hereby directed to take all appropriate measures within their authority to carry out the provisions of this order. Sec. 6. The Secretary of the Treasury, in consultation with the Secretary of State, is hereby authorized to submit the recurring and final reports to the Congress on the national emergency declared in this order, consistent with section 401(c) of the NEA (50 U.S.C. 1641(c)) and section 204(c) of IEEPA (50 U.S.C. 1703(c)). Sec. 7. The Secretary of the Treasury, in consultation with the Secretary of State, is hereby authorized to determine that circumstances no longer warrant the blocking of the property and interests in property of a person listed in the Annex to this order, and to take necessary action to give effect to that determination. Sec. 8. This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person. Sec. 9. This order is effective at 12:01 a.m. eastern daylight time on April 13, 2010.

THE WHITE HOUSE, April 12, 2010.

Billing code 3195–W9–P

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[FR Doc. 2010–8878 Filed 4–14–10; 11:15 am] Billing code 4811–33–C

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Reader Aids Federal Register Vol. 75, No. 72 Thursday, April 15, 2010

CUSTOMER SERVICE AND INFORMATION CFR PARTS AFFECTED DURING APRIL

Federal Register/Code of Federal Regulations At the end of each month, the Office of the Federal Register General Information, indexes and other finding 202–741–6000 publishes separately a List of CFR Sections Affected (LSA), which aids lists parts and sections affected by documents published since Laws 741–6000 the revision date of each title. Presidential Documents 3 CFR 1245...... 18430 Executive orders and proclamations 741–6000 Proclamations: 9 CFR The United States Government Manual 741–6000 8485...... 18747 206...... 16641 Other Services 8487...... 17025 Electronic and on-line services (voice) 741–6020 8488...... 17837 10 CFR Privacy Act Compilation 741–6064 8489...... 17839 140...... 16645 Public Laws Update Service (numbers, dates, etc.) 741–6043 8490...... 17841 431...... 17036 TTY for the deaf-and-hard-of-hearing 741–6086 8491...... 17843 Proposed Rules: 8492...... 17845 51...... 16360 8493...... 17847 430 ...... 16958, 17075, 19296 ELECTRONIC RESEARCH 8494...... 18749 431 ...... 17078, 17079, 17080, World Wide Web 8495...... 19181 19297 Full text of the daily Federal Register, CFR and other publications 8496...... 19183 is located at: http://www.gpoaccess.gov/nara/index.html 8497...... 19876 12 CFR Executive Orders: 4...... 17849 Federal Register information and research tools, including Public 19536...... 19869 205...... 16580 Inspection List, indexes, and links to GPO Access are located at: 611...... 18726 http://www.archives.gov/federallregister Administrative Orders: Memorandums: 613...... 18726 E-mail Memorandum of April 615...... 18726 FEDREGTOC-L (Federal Register Table of Contents LISTSERV) is 6, 2010 ...... 18045 619...... 18726 an open e-mail service that provides subscribers with a digital Memorandum of April 620...... 18726 form of the Federal Register Table of Contents. The digital form 7, 2010 ...... 19533 918...... 17037 of the Federal Register Table of Contents includes HTML and Presidential 1261...... 17037 PDF links to the full text of each document. Determinations: Proposed Rules: No. 2010-05 of April 7, 701...... 17083 To join or leave, go to http://listserv.access.gpo.gov and select 2010 ...... 19537 708a...... 17083 Online mailing list archives, FEDREGTOC-L, Join or leave the list No. 2010-06 of April 7, 708b...... 17083 (or change settings); then follow the instructions. 2010 ...... 19535 1203...... 17622 PENS (Public Law Electronic Notification Service) is an e-mail 1705...... 17622 service that notifies subscribers of recently enacted laws. 5 CFR 14 CFR To subscribe, go to http://listserv.gsa.gov/archives/publaws-l.html Proposed Rules: and select Join or leave the list (or change settings); then follow 532...... 17316 25...... 18399 the instructions. 550...... 18133 27...... 17041 29...... 17041 FEDREGTOC-L and PENS are mailing lists only. We cannot 7 CFR 39 ...... 16646, 16648, 16651, respond to specific inquiries. 1...... 17555 16655, 16657, 16660, 16662, Reference questions. Send questions and comments about the 3...... 17555 16664, 17295, 19193, 19196, Federal Register system to: [email protected] 91...... 17281 19199, 19201, 19203, 19207, The Federal Register staff cannot interpret specific documents or 205...... 17555 19209 regulations. 226...... 16325 67...... 17047 274...... 18377 71 ...... 16329, 16330, 16331, Reminders. Effective January 1, 2009, the Reminders, including 319...... 17289 16333, 16335, 16336, 17851, Rules Going Into Effect and Comments Due Next Week, no longer 735...... 17555 17852, 18047, 18402, 18403, appear in the Reader Aids section of the Federal Register. This 760...... 19185 19212 information can be found online at http://www.regulations.gov. 800...... 17555 73...... 17561 CFR Checklist. Effective January 1, 2009, the CFR Checklist no 900...... 17555 91...... 17041 longer appears in the Federal Register. This information can be 916...... 17027 97...... 19539, 19541 found online at http://bookstore.gpo.gov/. 917...... 17027 121...... 17041 925...... 17031 125...... 17041 FEDERAL REGISTER PAGES AND DATE, APRIL 929...... 18394 135...... 17041 944...... 17031 234...... 17050 16325–16640...... 1 948...... 17034 Proposed Rules: 16641–17024...... 2 1170...... 17555 21...... 18134 17025–17280...... 5 1245...... 18396 23...... 16676 17281–17554...... 6 1400...... 19185 25...... 16676 17555–17846...... 7 1412...... 19185 27...... 16676 17847–18046...... 8 1421...... 19185 29...... 16676 18047–18376...... 9 1435...... 17555 39 ...... 16361, 16683, 16685, 18377–18746...... 12 Proposed Rules: 16689, 16696, 17084, 17086, 18747–19180...... 13 916...... 17072 17630, 17632, 17879, 17882, 19181–19532...... 14 917...... 17072 17884, 17887, 17889, 18446, 19533–19872...... 15 956...... 18428 18774, 19564

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71 ...... 17322, 17637, 17891, 44...... 16666 51...... 17644 73...... 17874 17892 46...... 16666 59...... 17641 74...... 17055 70...... 16666 78...... 17055 15 CFR 39 CFR 90...... 19277 740...... 17052 28 CFR 111...... 17861 95...... 19277 748...... 17052 20...... 18751 Proposed Rules: 750...... 17052 Proposed Rules: 40 CFR 27...... 17349 762...... 17052 540...... 17324 9...... 16670 36...... 17109 902...... 18262 50...... 17004 73 ...... 19338, 19339, 19340 922...... 17055 29 CFR 51...... 17004, 17254 90...... 19340 2203...... 18403 52 ...... 16671, 17307, 17863, 16 CFR 2204...... 18403 17865, 17868, 18061, 18068, 48 CFR Proposed Rules: 4022...... 19542 18757, 19468 Ch. I...... 19168, 19179 312...... 17089 60...... 19252 Proposed Rules: Ch. XIV ...... 19828 61...... 19252 2590...... 19297 2...... 19168 17 CFR 63...... 19252 7...... 19168 30 CFR 70...... 17004 190...... 17297 17...... 19168 71...... 17004 232...... 17853 18...... 17512 22...... 19168 93...... 17254 74...... 17512 52...... 19168 18 CFR 180 ...... 17564, 17566, 17571, 75...... 17512 204...... 18030 17573, 17579, 19261, 19268, 40...... 16914 936...... 18048 206...... 18035 19272 284...... 16337 225...... 18035 31 CFR 272...... 17309 234...... 18034 20 CFR 721...... 16670 103...... 19241 235...... 18030, 18034 618...... 16988 Proposed Rules: 252...... 18030, 18035 32 CFR 51...... 19567 21 CFR Proposed Rules: 199...... 18051 52 ...... 16387, 16388, 16706, 31...... 19345 Ch. I ...... 16353 2004...... 17305 17894, 18142, 18143, 18782, 223...... 18041 2...... 19213 Proposed Rules: 19567 252...... 18041 10...... 16345 108...... 18138 60...... 19310 655...... 19302 61...... 19310 118...... 18751 49 CFR 524...... 16346 1701...... 16698 63...... 19310 814...... 16347 98 ...... 17331, 18455, 18576, 22...... 19285 1002...... 16351 33 CFR 18608, 18652 23...... 16357 1003...... 16351 83...... 19544 228...... 19311 350...... 17208 1004...... 16351 117 ...... 17561, 18055, 19245 272...... 17332 385...... 17208 1005...... 16351 147...... 18404 372...... 17333, 19319 395...... 17208 1010...... 16351 165 ...... 18055, 18056, 18058, 721...... 16706 396...... 17208 1020...... 16351 18755, 19246, 19248, 19250 761...... 17645 571 ...... 17590, 17604, 17605 1030...... 16351 167...... 17562 Proposed Rules: 42 CFR 1040...... 16351 Proposed Rules: 172...... 17111 1050...... 16351 100 ...... 16700, 17099, 17103 417...... 19678 173...... 17111 Proposed Rules: 150...... 16370 422...... 19678 176...... 17111 165...... 16363 165 ...... 16370, 16374, 16703, 423...... 19678 383...... 16391 814...... 16365 17106, 17329, 18449, 18451, 480...... 19678 384...... 16391 882...... 17093 18776, 18778, 19304, 19307 390...... 16391 44 CFR 890...... 17093 391...... 16391 34 CFR 64...... 18408 392...... 16391 24 CFR Ch. II...... 16668, 18407 65 ...... 18070, 18072, 18073, 1244...... 16712 570...... 17303 18076, 18079, 18082, 18084, 36 CFR 18086, 18088, 18090 50 CFR 26 CFR 1200...... 19555 67...... 18091 17 ...... 17062, 17466, 18107, 1...... 17854 1253...... 19555 Proposed Rules: 18782 301...... 17854 1280...... 19555 67...... 19320, 19328 32...... 18413 602...... 17854 Proposed Rules: 36...... 16636 45 CFR Proposed Rules: 1191...... 18781 92...... 18764 54...... 19297 1193...... 18781 89...... 18760 300...... 18110 1194...... 18781 286...... 17313 622...... 18427 27 CFR 1206...... 17638 Proposed Rules: 648 ...... 17618, 18113, 18262, 146...... 19297, 19335 18356 17...... 16666 37 CFR 19...... 16666 148...... 19297, 19335 665...... 17070 20...... 16666 41...... 19558 679 ...... 16359, 17315, 19561, 22...... 16666 Proposed Rules: 46 CFR 19562 24...... 16666 380...... 16377 393...... 18095 Proposed Rules: 25...... 16666 17 ...... 16404, 17352, 17363, 38 CFR 26...... 16666 47 CFR 17667, 18960, 19575, 19591, 27...... 16666 1...... 17857 2...... 19277 19592 28...... 16666 59...... 17859 11...... 19559 223...... 16713 31...... 16666 Proposed Rules: 36...... 17872 224...... 16713 40...... 16666 17...... 17641 54...... 17584, 17872 648...... 16716

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in ‘‘slip law’’ (individual H.R. 4957/P.L. 111–153 enacted public laws. To pamphlet) form from the Federal Aviation Administration subscribe, go to http:// LIST OF PUBLIC LAWS Superintendent of Documents, Extension Act of 2010 (Mar. listserv.gsa.gov/archives/ U.S. Government Printing 31, 2010; 124 Stat. 1084) This is a continuing list of publaws-l.html Office, Washington, DC 20402 public bills from the current S. 1147/P.L. 111–154 (phone, 202–512–1808). The session of Congress which Prevent All Cigarette Note: This service is strictly text will also be made Trafficking Act of 2009 (Mar. have become Federal laws. It for E-mail notification of new available on the Internet from 31, 2010; 124 Stat. 1087) may be used in conjunction laws. The text of laws is not with ‘‘P L U S’’ (Public Laws GPO Access at http:// Last List March 31, 2010 available through this service. Update Service) on 202–741– www.gpoaccess.gov/plaws/ 6043. This list is also index.html. Some laws may PENS cannot respond to available online at http:// not yet be available. Public Laws Electronic specific inquiries sent to this address. www.archives.gov/federal- H.R. 4872/P.L. 111–152 Notification Service register/laws.html. Health Care and Education (PENS) The text of laws is not Reconciliation Act of 2010 published in the Federal (Mar. 30, 2010; 124 Stat. PENS is a free electronic mail Register but may be ordered 1029) notification service of newly

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